The SilverSpeed Hydrophilic 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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (guidewire) and not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document discusses:

Device Description: The SilverSpeed™ Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque platinum distal coil, hydrophilically coated.
Intended Use: For general intravascular use to aid in selective placement of catheters in peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.
Testing:
- Biocompatibility: Verified in accordance with ISO 10993-1. Test results confirmed biocompatibility as an 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 tests.
Substantial Equivalence: The device was found substantially equivalent to a predicate device in intended use and principle of operation.

There is no mention of acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, nor any study on human reader performance with or without AI, as these concepts are specific to AI/ML device evaluations and not relevant to a guidewire's 510(k) submission.

Summary

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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.2 GoodyearIrvine, CA 92618	Contact:	Tom DaughtersRegulatory Affairs(949) 837-3700

Predicate Devices

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

Device Description

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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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 (301) 594-4586. 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 (800) 638-2041 or (301) 443-6597 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)Number(if known)
Device Name	SilverSpeed Hydrophilic Guidewire
Indicationsfor Use	The SilverSpeed Hydrophilic Guidewire is indicated for generalintravascular use to aid in the selective placement of catheters in theperipheral, visceral and cerebral vasculature during diagnostic and/ortherapeutic 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

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.