CLYDE CORONARY GUIDEWIRE

K970528 · Schneider (Europe) GmbH · DQX · Jun 10, 1997 · Cardiovascular

Device Facts

• Record ID: K970528
• Device Name: CLYDE CORONARY GUIDEWIRE
• Applicant: Schneider (Europe) GmbH
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Clyde Coronary Guidewire is a 0.014-inch diameter guidewire, 100-400 cm in length, designed for percutaneous coronary interventions. It features a stainless steel proximal shaft with PTFE coating and a flexible, shapeable distal tip containing a radiopaque tungsten spring coil. Used by interventional cardiologists in a clinical setting, the device is navigated through the vasculature to reach and cross stenotic lesions. By providing a track for the subsequent insertion of a coronary balloon dilation catheter, the guidewire facilitates the dilation procedure. The device is a mechanical tool; it does not involve electronic signals, software, or automated processing.

Clinical Evidence

Bench testing only. Biocompatibility testing, including hemolysis and cytotoxicity, was performed to demonstrate safety.

Technological Characteristics

0.014-inch diameter guidewire; 100-400 cm length. Materials: stainless steel proximal shaft, PTFE coating, radiopaque tungsten spring coil distal tip. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter in patients undergoing coronary intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• C-Thru Coronary Guidewire

Submission Summary (Full Text)

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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: [phone]

**Trade/Proprietary Name:** Clyde Coronary Guidewire
**Classification:** Class II
**Equivalent Devices** C-Thru Coronary Guidewire

## 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.

## 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 10 1997

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

Re: K970528
CLYDE™ Coronary Guidewire
Regulatory Class: II (two)
Product Code: DQX
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

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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 regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,


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

Enclosure

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Page 1 of 1

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)

[Signature]

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number 1970528

Prescription Use ☑ OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)