GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX

{0}------------------------------------------------ K112281 page 1 of 2 TriReme Medical, Inc. 2. PTA Balloon Catheter Family Special 510(k) Notification AUG 1 7 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: 925-931-1300 Ext 209<br>Fax: 925-931-1361 | | Date Prepared: | July 20, 2011 | General Information | Trade Name: | GliderXtreme™ PTA Balloon Catheter and 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: | VascuTrak PTA Dilatation Catheter (K082343) | | | EverCross 0.035" OTW PTA Dilatation Catheter (K082519) | | | GliderXtreme PTA Balloon Catheter (K101062) | | | GliderfleX PTA Balloon Catheter (K103534) | - 3. Intended Use The PTA Balloon Catheter family 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. - 4. Device Description All of the devices in the PTA Balloon Catheter family, including the GliderXtreme PTA Balloon Catheter and the GliderfleX PTA Balloon Catheter consist of a standard balloon dilatation catheter on a braided shaft with or without a hypotube and an atraumatic, tapered and beveled tip. The devices are compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F or 6F introducer sheath (or 6F or 7F guide catheter). Overall catheter lengths are approximately 100 cm to 150cm. The distal end 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. {1}------------------------------------------------ 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. All PTA Balloon Catheters in the family are supplied sterile and intended for single use only. - ર. 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 - Substantial Equivalence Comparison and Conclusion 6. The additional balloon sizes of the GliderXtreme™ and 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 devices 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, additional sizes of the GliderXtreme™ and GliderfleX™ PTA Balloon Catheters are considered substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 TriReme Medical, Inc. c/o William Sammons Intertek Testing Services NA, Inc. 2307 E Aurora Rd, Unit B7 Twinsburg, OH 44087 AUG 17 2011 Re: K112281 Trade/Device Name: GliderXtreme and GliderfleX PTA Balloon Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, LIT Dated: 8 August 2011 Received: 9 August 2011 Dear Mr. Sammons: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave review your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conimers prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vious hat have been that do not require approval of a premarket approval application (PMA). and Oosmetie Prov, roof the device, subject to the general controls provisions of the Act. The r our may, mereleve, mains 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 additerior. Thease noter u, 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 fray be subject de of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. William Sammons 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, iL Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## PTA Balloon Catheter Family Special 510(k) Notification ## Indications for Use 510(k) Number (XXXXX): Kリススタ | Device Name: GliderXtreme PTA Balloon Catheter and GliderfleX PTA Balloon Catheter Indications for Use: The PTA Balloon Catheter Family of devices, including the GliderXtreme PTA Balloon Catheter and the GliderfleX PTA Balloon Catheter are intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, illo-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature. The indication for use is same for all devices in the 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) 510(k) Numbe LL evices Page 4-1