BARD HYDROPHILLIC COATED GUIDE WIRE

K974713 · C.R. Bard, Inc. · DQX · Oct 14, 1998 · Cardiovascular

Device Facts

• Record ID: K974713
• Device Name: BARD HYDROPHILLIC COATED GUIDE WIRE
• Applicant: C.R. Bard, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Device Story

Bard Hydrophilic Coated Guide Wire; steerable wire designed for percutaneous catheter navigation. Used in coronary and peripheral vasculature to facilitate placement of diagnostic or interventional devices and cross target lesions. Operated by clinicians in clinical settings. Device functions as mechanical guide; hydrophilic coating reduces friction during vessel navigation. Substantially equivalent to existing Bard and Terumo guide wires.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance testing performed to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Hydrophilic coated guide wire; materials and construction similar to predicate Bard and Terumo guide wires. Mechanical device; no energy source or software. Sterilization method not specified.

Indications for Use

Indicated for percutaneous vessel entry via Seldinger technique (Angiography wires) and introduction/placement of diagnostic or interventional devices in coronary and peripheral vasculature to reach/cross target lesions (PTCA wires). No specific age/gender restrictions; no contraindications listed.

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

• Bard® Preamendment Angiographic Guide Wires
• Bard® PTCA Steerable Standard Guide Wire
• Bard® Silk™ Guide Wire
• Terumo Glidewire™

Submission Summary (Full Text)

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C.R. Bard, Inc. Requlatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821 508-667-2511 FAX: [phone]

K974713

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# SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

As required under Section 12, part (a)(I)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

# General Information

| Submitter Information: | |
|------------------------------|-----------------------------------------------------------------------------------------|
| Name: | C.R. Bard, Inc. |
| Address: | 129 Concord Road, Billerica, MA 01821 |
| Phone: | [phone] extension 4131 |
| Fax: | [phone] |
| Contact: | |
| Fred Boucher | |
| Regulatory Affairs Manager | |
| Date of Summary: | |
| December 16, 1997 | |
| Name of Device: | |
| | Bard® Hydrophilic Coated Guide Wire |
| Common/Usual Name of Device: | |
| Catheter Guide Wire | |
| Device Classification: | |
| | 21 CFR 870.1330 |
| Predicate Device(s): | |
| | Bard® Preamendment Angiographic Guide Wires<br>Bard® PTCA Steerable Standard Guide Wire |
| | Bard® Silk™ Guide Wire |
| | Terumo Glidewire™ |

Image /page/0/Picture/8 description: The image shows the word "BARD" in a stylized, blocky font. The letters are thick and outlined in black, with the interior of the letters being white. The font style gives the word a bold and somewhat retro appearance.

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## Description and Intended Use of Device: �

The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

#### Technological Characteristics Summary: �

The Bard Hydrophilic Coated Guide Wire is similar to the Terumo Glidewire regarding materials and construction, and is similar to Bard Silk Guide Wires, Bard Angiography Guide Wires and Bard PTCA Steerable Standard Guide Wire regarding materials and construction, packaging and sterilization. The indications for use are similar to both Terumo Glidewire and the Bard Guide Wires. They are all indicated for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

#### � Performance Data:

Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices.

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Public Health Service

OCT 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred L. Boucher Requlatory Affairs Manager Bard Cardiology Division C.R. Bard, Inc. 129 Concord Road P.O. Box 566 Billerica, MA 01821

Re: K974713 Bard® Hydrophilic Coated Guide Wires Trade Name: Requlatory Class: II Product Code: DQX Dated: July 16, 1998 Received: July 16, 1998

Dear Mr. Boucher:

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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this

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Paqe 2 - Mr. Fred Boucher

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 leqally 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 requlation (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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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

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## Indications For Use D.

Device Name: Hydrophilic Coated Guide Wire Indications for Use: Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. None Contraindications:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tn A. D

(Division Sign-Off) Division of Cardiovascula and Neurological Devic 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

Over-the Counter Use OR

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