CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

K111738 · Trireme Medical, Inc. · DQY · Dec 14, 2011 · Cardiovascular

Device Facts

• Record ID: K111738
• Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
• Applicant: Trireme Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 14, 2011
• 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

Chocolate PTA Balloon Catheter is a percutaneous transluminal angioplasty (PTA) device used for vessel dilatation. It features a braided shaft, atraumatic tapered/beveled tip, and a semi-compliant balloon with a Constraining Structure (CS) to assist in lesion dilatation. The device is compatible with standard 0.014" or 0.018" guidewires and 5F/6F introducer sheaths. Radiopaque markers on the balloon facilitate positioning under fluoroscopy. Operated by physicians in clinical settings, the device is inflated via a luer-connected inflation device. The CS design aims to provide controlled balloon expansion. The device is supplied sterile for single use. It benefits patients by restoring blood flow in stenotic peripheral arteries.

Clinical Evidence

Bench testing only. In vitro tests included balloon rated burst pressure, inflation/deflation, fatigue (balloon and CS), catheter body/bond strength, torsional strength, dimensional/profile verification, trackability, pushability, kink resistance, and device interface compatibility.

Technological Characteristics

Percutaneous balloon dilatation catheter; braided shaft; semi-compliant balloon with Constraining Structure (CS); hydrophilic coating; radiopaque markers; compatible with 0.014"/0.018" guidewires; 5F/6F sheath compatibility; 120-150 cm length; sterile, single-use.

Indications for Use

Indicated for balloon dilatation of lesions in peripheral vasculature (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)
• GliderXtreme PTA Balloon Catheter (K101062)

Submission Summary (Full Text)

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K111738

DEC 1 4 2011

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

## 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: | April 8, 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)<br>VascuTrak PTA Dilatation Catheter (K082343)<br>GliderXtreme PTA Balloon Catheter (K101062) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

#### 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.

Device Description 4.

> 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 GliderXtreme product. 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 hub and strain relief. The hub is

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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 Body Strength (Bond Strength) .
- . Torsional Strength
- Catheter Diameter, Balloon Profile and Tip Configuration .
- Balloon Compliance ●
- . Trackability, Pushability
- Kink Resistance .
- Device Interface Compatibility .
- 6. Substantial Equivalence Comparison and Conclusion

All Chocolate PTA Balloon Catheters are substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. Performance testing demonstrated that the Chocolate Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing. Therefore, All 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 seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body, and it is positioned above the words "USA".

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

Trireme Medical c/o Mr. Bhavesh Sheth 2307 E Aurora Rd., Unit B7 Twinsburg, OH 44087

DEC 1 4 2011

Re: K111738

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY/LIT Dated: November 22, 2011 Received: November 29, 2011

Dear Mr. Sheth:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Bhavesh Sheth

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,

M. A. Wilhelm

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

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## Indications for Use

510(k) Number (XXXXX): 《[1] 738

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 same for all 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

.g. Willhemen

(Division Sign-Off) Division of Cardiovascular Devices

1111738 510(k) Number

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