LUGE GUIDE WIRE

K973945 · Scimed Life Systems, Inc. · DQX · Jan 12, 1998 · Cardiovascular

Device Facts

• Record ID: K973945
• Device Name: LUGE GUIDE WIRE
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Device Story

The SCIMED Luge Guide Wire is a sterile, single-use intravascular device designed to facilitate the placement and exchange of therapeutic catheters, such as balloon dilatation catheters, during PTCA or other interventional procedures. It is operated by a physician in a clinical setting. The device functions as a mechanical guide within the vasculature to navigate therapeutic tools to a target site. It is not intended for use in the cerebral vasculature. The device is provided sterile for one-time use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

The device utilizes the same materials and methods of construction as the predicate SCIMED guide wire families. It is a sterile, single-use intravascular guide wire.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring the placement and exchange of balloon dilatation catheters or other therapeutic devices. Not indicated for use in the cerebral vasculature.

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

• SCIMED ChoICE Guide Wire
• SCIMED Sceptor Guide Wire
• SCIMED ChoICE PT Family of Guide Wires

Submission Summary (Full Text)

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510(k) Notification SCIMED® Luge™ Guide Wire

| Summary of Safety and Effectiveness, cont. | | Section 4 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| JAN 12 1998 | | |
| Intended Use | The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only. | |
| Summary of<br>Technological<br>Characteristics | The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires). | |
| Non-Clinical Test<br>Summary | The Luge Guide Wire is considered to be substantially equivalent to the currently marketed ChoICE, Sceptor and ChoICE PT Families of Guide Wires based on a comparison of the intended uses and designs and results of the testing and evaluations performed. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

Ms. Jill Townsend Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566

Re : K973945 SCIMED® Luge™ Guide Wire Requlatory Class: II (two) Product Code: DQX October 15, 1997 Dated: Received: October 16, 1997

Dear Ms. Townsend:

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 reqistration, 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 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 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.

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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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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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K973926
n/a

510(k) Number (if known):

Dental Implant Endosseous Device Name:

Indications For Use:

"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ewald Shipp

(Division Sian-Off and Ga 510k) Nu

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)