GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE by TRIREME MEDICAL, INC.

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 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.

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

AI/ML Overview

The provided text describes a medical device, the GliderfleX™ PTA Balloon Catheter, seeking 510(k) clearance from the FDA. The document outlines its intended use, device description, and performance data from bench testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it lists the types of in vitro bench tests performed and then concludes with a general statement about the results. The "reported device performance" is a high-level summary that the device "reliably achieved the desired effect and is safe for its intended use" and that "no new questions of safety or effectiveness were identified."

Acceptance Criteria (Test Type)	Reported Device Performance
Balloon Rated Burst Pressure	Met expectations
Balloon Inflation and Deflation	Met expectations
Balloon Fatigue	Met expectations
Catheter Body Strength (Bond Strength)	Met expectations
Torsional Strength	Met expectations
Catheter Diameter, Balloon Profile and Tip Configuration	Met expectations
Balloon Compliance	Met expectations
Trackability, Pushability	Met expectations
Kink Resistance	Met expectations
Device Interface Compatibility	Met expectations

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each of the bench tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically not applicable to purely in vitro bench testing of a device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The study described is an in vitro bench test of the device's physical and mechanical properties. There is no "ground truth" derived from expert interpretation of clinical data in this context. The "ground truth" is established by the specifications and engineering requirements of the device itself.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are relevant in studies involving human interpretation or clinical outcomes, which are not detailed in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes in vitro bench testing of the physical properties of the device, not a study involving human readers or clinical cases.

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

This question is not applicable to the GliderfleX™ PTA Balloon Catheter. This is a physical medical device (catheter), not a software algorithm or AI system. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and industry standards for balloon catheters. The bench tests evaluated the device's ability to meet predefined physical and mechanical properties, not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for a physical medical device undergoing in vitro bench testing. Training sets are typically used in machine learning or AI algorithm development.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" mentioned or implied by the described studies.

Summary

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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.7060 Koll Center Parkway, Suite 300Pleasanton, CA 94566	JAN - 5 2011
Contact Person:	Shiva ArdakaniVP of RA/QAPhone: 925-931-1300 Ext 209Fax: 925-931-1361
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)

1. Intended Use

1. 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.

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The GliderfleX™ 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 .
1. 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with flowing lines representing health and well-being.

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K103534

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).