GLIDER PTCA BALLOON CATHETER

K111544 · Trireme Medical, Inc. · LOX · Mar 2, 2012 · Cardiovascular

Device Facts

• Record ID: K111544
• Device Name: GLIDER PTCA BALLOON CATHETER
• Applicant: Trireme Medical, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Device Story

Glider PTCA Balloon Catheter is a torqueable, rapid-exchange balloon catheter used for percutaneous transluminal coronary angioplasty. Device features a semi-compliant balloon, braid-reinforced shaft, and hydrophilic coating for torque transmission. Compatible with 0.014" coronary guide wires and 6F guide catheters. Operated by physicians in clinical settings to dilate stenotic coronary arteries or bypass grafts. Inflation is achieved via a luer-connected inflation device at the proximal hub. Radiopaque markers assist in positioning. By expanding the balloon at specific pressures, the device restores vessel patency, improving myocardial perfusion and potentially reducing ischemic symptoms in patients with coronary artery disease.

Clinical Evidence

Bench testing only. Performance testing included dimensional verification, balloon preparation/deployment/retraction, flexibility/kink testing, rated burst pressure, fatigue, compliance, inflation/deflation, bond strength, tip pull, torque strength, radiopacity, coating integrity, particulate evaluation, and extensive biocompatibility testing (hemolysis, platelet/leucocyte counts, PTT, thromboresistance, complement activation, cytotoxicity, sensitization, and pyrogenicity).

Technological Characteristics

Rapid-exchange PTCA catheter; 135 cm length; semi-compliant balloon; braid-reinforced shaft; hydrophilic coating; hypotube proximal design; radiopaque markers. Compatible with 0.014" guidewires and 6F guide catheters. Sterile, single-use. Testing performed per FDA Guidance Class II Special Controls for PTCA Catheters (Sept 2010).

Indications for Use

Indicated for balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion in patients requiring percutaneous transluminal coronary angioplasty.

Regulatory Classification

Identification

Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.

Special Controls

*Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b) *Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.

Predicate Devices

• Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019
• EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133

Submission Summary (Full Text)

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MAR - 2 2012

# 5. 510(k) Summary

### Submitter's Name / Contact Person

| Submitter: | TriReme Medical, Inc.<br>7060 Koll Center Parkway, Suite 300<br>Pleasanton, CA 94566 U.S.A. |
|-----------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Shiva Ardakani<br>VP of Regulatory, Quality & Clinical<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 22, 2012 |

### General Information

| Trade Name: | Glider™ PTCA Balloon Catheter |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name: | PTCA catheter |
| Product Code: | LOX |
| Classification Name: | Percutaneous transluminal coronary angioplasty (PTCA) catheter<br>[21 CFR 870.5100(a)] |
| Predicate Device: | Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019<br>EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133 |

### Device Description

The Glider PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 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 and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braidreinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and 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 PTCA Balloon Catheter is supplied sterile and intended for single use.

## Intended Use / Indications

The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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# Technological Characteristics/Performance Testing/Substantial Equivalence

The Glider PTCA Balloon Catheter is substantially equivalent to the predicate device in intended use, indications for use, fundamental scientific technology, and important performance specifications. The device was subjected to the following performance tests according to FDA Guidance Class II Special Controls for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010):

- Dimensional Verification .
- Balloon Preparation, Deployment & Retraction .
- Flexibility & Kink .
- Balloon Rated Burst Pressure (RBP) .
- Balloon Fatigue .
- Balloon Compliance .
- Balloon Inflation and Deflation .
- . Catheter Bond Strength
- Tip Pull Test .
- . Torque Strength
- Radiopacity .
- Catheter Coating Integrity ◆
- . Particulate Evaluation
- Biocompatibility Testing Including: .
- 1. Hemolysis Assay Direct Contact
- 2. Hemolysis Assay Extract Method
- 3. Platelet & Leucocyte Counts
- 4. Partial Thromboplastin Time
- 5. Thromboresistance
- 6. Complement Activation C3a and SC5b-9 Assay
- 7. MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
- 8. Intracutaneous Reactivity Test
- 9. Guinea Pig Maximization Sensitization Test
- 10. Materials Mediated Rabbit Pyrogen Test
- 11. Acute Systemic Injection Test

No new questions of safety or effectiveness were identified during device testing; therefore, the Glider PTCA Balloon Catheter is considered substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAR - 2 2012

TriReme Medical, Inc. c/o Ms. Shiva Ardakani Vice President of Regulatory, Quality & Clinical 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

K111544 Re:

Trade Name: Glider™ PTCA Balloon Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: II (two) Product Code: LOX Dated: February 15, 2012 Received: February 16, 2012

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, 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 - Ms. Shiva Ardakani

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" (21 CFR 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. Hillebrand

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

Enclosures

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# Indications for Use

#### KIII544 510(k) Number (if known):

Device Name:

Glider™ PTCA Balloon Catheter

Indications for Use:

The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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)

M.g. Kelleher

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(Division Sian-Off) Division of Čardiovascular Devices

K1115-44 510(k) Number