April 13, 2022

Bend It Technologies Ltd.

℅ Sheila Hemeon-Heyer
President
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst, Massachusetts 01002

Re: K203842
Trade/Device Name: Bendit21 Microcatheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP, DQY
Dated: March 16, 2022
Received: March 17, 2022

Dear Sheila Hemeon-Heyer:

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.

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.32
Silver Spring, MD 20993
www.fda.gov
K203842 - Sheila Hemeon-Heyer Page 2

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,

Naira Muradyan -S
Naira Muradyan, Ph.D.
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional
and Neurodiagnostic Devices
OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K203842

Device Name

Bendit®21 Microcatheter

Indications for Use (Describe)

The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro
vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices.

Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

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

IZI Prescription Use (Part 21 CFR 801 Subpart D) 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 0MB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
K203842 510(k) Summary

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted per the
requirements of 21 CFR 807.92.

A. Submitter: Bend It Technologies Ltd.

25 Basel Street
Petach Tikva 4951038, Israel
Contact: Simona Beilin-Nissan
Title: Vice President Clinical and Regulatory Affairs
Tel #: +972 3 6747377
Email: [email protected]

B. Date Prepared: April 13, 2022

C. Device Name and Classification Information:

Trade Name: Bendit®21 Microcatheter

Common/Usual Name: Steerable microcatheter
Classification Name: Catheter, percutaneous, neurovasculature
Regulation: 21 CFR 870.1250
Product Code: QJP
Secondary Product Code: DQY
Review Panel: Neurology
Class: II

D. Predicate Device: Headway 21 Microcatheter, K093160

Reference Device: Bendit®2.7 Steerable Microcatheter, K200582

E. Device Description:

The Bendit21 Microcatheter is a steerable microcatheter with a steerable distal tip. The
tip’s deflection is controlled using the Steering Slider on the proximal Steering Handle. The
tip can be rotated bi-directionally while deflected by turning the Torque Knob on the
Steering Handle.

The total working length of the Bendit21 Microcatheter is 157 cm. It is comprised of two
Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser -cut
patterns along the 36 cm distal section. The laser cuts give the Bendit21 Microcatheter
its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The
distal 12 mm section is steerable using the proximal Steering Handle. The device
includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm
from the tip. The distal portion of the catheter shaft (75 cm) is covered with a hydrophilic
coating.

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K203842 510(k) Summary

Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects.
When the Steering Slider is released, the tip shape is locked. The Bendit21 lumen can
accommodate compatible guidewires (≤ 0.018 ''). A standard Luer lock port for
attachment of accessories is located at the proximal end of the Steering Handle.

The Bendit21 Microcatheter is compatible with the following types of therapeutic

devices:

• Embolization particles with maximum particle size of 500 m

• Coils with maximum coil wire size of 0.018’’
• Stents/Stent Retrievers/Flow Diverters

F. Indications for Use Statement:

The Bendit21 Microcatheter is intended for use in accessing target locations in the
peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic
agents, such as contrast media, and therapeutic devices.

Use only contrast media and therapeutic devices that have been cleared or approved for
use in the intended target area.

G. Technical Comparison with Predicate Device

The table below provides a technological comparison between the proposed Bendit21
Microcatheter and the predicate device. The similarities and differences between the
proposed and predicate devices are discussed following the table.

Proposed Device Predicate Device

Comparison
Bendit ®21 Microcatheter Headway 21 Microcatheter
510(k) # K203842 K093160 Not applicable

Regulation QJP, DQY (21 CFR DQY (21 CFR 870.1250) Same, new
870.1250) Product Code
created for
neurovascular use
since predicate
510(k) clearance
Indications for The Bendit21 Microcatheter is The Headway 21 Similar
use intended for use in accessing Microcatheter is intended for
target locations in the general intravascular use,
peripheral, coronary, and including the peripheral,
neuro vasculature and can be coronary and neuro
used to deliver both diagnostic vasculature for the infusion of
agents, such as contrast diagnostic agents, such as
media, and therapeutic contrast media, and

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K203842 510(k) Summary

Proposed Device Predicate Device

Comparison
Bendit ®21 Microcatheter Headway 21 Microcatheter
devices. therapeutic agents, such as
Use only contrast media and occlusion coils.
therapeutic devices that have
been cleared or approved for
use in the intended target
area.
Description A single lumen catheter A single lumen catheter Testing
designed to be introduced designed to be introduced demonstrated that
either with or without a over a steerable guidewire to the differences do
steerable guidewire to access access small, tortuous not raise new
small, torturous vasculature. vasculature. The semi-rigid questions of safety
The bendable proximal proximal section transitions to and effectiveness.
section transitions to a a flexible, shapeable distal tip
flexible, steerable distal tip to to facilitate advancement
facilitate advancement through vessels. Dual
through vessels. Dual radiopaque markers at the
radiopaque markers at the distal end facilitate
distal end facilitate fluoroscopic visualization.
fluoroscopic visualization. The outer surface of the
The outer surface of the microcatheter is coated with
microcatheter is coated with a hydrophilic polymer to
a hydrophilic polymer to increase lubricity. A luer
increase lubricity. A luer fitting on the microcatheter
fitting on the microcatheter hub is used for the
hub is used for the attachment of accessories.
attachment of accessories.
Microcatheter • Flexible catheter shaft with • Flexible catheter shaft with Performance
components PTFE inner liner and PTFE inner liner and testing of the
hydrophilic coating hydrophilic coating steerable tip and
• Steerable deflecting distal • Shapeable distal tip steering handle of
the subject device
tip • Luer at proximal end for
demonstrated that
• Steering handle attaching accessories (i.e.,
the differences do
• Luer at proximal end for syringes for injecting
not raise new
attaching accessories (i.e., liquids)
questions of safety
syringes for injecting and effectiveness.
liquids)

Catheter OD 3.1 Fr (1.03 mm, 0.041”) Proximal: 2.5 Fr (0.83 mm, Testing
0.033”) demonstrated that
Distal: 2.0 Fr (0.67 mm, the difference does
0.026”) not raise new
questions of safety
and effectiveness.

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K203842 510(k) Summary

Proposed Device Predicate Device

Comparison
Bendit ®21 Microcatheter Headway 21 Microcatheter
Catheter ID 0.53 mm, 0.021'' 0.53 mm, 0.021” Same
Catheter shaft 157 cm 156 cm Similar
length
Length of Distal 75 cm Distal 110 cm Testing
hydrophilic demonstrated that
coating the difference
does not raise new
questions of safety
and effectiveness.
# Lumens Single Single Same
Radiopaque Yes, two radiopaque markers Yes, two radiopaque markers Same
How provided Sterile, single-use, disposable Sterile, single-use, disposable Same

H. Discussion of Similarities and Differences

Indications for Use Statement

Both the proposed and predicate devices are microcatheters that are intended for use in
the peripheral, coronary, and neuro vasculature and can be used to deliver both
diagnostic agents and therapeutic devices.
Technological Characteristics
The proposed and primary predicate devices are both flexible microcatheters with
radiopaque, atraumatic tips, and a hydrophilic coating along the catheter shaft. The main
difference between the proposed and predicate microcatheters is that the proposed
device has a steerable tip that can be deflected and rotated (in-situ) using the proximal
steering handle, whereas the predicate device has a shapeable tip and is not steerable.
However, the reference device, the Bendit2.7 Steerable Microcatheter, has the same
steering mechanism as the Bendit21 Microcatheter. The Bendit2.7 Steerable
Microcatheter is 510(k) cleared for use in the peripheral vasculature.

I. Testing to Support Substantial Equivalence

In Vitro Bench Testing

The results of in vitro bench testing and animal testing support the substantial
equivalence of the Bendit21 Steerable Microcatheter. Testing was conducted in
accordance with ISO 10555-1:2013 “Intravascular catheters - Sterile and single-use
catheters - Part 1: General requirements” (including Amendment 1:2017), where
applicable, and internal test methods. The table below provides a summary of the in vitro
bench testing. All tests were conducted on both as manufactured (t=0) and accelerated

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K203842 510(k) Summary

aged (t=18 months) devices except where noted (see asterisks). Sample sizes for all tests
were established to demonstrate 95%/90% confidence/reliability in the test results.

Test Name Test Method Summary Results

Visual and Visual inspections f or extraneous matter, Pass. No visual evidence of
Dimensional surf ace def ects, sharp edges. f oreign matter, surf ace def ects
Inspections* Measurements of device dimensions, such or sharp edges. All
as angles, lengths, diameters. measurements met the pre-
def ined acceptance criteria.
Kink Resistance Microcatheter samples are wrapped around a Pass. The microcatheter
series of mandrels with decreasing diameters, demonstrated kink resistance
until kink is evident. in accordance with the test
acceptance criteria.
Simulated Use, Microcatheter samples are navigated to Pass. All samples were
including: dif f erent anatomical locations within a tortuous successf ully navigated through
• Pushability model and evaluated f or pushability, the tortuous model without
retractability and damage post testing. damage and met the pre-
• Retractability Measurements of forces at the proximal end def ined acceptance criteria for
• Torsional Strength that are required to cause movement at the f orces.
(Rotatability) distal end.
Peak Tensile Force Measurement of the f orces at each Pass. Tensile f orce to break for
Along the Catheter microcatheter junction needed to all samples f or all junctions met
Shaf t (including Tip separate the microcatheter into two or more the pre-def ined acceptance
Peak Tensile) pieces. criteria.
Air Leakage* Included generating a reduced pressure to the Pass. No evidence of air
microcatheter, and verif ying the device is air leakage.
leak proof .
Liquid Leakage* Applying liquid pressure to the microcatheter, Pass. No evidence of liquid
and verif ying the device is liquid leak proof. leakage.
Priming Volume* Measurement of the microcatheter priming Pass. Priming volume for all
volume and verif ication that it does not exceed samples met the pre-defined
the calculated volume. acceptance criteria.
Fatigue (Tip Testing f or tip deflection and tip rotation both Pass. All samples exceeded
Def lection and Tip in a tortuous simulated pathway and a the pre-def ined number of tip
Rotation) straight conf iguration. def lection and tip rotation cycles
without damage in both test
conf igurations.
Torque Strength Measurement of the number of rotation cycles Pass. All samples exceeded
(Torque to Failure) required to cause microcatheter breakage/kink the minimum number of cycles
when the tip is restrained, both in a tortuous set by the test acceptance
simulated pathway and a straight configuration. criterion bef ore f ailure.
Torque Transmission Measurement of the proximal-to-distal Pass. All measurements met
rotational ratio, between the microcatheter the pre-def ined acceptance
handle and the distal tip. criteria.
Flow Rate* Measurement of the microcatheter f low rate Pass. All measurements met
through a constant level tank based on amount the pre-def ined acceptance
of water collected during a pre-def ined time criteria.
period.

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K203842 510(k) Summary

Test Name Test Method Summary Results

Pressure Injection Evaluation of the ability of the microcatheter to
Pass. All samples withstood the
Flow Rate withstand high dynamic pressures, before and applied injection pressures
af ter passage of a representative worst-case under the conditions of the
therapeutic device within the inner lumen. testing without damage.
Burst Pressure* Measurement of the static pressure the Pass. All samples withstood the
microcatheter can withstand bef ore and after applied static pressure under
passage of a representative worst-case the conditions of the testing
therapeutic device within the inner lumen. without damage.
Interventional Device Assessment of the compatibility of the Pass. All samples were able to
Compatibility microcatheter to deliver representative deliver all therapeutic devices
therapeutic devices within the inner lumen, in used in the testing using
an anatomical tortuous model, in terms of acceptable delivery f orce and
delivery f orces and visible damage. without any visible damage to
the microcatheter.
Tip Def lection Force Measurement of the tip def lection force in an Pass. All measurements met
anatomical model. the predef ined acceptance
criteria.
Tip Flexibility* Characterization of the f orces that induce Pass. Tip f lexibility was
buckling def ormation at different distances comparable to the predicate
f rom the distal tip. device.
Particulate The light obscuration particle counting method Pass. Particulate generation
Charac teri zatio n of USP <788> was used to measure the total was acceptable and
number of particulates generated during comparable to the predicate
simulated use in a tortuous model bef ore and device.
af ter passage of a representative worst-case
therapeutic device within the inner lumen.
Coating Integrity Visual inspection of microcatheter surface to Pass. All samples
identif y the location and size of any coating demonstrated acceptable
voids bef ore and af ter simulated use. coating integrity bef ore and
af ter simulated use.
Coating Length Measurement of microcatheter coating Pass. The coating length f or
length. all samples met the pre-
def ined acceptance criteria.

*Tests with an asterisk were only conducted on “as manufactured” (t=0) devices because
the attributes measured by these tests were either covered under other tests conducted to
confirm device integrity after aging (t=18 months, accelerated aging) or determined to not be
affected by aging.

Animal Testing

The safety and performance of the Bendit21 Microcatheter compared to the predicate
Headway 21 Microcatheter was evaluated in a porcine vascular model. Interventionalists
used both the Bendit21 and the predicate Headway 21 microcatheters on opposite sides
of the same animal to navigate to targets in renal, intracranial, and coronary arteries of
various sizes. Animals were terminated at approximately 2 or 28 days post-procedure. The
study evaluated multiple passes of each catheter through the same vessels. Additionally,
the deflection and rotation of the Bendit21 Microcatheter tip to reach the target was tested

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K203842 510(k) Summary

to simulate worst-case clinical use conditions. Device safety was assessed based on the
animal’s overall clinical status, occurrence of vasospasm, vessel patency through
angiography, gross pathology and histologic evaluation of targeted vessels and
downstream organs. Usability was assessed using pre-defined criteria, including visibility,
trackability, pushability, torqueability, retraction and ease of use. Test results demonstrate
the substantial equivalence of the Bendit21 Microcatheter to the predicate Headway 21
Microcatheter.

Sterilization Validation

Ethylene oxide (EO) sterilization was validated to a Sterility Assurance Level (SAL) of 10 -6
using the half-cycle, overkill method per ISO 11135:2014, 2 nd edition, “Sterilization of
health-care products - Ethylene oxide - Requirements for the development, validation and
routine control of a sterilization process for medical devices.”

Bacterial endotoxin testing conducted using the LAL Test per USP 40 -NF35:2017 <85>
“Bacterial Endotoxins Test” confirmed endotoxin levels below 2.15 endotoxin units
(EU)/device. EO and Ethylene Chlorohydrin residuals were evaluated according to ISO
10993-7:2008 “Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals” and were below the limits specified in the standard.

Biocompatibility

The Bendit21 Microcatheter is an externally communicating device with limited duration

(<24 hours) of contact with circulating blood. Per FDA guidance, “Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process”," September 2020, the following tests were
conducted:

Test Standard and Study Name Test Method Summary Results

ISO 10993-5:2009 Cell viability was evaluated. If Moderately cytotoxic; In
Cytotoxicity Study Using the ISO viability is reduced to <50%, the addition, chemical
Elution Method device has a cytotoxic potential. characterization and
toxicological risk assessment
was conducted to support
acceptable cytotoxicity.
ISO 10993-10:2010 Animals tested with the test Non-sensitizer
ISO Guinea Pig Maximization extract should show no
Sensitization Test evidence of delayed dermal
contact sensitization.
ISO 10993-10:2010 Animals tested with the test Non-irritant
ISO Intracutaneous Study in Rabbits extract should exhibit similar
edema and erythema scores as
the negative control.

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K203842 510(k) Summary

Test Standard and Study Name Test Method Summary Results

ISO 10993-11:2017 No animals injected with test No acute systemic toxicity
ISO Acute Systemic Toxicity Study in article show a signif icantly
Mice greater biological reaction than
the animals treated with the
control article.
ISO 10993-11: 2017 Animals tested with test Non-pyrogenic
USP <151>, Pyrogen Test extract should not exhibit
USP Rabbit Pyrogen Study increase of body temperature
by more than 0.5°C.
ISO 10993-4:2017 ASTM Mean hemolytic index f or the Non-hemolytic
F756:2017 direct contact and indirect
ASTM Hemolysis Study contact should be < 2%.
ISO 10993-4:2017 The SC5b-9 concentration of Non-activator of the complement
SC5b-9 Complement the test sample shall not be system
Activation Assay statistically higher than both
the activated normal human
serum and negative controls.
ISO 10993-4:2017 No signif icant thrombi/emboli Non-thrombogenic
Thrombogenicity f ormation in the test article and
results are comparable
GLP Non-Anticoagulated between the test and control
Venous Implant (NAVI) devices.
Study of Thrombosis in
Canine Model

Package and Shelf-Life Validation Testing

The following package validation and shelf -life testing was completed, and all test results
met the requirements of the associated standard or protocol:

• Transportation testing according to ASTM D4169-16, “Standard Practice for

Performance Testing of Shipping Containers and Systems” after simulated
environmental and shipping conditions.
• 18 month accelerated aging (AA) in accordance with ASTM F1980-16, “Standard
Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.”
• Package integrity testing included the dye penetration test per ASTM F1929-15
and seal peel test per ASTM F88M/F88-15, at both t=0 and after AA t=18 months.
• Device integrity testing following AA t=18 months to confirm proper device
operation following aging and simulated distribution conditioning (see the table of
bench tests for testing summaries).

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K203842 510(k) Summary

J. Conclusion

The Bendit21 Microcatheter has intended use similar to the predicate and technological
characteristics similar to the predicate and reference devices. The differences do not
raise new questions of safety and effectiveness. The performance data demonstrate that
the device functions as intended. The information and testing presented in this 510(k)
demonstrate that the Bendit21 Microcatheter is substantially equivalent to the Headway
21 Microcatheter for use in the peripheral, coronary, and neuro vasculature.

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