To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Device Description

The Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires are steerable guide wires available in a maximum diameter of 0.0140" and in lengths of 190 cm DOC® extendable length and a 300 cm exchange length. The distal segment of the guide wire is coated with Hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal end of the guide wire is coated with polytetrafluorethylene (PTFE) and Microglide, which reduces friction of the wire within a catheter.

AI/ML Overview

The provided text describes a 510(k) summary for the HI-TORQUE ADVANCE™ and ADVANCE LITE™ Guide Wires. This is a medical device submission, and the information requested about acceptance criteria and studies (especially those relating to AI, human readers, ground truth, and training sets) is typically found in detailed performance study reports, not in a 510(k) summary. A 510(k) summary aims to establish substantial equivalence to a predicate device, often through bench testing.

Based on the provided text, I can extract the following:

1. A table of acceptance criteria and the reported device performance

The document states: "In vitro bench testing performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet the acceptance criteria and performed comparable to the predicate device." However, the specific acceptance criteria (e.g., tensile strength, friction coefficient, tip flexibility thresholds) and the quantitative reported device performance values are not detailed in this 510(k) summary. It only states that the criteria were met and performance was comparable to the predicate device.

Acceptance Criteria	Reported Device Performance
Details not provided in the document	Met acceptance criteria and performed comparable to the predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the in vitro bench testing. It also does not explicitly state the data provenance (e.g., country of origin) because it's in-vitro bench testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the type of data presented. The study described is in-vitro bench testing of a guide wire, which involves engineering and material science evaluations, not expert-based assessment of medical images or patient conditions to establish "ground truth."

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not what was performed for this device's bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC study or any involvement of AI in this 510(k) summary. This document pertains to the market clearance of a medical device (guide wire) based on its physical performance, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. No algorithm or AI component is mentioned for this medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For in-vitro bench testing, "ground truth" would typically refer to established engineering standards, material specifications, and physical measurements (e.g., force, dimension, friction) using calibrated equipment. The document indicates the device "met the acceptance criteria," implying comparison against such standards, but it doesn't elaborate on the specific nature of these criteria.

8. The sample size for the training set

This question is not applicable as there is no mention of a "training set" for an algorithm. The study is a bench test of a physical medical device.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as point 8.

Summary

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Koboyy9

MAY 30 2006

SECTION 7.0

510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the SMDA of 1990.

1. Submitter's Name:	Guidant Corporation
	Vascular Intervention
2. Submitter's Address:	26531 Ynez Road, Temecula, CA 92591
3. Telephone:	(951) 914-4581
4. Fax:	(951) 914-0339
5. Contact Person:	Jennifer Pae Riggs
6. Date Prepared:	February 17, 2006
7. Device Trade Name:	HI-TORQUE ADVANCE™ and ADVANCE LITE™
	Guide Wires with Hydrocoat Hydrophilic Coating
8. Device Common Name:	Guide Wire
9. Device Classification Name:	Catheter Guide Wire (74DQX)
10. Predicate Device:	ACS 0.014" Hi-Torque Floppy PATHFINDER™
	Guide Wire (cleared November 4, 1991)

11. Device Description:

12. Intended Use:

Technological Characteristics:

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate device.

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Performance Data:

In vitro bench testing performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet the acceptance criteria and performed comparable to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires may be considered substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three wavy lines below it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 30 2006

Guidant Corp. c/o Ms. Jennifer Pae Riggs Principal Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591

K060449 Re:

Hi-Torque (HT) ADVANCE™ and ADVANCE LITE™ Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: May 8, 2006 Received: May 9, 2006

Dear Ms. Riggs:

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.

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Page 2 - Ms. Jennifer Pae Riggs

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 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 (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours.

Duma R- lochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health 11.00

Enclosure

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INDICATION FOR USE K 06 0449

510(k) Number (if known):

Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires Device Names:

To facilitate the placement of interventional percutaneous Indications for Use: transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suana D. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 60449

Page | of

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.