SILVERSTREAK HYDROPHILIC GUIDEWIRE

K982543 · Micro Therapeutics, Inc. · DQX · Dec 11, 1998 · Cardiovascular

Device Facts

• Record ID: K982543
• Device Name: SILVERSTREAK HYDROPHILIC GUIDEWIRE
• Applicant: Micro Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

Device Story

SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel wire with a radiopaque, platinum distal coil. The device features a hydrophilic coating extending from the shapeable distal coil to the proximal 30cm. It is used by clinicians during intravascular procedures to facilitate the selective placement of catheters within peripheral, visceral, and cerebral vasculature. A torque device is included to assist in manual manipulation and introduction of the guidewire into catheter hubs or hemostasis valves. The device aids in navigating complex vascular anatomy, potentially improving procedural efficiency and catheter positioning accuracy.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in-vivo animal studies. Bench testing included dimensional inspection, tensile strength, flexibility, trackability, and particulate compatibility. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs) devices. Animal studies in rabbit and swine models confirmed performance equivalence to predicate devices.

Technological Characteristics

Stainless steel core; radiopaque platinum distal coil; hydrophilic coating. Dimensions: .010" diameter. Includes torque device for manipulation. Sterilized for single use. Class II device.

Indications for Use

Indicated for patients requiring selective catheter placement in peripheral, visceral, or cerebral vasculature for diagnostic or therapeutic procedures.

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

• Target Therapeutics, Inc. Dasher-10 Guidewire
• Target Therapeutics, Inc (BSC). Transend-10 Guidewire
• B. Braun Guidewire Introducer
• B. Braun Guidewire Torque Device

Submission Summary (Full Text)

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Micro Therapeutics, Inc.

6254.3

DEC 1 1 1998

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510(k) Summary of Safety and Effectiveness

# SilverSpeed™ Hydrophilic Guidewire

Prepared December 9, 1998

| Trade Name: | SilverSpeed™ Hydrophilic Guidewire | | |
|-------------------|----------------------------------------------------------------------------|-----------------|-------------------------------------------------------|
| Generic Name: | Guidewire, Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc.<br>1062-F Calle Negocio<br>San Clemente, CA 92673 | Contact: | Tom Daughters<br>Regulatory Affairs<br>[phone] |
| Predicate Devices | | | |

Target Therapeutics, Inc. Dasher-10 Guidewire Target Therapeutics, Inc (BSC). Transend-10 Guidewire B. Braun Guidewire Introducer B. Braun Guidewire Torque Device

### Device Description

The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introduction of the guidewire into the catheter hub and or hemostasis valve.

## Intended Use

The guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

# Testing

Biocompatibility of the guidewire has been verified in accordance with ISO 10993-1, Biological Eyaluation of Medical Devices. Test results confirmed biocompatibility of the guidewire when tested as an external communicating, blood contact, short duration (<24 hrs.) device.

In-vitro performance testing of the guidewire included dimensional inspection, tensile strength, flexibility, trackability, particulate compatibility tests. All testing of the product yelded acceptable results substantially equivalent to the predicate devices.

In-vivo animal studies were performed to assess the performance of the guidewire of rabbit and swine models. The studies demonstrated that the guidewire is substantially equivalent to the predicate devices.

### Summary of Substantial Equivalence

The SilverSpecd Hydrophilic Guidewire and accessories are substantially equivalent to the predicate devices in intended use and principles of operation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673

Re : K982543 SilverSpeed™ Hydrophilic Guidewire Trade Name: Regulatory Class: II Product Code: DOX November 5, 1998 Dated: November 9, 1998 Received:

Dear Mr. Daughters:

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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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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" (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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510(k) Number (if known): K982543

SilverSpeed™ Hydrophilic Guidewire Device Name:

Indications for Use: The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

A.D. Grantt
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over the Counter Use _ OR Prescription Use (Per 21 CFR 801.109)

Exhibit 7 Page 4