The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.

Device Description

The Clyde Coronary Guidewire is a 0.014" guidewire manufactured in lengths of 100-400 cm. The guidewire is made of a stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil. The distal 3 cm of the coil are very flexible and shapeable.

AI/ML Overview

The provided text (K970528) describes a 510(k) submission for the "Clyde Coronary Guidewire." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance as would typically be seen for a new technology or algorithm.

Therefore, many of the typical clinical study parameters requested (such as acceptance criteria table, sample sizes, expert qualifications, MRMC study, standalone performance, ground truth types, and training set details) are not applicable or not present in this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (C-Thru Coronary Guidewire) based on design, materials, and intended use, rather than meeting specific quantifiable performance metrics through a clinical or algorithmic study with acceptance criteria.
The "performance" discussed is related to the similarity in technological characteristics and a reduced biocompatibility battery.

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

Not applicable. This submission doesn't describe a "test set" in the context of a performance study with patient data or an algorithmic evaluation. The assessment is primarily based on a comparison of device specifications and limited in-vitro testing.

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

Not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy or clinical outcome for this type of device submission. The evaluation is on the physical and material properties of the guidewire.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, not performed, and not applicable. This is a medical device (guidewire), not an AI/imaging diagnostic device. Therefore, a study involving human readers and AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, not performed, and not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no "ground truth" in the sense of a reference standard for diagnostic performance. The "truth" in this context is the technical equivalence to a legally marketed device and compliance with material safety (biocompatibility).

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an algorithm requiring machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary of Information from the Provided Text:

The document describes a 510(k) submission for a coronary guidewire, not an AI or diagnostic imaging device. The primary method for demonstrating safety and effectiveness is by proving substantial equivalence to a currently marketed predicate device.

Key takeaway from the provided information:

Predicate Device: C-Thru Coronary Guidewire
Method of Equivalence: Detailed comparison of design and materials between the Clyde and C-Thru coronary guidewires.
Biocompatibility Testing: A reduced biocompatibility battery (consisting of hemolysis and cytotoxicity tests) was conducted due to the similarity in materials with the predicate device. The results indicated equivalence and safety.

This type of submission relies on showing that the new device is fundamentally similar to an already approved device, meaning it doesn't raise new questions of safety or effectiveness. Therefore, the detailed performance study parameters typically requested for new diagnostic algorithms or novel therapeutic devices are not present.

Summary

{0}------------------------------------------------

K970528

JUN 10-1997

510(k) Summary for Clyde Coronary Guidewire

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is

Date Prepared:	February 10, 1997
Sponsor:	Schneider (Europe) AG
	Ackerstrasse 6
	PO Box CH-8180
	Bulach, Switzerland
Contact:	Rudolf Ott
	V.P. Clinical and Regulatory Affairs
	Phone: 011-411-8721179
Trade/Proprietary Name:	Clyde Coronary Guidewire
Classification:	Class II
Equivalent Devices	C-Thru Coronary Guidewire

Device Description

Intended Use

The Clyde Coronary Guidewire is intended to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.

Technological Characteristics

Equivalence in technological characteristics was substantiated by a detailed comparison of the Clyde and C-Thru coronary guidewire design and materials. Because of the similarity in materials a reduced biocompatibility battery, consisting of hemolysis and cytotoxicity, was conducted.

The results of these comparisons indicated that the Clyde coronary guidewire is equivalent to the C-Thru coronary guidewire and is, therefore, safe for the intended use.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, arranged in a row. The profiles are simple and abstract, with only the basic outline of the face visible. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1997

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Mr. R. Ott Vice-President Clinical and Requlatory Affairs Schneider (Europe) AG Pfizer Hospital Products Group Ackerstrasse 6, P.O. Box CH-8180 Bulach/Switzerland

Re: K970528 CLYDE™ Coronary Guidewire Regulatory Class: II (two) Product Code: DOX Dated: May 26, 1997 Received: May 28, 1997

Dear Mr. Ott:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

{2}------------------------------------------------

regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ત્વ

{3}------------------------------------------------

510(k) Number (if known):

Device Name:

Clyde Coronary Guidewire

Indications for Use:

The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tuf. Re.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1970224 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.