GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE

K103534 · Trireme Medical, Inc. · DQY · Jan 5, 2011 · Cardiovascular

Device Facts

• Record ID: K103534
• Device Name: GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
• Applicant: Trireme Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

GliderfleX™ PTA Balloon Catheter is a percutaneous transluminal angioplasty device; used by physicians in clinical settings for peripheral artery lesion dilatation. Device features a braided shaft, atraumatic tapered/beveled tip, and semi-compliant balloon with radiopaque markers. Operates via standard inflation device connected to proximal luer hub; balloon expands to specific diameters at defined pressures. Compatible with 0.014"/0.018" guidewires and 5F/6F introducer sheaths. Provides mechanical dilatation of stenotic vessels to improve blood flow; benefits patient by restoring vascular patency.

Clinical Evidence

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

Technological Characteristics

Braided shaft; semi-compliant balloon; radiopaque markers; lubricious hydrophilic coating; plastic hub with luer connector. Compatible with 0.014"/0.018" guidewires and 5F/6F introducer sheaths. Lengths 120-150 cm. Sterile, single-use.

Indications for Use

Indicated for balloon dilatation of peripheral vascular lesions in iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries. Contraindicated for use in 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)
• EverCross .035" OTW PTA Dilatation Catheter (K082579)
• GliderXtreme PTA Balloon Catheter (K101062)

Submission Summary (Full Text)

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K103S34

## 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 | JAN - 5 2011 |
|----------------------|--------------------------------------------------------------------------------------|--------------|
| Contact Person: | Shiva Ardakani<br>VP of RA/QA<br>Phone: [phone] Ext 209<br>Fax: [phone] | |
| Date Prepared: | October 27, 2010 | |
| General Information | | |
| Trade Name: | GliderfleX™ 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) | |
| | EverCross .035" OTW PTA Dilatation Catheter (K082579) | |
| | GliderXtreme PTA Balloon Catheter (K101062) | |

- 3. Intended Use
2.

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

- 4. Device Description
The GliderfleX™ 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.

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 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 used to inflate the balloon; the luer connector is compatible with standard inflation devices.

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The GliderfleX™ PTA 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 .
- 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 GliderfleX™ 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 GliderfleX™ 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, All GliderfleX™ PTA Balloon Catheters are considered substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

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

Regulatory Technology Services LLC c/o Mr. Mark Job Responsible Third Party Official 1394 25" Street NW Buffalo, MN 55313

Re: K103534

JAN - 5 230

the country of the county of the county of

GliderfleX™ PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: December 16, 2010 Received: December 17, 2010

Dear Mr. Job:

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 udications for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate. 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.

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Page 2 - Mr. Mark Job

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman, M.D.

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): K103534

JAN - 5 2011

Device Name:_____ GliderfleX™ PTA Balloon Catheter

Indications For Use:

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

Prescription Use (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)

W.M.S.

rdiovascular Devices

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510(k) Number K103534