.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI

K993257 · Micro Therapeutics, Inc. · DQX · Oct 21, 1999 · Cardiovascular

Device Facts

• Record ID: K993257
• Device Name: .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
• Applicant: Micro Therapeutics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 21, 1999
• Decision: SESE
• Submission Type: Special
• 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 stainless steel guidewire featuring a radiopaque platinum distal coil; hydrophilic coating applied from the shapeable coil to the proximal 30cm. Device includes a torque device for manipulation and a guidewire introducer for catheter hub/hemostasis valve insertion. Used by clinicians in clinical settings for selective catheter placement in peripheral, visceral, and cerebral vasculature. Operates as a mechanical guide to facilitate navigation through the vascular system during diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs) device. In-vitro performance testing included dimensional inspection, tensile strength, torque strength, flexibility, trackability, particulate, and catheter compatibility.

Technological Characteristics

Stainless steel guidewire with radiopaque platinum distal coil. Hydrophilic coating on distal portion and proximal 30cm. Includes torque device and introducer. Biocompatibility per ISO 10993-1.

Indications for Use

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.

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

• Micro Therapeutics, Inc. .010" SilverSpeed™ Hydrophilic Guidewire
• B. Braun Guidewire Introducer & Guidewire Torque Device

Submission Summary (Full Text)

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K993257

OCT 21 1999

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## 510(k) Summary of Safety and Effectiveness SilverSpeed™ Hydrophilic Guidewire

Prepared September 23, 1999

| Trade Name: | SilverSpeed TM Hydrophilic Guidewire (.014", .016" and .018") | | |
|---------------|----------------------------------------------------------------|-----------------|-------------------------------------------------------|
| Generic Name: | Guidewire, Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, CA 92618 | Contact: | Tom Daughters<br>Regulatory Affairs<br>[phone] |

#### Predicate Devices

Micro Therapeutics, Inc. . 010" SilverSpeed™ Hydrophilic Guidewire B. Braun Guidewire Introducer & Guidewire Torque Device

#### Device Description

The SilverSpeed™ Hydrophilic Guidewire is a 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 introducer to ease the 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 Evaluation 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, torque strength, flexibility, trackability, particulate and catheter compatibility tests. All testing of the product yielded acceptable results substantially equivalent to the predicate device.

#### Summary of Substantial Equivalence

The SilverSpeed Hydrophilic Guidewire and accessories are substantially equivalent to the predicate device in intended use and principle of operation.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re : K993257 SilverSpeed Hydrophilic Guidewire Trade Name: Requlatory Class: II Product Code: DQX Dated: September 23, 1999 Received: September 29, 1999

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 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 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 - Mr. Tom Daughters

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 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 (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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,

Wally Siposkin MD

Wolf Sapirstein, 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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# Attachment 2

# Indications for Use Statement

| 510(k)<br>Number<br>(if known) | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SilverSpeed Hydrophilic Guidewire |
| Indications<br>for Use | The SilverSpeed Hydrophilic Guidewire is indicated for general<br>intravascular use to aid in the selective placement of catheters in the<br>peripheral, visceral and cerebral vasculature during diagnostic and/or<br>therapeutic procedures. |

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801. 109)

Over-The-Counter Use

Christopher Sapirstein

Division of Cardiovascular, Respir and Neurological Device 510(k) Number

File: Special 510k Attachments 09-20-99.doc