June 9, 2022

Taewoong Medical Co., Ltd

℅ Matthew Krueger
Senior Consultant
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria, VA 22314

Re: K221071
Trade/Device Name: Niti-S Biliary Slim M Stent
Regulation Number: 21 CFR§ 876.5010
Regulation Name: Biliary Catheter and Accessories
Regulatory Class: II
Product Code: FGE
Dated: April 7, 2022
Received: April 12, 2022

Dear Matthew Krueger:

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 and the limitations described below. 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.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.33
Silver Spring, MD 20993
www.fda.gov
K221071 - Matthew Krueger Page 2

The OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices has determined that there
is a reasonable likelihood that this device will be used for an intended use not identified in the proposed
labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act,
the following limitation must appear in the Warnings section of the device's labeling:

1. The safety and effectiveness of this device for use in the vascular system has not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch
box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade
name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a
new 510(k) is required before these limitations are modified in any way or removed from the device's
labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a
classification for your device and permits your device to proceed to the market. This letter will allow you to
begin marketing your device as described in your Section 510(k) premarket notification if the limitation
statement described above is added to your labeling.

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.

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.
K221071 - Matthew Krueger Page 3

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,

Courtney H. Lias -S
Courtney H. Lias, Ph.D.
Office Director
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: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (ifknown)

K221071

Device Name
Niti-S Biliary Slim M Stent

Indications for Use (Describe)

The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.

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

X Prescription Use (Part 21 CFR 801 Subpart D) E 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 (6120) Page 1 of 1 PSC PublisAing Servics (301) 443-6740 EF
 K221071
Page 1 of 5
510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Niti-S
Biliary Slim M Stent is provided below.

1. SUBMITTER
Applicant: Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-
do, Korea, 10022
TEL: +82-31-996-0641
FAX: +82-31-996-0645

Contact: Matthew Krueger

Senior Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: (571) 777-9505
Email: [email protected]

Submission Correspondent: Matthew Krueger

Senior Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: (571) 777-9505
Email: [email protected]

Date Prepared: 05/26/2022

2. DEVICE
Device Trade Name: Niti-S Biliary Slim M Stent
Device Common Name: Biliary catheter and accessories
Classification Name 21 CFR 876.5010, Biliary Catheter & Accessories
Regulatory Class: Class II
Product Code: FGE

3. PREDICATE DEVICE
Primary Predicate Device: Taewoong Medical Niti-S Biliary Stent (K073667)
Secondary Predicate Device: M.I.Tech Co., Ltd., HANAROSTENT Benefit™ Biliary (NNN)
(K202973)

4. DEVICE DESCRIPTION
The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system.
 K221071
Page 2 of 5
510(k) Summary

The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7
radiopaque markers; 3 in each end and 1 in the center. It has a diameter of 6 or 8 mm and the
length ranges from 40 to 120mm.

5. INTENDED USE/INDICATIONS FOR USE

The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the
biliary tree.

6. SUBSTANTIAL EQUIVALENCE

Comparison of Indications
Subject Device Primary Predicate (K073667) Secondary Predicate (K202973)
Indicated for the palliation of Indicated for the palliation of Indicated for the palliation of
malignant strictures in the biliary malignant strictures in the biliary malignant strictures in the biliary
tree. tree. tree.

Technological Comparisons
The table below compares the key technological feature of the subject devices to the primary
predicate device (Niti-S Biliary Stent, K073667) and the secondary predicate (HANAROSTENT
Benefit™ Biliary (NNN), K202973).
Table 1: Technological Comparison
Characteristic Subject Device Primary Predicate Device Secondary Predicate Device
510(k) number TBD K073667 K202973

Trade/Device Name Niti-S Biliary Slim M Niti-S Biliary Stent HANAROSTENT Benefit™
Stent Biliary (NNN)
Manufacturer Taewoong Medical Co., Taewoong Medical Co., Ltd. M.I. Tech Co., Ltd.
Ltd.
Regulation Number 21 CFR 876.5010 21 CFR 876.5010 21 CFR 876.5010

Indication for use The Niti-S Biliary Slim M The Niti-S Biliary Stent is The HANAROSTENT®
statement Stent is indicated for the indicated for the palliation of Benefit™ Biliary (NNN) is
palliation of malignant malignant strictures in the indicated for the palliation of
strictures in the biliary biliary tree. malignant strictures in the
tree. biliary tree.
Expansion method The stent is loaded into the The stent is loaded into the The stent is loaded into the
distal part of the delivery distal part of the delivery distal part of the delivery
device, and expanded in device, and expanded in the device, and expanded in the
the body by pulling the body by pulling the outer body by pulling the outer
outer sheath of the sheath of the delivery device. sheath of the delivery device.
delivery device.
 K221071
510(k) Summary Page 3 of 5

Characteristic Subject Device Primary Predicate Device Secondary Predicate Device

Method of Endoscopic Endoscopic, Percutaneous Endoscopic, Percutaneous
introduction
Sterility EO Sterilization EO Sterilization EO Sterilization

Stent photo

Stent material Nitinol, Pt/Ir, STS316L Nitinol, Pt/Ir, STS316L Nitinol, Gold

Stent lengths 40 mm, 50 mm, 60 mm, 40 mm, 50 mm, 60 mm, 70 40 mm, 120 mm
70 mm, 80 mm, 90 mm, mm, 80 mm, 90 mm, 100 mm,
100 mm, 120 mm 120 mm
Stent diameters 6 mm, 8 mm 8 mm, 10 mm 6 mm, 8 mm

Stent geometry − Cross & hook shape − Hook shape − Cross & hook shape
− Straight ends − Straight ends − Straight ends
− 9 radiopaque markers − 10 radiopaque markers − 9 radiopaque markers
Delivery system photo

Delivery system Teflon, PE, ABS Teflon, PE, ABS Polymeric materials
material
Delivery system 180 cm (Endoscopic) 180 cm (Endoscopic), 180 cm (Endoscopic),
length 50 cm (Percutaneous) 60 cm (Percutaneous)
Delivery system 6 Fr 8 Fr 5.9 Fr
profile
Guidewire (in inches) 0.025 0.035 0.025

7. PERFORAMNCE DATA
Biocompatibility Testing
The material of the subject device in its final finished form, including the stent and delivery
system, is identical to the Taewoong Medical Co. Ltd. Niti-S Biliary Stent cleared in K073667
including the formulation, processing and sterilization, and no other chemicals have been added
(e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
 K221071
510(k) Summary Page 4 of 5

Electrical safety and electromagnetic compatibility (EMC)

Not applicable. It contains no electric components, generates no electrical emissions, and
uses no electrical energy of any type.

Software Verification and Validation Testing

Not applicable. It contains no software of any type.

Bench Testing
The following tests were performed on the stent:

• Pitting Corrosion Potential,

• Galvanic Corrosion,
• Dimensional Verification,
• Foreshortening,
• Stent Integrity,
• Radial Compression Force,
• Radial Outward Force,
• Radiopacity,
• Magnetic resonance environment.
The following tests were performed on the Stent Delivery System (SDS):
• Delivery,
• Deployment,
• Withdrawal,
• SDS Bond Strength,
• Crossing Profile.

The following test was performed on the packaged components:

• Shipping test

Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this
device.

Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this
device.
 K221071
510(k) Summary Page 5 of 5

8. CONCLUSION
Based on the detailed comparison between the primary predicate device, secondary predicate
device and the subject device, the performance testing and conformance with applicable
standards, the Niti-S Biliary Slim M Stent can be found substantially equivalent to the predicate
device.