The Glider™ PTCA Balloon Dilatation 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 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 braid reinforced 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.

The currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.

AI/ML Overview

The provided text describes a 510(k) submission for the Glider™ PTCA Balloon Catheter, focusing on its substantial equivalence to predicate devices and the performance testing conducted. It does not describe a study involving AI, human readers, or the establishment of ground truth by experts in the context of an AI device.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as they relate to an AI device.

The document details the following for the Glider™ PTCA Balloon Catheter:

1. Acceptance Criteria and Device Performance:

The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported numerical results for each test. Instead, it states that "No new questions of safety or effectiveness were identified during device testing." This implies that the device met the implied acceptance criteria for each test to demonstrate substantial equivalence to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Verification (within specified tolerances)	Tested; no new safety/effectiveness issues identified
Balloon Preparation, Deployment & Retraction (functional)	Tested; no new safety/effectiveness issues identified
Flexibility & Kink (adequate)	Tested; no new safety/effectiveness issues identified
Balloon Rated Burst Pressure (RBP) (meets specifications)	Tested; no new safety/effectiveness issues identified
Balloon Fatigue (withstands stress over time)	Tested; no new safety/effectiveness issues identified
Balloon Compliance (expands to known diameters/lengths)	Tested; no new safety/effectiveness issues identified
Balloon Inflation and Deflation (functional)	Tested; no new safety/effectiveness issues identified
Catheter Bond Strength (adequate)	Tested; no new safety/effectiveness issues identified
Tip Pull Test (adequate strength)	Tested; no new safety/effectiveness issues identified
Torque Strength (adequate)	Tested; no new safety/effectiveness issues identified
Radiopacity (visible under fluoroscopy)	Tested; no new safety/effectiveness issues identified
Catheter Coating Integrity (intact)	Tested; no new safety/effectiveness issues identified
Particulate Evaluation (within limits)	Tested; no new safety/effectiveness issues identified
Biocompatibility Testing (Passes all listed tests)	Tested; no new safety/effectiveness issues identified

Biocompatibility Tests listed:

Hemolysis Assay Direct Contact
Hemolysis Assay Extract Method
Platelet & Leucocyte Counts
Partial Thromboplastin Time
Thromboresistance
Complement Activation C3a and SC5b-9 Assay
MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
Intracutaneous Reactivity Test
Guinea Pig Maximization Sensitization Test
Materials Mediated Rabbit Pyrogen Test
Acute Systemic Injection Test

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

The document does not specify the exact sample size for each performance test. It only states that "all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544." The testing appears to be primarily bench testing conducted on physical devices, not clinical data. The data provenance is not explicitly stated as country of origin, but the submission is from TriReme Medical, Inc. based in California, USA, implying the testing was likely conducted in the USA or under US regulations for medical devices. The nature of these tests classifies them as prospective bench tests on manufactured devices, not retrospective analysis of clinical data.

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

Not applicable. This is a premarket notification for a medical device (PTCA Balloon Catheter), not an AI device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the design specifications and established engineering/biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a submission for a physical medical device, not an AI device where human adjudication of results is relevant. The "adjudication" for these tests lies in comparing test results against predefined engineering and regulatory standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document describes a physical medical device (PTCA Balloon Catheter), not an AI-assisted diagnostic or interpretation system.

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 (expert consensus, pathology, outcomes data, etc):

For the performance testing mentioned, the "ground truth" is based on established engineering standards, device specifications (e.g., balloon diameters at specific pressures, bond strengths), and biocompatibility guidelines outlined in FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010). There is no "expert consensus" on clinical cases, pathology, or outcomes data used to establish ground truth for these bench tests.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

Summary

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5. 510(k) Summary

JUN 2 6 2012

Submitter's Name / Contact Person

Submitter:	TriReme Medical, Inc.7060 Koll Center Parkway, Suite 300Pleasanton, CA 94566 U.S.A.
Contact Person:	Shiva ArdakaniVP of Regulatory, Quality & ClinicalPhone: (925) 931-1300Fax: (925) 931-1361
Date Prepared:	June 5, 2011

General Information

Trade Name:	Glider™ PTCA Balloon Catheter
Common/Usual Name:	PTCA Catheter
Product Code:	LOX
Classification Name:	Percutaneous transluminal coronary angioplasty (PTCA) catheter[21 CFR 870.5100(a)]
Predicate Device:	Glider PTCA Balloon Catheter (TriReme Medical) – K111544Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133

Device Description

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diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.

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.

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 Percutaneous 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
o Particulate Evaluation
. Biocompatibility Testing Including:
- l . Hemolysis Assay Direct Contact
- 1. Hemolysis Assay Extract Method
- 1. Platelet & Leucocyte Counts
- 1. Partial Thromboplastin Time
- 1. Thromboresistance
- 1. Complement Activation C3a and SC5b-9 Assay
- 1. MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
- 1. Intracutaneous Reactivity Test
- 1. Guinea Pig Maximization Sensitization Test
- 1. Materials Mediated Rabbit Pyrogen Test
- 1. 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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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 26 2012

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

Re: K121681

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: June 5, 2012 Received: June 7, 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M S Hillemann

r ~ 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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K12168

Indications for Use

510(k) Number (XXXXX):

Device Name: Glider™ PTCA Balloon Catheter

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D).

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)

M. G. Wilhelm

Division Sign-Off) on of Cardiovascular Devices

510(k) Number K 12

Sit

Page 4-1

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. 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.(2)
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.