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.

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 braidreinforced 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.

AI/ML Overview

The provided text describes the 510(k) summary for the Glider™ PTCA Balloon Catheter. This device is a medical instrument and its evaluation focuses on physical performance and biocompatibility, not on AI/ML algorithm performance. Therefore, many of the requested categories related to AI/ML studies (such as sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this document.

Here's the information that can be extracted from the provided text, adapted for a medical device that doesn't involve AI/ML:

Acceptance Criteria and Device Performance

The device performance was evaluated against the "FDA Guidance Class II Special Controls for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)." This guidance document specifies the acceptance criteria for the various performance tests. The given document states that the device was subjected to these tests and no new questions of safety or effectiveness were identified, implying that the device met the established acceptance criteria.

Acceptance Criterion (Test Name)	Reported Device Performance
Dimensional Verification	Met criteria as no new safety/effectiveness issues identified.
Balloon Preparation, Deployment & Retraction	Met criteria as no new safety/effectiveness issues identified.
Flexibility & Kink	Met criteria as no new safety/effectiveness issues identified.
Balloon Rated Burst Pressure (RBP)	Met criteria as no new safety/effectiveness issues identified.
Balloon Fatigue	Met criteria as no new safety/effectiveness issues identified.
Balloon Compliance	Met criteria as no new safety/effectiveness issues identified.
Balloon Inflation and Deflation	Met criteria as no new safety/effectiveness issues identified.
Catheter Bond Strength	Met criteria as no new safety/effectiveness issues identified.
Tip Pull Test	Met criteria as no new safety/effectiveness issues identified.
Torque Strength	Met criteria as no new safety/effectiveness issues identified.
Radiopacity	Met criteria as no new safety/effectiveness issues identified.
Catheter Coating Integrity	Met criteria as no new safety/effectiveness issues identified.
Particulate Evaluation	Met criteria as no new safety/effectiveness issues identified.
Biocompatibility Testing (11 specific tests listed)	Met criteria as no new safety/effectiveness issues identified.

Study Details (Non-AI/ML focused):

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (e.g., number of catheters tested) for each physical performance and biocompatibility test. It only lists the types of tests performed.
- Data Provenance: The testing was presumably conducted by TriReme Medical, Inc. or a contracted lab, as part of their submission to the FDA. The country of origin for the data is not specified, but the submitter is based in Pleasanton, CA, U.S.A. The studies are by nature prospective, as the device was manufactured and then tested to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to a physical medical device like a PTCA catheter. "Ground truth" in this context would refer to the objective, measurable outcomes of the physical tests (e.g., actual burst pressure, measured dimensions). These are determined by laboratory equipment and standardized procedures, not by expert consensus in an observational or diagnostic context.
Adjudication method for the test set:
- Not applicable for physical performance and biocompatibility testing. Results are typically quantitative and objective measurements against predefined specifications.
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 as this is a physical medical device, not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device, not an AI/ML algorithm.
The type of ground truth used:
- For physical performance tests, the "ground truth" is established by the objective measurement of physical properties (e.g., direct measurement of dimensions, pressures, forces) against engineering specifications and regulatory guidance.
- For biocompatibility tests, the "ground truth" is established by laboratory assays and biological testing outcomes (e.g., observation of cell viability, measurement of hemolysis rates) against established biocompatibility standards and limits.
The sample size for the training set:
- Not applicable as this is a physical medical device. The concept of a "training set" is relevant for AI/ML models. For a physical device, development typically involves iterative design, prototyping, and testing, but not a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable as this is a physical medical device.

Summary

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MAR - 2 2012

5. 510(k) Summary

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:	February 22, 2012

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:	Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133

Device Description

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 braidreinforced 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.

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.

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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 Perculaneous 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 ◆
. Particulate Evaluation
Biocompatibility Testing Including: .
- 1. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 2 2012

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

K111544 Re:

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: February 15, 2012 Received: February 16, 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 (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.A. Hillebrand

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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Indications for Use

KIII544 510(k) Number (if known):

Device Name:

Glider™ PTCA Balloon Catheter

Indications for Use:

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.

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)

M.g. Kelleher

Page 1 of 1

(Division Sian-Off) Division of Čardiovascular Devices

K1115-44 510(k) Number

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.