CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)

K120677 · Trireme Medical, Inc. · LIT · Mar 15, 2012 · Cardiovascular

Device Facts

• Record ID: K120677
• Device Name: CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
• Applicant: Trireme Medical, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 15, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

Device Story

Standard PTA balloon dilatation catheter; features braided shaft, atraumatic tapered/beveled tip, and Constraining Structure (CS) on distal end. Compatible with 0.014"/0.018" guidewires and 5F/6F introducer sheaths/guide catheters. Used by physicians in clinical settings for peripheral artery angioplasty. Device inflated via standard inflation device connected to proximal luer hub; semi-compliant balloon expands to known diameters at specific pressures to dilate lesions. Radiopaque markers assist positioning. Lubricious hydrophilic coating facilitates tracking. Single-use, sterile device.

Clinical Evidence

Bench testing only. In vitro testing included balloon rated burst pressure, inflation/deflation, balloon/CS fatigue, catheter diameter, balloon profile, tip configuration, balloon compliance, trackability, pushability, kink resistance, and device interface compatibility.

Technological Characteristics

Braided shaft; semi-compliant balloon; Constraining Structure (CS); atraumatic tapered/beveled tip; lubricious hydrophilic coating; radiopaque markers. Compatible with 0.014"/0.018" guidewires and 5F/6F access. Sterile, single-use. Materials identical to approved PTA Balloon Catheter family.

Indications for Use

Indicated for balloon dilatation of peripheral vascular lesions in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Contraindicated for coronary or cerebral vasculature.

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

• NanoCross PTA Dilatation Catheter (K090849)
• VascuTrak PTA Dilatation Catheter (K082343)
• PTA Balloon Catheter Family (K101062, K103534, K111738)

Submission Summary (Full Text)

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K120677

### 510(k) Summary [As required by 21 CFR 807.92(c)]

MAR 1 5 2012

- 1. Submitter's Name / Contact Person

| Submitter: | TriReme Medical, Inc.<br>7060 Koll Center Parkway, Suite 300<br>Pleasanton, CA 94566 |
|---------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Shiva Ardakani<br>VP of RA/QA<br>Phone: [phone] Ext 209<br>Fax: [phone] |
| Date Prepared: | December 28, 2011 |
| General Information | |

| Trade Name: | Chocolate PTA Balloon Catheter |
|----------------------|---------------------------------------------------------|
| Common/Usual Name: | Angioplasty Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Product Code: | DQY / LIT |
| 510(k) number: | |
| Predicate Devices: | NanoCross PTA Dilatation Catheter (K090849) |
| | VascuTrak PTA Dilatation Catheter (K082343) |
| | PTA Balloon Catheter Family (K101062, K103534, K111738) |

#### 3. Intended Use

2.

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

- 4. Device Description
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic

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hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

- 5. Performance Data
Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. The following in vitro tests were performed:

- ◆ Balloon Rated Burst Pressure
- Balloon Inflation and Deflation .
- . Balloon Fatigue /CS Fatigue
- . Catheter Diameter, Balloon Profile and Tip Configuration
- . Balloon Compliance
- Trackability, Pushability .
- . Kink Resistance
- Device Interface Compatibility .
- Substantial Equivalence Comparison and Conclusion 6.

The additional balloon sizes of the Chocolate PTA Balloon Catheter are substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use. No new questions of safety or effectiveness were identified during device testing. Therefore, additional sizes of the Chocolate PTA Balloon Catheters are considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct lines forming the body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

MAR 1 5 2012

William Sammons Intertek Testing Services NA, Inc. 2307 E Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K120677

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 5, 2012 Received: March 6, 2012

Dear Mr. Sammons:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regarly manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food Drug commerce prior to May 28, 1970, the enactivent and of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval applicions of the Act . The and Cosmetic Act (Act) inal do not require the general controls provisions of the Act. The Act. The You may, meretore, market the device, secject to ween and registration, listing of
general controls provisions of the Act include requirements michranding and general controls provisions of the Act mercial valuations against mistranding and devices, good manufacturing placitics, idooming information related to contract liability. adulteration. Please note: CDKH does not evaluate information of misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (see above) mio cinter eigs) in affecting your device can be
may be subject to additional controls. Existem as affecting your device EDA may may be subject to additional comrois. Existing films 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FD found in the Code of Federal Regulations, This 20, 11:00 Levice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equivalents with other requirements of the Act
that FDA has made a determination that your device complies with other r

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Page 2 - Mr. William Sammons

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 . device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bramy
Direct

Bram/D. Zuckerman, M.D. Difector 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 (XXXXX):

Device Name: Chocolate PTA Balloon Catheter

Indications for Use:

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

ivision Sign-Off) scular Devices Division of Cardioy 510(k) Number

12/28/2011

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