(468 days)
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.
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 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.
This document is an FDA 510(k) summary for the Bendit21 Microcatheter, demonstrating its substantial equivalence to a predicate device. It is not an AI/ML device, therefore, the information requested about AI/ML specific criteria (such as training data, ground truth establishment methods for training data, expert adjudication, MRMC studies, and standalone performance) cannot be provided from this document.
However, based on the provided text, here's a breakdown of the acceptance criteria and the studies conducted for the Bendit21 Microcatheter:
The acceptance criteria for the Bendit21 Microcatheter are demonstrated through various in vitro bench tests and animal testing, confirming its safety, performance, and substantial equivalence to the predicate device. The general acceptance criterion for all tests is that the device must Pass, meaning its performance met pre-defined acceptance criteria, or it was comparable to the predicate device.
1. A table of acceptance criteria and the reported device performance:
Since specific quantitative acceptance limits for each metric are not explicitly stated in a table format with performance results, I will create a table summarizing the Test Name, the General Acceptance Criteria (inferred from "Results" column), and the Reported Device Performance.
| Test Name | General Acceptance Criteria (inferred) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspections | No visual evidence of foreign matter, surface defects, or sharp edges; All measurements meet pre-defined acceptance criteria. | Pass. No visual evidence of foreign matter, surface defects or sharp edges. All measurements met the pre-defined acceptance criteria. |
| Kink Resistance | Demonstrates kink resistance in accordance with test acceptance criteria. | Pass. The microcatheter demonstrated kink resistance in accordance with the test acceptance criteria. |
| Simulated Use (Pushability, Retractability, Torsional Strength) | Successfully navigated through tortuous model without damage; met pre-defined acceptance criteria for forces. | Pass. All samples were successfully navigated through the tortuous model without damage and met the pre-defined acceptance criteria for forces. |
| Peak Tensile Force Along the Catheter Shaft | Tensile force to break for all samples met pre-defined acceptance criteria. | Pass. Tensile force to break for all samples for all junctions met the pre-defined acceptance criteria. |
| Air Leakage | No evidence of air leakage. | Pass. No evidence of air leakage. |
| Liquid Leakage | No evidence of liquid leakage. | Pass. No evidence of liquid leakage. |
| Priming Volume | Priming volume met pre-defined acceptance criteria. | Pass. Priming volume for all samples met the pre-defined acceptance criteria. |
| Fatigue (Tip Deflection and Tip Rotation) | Exceeded pre-defined number of tip deflection and tip rotation cycles without damage. | Pass. All samples exceeded the pre-defined number of tip deflection and tip rotation cycles without damage in both test configurations. |
| Torque Strength (Torque to Failure) | Exceeded the minimum number of cycles set by the test acceptance criterion before failure. | Pass. All samples exceeded the minimum number of cycles set by the test acceptance criterion before failure. |
| Torque Transmission | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the pre-defined acceptance criteria. |
| Flow Rate | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the pre-defined acceptance criteria. |
| Pressure Injection Flow Rate | Withstood applied injection pressures under test conditions without damage. | Pass. All samples withstood the applied injection pressures under the conditions of the testing without damage. |
| Burst Pressure | Withstood applied static pressure under test conditions without damage. | Pass. All samples withstood the applied static pressure under the conditions of the testing without damage. |
| Interventional Device Compatibility | Able to deliver all therapeutic devices using acceptable delivery force and without visible damage. | Pass. All samples were able to deliver all therapeutic devices used in the testing using acceptable delivery force and without any visible damage to the microcatheter. |
| Tip Deflection Force | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the predefined acceptance criteria. |
| Tip Flexibility | Comparable to the predicate device. | Pass. Tip flexibility was comparable to the predicate device. |
| Particulate Characterization | Particulate generation was acceptable and comparable to the predicate device. | Pass. Particulate generation was acceptable and comparable to the predicate device. |
| Coating Integrity | Demonstrated acceptable coating integrity before and after simulated use. | Pass. All samples demonstrated acceptable coating integrity before and after simulated use. |
| Coating Length | Met pre-defined acceptance criteria. | Pass. The coating length for all samples met the pre-defined acceptance criteria. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for In Vitro Bench Testing: "Sample sizes for all tests were established to demonstrate 95%/90% confidence/reliability in the test results." The exact number for each test is not specified, but this statement indicates a statistically sound sample size was used for each.
- Sample Size for Animal Testing: Not explicitly stated as a number of animals, but refers to "a porcine vascular model" where "Interventionalists used both the Bendit21 and the predicate Headway 21 microcatheters on opposite sides of the same animal." This suggests a comparative study design within each animal.
- Data Provenance: The document implies the data was generated prospectively during the development and testing phase for FDA submission. The country of origin of the data is not explicitly stated, but the submitter (Bend It Technologies Ltd.) is located in Petach Tikva, Israel. The testing itself would likely have occurred in laboratories or facilities globally that comply with regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a medical device (microcatheter), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "ground truth" and "experts establishing ground truth" in the AI/ML sense (e.g., radiologist consensus for image labeling) does not directly apply.
For this device:
- Ground Truth for Bench Testing: Established by standardized test methods (e.g., ISO standards, internal test methods) and objective measurements.
- Ground Truth for Animal Testing: Established through direct observation during procedures ("Interventionalists used..."), angiography for vessel patency, and post-mortem gross pathology and histologic evaluation of targeted vessels and downstream organs.
- Experts: "Interventionalists" are mentioned as performing the animal studies. Their specific qualifications (e.g., "vascular surgeon with X years of experience") are not detailed, but it's implied they are qualified professionals for such procedures. For pathology and histology, the "ground truth" would be established by veterinary pathologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable in the context of this traditional medical device study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human subject data, particularly in imaging studies where multiple readers interpret cases and disagreements need resolution (common in AI/ML performance evaluation). For a physical medical device, performance is measured against objective laboratory standards or physiological responses in animal models.
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:
Not applicable. This is a traditional medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and material properties, and it is intended for use by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed in point 3, the "ground truth" for this device's performance evaluation was primarily based on:
- Objective Measurement against Pre-defined Specifications: For in vitro bench tests (e.g., dimensions, forces, flow rates, cycle counts before failure).
- Pathology and Histology: For animal testing (assessment of vessel damage, inflammation, etc.).
- Physiological Observations/Outcomes: In animal testing (e.g., animal's overall clinical status, occurrence of vasospasm, vessel patency through angiography).
8. The sample size for the training set:
Not applicable. This is a traditional medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as point 8.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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) |
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 PRAStaff(@fda.hhs.gov
"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."
{3}------------------------------------------------
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 #: +972 3 6747377 Email: simonabn@bendittech.com
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.
{4}------------------------------------------------
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 DeviceBendit®21 Microcatheter | Predicate DeviceHeadway21 Microcatheter | Comparison | |
|---|---|---|---|
| 510(k) # | K203842 | K093160 | Not applicable |
| Regulation | QJP, DQY (21 CFR870.1250) | DQY (21 CFR 870.1250) | Same, newProduct Codecreated forneurovascular usesince predicate510(k) clearance |
| Indications foruse | The Bendit21 Microcatheter isintended for use in accessingtarget locations in theperipheral, coronary, andneuro vasculature and can beused to deliver both diagnosticagents, such as contrastmedia, and therapeutic | The Headway 21Microcatheter is intended forgeneral intravascular use,including the peripheral,coronary and neurovasculature for the infusion ofdiagnostic agents, such ascontrast media, and | Similar |
| Proposed DeviceBendit®21 Microcatheter | Predicate DeviceHeadway 21 Microcatheter | Comparison | |
| devices.Use only contrast media andtherapeutic devices that havebeen cleared or approved foruse in the intended targetarea. | therapeutic agents, such asocclusion coils. | ||
| Description | A single lumen catheterdesigned to be introducedeither with or without asteerable guidewire to accesssmall, torturous vasculature.The bendable proximalsection transitions to aflexible, steerable distal tip tofacilitate advancementthrough vessels. Dualradiopaque markers at thedistal end facilitatefluoroscopic visualization.The outer surface of themicrocatheter is coated witha hydrophilic polymer toincrease lubricity. A luerfitting on the microcatheterhub is used for theattachment of accessories. | A single lumen catheterdesigned to be introducedover a steerable guidewire toaccess small, tortuousvasculature. The semi-rigidproximal section transitions toa flexible, shapeable distal tipto facilitate advancementthrough vessels. Dualradiopaque markers at thedistal end facilitatefluoroscopic visualization.The outer surface of themicrocatheter is coated witha hydrophilic polymer toincrease lubricity. A luerfitting on the microcatheterhub is used for theattachment of accessories. | Testingdemonstrated thatthe differences donot raise newquestions of safetyand effectiveness. |
| Microcathetercomponents | • Flexible catheter shaft withPTFE inner liner andhydrophilic coating• Steerable deflecting distaltip• Steering handle• Luer at proximal end forattaching accessories (i.e.,syringes for injectingliquids) | • Flexible catheter shaft withPTFE inner liner andhydrophilic coating• Shapeable distal tip• Luer at proximal end forattaching accessories (i.e.,syringes for injectingliquids) | Performancetesting of thesteerable tip andsteering handle ofthe subject devicedemonstrated thatthe differences donot raise newquestions of safetyand effectiveness. |
| Catheter OD | 3.1 Fr (1.03 mm, 0.041") | Proximal: 2.5 Fr (0.83 mm,0.033")Distal: 2.0 Fr (0.67 mm,0.026") | Testingdemonstrated thatthe difference doesnot raise newquestions of safetyand effectiveness. |
| Proposed DeviceBendit®21 Microcatheter | Predicate DeviceHeadway21 Microcatheter | Comparison | |
| Catheter ID | 0.53 mm, 0.021" | 0.53 mm, 0.021" | Same |
| Catheter shaftlength | 157 cm | 156 cm | Similar |
| Length ofhydrophiliccoating | Distal 75 cm | Distal 110 cm | Testingdemonstrated thatthe differencedoes not raise newquestions of safetyand 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 |
{5}------------------------------------------------
{6}------------------------------------------------
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
{7}------------------------------------------------
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 andDimensionalInspections* | Visual inspections for extraneous matter,surface defects, sharp edges.Measurements of device dimensions, suchas angles, lengths, diameters. | Pass. No visual evidence offoreign matter, surface defectsor sharp edges. Allmeasurements met the pre-defined acceptance criteria. |
| Kink Resistance | Microcatheter samples are wrapped around aseries of mandrels with decreasing diameters,until kink is evident. | Pass. The microcatheterdemonstrated kink resistancein accordance with the testacceptance criteria. |
| Simulated Use,including:• Pushability• Retractability• Torsional Strength(Rotatability) | Microcatheter samples are navigated todifferent anatomical locations within a tortuousmodel and evaluated for pushability,retractability and damage post testing.Measurements of forces at the proximal endthat are required to cause movement at thedistal end. | Pass. All samples weresuccessfully navigated throughthe tortuous model withoutdamage and met the pre-defined acceptance criteria forforces. |
| Peak Tensile ForceAlong the CatheterShaft (including TipPeak Tensile) | Measurement of the forces at eachmicrocatheter junction needed toseparate the microcatheter into two or morepieces. | Pass. Tensile force to break forall samples for all junctions metthe pre-defined acceptancecriteria. |
| Air Leakage* | Included generating a reduced pressure to themicrocatheter, and verifying the device is airleak proof. | Pass. No evidence of airleakage. |
| Liquid Leakage* | Applying liquid pressure to the microcatheter,and verifying the device is liquid leak proof. | Pass. No evidence of liquidleakage. |
| Priming Volume* | Measurement of the microcatheter primingvolume and verification that it does not exceedthe calculated volume. | Pass. Priming volume for allsamples met the pre-definedacceptance criteria. |
| Fatigue (TipDeflection and TipRotation) | Testing for tip deflection and tip rotation bothin a tortuous simulated pathway and astraight configuration. | Pass. All samples exceededthe pre-defined number of tipdeflection and tip rotation cycleswithout damage in both testconfigurations |
| Torque Strength(Torque to Failure) | Measurement of the number of rotation cyclesrequired to cause microcatheter breakage/kinkwhen the tip is restrained, both in a tortuoussimulated pathway and a straight configuration. | Pass. All samples exceededthe minimum number of cyclesset by the test acceptancecriterion before failure. |
| Torque Transmission | Measurement of the proximal-to-distalrotational ratio, between the microcatheterhandle and the distal tip. | Pass. All measurements metthe pre-defined acceptancecriteria. |
| Flow Rate* | Measurement of the microcatheter flow ratethrough a constant level tank based on amountof water collected during a pre-defined timeperiod. | Pass. All measurements metthe pre-defined acceptancecriteria. |
| Test Name | Test Method Summary | Results |
| Pressure InjectionFlow Rate | Evaluation of the ability of the microcatheter towithstand high dynamic pressures, before andafter passage of a representative worst-casetherapeutic device within the inner lumen. | Pass. All samples withstood theapplied injection pressuresunder the conditions of thetesting without damage. |
| Burst Pressure* | Measurement of the static pressure themicrocatheter can withstand before and afterpassage of a representative worst-casetherapeutic device within the inner lumen. | Pass. All samples withstood theapplied static pressure underthe conditions of the testingwithout damage. |
| Interventional DeviceCompatibility | Assessment of the compatibility of themicrocatheter to deliver representativetherapeutic devices within the inner lumen, inan anatomical tortuous model, in terms ofdelivery forces and visible damage. | Pass. All samples were able todeliver all therapeutic devicesused in the testing usingacceptable delivery force andwithout any visible damage tothe microcatheter. |
| Tip Deflection Force | Measurement of the tip deflection force in ananatomical model. | Pass. All measurements metthe predefined acceptancecriteria. |
| Tip Flexibility* | Characterization of the forces that inducebuckling deformation at different distancesfrom the distal tip. | Pass. Tip flexibility wascomparable to the predicatedevice. |
| ParticulateCharacterization | The light obscuration particle counting methodof USP <788> was used to measure the totalnumber of particulates generated duringsimulated use in a tortuous model before andafter passage of a representative worst-casetherapeutic device within the inner lumen. | Pass. Particulate generationwas acceptable andcomparable to the predicatedevice. |
| Coating Integrity | Visual inspection of microcatheter surface toidentify the location and size of any coatingvoids before and after simulated use. | Pass. All samplesdemonstrated acceptablecoating integrity before andafter simulated use. |
| Coating Length | Measurement of microcatheter coatinglength. | Pass. The coating length forall samples met the pre-defined acceptance criteria. |
{8}------------------------------------------------
*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
{9}------------------------------------------------
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 10993-5:2009Cytotoxicity Study Using the ISOElution Method | Cell viability was evaluated. Ifviability is reduced to <50%, thedevice has a cytotoxic potential. | Moderately cytotoxic; Inaddition, chemicalcharacterization andtoxicological risk assessmentwas conducted to supportacceptable cytotoxicity. |
| ISO 10993-10:2010ISO Guinea Pig MaximizationSensitization Test | Animals tested with the testextract should show noevidence of delayed dermalcontact sensitization. | Non-sensitizer |
| ISO 10993-10:2010ISO Intracutaneous Study in Rabbits | Animals tested with the testextract should exhibit similaredema and erythema scores asthe negative control. | Non-irritant |
{10}------------------------------------------------
| Test Standard and Study Name | Test Method Summary | Results |
|---|---|---|
| ISO 10993-11:2017ISO Acute Systemic Toxicity Study inMice | No animals injected with testarticle show a significantlygreater biological reaction thanthe animals treated with thecontrol article. | No acute systemic toxicity |
| ISO 10993-11: 2017USP <151>, Pyrogen TestUSP Rabbit Pyrogen Study | Animals tested with testextract should not exhibitincrease of body temperatureby more than 0.5°C. | Non-pyrogenic |
| ISO 10993-4:2017 ASTMF756:2017ASTM Hemolysis Study | Mean hemolytic index for thedirect contact and indirectcontact should be < 2%. | Non-hemolytic |
| ISO 10993-4:2017SC5b-9 ComplementActivation Assay | The SC5b-9 concentration ofthe test sample shall not bestatistically higher than boththe activated normal humanserum and negative controls. | Non-activator of the complementsystem |
| ISO 10993-4:2017ThrombogenicityGLP Non-AnticoagulatedVenous Implant (NAVI)Study of Thrombosis inCanine Model | No significant thrombi/emboliformation in the test article andresults are comparablebetween the test and controldevices. | 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).
{11}------------------------------------------------
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.
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).