The GliderXtreme™ 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 Description

The GliderXtreme™ 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" and 0.018" 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 intended for guidewire use is contained within the catheter. The balloon catheters are available in Rapid Exchange or Over-The-Wire configuration.

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

AI/ML Overview

The provided 510(k) summary for the GliderXtreme™ PTA Balloon Catheter (K101062) describes the performance data as "Bench testing was performed to support a determination of substantial equivalence." This means the device's performance was evaluated through a series of in vitro tests, not clinical studies involving human or animal subjects. As such, many of the requested categories (e.g., sample size for test set, experts, adjudication, MRMC studies, ground truth for training/test set) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of tests performed but does not explicitly state quantitative acceptance criteria or specific numerical results. It broadly states that "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." And "Performance testing demonstrated that the GliderXtreme™ PTA Balloon Catheter reliably achieved the desired effect and is safe for its intended use."

Test Category	Reported Device Performance
Balloon Rated Burst Pressure	Performed, details not provided.
Balloon Inflation and Deflation	Performed, details not provided.
Balloon Fatigue	Performed, details not provided.
Catheter Body Strength (Bond Strength)	Performed, details not provided.
Torsional Strength	Performed, details not provided.
Catheter Diameter, Balloon Profile and Tip Configuration	Performed, details not provided.
Balloon Compliance	Performed, details not provided.
Trackability, Pushability	Performed, details not provided.
Kink Resistance	Performed, details not provided.
Device Interface Compatibility	Performed, details not provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The studies were bench testing (in vitro/laboratory tests), not clinical studies with patient data.
Data Provenance: Not applicable, as no human data was used. The tests were performed in a lab setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No expert ground truth was established as this was bench testing.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method was used as this was bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not performed. This device is a physical medical device, not a diagnostic algorithm that would typically involve human readers interpreting images.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for a "ground truth" in the diagnostic sense. For each bench test, the "ground truth" or reference was likely defined by engineering specifications, validated test methods, and industry standards for medical device performance. For example, balloon burst pressure would be compared against a predefined burst pressure specification.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of bench testing for a physical device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" or associated ground truth for this type of submission.

Summary

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K101062

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

1. Submitter's Name / Contact Person

Submitter:	TriReme Medical, Inc.7060 Koll Center Parkway, Suite 300Pleasanton, CA 94566
Contact Person:	Shiva ArdakaniVP of RA/QAPhone: 925-931-1300 Ext 209Fax: 925-931-1361
Date Prepared:	May 4, 2010

General Information

Trade Name:	GliderXtreme™ 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)Sterling ES MR and OTW PTA Balloon Dilatation Catheters

MAY 12 2010Balloon Dilatation Catheters (K080982)

EverCross .035" OTW PTA Dilatation Catheter (K082579)

3. Intended Use

1. Device Description
  The GliderXtreme™ 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" and 0.018" guidewires and 5F introducer sheaths (or 6F guide catheters). Overall catheter length is approximately 135 cm.

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devices. A second lumen intended for guidewire use is contained within the catheter. The balloon catheters are available in Rapid Exchange or Over-The-Wire configuration.

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

1. 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 ◆

ર્ભ . Substantial Equivalence Comparison and Conclusion

All GliderXtreme™ 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 GliderXtreme™ 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 GliderXtreme™ PTA Balloon Catheters are considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing a symbol of health or 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

MAY 1 2 2010

Re: K101062

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: May 10, 2010 Received: May 11, 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 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 -- 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

er R. lahmen

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 (K094049): K i U (06 2

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.

The indication for use is same for all Glider 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

unner R. Vc. Anner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).