(111 days)
Not Found
No
The description focuses on the mechanical and material properties of the microcatheter and its manual steering mechanism. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a microcatheter for delivery of diagnostic or embolic materials, which are the therapeutic components, making this a delivery device rather than a therapeutic device itself.
No
The device is a microcatheter used for the delivery of materials. While it can deliver diagnostic materials, it is not described as performing the diagnosis itself.
No
The device description clearly details a physical, steerable microcatheter with mechanical components (hypo tubes, steering slider, torque knob) and a hydrophilic coating. The performance studies also focus on physical properties and simulated use of a tangible device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use in the peripheral vasculature" and for the "delivery of diagnostic, embolic materials into the vasculature." This describes a device used within the body for interventional procedures, not for testing samples outside the body.
- Device Description: The description details a physical catheter with a steerable tip, lumen for guidewires, and a Luer lock port. This is consistent with an interventional medical device, not an IVD which typically involves reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the Bendit2.7 Steerable Microcatheter is an interventional medical device used for accessing and delivering materials within the peripheral vasculature, not an IVD.
N/A
Intended Use / Indications for Use
The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic materials into the vasculature.
The Bendit2.7 is not intended to be used in intracranial or coronary vessels.
Product codes
KRA
Device Description
The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.
The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The distal 80 cm of the shaft is covered with a hydrophilic coating.
Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Catheter insertion and tip placement under imaging guidance.
Anatomical Site
peripheral 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)
The following tests were conducted to verify the design changes resulting in the modified device:
- Visual inspections and dimensional verifications
- Tensile bond strength at the tip and luer connections
- Torsional bond strength
- Kink resistance
- Power Injection (for Flowrate and Device Pressure)
- Coating integrity
- Corrosion
- Pushability, Retraction, and Torqueability
- Simulated use validation testing, including trackability
- Chemical characterization according to ISO 10993-17-2020 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances and a toxicological risk assessment
All test results met the pre-defined test acceptance criteria.
No animal or clinical tests were required to validate the changes to the Bendit2.7™ Steerable Microcatheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 25, 2020
Bend It Technologies Ltd. % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC P.O. Box 2151 Amherst, Massachusetts 01004-2151
Re: K200582
Trade/Device Name: Bendit2.7 Steerable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 6, 2020 Received: May 6, 2020
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200582
Device Name
Bendit2.7TM Steerable Microcatheter
Indications for Use (Describe)
The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic materials into the vasculature.
The Bendit2.7 is not intended to be used in intracranial or coronary vessels.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | Heyer Regulatory Solutions LLC
P.O. Box 2151
Amherst, MA 01004-2151
Contact: Sheila Hemeon-Heyer
Sheila@heyer-regulatory.com |
| ---- | ------------ | ------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
- B. Manufacturer/ Bend It Technologies, Ltd 510(k) Applicant: 25 Basel Street Petach Tikva 4951038, Israel Contact: Simona Beilin-Nissan Title: VP Clinical and Regulatory Affairs Tel #: +972 3 6747377 Email: simonabn@bendittech.com
C. Date Prepared: June 17, 2020
D. Device Name and Classification Information:
| Trade Name: | Bendit2.7™ Steerable Microcatheter |
|---|---|
| Common/Usual Name: | Diagnostic Intravascular Catheter |
| Regulation: | 21 CFR 870.1200 |
| Product Code: | KRA |
| Review Panel: | Cardiovascular |
| Class: | II |
- E. Predicate Device: Bendit2.7™ Steerable Microcatheter, K190126
F. Summary Device Description:
The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.
The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The distal 80 cm of the shaft is covered with a hydrophilic coating.
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 Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.
G. Indications for Use Statement:
The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.
The Bendit2.7™ is not intended to be used in intracranial or coronary vessels.
H. Technical Comparison with Predicate Devices
The table below provides a technological comparison between the proposed Bendit2.7™ and the previously cleared Bendit2.7™ devices. The similarities and differences between the proposed and predicate devices are discussed following the table.
| | Predicate Device
Bendit2.7 ™ cleared under
K190126 | Proposed Device
Modified Bendit2.7 ™ | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The Bendit2.7 ™Steerable
Microcatheter is intended for
general intravascular use, in
the peripheral vasculature. The
microcatheter can be used for
the delivery of diagnostic,
embolic, or therapeutic
materials into the vasculature.
The Bendit2.7 is not intended to
be used in intracranial or
coronary vessels. | The Bendit2.7™Steerable
Microcatheter is intended for
general intravascular use, in
the peripheral vasculature. The
microcatheter can be used for
the delivery of diagnostic,
embolic, or therapeutic
materials into the vasculature.
The Bendit2.7 is not intended
to be used in intracranial or
coronary vessels. | Same |
| Catheter type | Steerable microcatheter | Steerable microcatheter | Same |
| Microcatheter
Components | Catheter shaft, steerable
deflecting tip, steering handle | Catheter shaft, steerable
deflecting tip, steering handle | Same |
| Mode of
operation | Catheter insertion and tip
placement under imaging
guidance.
Tip deflection controlled using
manual steering mechanism
external to the body.
Tip deflection achieved via two
NiTi hypo tubes connected at
the distal end of catheter with | Catheter insertion and tip
placement under imaging
guidance.
Tip deflection controlled using
manual steering mechanism
external to the body.
Tip deflection achieved via two
NiTi hypo tubes connected at
the distal end of catheter with | Same |
| | Predicate Device
Bendit2.7 ™ cleared under
K190126 | Proposed Device
Modified Bendit2.7 ™ | Comparison |
| | laser-cut patterns that provide
tip flexibility.
Material injection via syringe
connection to luer at proximal
end of catheter. | laser-cut patterns that provide
tip flexibility.
Material injection via syringe
connection to luer at proximal
end of catheter. | |
| Catheter OD | 2.7 Fr | 2.7 Fr | Same |
| Catheter ID | 0.021" | 0.021" | Same |
| Catheter shaft
length | 130 cm | 130 cm | Same |
| Hydrophilic
coating on shaft | Yes, 130 cm | Yes, 80 cm | Change |
| PTFE coating on
inner tube | No | Yes | Change |
| Inner connection
tube | Yes | No | Change |
| Compatible
guidewire | ≤ 0.018" | ≤ 0.018" | Same |
| # Lumens | Single | Single | Same |
| Fill volume | 0.45 mL | 0.45 mL | Same |
| Max injection
pressure | 1000 psi | 1000 psi | Same |
| Deflecting tip | Yes | Yes | Same |
| Max tip
deflection angle | 180° from neutral position in
one direction | 180° from neutral position in
one direction | Same |
| Max tip rotation | 100° in both directions
(clockwise and counter
clockwise) | 100° in both directions
(clockwise and counter
clockwise) | Same |
| Radiopaque | Yes, radiopaque (70%
tungsten) tip | Yes, radiopaque (80%
tungsten) tip | Change |
| Steering
mechanism | Slider used to deflect tip
Knob used to rotate tip | Slider used to deflect tip
Knob used to rotate tip | Same |
| Steering lock
mechanism | Yes | Yes | Same |
| Max
microsphere size | 700 μm | 700 μm | Same |
| Max coil size | 0.018" (0.46 mm) | 0.018" (0.46 mm) | Same |
| | Predicate Device
Bendit2.7™ cleared under
K190126 | Proposed Device
Modified Bendit2.7 ™ | Comparison |
| Biocompatibility | Complies with all required
testing per FDA guidance for
application of ISO 10993-1 | Complies with all required
testing per FDA guidance for
application of ISO 10993-1 | Same |
| Use restriction | Single-use, disposable | Single-use, disposable | Same |
| Sterilization | Ethylene oxide, SAL 10-6 | Ethylene oxide, SAL 10-6 | Same |
5
6
l. Discussion of Differences
Four design changes have been made to the Bendit2.7™ Steerable Microcatheter. The changes are to improve ease of use and do not change the device indications for use, introduce any new functionality, change or introduce any new risks, or change the fundamental scientific technology of the device.
-
- The length of hydrophilic coating on the catheter shaft is reduced to cover the distal 80 cm instead of the entire 130 cm length. This change is to facilitate user handling of the catheter shaft portion that does not enter the body.
-
- The amount of Tungsten in the catheter tip is increased from 70% to improve tip visibility on imaging.
-
- A PTFE coating is added to the outer surface of the inner tube to decrease friction within the catheter during bending.
-
- The inner connection tube was removed as it was determined not to be necessary for sufficient bond strength at the luer / inner tube connection.
Testing to Support Substantial Equivalence J.
The following tests were conducted to verify the design changes resulting in the modified device:
-
- Visual inspections and dimensional verifications
-
- Tensile bond strength at the tip and luer connections
-
- Torsional bond strength
-
- Kink resistance
-
- Power Injection (for Flowrate and Device Pressure)
-
- Coating integrity
-
- Corrosion
-
- Pushability, Retraction, and Torqueability
-
- Simulated use validation testing, including trackability
-
- Chemical characterization according to ISO 10993-17-2020 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances and a toxicological risk assessment
7
All test results met the pre-defined test acceptance criteria.
No animal or clinical tests were required to validate the changes to the Bendit2.7™ Steerable Microcatheter.
K. Conclusion
The information and testing presented in this 510(k) demonstrate that the modified Bendit2.7™ Steerable Microcatheter is substantially equivalent to the original Bendit2.7 Steerable Microcatheter previously cleared under K190126.