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.

Device Description

The Glider™ 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" 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 within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip.

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

AI/ML Overview

Here's an analysis of the provided text regarding the TriReme Medical Glider™ PTA Balloon Catheter:

The provided document is a 510(k) Summary and related FDA correspondence for a medical device. It does not contain information about acceptance criteria, device performance metrics, or a study that specifically "proves the device meets acceptance criteria" in the way one would describe an AI/software-as-a-medical-device (SaMD) study.

This document describes a physical medical device (a balloon catheter) and its clearance through the FDA's 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel clinical effectiveness through large-scale trials with predefined acceptance criteria.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission. I will address the points that can be inferred or explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/SaMD device. For physical devices like this catheter, "acceptance criteria" are typically related to engineering specifications (e.g., burst pressure, fatigue resistance, dimensional accuracy) and "performance" refers to how the device meets these specifications during bench testing. This document states "Bench testing was performed... 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." However, specific quantifiable acceptance criteria and their corresponding reported values are not disclosed in this summary. The FDA's 510(k) summary typically doesn't detail these engineering specifics.

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

Not applicable for a clinical test set in the context of AI/SaMD. The "test set" here would refer to the physical devices subjected to bench testing. The sample size for these engineering tests is not provided in the summary. Data provenance is not relevant in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for a physical device. "Ground truth" as it relates to expert consensus for image annotation or clinical diagnosis is not relevant for the bench testing of a physical catheter.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for AI/SaMD, to establish ground truth from expert opinions. This is not relevant for bench testing of a physical device.

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

No. An MRMC study is a type of clinical trial often used for diagnostic devices (including AI/SaMD) to compare the performance of human readers with and without AI assistance. This document describes a physical interventional device, and no such study is mentioned or implied.

6. If a Standalone (Algorithm Only) Performance Study was done

No. This question is exclusively applicable to AI/SaMD.

7. The Type of Ground Truth Used

Not applicable for a clinical ground truth. For the bench testing of this physical device, the "ground truth" would be established by objective, measurable physical properties and engineering standards (e.g., pressure sensors for burst pressure, calipers for dimensions, flow meters for fluid dynamics). It's based on physical measurements against pre-defined engineering specifications, not expert consensus or pathology in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This question exclusively applies to AI/SaMD.

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

Not applicable. This question exclusively applies to AI/SaMD.

Summary of what can be extracted from the document:

Device Name: Glider™ PTA Balloon Catheter
Intended Use: Balloon dilatation of lesions in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries), not for coronary or cerebral vasculature.
Regulatory Pathway: 510(k) Premarket Notification.
Basis for Clearance: Substantial equivalence to predicate devices (NanoCross PTA Dilatation Catheter (K090849) and Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)).
Evidence of Performance: "Bench testing was performed... 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."
Conclusion: "Performance testing and biocompatibility testing demonstrated that the Glider™ 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."

Key Takeaway: This document is about the regulatory clearance process for a physical medical device. The types of "acceptance criteria" and "studies" you're asking about are more typical for AI/Software as a Medical Device (SaMD) or clinical trial reports, which differ significantly from a 510(k) summary for a physical product.

Summary

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109 4019.

TriReme Medical

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

Submitter's Name / Contact Person -

Submitter:

TriReme Medical. Inc. 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

FEB 1 2 2010

Contact Person:	Eitan Konstantino, Ph.D.
	President & CEO
	Phone: 925-931-1300
	Fax: 925-931-1361

Date Prepared: November 23, 2009

1. General Information

Trade Name:	Glider™ PTA Balloon Catheter
Common/Usual Name:	Angioplasty Catheter
Classification Name:	Percutaneous Catheter (21 CFR 870.1250)
Product Code:	DQY / LIT

Predicate Devices:

NanoCross PTA Dilatation Catheter (K090849)

Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)

3. Intended Use

4. Device Description

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

7060 Koll Center Parkway, Suite 300

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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.

Substantial Equivalence Comparison and Conclusion 6.
The Glider™ PTA Balloon Catheter is substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. Performance testing and biocompatibility testing demonstrated that the Glider™ 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, the Glider™ PTA Balloon Catheter is considered substantially equivalent to the predicate devices.

friReme Medical

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health 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

FEB 1 2 2010

Re: K094019

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: February 1, 2010 Received: February 2, 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 fram of 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,

vunia R. Vi mener

ABram 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):

Device Name: Glider™ PTA Balloon Catheter

Indications for Use:

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)

R. Vihnes

ivision Sign-UT) Division Sign-Om)
Division of Cardiovascular Devices

510(k) Number K094014

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).