U.S. Food & Drug: Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
U.S. Food & Drug: Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
U.S. Food & Drug: Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
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
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
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.
Device Name
Bendit®21 Microcatheter
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.
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.
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.
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 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.
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.
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
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.
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
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.
*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
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 following package validation and shelf -life testing was completed, and all test results
met the requirements of the associated standard or protocol:
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.