(206 days)
Direxion Torqueable Microcatheter, K132947
No
The device description focuses on the mechanical design and steerable features of the microcatheter, with no mention of AI or ML technology. The performance studies are based on bench and animal testing, not algorithmic performance.
Yes
Explanation: The device is explicitly stated to "be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature."
Yes
The "Intended Use / Indications for Use" section states: "The microcatheter can be used for the delivery of diagnostic... materials into the vasculature." This indicates one of its intended functions is related to diagnosis.
No
The device description clearly details a physical medical device (microcatheter) with mechanical components (steerable tip, steering handle, torque knob, hypo tubes, etc.) and materials (Nitinol, hydrophilic coating). It is not solely software.
Based on the provided information, the Bendit2.7 Steerable Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use in the peripheral vasculature" for the "delivery of diagnostic, embolic, or therapeutic materials." This describes a device used within the body for interventional procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical catheter with a steerable tip, designed for insertion into blood vessels. This is consistent with an interventional medical device.
- Anatomical Site: The specified anatomical site is the "Peripheral vasculature," which is within the human body.
- Intended User / Care Setting: The intended user is "Interventional radiologists," who perform procedures within the body.
- Performance Studies: The performance studies described are "In Vitro Bench Testing" (testing the device itself) and "Animal Testing" (evaluating performance in a living organism). These are typical for interventional devices, not IVDs which would involve testing biological samples.
In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Bendit2.7 does not perform this function.
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, or therapeutic 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 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
Not Found
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
In Vitro Bench Testing:
Finished, sterilized, unaged and aged samples (minimum 6 months equivalent accelerated aged) of the Bendit2.7 Steerable Microcatheter were tested and shown to meet the design inputs established for the device. The results of all tests met their pre-defined acceptance criteria.
Unaged (TO) Testing:
- Visual inspections and dimensional verifications
- Tip tensile bond strength
- Liquid leakage
- Air leakage
- Power Injection (for Flowrate and Device Pressure)
- Coating integrity
- Particulates
- Simulated use testing in a tortuous model to evaluate performance handling / usability
- Package integrity testing
Aged (>=T6 months) Testing:
- Visual inspections and dimensional verifications
- Flow rate
- Priming volume
- Tensile bond strength at main catheter junctions, including the catheter tip
- Torsional bond strength
- Liquid leakage
- Air leakage
- Kink resistance
- Power Injection (for Flowrate and Device Pressure)
- Coating integrity
- Particulates
- Corrosion
- Tip deflection cycles
- Tip rotation cycles
- Pushability and trackability
- Retraction
- Torqueability
- Simulated use testing in a tortuous model to evaluate performance handling / usability
- Package integrity testing
Animal Testing:
The performance of the Bendit2.7 to reach target vessels and delivery diagnostic, embolic and therapeutic agents was evaluated in five different animal studies by four different interventional radiologists. Performance and handling characteristics of the Bendi2.7 were compared to the SwiftNINJA Steerable Microcatheter in one study and to the Direxion Torquable Microcatheter in a second study. Bendit2.7 was evaluated as equivalent when compared to both the SwiftNINJA and Direxion on all performance criteria including handling, tracking, and radiopacity/tip visualization.
Sterilization Validation:
Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 10^-6 using the half-cycle, overkill method per ISO 11135:2014, 200 edition. Bacterial endotoxin testing confirmed endotoxin levels well below the limit of the standard ( Pyrogen Test (USP Rabbit Test)
- Hemocompatibility per ISO 10993-4:2017, including hemolysis per ASTM F756-17; complement activation, and in vivo thrombogenicity
Package Testing after Aging and Simulated Transportation Testing:
Samples were subjected to simulated environmental and shipping conditions and tested in accordance with ASTM D4169. Package integrity tests included the dye penetration test per ASTM F1929-15 and seal peel test per ASTM F88M/F88-15. All package and device integrity tests were passed.
Key Metrics
Not Found
Predicate Device(s)
SwiftNINJA, K161921
Reference Device(s)
Direxion Torqueable Microcatheter, K132947
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(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). The logo consists of two parts: on the left, there is a seal with an eagle and text around it, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
August 22, 2019
Bend It Technologies Ltd % Ms. Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K190126
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: July 19, 2019 Received: July 22, 2019
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190126
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, or therapeutic 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) | |||
|---|---|---|---|
| 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: | 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: Nitza Shoham, PhD Title: VP Clinical and Requlatory Affairs Tel #: +972 3 6747377 Email: nitza.shoham@bendittech.com
C. Date Prepared: August 20, 2019
D. Device Name and Classification Information:
| Trade Name: | Bendit2.7™ Steerable Microcatheter |
|---|---|
| Common/Usual Name: | Continuous Flush Catheter |
| Regulation: | 21 CFR 870.1210 |
| Product Code: | KRA |
| Review Panel: | Cardiovascular |
| Class: | II |
- E. Primary: SwiftNINJA, K161921 Predicate Device: Reference: Direxion Torqueable Microcatheter, K132947
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
4
section is steerable and includes a radiopaque atraumatic tip. 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.
Indications for Use Statement: G.
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 predicate device. The similarities and differences between the proposed and predicate devices are discussed following the table.
| | Proposed Device
Bendit2.7TM | Primary Predicate
SwiftNINJA | Reference Predicate
Direxion |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Bendit2.7TM 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 SwiftNINJA is intended for
general intravascular use,
including peripheral and
coronary vasculature. Once the
subselective region has been
accessed, the microcatheter
can be used for the controlled
and selective infusion of
diagnostic, embolic, or
therapeutic materials into the
vasculature. The catheter
should not be used in the
cerebral vessels. | The Direxion Microcatheter
is intended for peripheral
vascular use. The pre-
loaded Fathom and
Transend Guidewires can
be used to selectively
introduce and position the
microcatheter in the
peripheral vasculature. The
microcatheter can be used
for controlled and selective
infusion of diagnostic,
embolic, or therapeutic
materials into the vessel. |
| Catheter type | Steerable microcatheter | Steerable microcatheter | Distal tips are steam
shapeable |
| Microcatheter
Components | Catheter shaft, steerable
deflecting tip, steering handle | Catheter shaft, steerable
articulating tip, steering handle | Catheter shaft with luer on
proximal end with rotating
hemostatic valve (RHV) or
Y-adapter, pre-loaded on
guidewire, with a variety of
tip shapes (Straight, Bern.) |
| | Proposed Device
Bendit2.7TM | Primary Predicate
SwiftNINJA | Reference Predicate
Direxion
(Swan Neck, and J Shape) |
| 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
laser-cut patterns that provide
tip flexibility.
Material injection via syringe
connection to luer at proximal
end of catheter. | Catheter insertion and tip
placement under imaging
guidance.
Tip articulation controlled using
manual steering mechanism
external to the body.
Tip articulation achieved via
two wires running along the
inner walls of the catheter shaft
from handle to tip.
Material injection via syringe
connection to luer at proximal
end of catheter. | Catheter insertion and tip
placement under imaging
guidance.
Tip are steam shapeable to
aid in reaching the target.
Material injection via
syringe connection to luer a
proximal end of catheter. |
| Catheter OD | 2.7 Fr | 2.9 Fr (proximal) / 2.4 Fr
(distal) | 2.7 Fr (proximal) / 2.5 Fr
(distal) |
| Catheter ID | 0.021" | 0.021" | 0.021" |
| Catheter shaft
length | 130 cm | 125 cm | 105, 130, 155 cm |
| Hydrophilic
coating on shaft | Yes | Yes | Yes |
| Compatible
guidewire | ≤ 0.018" | ≤ 0.018" | ≤ 0.018" |
| # Lumens | Single | Single | Single |
| Fill volume | 0.45 mL | 0.49 mL | Unknown |
| Max injection
pressure | 1000 psi | 1000 psi | 1200 psi |
| Deflecting tip | Yes | Yes | No, steam shapeable |
| Max tip
deflection angle | 180° from neutral position in
one direction | ± 180° from neutral position | N/A, tips are
steam shapeable |
| Max tip rotation | 100° in both directions
(clockwise and counter
clockwise) | No mechanism for tip rotation
separate from manually rotating
catheter shaft. | No mechanism for tip
rotation separate from
manually rotating catheter
shaft. |
| Radiopaque | Yes, radiopaque (tungsten) tip | Yes, two radiopaque (tungsten)
markers in tip | Yes, one or two radiopaque
markers in tip, depending
on model |
| Steering
mechanism | Slider used to deflect tip
Knob used to rotate tip | Steering wheel used to deflect
tip | N/A, not steerable |
| Steering lock
mechanism | Yes | Yes | N/A |
| | Proposed Device
Bendit2.7TM | Primary Predicate
SwiftNINJA | Reference Predicate
Direxion |
| Max
microsphere
size | 700 μm | 700 μm | 700 μm |
| Max coil size | 0.018" (0.46 mm) | 0.018" (0.46 mm) | Unknown |
| Biocompatibility | Complies with all required
testing per FDA guidance for
application of ISO 10993-1 | Per 510(k) Summary, complies
with all required testing per
FDA guidance for application of
ISO 10993-1 | Assume compliance with
ISO 10993-1 |
| Use restriction | Single-use, disposable | Single-use, disposable | Single-use, disposable |
| Sterilization | Ethylene oxide, SAL 10-6 | Ethylene oxide, SAL 10-6 | Unknown |
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l. Discussion of Similarities and Differences
The Bendit2.7 has substantially equivalent indications for use as the predicate devices as all three devices are indicated for use in delivering diagnostic, embolic, or therapeutic materials into the peripheral vasculature.
The proposed and primary predicate devices are both steerable microcatheters consisting of a catheter shaft, steerable articulating tip, and steering mechanism in the handle. The mechanism of deflecting and rotating the tip are different between the two devices. However, testing provided in this 510(k) supports the substantial equivalence of the Bendit2.7 tip deflection mechanism to that of the predicate device.
The Bendit2.7 catheter is similar in size to both the primary and predicate devices, including OD, ID, fill volume, and catheter length. All devices are single lumen with a hydrophilic coating on the catheter shaft, radiopaque tips, and are intended for single patient use only.
The patient contacting materials of the Bendit2.7 have been shown to be biocompatible for short-term (≤ 24 hours) contact with circulating blood in compliance with the requirements of ISO 10993-1:2009.
J. Testing to Support Substantial Equivalence
In Vitro Bench Testing
The results of in vitro bench testing and animal testing provide comprehensive data to support the substantial equivalence of the Bendit2.7 Steerable Microcatheter. Testing was conducted in accordance with ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements (including Amendment 1:2017), where applicable.
Finished, sterilized, unaged and aged samples (minimum 6 months equivalent accelerated aged) of the Bendit2.7 Steerable Microcatheter were tested and shown to meet the design
7
inputs established for the device. The results of all tests met their pre-defined acceptance criteria. The following attributes were verified in bench testing:
Unaged (TO) Testing
- Visual inspections and dimensional verifications
- Tip tensile bond strength
- Liquid leakage .
- Air leakage ●
- Power Injection (for Flowrate and Device Pressure)
- Coating integrity ●
- Particulates ●
- . Simulated use testing in a tortuous model to evaluate performance handling / usability
- . Package integrity testing
Aged (≥T6 months) Testing
- . Visual inspections and dimensional verifications
- Flow rate
- Primina volume o
- Tensile bond strength at main catheter ● junctions, including the catheter tip
- Torsional bond strength ●
- Liquid leakage ●
- Air leakage ●
- Kink resistance
- Power Injection (for Flowrate and Device ● Pressure)
- Coating integrity
- Particulates o
- Corrosion ●
- Tip deflection cvcles ●
- Tip rotation cycles ●
- Pushability and trackability
- Retraction o
- Torqueability ●
- Simulated use testing in a tortuous model o to evaluate performance handling / usability
- Package integrity testing ●
Animal Testing
The performance of the Bendit2.7 to reach target vessels and delivery diagnostic , embolic and therapeutic agents was evaluated in five different animal studies by four different interventional radiologists. Performance and handling characteristics of the Bendi2.7 were compared to the SwiftNINJA Steerable Microcatheter in one study and to the Direxion Torquable Microcatheter in a second study. Bendit2.7 was evaluated as equivalent when compared to both the SwiftNINJA and Direxion on all performance criteria including handling, tracking, and radiopacity/tip visualization.
8
Sterilization Validation
Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 10° using the half-cycle, overkill method per ISO 11135:2014, 200 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 well below the limit of the standard ( Pyrogen Test (USP Rabbit Test)
- Hemocompatibility per ISO 10993-4:2017 per Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood, including hemolysis per ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials; complement activation, and in vivo thrombogenicity
Package Testing after Aging and Simulated Transportation Testing
Samples of Bendit2.7 microcatheters that had been 2X EtO sterilized and aged in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices were then subjected to simulated environmental and shipping conditions and tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. Package integrity tests included the dye penetration test per ASTM F1929-15 and seal peel test per ASTM F88M/F88-15. Devices were subjected to integrity testing to confirm proper operation following aging and simulated distribution conditioning. All package and device integrity tests were passed.
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K. Conclusion
The information and testing presented in this 510(k) demonstrate that the Bendit2.7™ Steerable Microcatheter is substantially equivalent to the SwiftNINJA Steerable Microcatheter for the delivery of diagnostic, embolic, or therapeutic materials into the peripheral vasculature.