Bendit21 Microcatheter

K203842 · Bend IT Technologies, Ltd. · QJP · Apr 13, 2022 · Cardiovascular

Device Facts

• Record ID: K203842
• Device Name: Bendit21 Microcatheter
• Applicant: Bend IT Technologies, Ltd.
• Product Code: QJP · Cardiovascular
• Decision Date: Apr 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Steerable microcatheter for accessing peripheral, coronary, and neuro vasculature. Input: manual manipulation by clinician. Operation: proximal steering handle controls distal tip deflection via internal Nitinol hypo tubes; torque knob enables bi-directional tip rotation. Output: access to target vessel for delivery of diagnostic agents or therapeutic devices (coils, stents, particles). Used in clinical settings (e.g., cath lab) by physicians. Benefits: enhanced maneuverability in tortuous anatomy via steerable tip compared to standard shapeable-tip catheters. Healthcare provider uses fluoroscopic visualization to navigate; device facilitates precise placement of therapeutic implants or contrast media.

Clinical Evidence

No human clinical data. Safety and performance supported by in vitro bench testing and porcine vascular model. Bench testing (ISO 10555-1) confirmed kink resistance, tensile strength, leak resistance, and compatibility with therapeutic devices. Animal study (porcine) evaluated navigation in renal, intracranial, and coronary arteries; assessed safety via angiography, histology, and clinical status. Results showed performance comparable to predicate.

Technological Characteristics

Nitinol hypo tube construction with laser-cut patterns for flexibility/torque. Hydrophilic coating on distal 75 cm. Two radiopaque markers. Dimensions: 157 cm length, 3.1 Fr OD, 0.021" ID. Steering mechanism: proximal handle with slider (deflection) and knob (rotation). Sterile, single-use, EO sterilized (ISO 11135). Biocompatibility per ISO 10993. Packaging/shelf-life per ASTM D4169, F1980, F1929, F88.

Indications for Use

Indicated for accessing peripheral, coronary, and neuro vasculature to deliver diagnostic agents (e.g., contrast media) and therapeutic devices (e.g., embolization particles, coils, stents, stent retrievers, flow diverters) in patients requiring such interventions.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Headway 21 Microcatheter (K093160)

Reference Devices

• Bendit®2.7 Steerable Microcatheter (K200582)

Submission Summary (Full Text)

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April 13, 2022

Image /page/0/Picture/1 description: The image contains 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 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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

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) | | | |
|-------------------------------------------------|---------------------------------------------|--|--|
| X 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: Bend It Technologies Ltd. 25 Basel Street Petach Tikva 4951038, Israel Contact: Simona Beilin-Nissan Vice President Clinical and Requlatory Affairs Title: Tel #: [phone] Email: [e-mail]
#### 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 |

#### Device Description: ய்

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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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 µm
- · Coils with maximum coil wire size of 0.018"
- · Stents/Stent Retrievers/Flow Diverters

#### F. Indications for UseStatement:

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<br>Bendit®21 Microcatheter | Predicate Device<br>Headway21 Microcatheter | Comparison |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K203842 | K093160 | Not applicable |
| Regulation | QJP, DQY (21 CFR<br>870.1250) | DQY (21 CFR 870.1250) | Same, new<br>Product Code<br>created for<br>neurovascular use<br>since predicate<br>510(k) clearance |
| Indications for<br>use | The Bendit21 Microcatheter is<br>intended for use in accessing<br>target locations in the<br>peripheral, coronary, and<br>neuro vasculature and can be<br>used to deliver both diagnostic<br>agents, such as contrast<br>media, and therapeutic | The Headway 21<br>Microcatheter is intended for<br>general intravascular use,<br>including the peripheral,<br>coronary and neuro<br>vasculature for the infusion of<br>diagnostic agents, such as<br>contrast media, and | Similar |
| | Proposed Device<br>Bendit®21 Microcatheter | Predicate Device<br>Headway 21 Microcatheter | Comparison |
| | devices.<br>Use only contrast media and<br>therapeutic devices that have<br>been cleared or approved for<br>use in the intended target<br>area. | therapeutic agents, such as<br>occlusion coils. | |
| Description | A single lumen catheter<br>designed to be introduced<br>either with or without a<br>steerable guidewire to access<br>small, torturous vasculature.<br>The bendable proximal<br>section transitions to a<br>flexible, steerable distal tip to<br>facilitate advancement<br>through vessels. Dual<br>radiopaque markers at the<br>distal end facilitate<br>fluoroscopic visualization.<br>The outer surface of the<br>microcatheter is coated with<br>a hydrophilic polymer to<br>increase lubricity. A luer<br>fitting on the microcatheter<br>hub is used for the<br>attachment of accessories. | A single lumen catheter<br>designed to be introduced<br>over a steerable guidewire to<br>access small, tortuous<br>vasculature. The semi-rigid<br>proximal section transitions to<br>a flexible, shapeable distal tip<br>to facilitate advancement<br>through vessels. Dual<br>radiopaque markers at the<br>distal end facilitate<br>fluoroscopic visualization.<br>The outer surface of the<br>microcatheter is coated with<br>a hydrophilic polymer to<br>increase lubricity. A luer<br>fitting on the microcatheter<br>hub is used for the<br>attachment of accessories. | Testing<br>demonstrated that<br>the differences do<br>not raise new<br>questions of safety<br>and effectiveness. |
| Microcatheter<br>components | • Flexible catheter shaft with<br>PTFE inner liner and<br>hydrophilic coating<br>• Steerable deflecting distal<br>tip<br>• Steering handle<br>• Luer at proximal end for<br>attaching accessories (i.e.,<br>syringes for injecting<br>liquids) | • Flexible catheter shaft with<br>PTFE inner liner and<br>hydrophilic coating<br>• Shapeable distal tip<br>• Luer at proximal end for<br>attaching accessories (i.e.,<br>syringes for injecting<br>liquids) | Performance<br>testing of the<br>steerable tip and<br>steering handle of<br>the subject device<br>demonstrated that<br>the differences do<br>not raise new<br>questions of safety<br>and effectiveness. |
| Catheter OD | 3.1 Fr (1.03 mm, 0.041") | Proximal: 2.5 Fr (0.83 mm,<br>0.033")<br>Distal: 2.0 Fr (0.67 mm,<br>0.026") | Testing<br>demonstrated that<br>the difference does<br>not raise new<br>questions of safety<br>and effectiveness. |
| | Proposed Device<br>Bendit®21 Microcatheter | Predicate Device<br>Headway21 Microcatheter | Comparison |
| Catheter ID | 0.53 mm, 0.021" | 0.53 mm, 0.021" | Same |
| Catheter shaft<br>length | 157 cm | 156 cm | Similar |
| Length of<br>hydrophilic<br>coating | Distal 75 cm | Distal 110 cm | Testing<br>demonstrated that<br>the difference<br>does not raise new<br>questions of safety<br>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 |

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#### 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.

#### l. 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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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<br>Dimensional<br>Inspections* | Visual inspections for extraneous matter,<br>surface defects, sharp edges.<br>Measurements of device dimensions, such<br>as angles, lengths, diameters. | Pass. No visual evidence of<br>foreign matter, surface defects<br>or sharp edges. All<br>measurements met the pre-<br>defined acceptance criteria. |
| Kink Resistance | Microcatheter samples are wrapped around a<br>series of mandrels with decreasing diameters,<br>until kink is evident. | Pass. The microcatheter<br>demonstrated kink resistance<br>in accordance with the test<br>acceptance criteria. |
| Simulated Use,<br>including:<br>• Pushability<br>• Retractability<br>• Torsional Strength<br>(Rotatability) | Microcatheter samples are navigated to<br>different anatomical locations within a tortuous<br>model and evaluated for pushability,<br>retractability and damage post testing.<br>Measurements of forces at the proximal end<br>that are required to cause movement at the<br>distal end. | Pass. All samples were<br>successfully navigated through<br>the tortuous model without<br>damage and met the pre-<br>defined acceptance criteria for<br>forces. |
| Peak Tensile Force<br>Along the Catheter<br>Shaft (including Tip<br>Peak Tensile) | Measurement of the forces at each<br>microcatheter junction needed to<br>separate the microcatheter into two or more<br>pieces. | Pass. Tensile force to break for<br>all samples for all junctions met<br>the pre-defined acceptance<br>criteria. |
| Air Leakage* | Included generating a reduced pressure to the<br>microcatheter, and verifying the device is air<br>leak proof. | Pass. No evidence of air<br>leakage. |
| Liquid Leakage* | Applying liquid pressure to the microcatheter,<br>and verifying the device is liquid leak proof. | Pass. No evidence of liquid<br>leakage. |
| Priming Volume* | Measurement of the microcatheter priming<br>volume and verification that it does not exceed<br>the calculated volume. | Pass. Priming volume for all<br>samples met the pre-defined<br>acceptance criteria. |
| Fatigue (Tip<br>Deflection and Tip<br>Rotation) | Testing for tip deflection and tip rotation both<br>in a tortuous simulated pathway and a<br>straight configuration. | Pass. All samples exceeded<br>the pre-defined number of tip<br>deflection and tip rotation cycles<br>without damage in both test<br>configurations |
| Torque Strength<br>(Torque to Failure) | Measurement of the number of rotation cycles<br>required to cause microcatheter breakage/kink<br>when the tip is restrained, both in a tortuous<br>simulated pathway and a straight configuration. | Pass. All samples exceeded<br>the minimum number of cycles<br>set by the test acceptance<br>criterion before failure. |
| Torque Transmission | Measurement of the proximal-to-distal<br>rotational ratio, between the microcatheter<br>handle and the distal tip. | Pass. All measurements met<br>the pre-defined acceptance<br>criteria. |
| Flow Rate* | Measurement of the microcatheter flow rate<br>through a constant level tank based on amount<br>of water collected during a pre-defined time<br>period. | Pass. All measurements met<br>the pre-defined acceptance<br>criteria. |
| Test Name | Test Method Summary | Results |
| Pressure Injection<br>Flow Rate | Evaluation of the ability of the microcatheter to<br>withstand high dynamic pressures, before and<br>after passage of a representative worst-case<br>therapeutic device within the inner lumen. | Pass. All samples withstood the<br>applied injection pressures<br>under the conditions of the<br>testing without damage. |
| Burst Pressure* | Measurement of the static pressure the<br>microcatheter can withstand before and after<br>passage of a representative worst-case<br>therapeutic device within the inner lumen. | Pass. All samples withstood the<br>applied static pressure under<br>the conditions of the testing<br>without damage. |
| Interventional Device<br>Compatibility | Assessment of the compatibility of the<br>microcatheter to deliver representative<br>therapeutic devices within the inner lumen, in<br>an anatomical tortuous model, in terms of<br>delivery forces and visible damage. | Pass. All samples were able to<br>deliver all therapeutic devices<br>used in the testing using<br>acceptable delivery force and<br>without any visible damage to<br>the microcatheter. |
| Tip Deflection Force | Measurement of the tip deflection force in an<br>anatomical model. | Pass. All measurements met<br>the predefined acceptance<br>criteria. |
| Tip Flexibility* | Characterization of the forces that induce<br>buckling deformation at different distances<br>from the distal tip. | Pass. Tip flexibility was<br>comparable to the predicate<br>device. |
| Particulate<br>Characterization | The light obscuration particle counting method<br>of USP <788> was used to measure the total<br>number of particulates generated during<br>simulated use in a tortuous model before and<br>after passage of a representative worst-case<br>therapeutic device within the inner lumen. | Pass. Particulate generation<br>was acceptable and<br>comparable to the predicate<br>device. |
| Coating Integrity | Visual inspection of microcatheter surface to<br>identify the location and size of any coating<br>voids before and after simulated use. | Pass. All samples<br>demonstrated acceptable<br>coating integrity before and<br>after simulated use. |
| Coating Length | Measurement of microcatheter coating<br>length. | Pass. The coating length for<br>all samples met the pre-<br>defined acceptance criteria. |

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*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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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 \$ using the half-cycle, overkill method per ISO 11135:2014, 2nd 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 quidance. "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<br>Cytotoxicity Study Using the ISO<br>Elution Method | Cell viability was evaluated. If<br>viability is reduced to <50%, the<br>device has a cytotoxic potential. | Moderately cytotoxic; In<br>addition, chemical<br>characterization and<br>toxicological risk assessment<br>was conducted to support<br>acceptable cytotoxicity. |
| ISO 10993-10:2010<br>ISO Guinea Pig Maximization<br>Sensitization Test | Animals tested with the test<br>extract should show no<br>evidence of delayed dermal<br>contact sensitization. | Non-sensitizer |
| ISO 10993-10:2010<br>ISO Intracutaneous Study in Rabbits | Animals tested with the test<br>extract should exhibit similar<br>edema and erythema scores as<br>the negative control. | Non-irritant |

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

## 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 F 1929-15 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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#### 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.