The Bard Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary or peripheral vasculature and may be used to reach and cross a target lesion.

Device Description

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the Bard Hydrophilic Coated Guide Wires, focusing on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria.

The "Performance Data" section states: "Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices. This testing supports the guide wires covered under this 510(k) as they are of the same design and materials of construction. No changes have been made that would warrant additional testing."

This statement indicates that testing was done, but it does not detail the acceptance criteria, the specific performance metrics, the results, or the methodology of those tests. It relies on the concept of "substantial equivalence" to predicate devices (Bard Preamendment Angiographic Guide Wires, Bard PTCA Steerable Standard Guide Wire, Bard Silk Guide Wire, and Terumo Glidewire) rather than presenting new performance data against pre-defined criteria for this specific device.

Therefore, I cannot populate the requested table and sections with information directly from the provided text because these specific details are not available. The document suggests that the device's performance is deemed acceptable because it is substantially equivalent to already approved devices, implying it would meet their implicit performance standards without requiring new, explicit acceptance criteria to be established or proven in this submission.

Summary

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Bard Electrophysiology Division C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851 (800) 282-1332 (978) 441-6202 Fax: (978) 323-2222 BardEP@CRBARD.COM http://www.BardEP.com

BARD

510(k) SUMMARY FOR THE VI. BARD HYDROPHILIC COATED GUIDE WIRES

As required under Section 12, part (a)(1)(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:	55 Technology Drive, Suite 1Lowell, MA 01851
Phone:	(978) 323-2216 (Direct Line)
Fax:	(978) 323-2222

Contact:

Deborah L. Herrington Regulatory Affairs Manager

Date of Summary:

September 3, 1999

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 Hydrophilic Coated Guide Wire

Bard Preamendment Angiographic Guide Wires
Bard PTCA Steerable Standard Guide Wire
Bard Silk Guide Wire

Terumo Glidewire

Image /page/0/Picture/23 description: The image shows the logo for Bard Electrophysiology. The logo consists of a heart shape on the left, followed by the word "Bard" in a larger font and the word "electrophysiology" in a smaller font below it. The heart shape is stylized and has a small circle above it.

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Description and Intended Use of Device:

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 discussed in this 510(k) is similar the Bard Hydrophilic Coated Guide Wires discussed in K974713 which were 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. This testing supports the guide wires covered under this 510(k) as they are of the same design and materials of construction. No changes have been made that would warrant additional testing.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 2 1999

Ms. Deborah L. Herrington Regulatory Affairs Manager C.R. Bard, Inc. 55 Technology Drive, Suite 1 Lowell, MA 01851

Re: K993000 Trade Name: Bard Hydrophilic Coated Guide Wires Regulatory Class: II Product Code: DQX Dated: September 3, 1999 September 7, 1999 Received:

Dear Ms. Herrington:

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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Ms. Deborah L. Herrington

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 (301) Additionally, for questions on the promotion and advertising 594-4586. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Lyneth Jahil for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D. INDICATIONS FOR USE

Bard Hydrophilic Coated Guide Wires Device Name:

Indications for Use:

The Bard Hydrophilic Coated Angiography Guide Wires are indicated for percutaneous entry into a vessel using the Seldinger technique.

Contraindications: None

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use __

L. alml. de Leon 1/1/99

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 993000 510(k) Number

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.