GLIDER PTA BALLOON CATHETER

K094019 · Trireme Medical, Inc. · DQY · Feb 12, 2010 · Cardiovascular

Device Facts

• Record ID: K094019
• Device Name: GLIDER PTA BALLOON CATHETER
• Applicant: Trireme Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Glider™ 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

Glider PTA Balloon Catheter is a standard balloon dilatation catheter for peripheral vascular interventions. Device features a braided shaft, atraumatic tapered tip, and semi-compliant balloon. Compatible with 0.014" guidewires and 5F introducer sheaths/6F guide catheters. Operated by physicians in clinical settings to dilate stenotic lesions. Inflation achieved via luer-connected inflation device at proximal hub. Radiopaque markers facilitate positioning under fluoroscopy. Single-use, sterile device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Braided shaft, semi-compliant balloon, hydrophilic coating, radiopaque markers. Compatible with 0.014" guidewires. Sterile, single-use. No software or electronic components.

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)
• Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)

Submission Summary (Full Text)

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109 4019.

TriReme Medical

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

Submitter's Name / Contact Person -

Submitter:

TriReme Medical. Inc. 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

FEB 1 2 2010

| Contact Person: | Eitan Konstantino, Ph.D. |
|-----------------|--------------------------|
| | President & CEO |
| | Phone: [phone] |
| | Fax: [phone] |

Date Prepared: November 23, 2009

- 2. General Information

| Trade Name: | Glider™ PTA Balloon Catheter |
|----------------------|-----------------------------------------|
| Common/Usual Name: | Angioplasty Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Product Code: | DQY / LIT |

Predicate Devices:

NanoCross PTA Dilatation Catheter (K090849)

Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)

#### 3. Intended Use

The Glider™ 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 Glider™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" guidewires and 5F introducer sheaths (or 6F guide catheters). Overall catheter length is approximately 135 cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is available in multiple sizes and contains one or two radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter design of a hypotube 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. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip.

The Glider™ PTA Balloon Catheters are supplied sterile and intended for single use.

7060 Koll Center Parkway, Suite 300

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### 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.

- Substantial Equivalence Comparison and Conclusion 6.
The Glider™ PTA Balloon Catheter is substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. Performance testing and biocompatibility testing demonstrated that the Glider™ PTA 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, the Glider™ PTA Balloon Catheter is considered substantially equivalent to the predicate devices.

friReme Medical

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

TriReme Medical, Inc. c/o Chris Lavanchy Primary Reviewer CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

FEB 1 2 2010

Re: K094019

Trade/Device Name: Glider PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: February 1, 2010 Received: February 2, 2010

Dear Mr. Lavanchy:

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 fram of 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. Chris Lavanchy

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,

vunia R. Vi mener

ABram 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):

Device Name: Glider™ PTA Balloon Catheter

Indications for Use:

The Glider™ 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.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vihnes

ivision Sign-UT) Division Sign-Om)
Division of Cardiovascular Devices

510(k) Number K094014

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