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

K130414 · Trireme Medical, Inc. · LIT · Jun 15, 2013 · Cardiovascular

Device Facts

• Record ID: K130414
• Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
• Applicant: Trireme Medical, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Chocolate PTA Balloon Catheter is a percutaneous transluminal angioplasty (PTA) device used for peripheral artery lesion dilatation. Device features a braided shaft, atraumatic tapered/beveled tip, and a semi-compliant balloon with a Constraining Structure (CS) to assist in lesion expansion. Radiopaque markers facilitate positioning. Operated by physicians in clinical settings; compatible with standard 0.014"/0.018" guidewires and 5F/6F introducer sheaths/guide catheters. Device is inflated via standard inflation devices connected to a proximal luer hub. By expanding the balloon at specific pressures, the device dilates stenotic peripheral vessels, improving blood flow. Supplied sterile for single use.

Clinical Evidence

Bench testing only. In vitro testing included peak friction force measurements in an established peripheral model to support substantial equivalence.

Technological Characteristics

Percutaneous balloon dilatation catheter; braided shaft; semi-compliant balloon with Constraining Structure (CS); radiopaque markers; luer connector for inflation; compatible with 0.014"/0.018" guidewires and 5F/6F sheaths; sterile, single-use; non-hydrophilic distal shaft.

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

• B. Braun Mini Ghost (K051343)
• Chocolate PTA Balloon Catheter Family (K111738, K120677, K121402 and K122070)

Submission Summary (Full Text)

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# K130414 p. 1 of 2

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

# JUN 1 4 2013

- 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/CA<br>Phone: [phone] Ext 209<br>Fax: [phone] |
| Date Prepared: | February 14, 2013 |

General Information

| Trade Name: | Chocolate PTA Balloon Catheter |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Angioplasty Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Product Code: | LIT |
| 510(k) number: | |
| Predicate Devices: | B. Braun Mini Ghost (K051343)<br>Chocolate PTA Balloon Catheter Family (K111738, K120677,<br>K121402 and K122070) |

#### 3. Intended Use

2.

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.

- 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 the hydrophilic coating of the braided shaft will become optional. The proximal end of the device is a common PTA

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catheter connected to a plastic 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:

- . Peak friction force in a established peripheral model
- 6. Substantial Equivalence Comparison and Conclusion

The Chocolate PTA Balloon Catheter without hydrophilic coating on the distal portion of the braided shaft is 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, Chocolate PTA Balloon Catheters with the hydrophilic coating removed are considered substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an abstract human figure with three arms or lines extending from the body. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.

Public Health Service

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

June 15, 2013

TriReme Medical, Inc. Ms. Shiva Ardakani VP of Regulatory, Clinical and Quality 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

Re: K130414

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: April 26, 2013 Received: April 29, 2013

#### Dear Ms. Ardakani:

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. Ilisting 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 - Ms. Shiva Ardakani

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Bram D.Zuckerman -S

Bram 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):

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)

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

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

Bram D. Zuckerman -S
2013.06.15 06:33:57 -04'00'

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