The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic materials into the vasculature.

The Bendit2.7 is not intended to be used in intracranial or coronary vessels.

Device Description

The Bendit2.7™ 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 Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The distal 80 cm of the shaft 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 Bendit2.7™ 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.

AI/ML Overview

This document describes the Bendit2.7 Steerable Microcatheter and its substantial equivalence to a previously cleared device (K190126) following design changes.

The focus here is not on an AI/ML device, but rather a medical device with mechanical and material changes. Therefore, much of the requested information regarding AI/ML studies (such as MRMC studies, ground truth establishment for training, expert qualifications for ground truth in test sets, and separate training/test sets) is not applicable to this submission.

Here's the breakdown based on the provided text, addressing only the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All test results met the pre-defined test acceptance criteria." However, the specific acceptance criteria values are not explicitly detailed in the provided document, nor are the quantitative results for each test. Instead, the document lists the types of tests performed to verify the design changes:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Physical Performance:
Visual inspections and dimensional verifications	Met pre-defined test acceptance criteria
Tensile bond strength (tip and luer connections)	Met pre-defined test acceptance criteria
Torsional bond strength	Met pre-defined test acceptance criteria
Kink resistance	Met pre-defined test acceptance criteria
Pushability, Retraction, and Torqueability	Met pre-defined test acceptance criteria
Simulated use validation testing (including trackability)	Met pre-defined test acceptance criteria
Material/Functional Performance:
Power Injection (for Flowrate and Device Pressure)	Met pre-defined test acceptance criteria
Coating integrity	Met pre-defined test acceptance criteria
Corrosion	Met pre-defined test acceptance criteria
Chemical characterization according to ISO 10993-17-2020 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances and a toxicological risk assessment	Met pre-defined test acceptance criteria

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each of the listed tests. The data provenance is derived from in vitro bench testing performed by the manufacturer (Bend It Technologies, Ltd, Israel). It is not clinical data, nor does it involve human subjects or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the evaluation involved in vitro bench testing of a physical medical device, not an AI/ML system requiring expert-derived ground truth.

4. Adjudication method for the test set

This question is not applicable as the evaluation involved in vitro bench testing of a physical medical device, not an AI/ML system requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical microcatheter, not an AI/ML diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical microcatheter, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering specifications and recognized industry standards for medical devices (e.g., ISO 10993-17-2020 for biocompatibility, and internal specifications for physical properties like tensile strength, kink resistance, etc.). The tests verify that the device meets these pre-defined engineering and safety specifications.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

This question is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 25, 2020

Bend It Technologies Ltd. % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC P.O. Box 2151 Amherst, Massachusetts 01004-2151

Re: K200582

Trade/Device Name: Bendit2.7 Steerable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 6, 2020 Received: May 6, 2020

Dear Ms. 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

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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 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-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200582

Device Name

Bendit2.7TM Steerable Microcatheter

Indications for Use (Describe)

The Bendit2.7 is not intended to be used in intracranial or coronary vessels.

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)

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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:	Heyer Regulatory Solutions LLCP.O. Box 2151Amherst, MA 01004-2151Contact: Sheila Hemeon-HeyerSheila@heyer-regulatory.com
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B. Manufacturer/ Bend It Technologies, Ltd 510(k) Applicant: 25 Basel Street Petach Tikva 4951038, Israel Contact: Simona Beilin-Nissan Title: VP Clinical and Regulatory Affairs Tel #: +972 3 6747377 Email: simonabn@bendittech.com

C. Date Prepared: June 17, 2020

D. Device Name and Classification Information:

Trade Name:	Bendit2.7™ Steerable Microcatheter
Common/Usual Name:	Diagnostic Intravascular Catheter
Regulation:	21 CFR 870.1200
Product Code:	KRA
Review Panel:	Cardiovascular
Class:	II

E. Predicate Device: Bendit2.7™ Steerable Microcatheter, K190126

F. Summary Device Description:

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G. Indications for Use Statement:

The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.

The Bendit2.7™ is not intended to be used in intracranial or coronary vessels.

H. Technical Comparison with Predicate Devices

The table below provides a technological comparison between the proposed Bendit2.7™ and the previously cleared Bendit2.7™ devices. The similarities and differences between the proposed and predicate devices are discussed following the table.

	Predicate DeviceBendit2.7 ™ cleared underK190126	Proposed DeviceModified Bendit2.7 ™	Comparison
Indications forUse	The Bendit2.7 ™SteerableMicrocatheter is intended forgeneral intravascular use, inthe peripheral vasculature. Themicrocatheter can be used forthe delivery of diagnostic,embolic, or therapeuticmaterials into the vasculature.The Bendit2.7 is not intended tobe used in intracranial orcoronary vessels.	The Bendit2.7™SteerableMicrocatheter is intended forgeneral intravascular use, inthe peripheral vasculature. Themicrocatheter can be used forthe delivery of diagnostic,embolic, or therapeuticmaterials into the vasculature.The Bendit2.7 is not intendedto be used in intracranial orcoronary vessels.	Same
Catheter type	Steerable microcatheter	Steerable microcatheter	Same
MicrocatheterComponents	Catheter shaft, steerabledeflecting tip, steering handle	Catheter shaft, steerabledeflecting tip, steering handle	Same
Mode ofoperation	Catheter insertion and tipplacement under imagingguidance.Tip deflection controlled usingmanual steering mechanismexternal to the body.Tip deflection achieved via twoNiTi hypo tubes connected atthe distal end of catheter with	Catheter insertion and tipplacement under imagingguidance.Tip deflection controlled usingmanual steering mechanismexternal to the body.Tip deflection achieved via twoNiTi hypo tubes connected atthe distal end of catheter with	Same
	Predicate DeviceBendit2.7 ™ cleared underK190126	Proposed DeviceModified Bendit2.7 ™	Comparison
	laser-cut patterns that providetip flexibility.Material injection via syringeconnection to luer at proximalend of catheter.	laser-cut patterns that providetip flexibility.Material injection via syringeconnection to luer at proximalend of catheter.
Catheter OD	2.7 Fr	2.7 Fr	Same
Catheter ID	0.021"	0.021"	Same
Catheter shaftlength	130 cm	130 cm	Same
Hydrophiliccoating on shaft	Yes, 130 cm	Yes, 80 cm	Change
PTFE coating oninner tube	No	Yes	Change
Inner connectiontube	Yes	No	Change
Compatibleguidewire	≤ 0.018"	≤ 0.018"	Same
# Lumens	Single	Single	Same
Fill volume	0.45 mL	0.45 mL	Same
Max injectionpressure	1000 psi	1000 psi	Same
Deflecting tip	Yes	Yes	Same
Max tipdeflection angle	180° from neutral position inone direction	180° from neutral position inone direction	Same
Max tip rotation	100° in both directions(clockwise and counterclockwise)	100° in both directions(clockwise and counterclockwise)	Same
Radiopaque	Yes, radiopaque (70%tungsten) tip	Yes, radiopaque (80%tungsten) tip	Change
Steeringmechanism	Slider used to deflect tipKnob used to rotate tip	Slider used to deflect tipKnob used to rotate tip	Same
Steering lockmechanism	Yes	Yes	Same
Maxmicrosphere size	700 μm	700 μm	Same
Max coil size	0.018" (0.46 mm)	0.018" (0.46 mm)	Same
	Predicate DeviceBendit2.7™ cleared underK190126	Proposed DeviceModified Bendit2.7 ™	Comparison
Biocompatibility	Complies with all requiredtesting per FDA guidance forapplication of ISO 10993-1	Complies with all requiredtesting per FDA guidance forapplication of ISO 10993-1	Same
Use restriction	Single-use, disposable	Single-use, disposable	Same
Sterilization	Ethylene oxide, SAL 10-6	Ethylene oxide, SAL 10-6	Same

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l. Discussion of Differences

Four design changes have been made to the Bendit2.7™ Steerable Microcatheter. The changes are to improve ease of use and do not change the device indications for use, introduce any new functionality, change or introduce any new risks, or change the fundamental scientific technology of the device.

1. The length of hydrophilic coating on the catheter shaft is reduced to cover the distal 80 cm instead of the entire 130 cm length. This change is to facilitate user handling of the catheter shaft portion that does not enter the body.
1. The amount of Tungsten in the catheter tip is increased from 70% to improve tip visibility on imaging.
1. A PTFE coating is added to the outer surface of the inner tube to decrease friction within the catheter during bending.
1. The inner connection tube was removed as it was determined not to be necessary for sufficient bond strength at the luer / inner tube connection.

Testing to Support Substantial Equivalence J.

The following tests were conducted to verify the design changes resulting in the modified device:

1. Visual inspections and dimensional verifications
1. Tensile bond strength at the tip and luer connections
1. Torsional bond strength
1. Kink resistance
1. Power Injection (for Flowrate and Device Pressure)
1. Coating integrity
1. Corrosion
1. Pushability, Retraction, and Torqueability
1. Simulated use validation testing, including trackability
1. Chemical characterization according to ISO 10993-17-2020 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances and a toxicological risk assessment

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All test results met the pre-defined test acceptance criteria.

No animal or clinical tests were required to validate the changes to the Bendit2.7™ Steerable Microcatheter.

K. Conclusion

The information and testing presented in this 510(k) demonstrate that the modified Bendit2.7™ Steerable Microcatheter is substantially equivalent to the original Bendit2.7 Steerable Microcatheter previously cleared under K190126.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).