(206 days)
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™ 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.
The provided text describes the Bendit2.7™ Steerable Microcatheter and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC, etc.) from a clinical study, nor does it detail a study that proves the device meets such criteria in the context of an AI/ML device.
The document focuses on the substantial equivalence of a physical medical device (a microcatheter) to a predicate device, primarily through bench testing and animal studies to demonstrate its functional and safety performance, rather than an AI/ML component's diagnostic or predictive accuracy.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to the data provided in this document, as it pertains to a physical medical device.
I can, however, extract related information from the document as best as possible, focusing on the available "acceptance criteria" through the lens of device performance testing.
1. Table of Acceptance Criteria and Reported Device Performance (based on the provided document):
| Acceptance Criteria (Implied from Testing) | Reported Device Performance |
|---|---|
| Visual inspections and dimensional verifications for unaged and aged samples. | Met established design inputs. |
| Tip tensile bond strength. | Met established design inputs. |
| Liquid and Air leakage. | Met established design inputs. |
| Power Injection (Flowrate and Device Pressure). | Met established design inputs. |
| Coating integrity. | Met established design inputs. |
| Particulates. | Met established design inputs. |
| Simulated use testing in a tortuous model (handling/usability). | Met established design inputs. In animal studies, Bendit2.7 was evaluated as equivalent to SwiftNINJA and Direxion on all performance criteria including handling, tracking, and radiopacity/tip visualization. |
| Package integrity testing (before/after aging and transport). | Met established design inputs. All package and device integrity tests were passed after aging and simulated distribution conditioning. |
| Flow rate for aged samples. | Met established design inputs. |
| Priming volume for aged samples. | Met established design inputs. |
| Tensile bond strength at main catheter junctions. | Met established design inputs. |
| Torsional bond strength. | Met established design inputs. |
| Kink resistance. | Met established design inputs. |
| Corrosion. | Met established design inputs. |
| Tip deflection cycles. | Met established design inputs. |
| Tip rotation cycles. | Met established design inputs. |
| Pushability and trackability. | Met established design inputs. |
| Retraction. | Met established design inputs. |
| Torqueability. | Met established design inputs. |
| Sterilization Validation (SAL of 10^-6, Endotoxin levels, Residuals). | Ethylene oxide sterilization validated to SAL of 10^-6 per ISO 11135:2014. Bacterial endotoxin levels <20.0 EU/Device per USP 40-NF35:2017 <85>. Sterilization residuals evaluated per ISO 10993-7. |
| Biocompatibility (Cytotoxicity, Sensitization/Irritation, Systemic Toxicity, Pyrogenicity, Hemocompatibility). | Confirmed in tests per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, USP 40-NF35:2017 <151>, and ISO 10993-4:2017 including ASTM F756-17. |
Study that proves the device meets the acceptance criteria:
The primary studies conducted to demonstrate that the Bendit2.7™ Steerable Microcatheter meets its acceptance criteria for substantial equivalence are:
- In Vitro Bench Testing: This involved testing finished, sterilized, unaged, and accelerated-aged samples of the device against predefined design inputs.
- Animal Testing: This involved evaluating the device's performance in reaching target vessels and delivering materials.
- Sterilization Validation: This involved validating the ethylene oxide sterilization process.
- Biocompatibility Testing: This involved testing for various biological responses to patient-contacting materials.
- Package Testing: This involved testing package integrity after aging and simulated transportation.
Details requested that are NOT APPLICABLE to this document (as it concerns a physical medical device, not an AI/ML diagnostic/predictive system):
- 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices and animal models, not a dataset for an algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of diagnostic "ground truth." For the animal studies, four interventional radiologists evaluated performance, which could be considered expert evaluation, but not for establishing a "ground truth" for diagnostic labels.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the animal studies, the "ground truth" was the observed performance of the device by interventional radiologists against the predicate devices in terms of handling, tracking, and radiopacity/tip visualization. For bench tests, "ground truth" was meeting design specifications.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
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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
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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
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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 DeviceBendit2.7TM | Primary PredicateSwiftNINJA | Reference PredicateDirexion | |
|---|---|---|---|
| Indications forUse | The Bendit2.7TM SteerableMicrocatheter is intended forgeneral intravascular use, inthe peripheral vasculature. Themicrocatheter can be used forthe delivery of diagnostic,embolic, or therapeuticmaterials into the vasculature.The Bendit2.7 is not intended tobe used in intracranial orcoronary vessels. | The SwiftNINJA is intended forgeneral intravascular use,including peripheral andcoronary vasculature. Once thesubselective region has beenaccessed, the microcathetercan be used for the controlledand selective infusion ofdiagnostic, embolic, ortherapeutic materials into thevasculature. The cathetershould not be used in thecerebral vessels. | The Direxion Microcatheteris intended for peripheralvascular use. The pre-loaded Fathom andTransend Guidewires canbe used to selectivelyintroduce and position themicrocatheter in theperipheral vasculature. Themicrocatheter can be usedfor controlled and selectiveinfusion of diagnostic,embolic, or therapeuticmaterials into the vessel. |
| Catheter type | Steerable microcatheter | Steerable microcatheter | Distal tips are steamshapeable |
| MicrocatheterComponents | Catheter shaft, steerabledeflecting tip, steering handle | Catheter shaft, steerablearticulating tip, steering handle | Catheter shaft with luer onproximal end with rotatinghemostatic valve (RHV) orY-adapter, pre-loaded onguidewire, with a variety oftip shapes (Straight, Bern.) |
| Proposed DeviceBendit2.7TM | Primary PredicateSwiftNINJA | Reference PredicateDirexion(Swan Neck, and J Shape) | |
| Mode ofoperation | Catheter insertion and tipplacement under imagingguidance.Tip deflection controlled usingmanual steering mechanismexternal to the body.Tip deflection achieved via twoNiTi hypo tubes connected atthe distal end of catheter withlaser-cut patterns that providetip flexibility.Material injection via syringeconnection to luer at proximalend of catheter. | Catheter insertion and tipplacement under imagingguidance.Tip articulation controlled usingmanual steering mechanismexternal to the body.Tip articulation achieved viatwo wires running along theinner walls of the catheter shaftfrom handle to tip.Material injection via syringeconnection to luer at proximalend of catheter. | Catheter insertion and tipplacement under imagingguidance.Tip are steam shapeable toaid in reaching the target.Material injection viasyringe connection to luer aproximal 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 shaftlength | 130 cm | 125 cm | 105, 130, 155 cm |
| Hydrophiliccoating on shaft | Yes | Yes | Yes |
| Compatibleguidewire | ≤ 0.018" | ≤ 0.018" | ≤ 0.018" |
| # Lumens | Single | Single | Single |
| Fill volume | 0.45 mL | 0.49 mL | Unknown |
| Max injectionpressure | 1000 psi | 1000 psi | 1200 psi |
| Deflecting tip | Yes | Yes | No, steam shapeable |
| Max tipdeflection angle | 180° from neutral position inone direction | ± 180° from neutral position | N/A, tips aresteam shapeable |
| Max tip rotation | 100° in both directions(clockwise and counterclockwise) | No mechanism for tip rotationseparate from manually rotatingcatheter shaft. | No mechanism for tiprotation separate frommanually rotating cathetershaft. |
| Radiopaque | Yes, radiopaque (tungsten) tip | Yes, two radiopaque (tungsten)markers in tip | Yes, one or two radiopaquemarkers in tip, dependingon model |
| Steeringmechanism | Slider used to deflect tipKnob used to rotate tip | Steering wheel used to deflecttip | N/A, not steerable |
| Steering lockmechanism | Yes | Yes | N/A |
| Proposed DeviceBendit2.7TM | Primary PredicateSwiftNINJA | Reference PredicateDirexion | |
| Maxmicrospheresize | 700 μm | 700 μm | 700 μm |
| Max coil size | 0.018" (0.46 mm) | 0.018" (0.46 mm) | Unknown |
| Biocompatibility | Complies with all requiredtesting per FDA guidance forapplication of ISO 10993-1 | Per 510(k) Summary, complieswith all required testing perFDA guidance for application ofISO 10993-1 | Assume compliance withISO 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
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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.
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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 <85> Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard (<20.0 EU/Device), Sterilization residuals were evaluated according to ISO 10993-7:
Biocompatibility
The Bendit2.7 is externally communicating in short-term (<24 hours) contact with circulating blood. Biocompatibility of the patient contacting materials was confirmed in the following tests:
- o Cytotoxity per ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization and Irritation per IO 10993-10:2010 Biological evaluation of medical ● devices - Part 10: Tests for irritation and skin sensitization
- Acute systemic toxicity per IO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- o Material-mediated pyrogenicity per USP 40-NF35:2017 <151> 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.
§ 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).