Chameleon PTA Balloon Catheter

K163231 · Av Medical Technologies, Ltd. · LIT · Jan 17, 2017 · Cardiovascular

Device Facts

• Record ID: K163231
• Device Name: Chameleon PTA Balloon Catheter
• Applicant: Av Medical Technologies, Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Jan 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Over-the-wire, multi-lumen balloon catheter; enables angioplasty and infusion of diagnostic/therapeutic fluids (e.g., contrast media) via dedicated opening proximal to balloon. Multi-lumen shaft contains balloon inflation/deflation lumen and guide wire lumen (also serves as infusion lumen). Used by physicians in clinical settings for peripheral vascular procedures. Provides mechanical dilation of vessels/fistulae; allows localized fluid delivery. Benefits include combined angioplasty and infusion capability in single device.

Clinical Evidence

Bench testing only. Evaluated via dimensional inspection, balloon compliance, inflation/deflation time, simulated use, kink resistance, air leakage, burst, fatigue, and leakage testing. Infusion flow rate and leakage testing performed to support infusion indication. All results met predetermined acceptance criteria.

Technological Characteristics

Over-the-wire, multi-lumen balloon catheter. Features balloon inflation/deflation lumen and guide wire/infusion lumen. Includes dedicated infusion opening proximal to balloon. 12.0x40mm balloon size. 15-month shelf life. Mechanical device; no software or electronic components.

Indications for Use

Indicated for percutaneous transluminal angioplasty of femoral, iliac, and renal arteries and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for coronary or cerebral vasculature, stent delivery/expansion, and patients unable to tolerate anticoagulation therapy.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: [e-mail] Tel: [phone] 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.

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.

## 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.