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.

Device Description

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids 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 a medical device (Chameleon PTA Balloon Catheter), not a study for an AI/ML medical device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/ML-driven diagnostic or assistive technology.

The document primarily focuses on establishing "substantial equivalence" of a new version of the existing Chameleon PTA Balloon Catheter (with new balloon sizes) to a legally marketed predicate device. This type of submission relies heavily on bench testing and simulated use to demonstrate that the physical and functional characteristics of the device remain safe and effective for its intended purpose.

Here's why the requested information cannot be extracted from the provided text:

No AI/ML Component: The device is a physical medical instrument (a balloon catheter used in angioplasty), not a software or AI/ML algorithm that interprets medical images or data.
No Diagnostic Performance: The "performance data" mentioned (Section 13) refers to mechanical and physical properties of the catheter (e.g., balloon compliance, burst pressure, fatigue, leakage), not diagnostic accuracy (e.g., sensitivity, specificity) of an AI system.
No Human Readers/Experts for Interpretation: The context of "human readers" assisting with AI or "expert consensus" for ground truth isn't relevant to a physical catheter's mechanical performance.

However, I can extract what is relevant to the document about its "acceptance criteria" and "study" (bench testing):

Acceptance Criteria and Reported Device Performance (as pertains to this physical device)

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."

While specific numerical targets or thresholds for each bench test are not provided in this summary document, the general categories of acceptance criteria and the finding that they were met are clear.

Acceptance Criteria Category (Related to Bench Testing)	Reported Device Performance
Dimensional Inspection	Met established specifications
Balloon Compliance	Met established specifications
Balloon Burst Pressure	Met established specifications
Fatigue Resistance	Met established specifications
Leakage	Met established specifications
Overall Performance for Intended Use	Met all predetermined acceptance criteria of design verification and validation

Regarding the specific questions in your prompt, here's why they are largely unanswerable from this document:

A table of acceptance criteria and the reported device performance: Partially addressed above for mechanical properties, but no diagnostic performance like an AI would have.
Sample sizes used for the test set and the data provenance: Sample sizes for bench tests (e.g., N=X catheters tested for burst pressure) are not detailed. Data provenance is "bench testing and simulated use," implying lab conditions. No patient data is involved for this type of device submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical properties is derived from engineering specifications and testing methods, not expert human interpretation of medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML diagnostic studies, not device mechanical testing.
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 for AI/ML diagnostic studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, the "ground truth" for its performance is adherence to engineering specifications and performance benchmarks (e.g., it must not burst below X pressure, it must meet Y compliance).
The sample size for the training set: Not applicable. There is no AI/ML model to train.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (catheter) and illustrates a "substantial equivalence" pathway, not a submission for an AI/ML-driven medical device requiring clinical performance evaluation of diagnostic accuracy.

Summary

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Public Health Service

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March 30, 2017

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

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

Re: K170635

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: March 2, 2017 Received: March 3, 2017

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

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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 the quality systems (QS) 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.

Sincerelv.

Fernando Aguel
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) K170635

Device Name Chameleon PTA Balloon Catheter

Indications for Use (Describe)

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.

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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Special 510(k) Summary

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

Date 510(k) Summary Prepared: 4.

March 29, 2017

5. Trade Name:

Chameleon PTA Balloon Catheter

6. Common Name:

Angioplasty, Peripheral, Transluminal Catheter

7. Classification Name:

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, K163231

9. Purpose of Submission

This Special 510(k) premarket notification submission addresses a line extension to the Chameleon PTA Balloon Catheter. Specifically, the line extension is for the addition of two new balloon diameter sizes of 9.0mm and 10.0mm within the previously cleared range of available balloon diameter sizes.

10. Device Description:

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11. Indications for Use:

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. ●

12. Technological Characteristics

The Chameleon PTA Balloon Catheter changes include the addition of the 9.0X40mm & 10.0X40mm balloon sizes. 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, K163231.

13. 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 performed with the 9.0X40mm & 10.0X40mm balloon sizes included dimensional inspection, balloon compliance, balloon burst, fatigue, and leakage.

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

14. 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).