The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.

Device Description

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, September 4, 1990).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating has a radiopaque tip and is are available with either a straight tip configuration, which allows the physician to shape the guide wire tip in a preferred shape, or a pre-shaped "J" tip configuration, which allows the physician the convenience using a guide wire with the tip pre-shaped.

The hydrophilic coating is intended to facilitate wire movement within 0.014" diameter devices. The proximal shaft of the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is coated with polytetrafluoroethylene (PTFE).

AI/ML Overview

This 510(k) summary describes a medical device, the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating, and its performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the new device "met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ Guide Wire." While specific quantitative acceptance criteria are not provided, the "similar performance" to the predicate device serves as the de facto acceptance criterion. The performance data is summarized as follows:

Acceptance Criterion (Implicit)	Reported Device Performance
Performance similar to predicate ACS HI-TORQUE® IRON MAN™ Guide Wire across specified tests.	Bench Testing: Demonstrated performance similar to the predicate device in: - Accelerated Aging - Distal Tip Pull Test - Distal Tip Turns-to-Failure Test - Rotational Accuracy Test - Tip Flexibility Test - Coating Adherence/Integrity In vivo Animal Testing: Performed equivalently to predicate devices in a canine model with healthy coronary arteries.

2. Sample Sizes and Data Provenance for the Test Set:

Bench Testing: The document does not specify the exact sample sizes used for each bench test.
In vivo Animal Testing: The test set involved a "canine model with healthy coronary arteries." The specific number of animals or trials is not provided.
Data Provenance: The data appears to be prospective as it was generated specifically for the 510(k) submission. The country of origin is not explicitly stated but can be inferred to be the United States, given the submission to the FDA.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the described study is for a medical device (guide wire) and the performance assessment is based on physical and mechanical testing, not interpretation of medical images or patient data by experts. Therefore, there is no "ground truth" established by experts in the context of radiology or clinical diagnosis.

4. Adjudication Method:

This section is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. The study described is for a medical device (guide wire) and focuses on its physical and mechanical performance compared to a predicate device, not on the improvement of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

This section is not applicable. The device is a physical medical device (guide wire), not a software algorithm or AI model.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through objective physical and mechanical measurements derived from bench testing and physiological observations/measurements from the in vivo animal study. The comparison to the predicate device's known performance serves as the benchmark.

8. Sample Size for the Training Set:

This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How Ground Truth for the Training Set Was Established:

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

Summary

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APR 2 4 1998

4980294

510(k) SUMMARY

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

1.	Submitter's Name:	Guidant Corporation
		Advanced Cardiovascular Systems, Inc.
	Submitter's Address:	3200 Lakeside Drive
		Santa Clara, CA 95052
	Telephone:	408-235-3480
	Fax:	408-235-3743
	Contact Person:	David Kolesar
	Date Prepared:	January 26, 1998
2.	Device Trade Name:	ACS HI-TORQUE® SUPER S'PORT™ Guide Wire withHYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE®
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Device:	ACS HI-TORQUE® IRON MAN™ Guide Wire (K963702)
		ACS HI-TORQUE®BALANCE™ Guide Wire withHYDROCOAT™ Hydrophilic Coating (K973494)

4. Device Description:

131

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న. Intended Use:
The the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:
To facilitate the placement of balloon dilatation catheters during percutaneous . transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The wire is also intended to facilitate the placement of equipment such as . atherectomy and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
Technological Characteristics: 6.

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate device

1. Performance Data:
  Bench testing was performed to demonstrate that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ Guide Wire. The following tests were performed:
Accelerated Aging .
. Distal Tip Pull Test
. Distal Tip Turns-to-Failure Test
. Rotational Accuracy Test
. Tip Flexibility Test
Coating Adherence/Integrity .

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In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating in comparison to the predicate guide wire. The results showed that the new wires performed in an equivalent manner to the predicate devices.

The results from the bench tests plus the animal testing showed that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the ACS HI-TORQUE® IRON MAN™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

8. Conclusions:

Since the new guide wires have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the ACS HI-TORQUE® IRON MAN™ Guide Wire.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Mr. David Kolesar Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95052

Re: K980294 ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Trade Name: Hydrocoat™ Hydrophilic Coating Requlatory Class: II Product Code: DQX January 26, 1998 Dated: Received: January 27, 1998

Dear Mr. Kolesar:

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 reqistration, 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 action. In addition, FDA may publish further announcements

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Page 2 - Mr. Melinyshyn

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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,

Thomas J. Callahon

Thomas J. Callaman, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

DEVICE NAME:

ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating

INDICATIONS FOR USE:

CONTRAINDICATIONS:

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is not intended for use in the cerebral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Div. of Cardiovascular, Respiratory,and Neurological Devices
510(k) Number	K980294

Prescription Use(Per 21 CFR 801.109	OR	Over-The-Counter(Optional Format 1-1-96)

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.