To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices.

Device Description

The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in 175 cm and 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TORQUE PILOT™ 200 Guide Wires). The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter. The proximal section of the wire is coated with polytetrafluroethylene (PTFE). The distal, polyurethane-covered area, of the wire is coated with hydrocoat hydrophilic coating.

AI/ML Overview

The provided text is a 510(k) summary for guide wires and does not contain information about acceptance criteria or a study proving that a device meets those criteria. It states that "The results of the verification testing demonstrate that the HI-TORQUE PILOT™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program." However, it does not elaborate on what those acceptance criteria are, what specific performance metrics were measured, or details about the study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the input text. The information is not present in the document.

Summary

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Appendix A – 510(k) Summary

Submitter	Guidant Corporation, Vascular Intervention
Submitter'sAddress	26351 Ynez RoadTemecula, CA 92591
Telephone	(909) 914-4527
Fax	(909) 914-0339
Contact Person	Stacey Brown
Date Prepared	February 20, 2003
Device TradeName	HI-TORQUE PILOT™ 50 Guide Wire with Hydrocoat Hydrophilic CoatingHI-TORQUE PILOT™ 150 Guide Wire with Hydrocoat Hydrophilic CoatingHI-TORQUE PILOT™ 200 Guide Wire with Hydrocoat Hydrophilic Coating
DeviceCommon Name	Guide Wire
DeviceClassificationName	Guide Wire Catheter
DeviceClassification	Class II
Summary ofsubstantialequivalence	The design, materials, method of delivery and intended use features of theHI-TORQUE PILOT™ Guide Wires with Hydrocoat Hydrophilic Coating aresubstantially equivalent with regard to these features in the predicate device,the HI-TORQUE WHISPER™ MS Guide Wire with Hydrocoat HydrophilicCoating (K002206, August 24, 2000; K013092, December 13, 2001; andK020340, March 1, 2002).

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Devicedescription	The HI-TORQUE PILOT™ Guide Wire with Hydrocoat HydrophilicCoating is a guide wire with a maximum diameter of 0.0140" and is availablein 175 cm and 190cm extendable lengths and a 300 cm exchange length.
	There are three HI-TORQUE PILOT™ Guide Wire designs with varyingtip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150,and HI-TORQUE PILOT™ 200 Guide Wires).
	The distal tip of the guide wire is available either as a straight tip that isshapeable, or as a pre-shaped "J". The straight shape allows the physicianto shape the tip according to his/her preference; the J shapes provide thephysician the convenience of a J shape without manual shaping. Brachialand femoral markers are located on the proximal segment of the 190 cmand 300 cm guide wires to indicate when the tip of the guide wire is aboutto exit the guide catheter.
	The proximal section of the wire is coated with polytetrafluroethylene(PTFE). The distal, polyurethane-covered area, of the wire is coated withhydrocoat hydrophilic coating.
Intended Use	To facilitate the placement of balloon dilatation catheters during percutaneoustransluminal coronary angioplasty (PTCA) and percutaneous transluminalangioplasty (PTA) and compatible stent devices.
Technologicalcharacteristics	The HI-TORQUE PILOT™ Guide Wire incorporates the same fundamentalscientific technology as the predicate device.
Performancedata	The results of the verification testing demonstrate that the HI-TORQUEPILOT™ Guide Wires meet the established acceptance criteria and performsin a manner equivalent to the predicate device. No new safety or effectivenessissues were raised during the testing program.

・・・・・・・・・

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Guidant Corporation Ms. Stacey Brown Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628

Re: K030549

Trade/Device Name: HI-TOROUE PILOT™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 15, 2003 Received: April 16, 2003

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Stacey Brown

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Bram D. Zuckerman, M.D.

am D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix B – Indications for Use Statement

510(k) number (if known)	K030549
Device name	HI-TORQUE PILOT TM 50 Guide Wire with Hydrocoat Hydrophilic CoatingHI-TORQUE PILOT TM 150 Guide Wire with Hydrocoat Hydrophilic CoatingHI-TORQUE PILOT TM 200 Guide Wire with Hydrocoat Hydrophilic Coating
Intended Use	To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices.

PLEASE DÓ NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)
	(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K030549

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.