(468 days)
No
The description focuses on the mechanical and material properties of the microcatheter and its manual steering mechanism. There is no mention of AI, ML, or any computational analysis of data for device operation or decision-making.
No
The device is a microcatheter intended for delivering diagnostic agents and therapeutic devices, not for providing therapy itself.
No
The "Intended Use / Indications for Use" section states that the device "can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices." While it delivers diagnostic agents, the device itself is a delivery tool, not a diagnostic device that performs a diagnosis.
No
The device description clearly details a physical microcatheter with a steerable tip, steering handle, and other hardware components. It is not solely software.
Based on the provided information, the Bendit®21 Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for accessing target locations within the body (peripheral, coronary, and neuro vasculature) and delivering diagnostic agents (like contrast media) and therapeutic devices. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Performance Studies: The performance studies involve in vitro bench testing (testing the physical properties of the device) and animal testing (using the device in a living organism). These are not studies typically associated with IVD devices, which analyze samples outside the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Bendit®21 Microcatheter is a medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: In Vitro Bench Testing
Sample Size: Sample sizes for all tests were established to demonstrate 95%/90% confidence/reliability in the test results. Specific sample sizes for individual tests are not provided.
Key Results:
- Visual and Dimensional Inspections: Pass. No visual evidence of foreign matter, surface defects or sharp edges. All measurements met the pre-defined acceptance criteria.
- Kink Resistance: Pass. The microcatheter demonstrated kink resistance in accordance with the test acceptance criteria.
- Simulated Use (Pushability, Retractability, Torsional Strength): 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 (including Tip Peak Tensile): Pass. Tensile force to break for all samples for all junctions met the pre-defined acceptance criteria.
- Air Leakage: Pass. No evidence of air leakage.
- Liquid Leakage: Pass. No evidence of liquid leakage.
- Priming Volume: Pass. Priming volume for all samples met the pre-defined acceptance criteria.
- Fatigue (Tip Deflection and Tip Rotation): 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): Pass. All samples exceeded the minimum number of cycles set by the test acceptance criterion before failure.
- Torque Transmission: Pass. All measurements met the pre-defined acceptance criteria.
- Flow Rate: Pass. All measurements met the pre-defined acceptance criteria.
- Pressure Injection Flow Rate: Pass. All samples withstood the applied injection pressures under the conditions of the testing without damage.
- Burst Pressure: Pass. All samples withstood the applied static pressure under the conditions of the testing without damage.
- Interventional Device Compatibility: 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: Pass. All measurements met the predefined acceptance criteria.
- Tip Flexibility: Pass. Tip flexibility was comparable to the predicate device.
- Particulate Characterization: Pass. Particulate generation was acceptable and comparable to the predicate device.
- Coating Integrity: Pass. All samples demonstrated acceptable coating integrity before and after simulated use.
- Coating Length: Pass. The coating length for all samples met the pre-defined acceptance criteria.
Study Type: Animal Testing
Sample Size: Not specified, but involved using both the Bendit21 and predicate Headway 21 microcatheters on opposite sides of the same animal.
Key Results: Test results demonstrate the substantial equivalence of the Bendit21 Microcatheter to the predicate Headway 21 Microcatheter. 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.
Study Type: Sterilization Validation
Key Results: 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. Bacterial endotoxin testing confirmed endotoxin levels below 2.15 endotoxin units (EU)/device. EO and Ethylene Chlorohydrin residuals were below the limits specified in ISO 10993-7:2008.
Study Type: Biocompatibility
Key Results:
- Cytotoxicity Study: Moderately cytotoxic; In addition, chemical characterization and toxicological risk assessment was conducted to support acceptable cytotoxicity.
- Guinea Pig Maximization Sensitization Test: Non-sensitizer
- Intracutaneous Study in Rabbits: Non-irritant
- Acute Systemic Toxicity Study in Mice: No acute systemic toxicity
- Pyrogen Test: Non-pyrogenic
- Hemolysis Study: Non-hemolytic
- SC5b-9 Complement Activation Assay: Non-activator of the complement system
- Thrombogenicity Study: Non-thrombogenic
Study Type: Package and Shelf-Life Validation Testing
Key Results: All test results met the requirements of the associated standard or protocol for transportation testing, 18 month accelerated aging, package integrity testing, and device integrity testing following aging and simulated distribution conditioning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
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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 #: +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 Device
Bendit®21 Microcatheter | Predicate Device
Headway21 Microcatheter | Comparison |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K203842 | K093160 | Not applicable |
| Regulation | QJP, DQY (21 CFR
870.1250) | DQY (21 CFR 870.1250) | Same, new
Product Code
created for
neurovascular use
since predicate
510(k) clearance |
| Indications for
use | 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 | The Headway 21
Microcatheter is intended for
general intravascular use,
including the peripheral,
coronary and neuro
vasculature for the infusion of
diagnostic agents, such as
contrast media, and | Similar |
| | Proposed Device
Bendit®21 Microcatheter | Predicate Device
Headway 21 Microcatheter | Comparison |
| | devices.
Use only contrast media and
therapeutic devices that have
been cleared or approved for
use in the intended target
area. | therapeutic agents, such as
occlusion coils. | |
| Description | A single lumen catheter
designed to be introduced
either with or without a
steerable guidewire to access
small, torturous vasculature.
The bendable proximal
section transitions to a
flexible, steerable distal tip to
facilitate advancement
through vessels. Dual
radiopaque markers at the
distal end facilitate
fluoroscopic visualization.
The outer surface of the
microcatheter is coated with
a hydrophilic polymer to
increase lubricity. A luer
fitting on the microcatheter
hub is used for the
attachment of accessories. | A single lumen catheter
designed to be introduced
over a steerable guidewire to
access small, tortuous
vasculature. The semi-rigid
proximal section transitions to
a flexible, shapeable distal tip
to facilitate advancement
through vessels. Dual
radiopaque markers at the
distal end facilitate
fluoroscopic visualization.
The outer surface of the
microcatheter is coated with
a hydrophilic polymer to
increase lubricity. A luer
fitting on the microcatheter
hub is used for the
attachment of accessories. | Testing
demonstrated that
the differences do
not raise new
questions of safety
and effectiveness. |
| Microcatheter
components | • Flexible catheter shaft with
PTFE inner liner and
hydrophilic coating
• Steerable deflecting distal
tip
• Steering handle
• Luer at proximal end for
attaching accessories (i.e.,
syringes for injecting
liquids) | • Flexible catheter shaft with
PTFE inner liner and
hydrophilic coating
• Shapeable distal tip
• Luer at proximal end for
attaching accessories (i.e.,
syringes for injecting
liquids) | Performance
testing of the
steerable tip and
steering handle of
the subject device
demonstrated that
the differences do
not raise new
questions of safety
and 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") | Testing
demonstrated that
the difference does
not raise new
questions of safety
and effectiveness. |
| | Proposed Device
Bendit®21 Microcatheter | Predicate Device
Headway21 Microcatheter | Comparison |
| Catheter ID | 0.53 mm, 0.021" | 0.53 mm, 0.021" | Same |
| Catheter shaft
length | 157 cm | 156 cm | Similar |
| Length of
hydrophilic
coating | Distal 75 cm | Distal 110 cm | Testing
demonstrated that
the difference
does not raise new
questions of safety
and effectiveness. |
| # Lumens | Single | Single | Same |
| Radiopaque | Yes, two radiopaque markers | Yes, two radiopaque markers | Same |
| How provided | Sterile, single-use, disposable | Sterile, single-use, disposable | Same |
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 and | ||
| Dimensional | ||
| Inspections* | Visual inspections for extraneous matter, | |
| surface defects, sharp edges. | ||
| Measurements of device dimensions, such | ||
| as angles, lengths, diameters. | Pass. No visual evidence of | |
| foreign matter, surface defects | ||
| or sharp edges. All | ||
| measurements met the pre- | ||
| defined acceptance criteria. | ||
| Kink Resistance | Microcatheter samples are wrapped around a | |
| series of mandrels with decreasing diameters, | ||
| until kink is evident. | Pass. The microcatheter | |
| demonstrated kink resistance | ||
| in accordance with the test | ||
| acceptance criteria. | ||
| Simulated Use, | ||
| including: | ||
| • Pushability | ||
| • Retractability | ||
| • Torsional Strength | ||
| (Rotatability) | Microcatheter samples are navigated to | |
| different anatomical locations within a tortuous | ||
| model and evaluated for pushability, | ||
| retractability and damage post testing. | ||
| Measurements of forces at the proximal end | ||
| that are required to cause movement at the | ||
| distal end. | 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 (including Tip | ||
| Peak Tensile) | Measurement of the forces at each | |
| microcatheter junction needed to | ||
| separate the microcatheter into two or more | ||
| pieces. | Pass. Tensile force to break for | |
| all samples for all junctions met | ||
| the pre-defined acceptance | ||
| criteria. | ||
| Air Leakage* | Included generating a reduced pressure to the | |
| microcatheter, and verifying the device is air | ||
| leak proof. | Pass. No evidence of air | |
| leakage. | ||
| Liquid Leakage* | Applying liquid pressure to the microcatheter, | |
| and verifying the device is liquid leak proof. | Pass. No evidence of liquid | |
| leakage. | ||
| Priming Volume* | Measurement of the microcatheter priming | |
| volume and verification that it does not exceed | ||
| the calculated volume. | Pass. Priming volume for all | |
| samples met the pre-defined | ||
| acceptance criteria. | ||
| Fatigue (Tip | ||
| Deflection and Tip | ||
| Rotation) | Testing for tip deflection and tip rotation both | |
| in a tortuous simulated pathway and a | ||
| straight configuration. | 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) | Measurement of the number of rotation cycles | |
| required to cause microcatheter breakage/kink | ||
| when the tip is restrained, both in a tortuous | ||
| simulated pathway and a straight configuration. | Pass. All samples exceeded | |
| the minimum number of cycles | ||
| set by the test acceptance | ||
| criterion before failure. | ||
| Torque Transmission | Measurement of the proximal-to-distal | |
| rotational ratio, between the microcatheter | ||
| handle and the distal tip. | Pass. All measurements met | |
| the pre-defined acceptance | ||
| criteria. | ||
| Flow Rate* | Measurement of the microcatheter flow rate | |
| through a constant level tank based on amount | ||
| of water collected during a pre-defined time | ||
| period. | Pass. All measurements met | |
| the pre-defined acceptance | ||
| criteria. | ||
| Test Name | Test Method Summary | Results |
| Pressure Injection | ||
| Flow Rate | Evaluation of the ability of the microcatheter to | |
| withstand high dynamic pressures, before and | ||
| after passage of a representative worst-case | ||
| therapeutic device within the inner lumen. | Pass. All samples withstood the | |
| applied injection pressures | ||
| under the conditions of the | ||
| testing without damage. | ||
| Burst Pressure* | Measurement of the static pressure the | |
| microcatheter can withstand before and after | ||
| passage of a representative worst-case | ||
| therapeutic device within the inner lumen. | Pass. All samples withstood the | |
| applied static pressure under | ||
| the conditions of the testing | ||
| without damage. | ||
| Interventional Device | ||
| Compatibility | Assessment of the compatibility of the | |
| microcatheter to deliver representative | ||
| therapeutic devices within the inner lumen, in | ||
| an anatomical tortuous model, in terms of | ||
| delivery forces and 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 | Measurement of the tip deflection force in an | |
| anatomical model. | Pass. All measurements met | |
| the predefined acceptance | ||
| criteria. | ||
| Tip Flexibility* | Characterization of the forces that induce | |
| buckling deformation at different distances | ||
| from the distal tip. | Pass. Tip flexibility was | |
| comparable to the predicate | ||
| device. | ||
| Particulate | ||
| Characterization | The light obscuration particle counting method | |
| of USP was used to measure the total | ||
| number of particulates generated during | ||
| simulated use in a tortuous model before and | ||
| after passage of a representative worst-case | ||
| therapeutic device within the inner lumen. | Pass. Particulate generation | |
| was acceptable and | ||
| comparable to the predicate | ||
| device. | ||
| Coating Integrity | Visual inspection of microcatheter surface to | |
| identify the location and size of any coating | ||
| voids before and after simulated use. | Pass. All samples | |
| demonstrated acceptable | ||
| coating integrity before and | ||
| after simulated use. | ||
| Coating Length | Measurement of microcatheter coating | |
| length. | Pass. The coating length for | |
| all 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 "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 (, Pyrogen Test
USP Rabbit Pyrogen Study | Animals tested with test
extract should not exhibit
increase of body temperature
by more than 0.5°C. | Non-pyrogenic |
| ISO 10993-4:2017 ASTM
F756:2017
ASTM Hemolysis Study | Mean hemolytic index for the
direct contact and indirect
contact should be