September 6, 2019

Jiangsu Micsafe Medical Technology Co., Ltd.

Tony Yang
General Manager
Xituan Industrial Park, Dafeng District
Yancheng, 224125 Cn

Re: K183665
Trade/Device Name: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile
Syringe with Needle, Hypodermic Needle for Single Use
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: MEG, FMF, FMI
Dated: July 30, 2019
Received: July 30, 2019

Dear Tony Yang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.06
Silver Spring, MD 20993
www.fda.gov
K183665 - Tony Yang Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rumi Young Rumi Young -S

c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Rumi Young -S,

-S 0.9.2342.19200300.100.1.1=2002467913
2019.09.06 10:11:59 -04'00'

For CAPT Alan M. Stevens

Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices,
and Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K183665

Device Name
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

Indications for Use (Describe)

Safety Needles
The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for
medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually
activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Sterile Syringe
The sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the
aspiration and injection of fluids for medical purpose.

Sterile Syringe with Safety Needle

The sterile syringe with safety needle is intended for use in the aspiration and injection of fluids for medical purpose.
After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the
needle immediately after use to minimize risk of accidental needle sticks.

Sterile Syringe with Needle

The sterile syringe with needle is intended for use the aspiration and injection of fluids for medical purpose.

Hypodermic Needles for Single Use

The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for
medical purpose.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
MICSAFE MEDICAL GROUP

510(k) Summary (K183665)

Submitter Information
Company: Jiangsu Micsafe Medical Technology Co., Ltd.
Address: Xituan Industrial Park, Dafeng District, Yancheng City,
Jiangsu Province, 224125, China
Phone: 086-13651929266 Contact: Tony Yang, General Manager
Date: Sept 3, 2018

Device Information

Trade/Device Name: Safety Needles

Sterile Syringe
Sterile Syringe with Safety Needle
Sterile Syringe with Needle
Hypodermic Needle for Single Use

Classification: Class II
Regulation Number: 880.5860
Regulation Name: Piston syringe
Product Code(s): MEG, FMF, FMI

Common Name(s):Syringe, Antistick

Syringe, Piston
Needle, Hypodermic, Single Lumen

Type of use: Prescription use only

Predicate Device: Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe
With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable
Needle (K170651)

Device Description
(1)Safety Needles
The Safety Needles are intended for manual and single use only. They consist of a needle cap,
needle tube and hub with protector. The proposed device is compatible for use with a luer slip or
luer lock syringe. The safety sheath will be manually activated to cover the needle immediately
after use to minimize risk of accidental needle sticks.

Page 1 of 13
MICSAFE MEDICAL GROUP

(2)Sterile Syringe
The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger,
and Piston. The syringes are available with luer slip and luer lock connector types and are
available in different sizes. They are intended to be connected to a safety/hypodermic needle.

(3)Sterile Syringe with Safety Needle

This product is intended for manual and single use only. The Sterile Syringe with Safety Needle
consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or
luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The
safety sheath will be manually activated to cover the needle immediately after use to minimize
risk of accidental needle sticks.

(4)Sterile Syringe with Needle

The Sterile Syringe with Needle is intended for manual and single use only. It consists of a
hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a
variety of syringe and needle sizes.

(5)Hypodermic Needles for Single Use

The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle
tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.

Configurations and Sizes

(1)Safety Needles
18G; 20G; 21G; 22G; 23G; 25G; 26G
(2)Sterile Syringe
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
(3)Sterile Syringe with Safety Needle
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Needle Size:18G; 20G; 21G; 22G; 23G; 25G; 26G
(4)Sterile Syringe with Needle
Luer Slip 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Luer Slip Eccentric 20ml, 30ml, 50ml
Luer Lock 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml
Needle Size:18G ; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G;
29G; 30G; 31G

Page 2 of 13
MICSAFE MEDICAL GROUP
(5)Hypodermic Needles for Single Use
18G; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G; 29G; 30G;
31G

Needle lengths

Indications for Use

(1)Safety Needles
The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and
injection of fluids for medical purpose. After withdrawal of the needle from the body, the
attached needle safety shield can be manually activated to cover the needle immediately after use
to minimize risk of accidental needlestick.

(2)Sterile Syringe
The sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a

Page 3 of 13
MICSAFE MEDICAL GROUP
hypodermic needle for the aspiration and injection of fluids for medical purpose.

(3)Sterile Syringe with Safety Needle

The sterile syringe with safety needle is intended for use in the aspiration and injection of fluids
for medical purpose. After withdrawal of the needle from the body, the attached needle safety
shield can be manually activated to cover the needle immediately after use to minimize risk of
accidental needle sticks.

(4)Sterile Syringe with Needle

The sterile syringe with needle is intended for use the aspiration and injection of fluids for
medical purpose.

(5)Hypodermic Needles for Single Use

The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration
and injection of fluids for medical purpose.

Comparison of Indications for Use and Technological Characteristics

(1)Safety Needles
Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Identification Safety needle for single use The sterile disposable safety needle-
K170651
Classification & Intended Use
Classification Product Code: FMI Class: 2 Product Code: MEG,FMF,FMI
Class: 2
The safety needles are intended to The sterile disposable safety needle is
be used with a luer slip or luer intended to be used with a luer slip or
lock syringe for aspiration and luer lock syringe for aspiration and
injection of fluids for medical injection of fluids for medical purpose.
purpose. After withdrawal of the After withdrawal of the needle from the
needle from the body, the body, the attached needle safety shield
Intended Use
attached needle safety shield can can be manually activated to cover the
be manually activated to cover needle immediately after use to
the needle immediately after use minimize risk of accidental needestick.
to minimize risk of accidental
needlestick.

Technological Characteristics
Configurations Needle cap (Polypropylene) Needle cap(Polypropylene)
and Materials Needle tube (SUS304) Needle tube (SUS304)

Page 4 of 13
MICSAFE MEDICAL GROUP
Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Hub with protector Needle hub with safety
(Polypropylene) sheath(Polypropylene)
18G, 20G, 21G, 22G, 23G, 25G, 16G, 18G, 19G, 20G, 21G, 22G, 23G,
and 26G 24G, 25G, 26G, 27G, 28G, 29G, and 30G
Size
Needle length: Needle length:
1/2"-2" 5/16"-1 1/2"
Sterile Yes (EO) Yes (EO)
Single Use Yes Yes
Safety &
Effectiveness
Conforms to the requirement of Conforms to the requirement of ISO
ISO 10993 series Standards 10993 series Standards
No Cytotoxicity No Cytotoxicity
No Irritation to Skin No Irritation to Skin
Biocompatibility No significant evidence of No significant evidence of sensitization
sensitization
No systemic toxicity No systemic toxicity
No Hemolysis No Hemolysis
Non pyrogenic Non pyrogenic
Performance Conforms with the requirements Conforms with the requirements of ISO
safety & of ISO 7864 and ISO 9626. 7864 and ISO 9626.
effectiveness Needle Safety Feature: Testing Needle Safety Feature: Specifications
conducted per ISO 23908:2011. not provided.
Force to activate safety mode:
NMT 10N
Force to disengage safety mode:
NLT 20N
Force to separate safety feature
from needle hub: NLT 50N

Discussion:
The indications for use statement for the subject device is identical to the predicate. Differences
in needle lengths and gauges were addressed through ISO 7864 and ISO 9626 testing.
Differences in needle safety specifications were addressed through simulated needle safety
activation and verification of the specifications. The differences identified do not raise different
questions of safety and effectiveness.

(2) Sterile Syringe

Page 5 of 13
MICSAFE MEDICAL GROUP
Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Identification Sterile Syringe The sterile disposable syringe-
K170651
Classification & Intended Use
Classification Product Code: FMF Product Code: MEG,FMF,FMI
Class: 2 Class: 2
Intended Use The sterile syringe is a sterile luer The sterile disposable syringe is a
lock or luer slip syringe which is sterile luer lock or luer slip syringe
intended to be used with a which is intended to be used with a
hypodermic needle for the hypodermic needle for the aspiration
aspiration and injection of fluids for and injection of fluids for medical
medical purpose. purpose.
Technological Characteristics
Barrel (Polypropylene) Barrel (Polypropylene)
Configurations
Plunger (Polypropylene) Plunger (Polypropylene)
and Materials
Stopper (Polyisoprene) Stopper (Polyisoprene)
1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,
50ml, and 60ml 30ml, 50ml, and 60ml
Size
Luer Lock/Luer Slip/Luer slip Luer Lock/Luer Slip
Eccentric
Sterile Yes (EO) Yes (EO)
Single Use Yes Yes
Safety &
Effectiveness
Conforms to the requirement of ISO Conforms to the requirement of ISO
10993 series Standards 10993 series Standards
No Cytotoxicity No Cytotoxicity
No Irritation to Skin No Irritation to Skin
Biocompatibility No significant evidence of No significant evidence of
sensitization sensitization
No systemic toxicity No systemic toxicity
No Hemolysis No Hemolysis
Non pyrogenic Non pyrogenic
Performance Conforms with the requirements of Conforms with the requirements of
safety & ISO 7886 and ISO 80369-7. ISO 7886 and ISO 594-1/-2.
effectiveness

Discussion:
The indications for use statement for the subject device is identical to the predicate. Differences

Page 6 of 13
MICSAFE MEDICAL GROUP
in connections (i.e., addition of eccentric luer slip models) were addressed through ISO 7886 and
ISO 80369 testing. The technological differences do not raise different questions of safety and
effectiveness.

(3) Sterile Syringe with Safety Needle

Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Identification Sterile syringe with safety needles The sterile disposable syringe with
safety needle- K170651
Classification & Intended Use
Product Code: MEG,FMF,FMI Product Code: MEG,FMF,FMI
Classification
Class: 2 Class: 2
The sterile syringe with safety The sterile disposable syringes with
needle is intended for use in the Safety Needle is intended for use in
aspiration and injection of fluids for the aspiration and injection of fluids
medical purpose. After withdrawal for medical purpose. After
of the needle from the body, the withdrawal of the needle from the
Intended Use
attached needle safety shield can be body, the attached needle safety
manually activated to cover the shield can be manually activated to
needle immediately after use to cover the needle immediately after
minimize risk of accidental needle use to minimize risk of accidental
sticks. needle sticks.
Technological Characteristics
Barrel (Polypropylene) Barrel (Polypropylene)
Plunger (Polypropylene) Plunger (Polypropylene)
Stopper (Polyisoprene) Stopper (Polyisoprene)
Configurations
Needle cap (Polypropylene) Needle cap (Polypropylene)
and Materials
Needle tube (SUS304) Needle tube (SUS304)
Hub with protector (Polypropylene) Needle hub with safety sheath
(Polypropylene)
1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,
50ml, and 60ml 30ml, 50ml, and 60ml
Luer Lock/Luer Slip/Luer slip Luer Lock/Luer Slip 16G, 18G, 19G,
Eccentric 20G, 21G, 22G, 23G, 24G, 25G, 26G,
Size
18G, 20G, 21G, 22G, 23G, 25G, and 27G, 28G, 29G, and 30G
26G Needle length:
Needle length: 5/16"-1 1/2"
1/2"-2"
Sterile Yes (EO) Yes (EO)
Single Use Yes Yes

Page 7 of 13
MICSAFE MEDICAL GROUP
Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Safety &
Effectiveness
Biocompatibility Conforms to the requirement of ISO Conforms to the requirement of ISO
10993 series Standards 10993 series Standards
No Cytotoxicity No Cytotoxicity
No Irritation to Skin No Irritation to Skin
No significant evidence of No significant evidence of
sensitization sensitization
No systemic toxicity No systemic toxicity
No Hemolysis No Hemolysis
Non pyrogenic Non pyrogenic
Conforms with the requirements of Conforms with the requirements of
ISO 7864, ISO 9626, ISO 7886, and ISO 7864, ISO 9626, ISO 7886, and
ISO 80369-7. ISO 594-1/-2.
Needle Safety Feature: Testing Needle Safety Feature: Specifications
Performance conducted per ISO 23908:2011. not provided.
safety & Force to activate safety mode: NMT
effectiveness 10N
Force to disengage safety mode:
NLT 20N
Force to separate safety feature from
needle hub: NLT 50N

Discussion:
The indications for use statement for the subject device is identical to the predicate. Differences
in needle gauges, needle lengths and addition of eccentric luer slip models were addressed
through ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7 testing. Differences in needle safety
specifications were addressed through simulated needle safety activation and verification of the
specifications. The differences identified do not raise different questions of safety and
effectiveness.

(4) Sterile Syringe with Needle

Comparison Items Subject Device (K183665) Predicate Device (K170651)
Sterile syringe with needles The sterile disposable syringe with
Identification
needle- K170651
Classification & Intended Use
Classification Product Code: MEG,FMF,FMI Product Code: MEG,FMF,FMI

Page 8 of 13
MICSAFE MEDICAL GROUP
Comparison Items Subject Device (K183665) Predicate Device (K170651)
Class: 2 Class: 2
The sterile syringe with needle is The sterile disposable syringe with
intended for use the aspiration and needle is intended for use in the
Intended Use
injection of fluids for medical aspiration and injection of fluids for
purpose. medical purpose.
Technological Characteristics
Barrel (Polypropylene) Barrel (Polypropylene)
Plunger (Polypropylene) Plunger (Polypropylene)
Configurations and Stopper (Polyisoprene) Stopper (Polyisoprene)
Materials Needle cap (Polypropylene) Needle cap (Polypropylene)
Needle tube (SUS304) Needle tube (SUS304)
Needle hub (Polypropylene) Needle hub (Polypropylene)
1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,
50ml, and 60ml 30ml, 50ml, and 60ml
Luer Lock/Luer Slip/Luer slip Luer Lock/Luer Slip 16G, 18G, 19G,
Eccentric 20G, 21G, 22G, 23G, 24G, 25G, 26G,
Size 18G, 19G, 20G, 21G, 22G, 23G, 27G, 28G, 29G, and 30G
24G, 25G, 26G, 27G, 28G, 29G, Needle length:
30G, and 31G 5/16"-1 1/2"
Needle length:
1/2"-2"
Sterile Yes (EO) Yes (EO)
Single Use Yes Yes
Safety &
Effectiveness
Conforms to the requirement of Conforms to the requirement of ISO
ISO 10993 series Standards 10993 series Standards
No Cytotoxicity No Cytotoxicity
No Irritation to Skin No Irritation to Skin
Biocompatibility No significant evidence of No significant evidence of
sensitization sensitization
No systemic toxicity No systemic toxicity
No Hemolysis No Hemolysis
Non pyrogenic Non pyrogenic
Conforms with the requirements of Conforms with the requirements of
Performance safety
ISO 7864, ISO 9626, ISO 7886, ISO 7864, ISO 9626, ISO 7886, and
& effectiveness
and ISO 80369-7. ISO 594-1/-2.

Discussion:

Page 9 of 13
MICSAFE MEDICAL GROUP
The indications for use statement for the subject device is identical to the predicate. Differences
in luer connection (i.e., addition of luer slip Eccentric), needle gauges and needle lengths were
addressed through ISO 7864, ISO 9626, ISO 7886, and ISO 80369 testing. The differences
identified do not raise different questions of safety and effectiveness.

(5) Hypodermic Needles for Single Use

Comparison Subject Device (K183665) Predicate Device (K170651)
Items
Identification Hypodermic needle for single use The sterile disposable needle-
K170651
Classification & Intended Use
Product Code: FMI Class: 2 Product Code: MEG,FMF,FMI,
Classification
Class: 2
The hypodermic needle is intended The sterile disposable needle is
to be used with a luer slip or luer intended to be used with a luer slip
Intended Use lock syringe for aspiration and or luer lock syringe for aspiration
injection of fluids for medical and injection of fluids for medical
purpose. purpose.
Technological Characteristics
Needle cap (Polypropylene) Needle cap (Polypropylene)
Configuration Needle tube (SUS304) Needle tube (SUS304)
Needle hub (Polypropylene) Needle hub (Polypropylene)
18G, 19G, 20G, 21G, 22G, 23G, 24G, 16G, 18G, 19G, 20G, 21G, 22G, 23G,
25G, 26G, 27G, 28G, 29G, 30G, and 24G, 25G, 26G, 27G, 28G, 29G, and
Size
31G Needle length: 30G Needle length:
1/2"-2" 5/16"-1 1/2"
Sterile Yes (EO) Yes (EO)
Single Use Yes Yes
Safety &
Effectiveness
Conforms to the requirement of Conforms to the requirement of ISO
ISO 10993 series Standards 10993 series Standards
No Cytotoxicity No Cytotoxicity
No Irritation to Skin No Irritation to Skin
Biocompatibility No significant evidence of No significant evidence of
sensitization sensitization
No systemic toxicity No systemic toxicity
No Hemolysis No Hemolysis
Non pyrogenic Non pyrogenic
Performance safety Conforms with the requirements of Conforms with the requirements of

Page 10 of 13
MICSAFE MEDICAL GROUP
Comparison Subject Device (K183665) Predicate Device (K170651)
Items
& effectiveness ISO 7864 and ISO 9626. ISO 7864 and ISO 9626.

Discussion:
The indications for use statement for the subject device is identical to the predicate. Differences
in needle gauges and lengths were addressed through ISO 7864 and ISO 9626 testing. The
differences identified do not raise different questions of safety and effectiveness.

Performance Testing
The subject device was tested/analyzed according to the following standards in order to ensure
its effectiveness and safety:
1) Biocompatibility:
Needle: Externally communicating, blood path indirect with limited patient contact
Syringe: Externally communicating, blood path indirect with prolonged patient contact
Testing according to:
 ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part
5: Tests For In Vitro Cytotoxicity;
 ANSI AAMI ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part
10: Tests For Irritation And Skin Sensitization;
 ANSI AAMI ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices - Part
11: Tests For Systemic Toxicity;
 ISO 10993-4:Third Edition 2017-04, Biological Evaluation Of Medical Devices--Part 4:
Selection Of Tests For Interactions With Blood;
 ASTM F756-17, Standard Practice For Assessment Of Hemolytic Properties Of Materials.

2) Performance testing according to ISO 7864 Fourth Edition 2016-08-01, Sterile Hypodermic
Needles For Single Use - Requirements And Test Methods:
 Cleanliness
 Limits for acidity or alkalinity
 Limits for extractable metals
 Color coding
 Conical fitting
 Color of hub
 Needle cap
 Tolerances on length
 Freedom from defects
 Lubricant
 Needle point
 Bond between hub and needle tube

Page 11 of 13
MICSAFE MEDICAL GROUP
 Patency of lumen
 Sharps injury protection

3) Performance testing according to ISO 7886-1 Second Edition 2017-05, Sterile Hypodermic
Syringes For Single Use - Part 1: Syringes For Manual Use:
 Limits for acidity or alkalinity
 Limits for extractable metals
 Lubricant
 Tolerance on graduated capacity
 Scale
 Numbering of scales
 Overall length of scale to nominal capacity line
 Position of scale
 Barrel flanges
 Minimum length between barrel flanges and plunger push-button
 Conical fitting
 Position of nozzle on end of barrel
 Nozzle lumen
 Dead space
 Freedom from air and liquid leakage past plunger stopper
 Force to operate the position
 Fit of plunger stopper/plunger in barrel

4) Performance testing according to ISO 80369-7 First Edition 2016-10-15, Small-Bore

Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For
Intravascular Or Hypodermic Applications:
 Leakage by pressure decay
 Positive pressure liquid leakage
 Sub-atmospheric pressure air leakage
 Stress cracking
 Resistance to separation from axial load
 Resistance to separation from unscrewing
 Resistance to overriding

5) Performance testing according to ISO 9626 Second Edition 2016-08-01, Stainless Steel
Needle Tubing For The Manufacture Of Medical Devices - Requirements And Test Methods:
 Dimensions
 Stiffness
 Resistance to breakage
 Resistance to corrosion

Page 12 of 13
MICSAFE MEDICAL GROUP

6) Additional Performance testing for the Safety Needles/ Sterile Syringe/Sterile Syringe with
Safety Needle/Sterile Syringe with Needle/Hypodermic Needle for Single Use:
 Conical fitting to ISO 80369-7
 Sharps Injury Protection Test Report to ISO 23908:2011
 Particulate Testing per USP <788>

Clinical Testing
Not applicable

Conclusion
The subject and predicate device have similar technological characteristics, are provided sterile,
and are intended for single use. Differences in configurations and sizes have been evaluated by
non-clinical bench testing per ISO 7864, ISO 9626, ISO 7886 and ISO 80369-7. Furthermore,
both devices were tested for biocompatibility per ISO 10993-1. Hence, we conclude that the
subject device was demonstrated to be substantially equivalent to the predicate device.

Page 13 of 13