The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

Device Description

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

AI/ML Overview

This document is a 510(k) premarket notification for the Chameleon PTA Balloon Catheter, and as such, it does not contain the detailed information about acceptance criteria and specific study results that would be found in a clinical study report or a more comprehensive technical document. The FDA 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

However, based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." and "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the reported device performance values are not detailed in this summary. The summary mentions categories of bench tests performed but does not provide the quantitative acceptance criteria for each or the device's results against those criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: The document does not specify the sample size for any of the bench tests.
Data Provenance: The tests described are "bench testing and simulated use test data." This implies the data is prospective in nature (generated specifically for this submission). The country of origin for the testing or data is not explicitly stated, but the manufacturer (AV Medical Technologies Ltd.) is located in Tel Aviv, Israel, suggesting the testing likely occurred there or under their supervision.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the studies described are bench tests and simulated use, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the studies described are bench tests, not clinical studies involving human interpretation that would require adjudication.

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:

This is not applicable. The device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench testing, the "ground truth" would be established engineering specifications and applicable standards (e.g., ISO standards for medical devices). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning algorithm that requires a training set. The "Chameleon PTA Balloon Catheter" is an over-the-wire, multi-lumen balloon catheter.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as above.

Summary of available and unavailable information:

Category	Information Available in Document
1. Acceptance Criteria & Reported Performance	Acceptance Criteria: Stated that "predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols" were met. Reported Performance: Stated that "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." However, specific numerical criteria and actual performance values for each test are not provided.
2. Sample Size (Test Set) & Data Provenance	Sample Size: Not specified. Data Provenance: "bench testing and simulated use test data," implying prospective bench testing. Origin likely Israel (manufacturer location).
3. Number & Qualifications of Experts (Ground Truth)	Not applicable. (Bench testing, not clinical data requiring expert review for ground truth).
4. Adjudication Method (Test Set)	Not applicable. (Bench testing).
5. MRMC Comparative Effectiveness Study	Not applicable. (Device is a physical catheter, not AI).
6. Standalone Algorithm Performance	Not applicable. (Device is a physical catheter, not an algorithm).
7. Type of Ground Truth Used	Engineering specifications and applicable industry standards.
8. Sample Size (Training Set)	Not applicable. (Device is not an AI/ML algorithm).
9. How Ground Truth (Training Set) Established	Not applicable. (Device is not an AI/ML algorithm).

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 17, 2017

AV Medical Technologies Ltd. % Ms. Eliza Malo Director, Regulatory Affairs Dohmen Life Science Services, LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, CO 80033

Re: K163231

Trade/Device Name: Chameleon PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, KRA Dated: November 16, 2016 Received: November 17, 2016

Dear Ms. Malo:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel-S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163231

Device Name Chameleon PTA Balloon Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary - K163231

510(k) Owner: 1.

AV Medical Technologies Ltd.

2. Address:

21 B Habarzel St. Tel Aviv, 6971029, ISRAEL

3. Contact Person:

Eliza Malo, M.S. RA; Director, Regulatory Affairs Email: eliza.malo@dlss.com Tel: 303 832 8200 Direct: 303 952 7267

4. Date 510(k) Summary Prepared:

January 10, 2017

Trade Name: 5.

Chameleon PTA Balloon Catheter

6. Common Name:

Angioplasty, Peripheral, Transluminal Catheter

Classification Name: 7.

21 CFR 870.1250, Percutaneous Catheter (LIT) 21 CFR 870.1210, Continuous Flush Catheter (KRA)

Predicate Device(s): 8.

AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K151678 Micro Medical Solutions, Inc., MMS Guide Catheter, K152625

Device Description: 9.

Indications for Use:

The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

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DO NOT use the Chameleon Device:

For coronary arteries nor for the delivery and/or expansion of stents. ●
In patients who cannot tolerate anticoagulation therapy. ●

10. Technological Characteristics

The Chameleon PTA Balloon Catheter changes include the addition of the 12.0X40mm balloon size and the increase in shelf life to 15 months. The Chameleon PTA Balloon Catheter has substantially equivalent indications for use, principle of operation, and technological characteristics as the AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K151678.

11. Performance Data (Nonclinical)

The Chameleon PTA Balloon Catheter was evaluated using bench testing and simulated use test data to confirm the performance characteristics.

Bench top tests included: dimensional inspection, balloon compliance, balloon inflation/deflation time, balloon simulated use, kink resistance, air leakage, balloon Burst, Fatigue and Leakage. Infusion tests, such as flow rate and leakage testing were performed on the predicate to support the infusion indication.

All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.

12. Conclusion

The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols.

The Chameleon PTA Balloon Catheter is substantially equivalent to the legally marketed predicate.

Regulation Number and Section

§ 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).