The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

Device Description

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a nominal diameter of 0.035 inches and three lengths: a 145, a 190 cm and a 300 cm exchange length.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire, and thus does not contain information about software or AI. Therefore, most of the requested fields related to AI/software performance studies are not applicable.

Here's the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Distal Tip Pull Test	Maintain performance similar to predicate device	Met acceptance criteria, performed similar to predicate device
Turns-to-Failure Test	Maintain performance similar to predicate device	Met acceptance criteria, performed similar to predicate device
Rotational Accuracy Test	Maintain performance similar to predicate device	Met acceptance criteria, performed similar to predicate device
Tip Flexibility Test	Maintain performance similar to predicate device	Met acceptance criteria, performed similar to predicate device

Note: The document states that the new device "met the acceptance criteria and performed similar to the predicate Wholey Hi-Torque Standard® Guide Wire" for all listed tests, implying that the acceptance criteria were set based on the performance of the predicate device. Specific numerical acceptance values or performance metrics are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was bench testing, not a clinical study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for bench tests is based on engineering specifications and physical measurements, not expert human assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was 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
Not applicable. This is a physical medical device (catheter guide wire), not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For bench tests, the ground truth is established by engineering standards, physical measurements, and comparison to the predicate device's known performance.

8. The sample size for the training set
Not applicable. This is a physical medical device.

9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.

Summary

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K980119

MAR 20 1998

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
	Submitter's Address:	Advanced Cardiovascular Systems, Inc.3200 Lakeside DriveSanta Clara, CA 95054
	Telephone:	408-235-3995
	Fax:	408-235-3743
	Contact Person:	Susan Silavin, Ph.D.
	Date Prepared:	January 12, 1998
2.	Device Trade Name:	ACS HI-TORQUE WHOLEY SUPRA CORE™Guide Wire
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Devices:	Wholey Hi-Torque Standard® Guide Wire (K852123,approved June 19, 1985 and K861765 approved May 30, 1986),Hi-Torque S'Port-T™ Guide Wire (K915554, approvedFebruary 9, 1993) andMedi-tech Amplatz Super Stiff Guide Wire(K942382, approved August 22, 1994)

Device Description:

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a nominal diameter of 0.035 inches and three lengths: a 145, a 190 cm and a 300 cm exchange length.

ડ. Intended Use:

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures.

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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.
Performance Data: 7.
Bench testing was performed to demonstrate that the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire met the acceptance criteria and performed similar to the predicate Wholey Hi-Torque Standard® Guide Wire. The following tests were performed:
Distal Tip Pull Test .
Turns-to-Failure Test .
Rotational Accuracy Test .
. Tip Flexibility Test

The results from the bench tests showed that the new ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire met acceptance criteria and performed in a manner equivalent to the predicate Wholey Hi-Torque Standard® Guide Wire. No new safety or effectiveness issues were raised during the testing program.

1. Conclusions:
  Since the new guide wire has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire may be considered substantially equivalent to the predicate Wholey Hi-Torque Standard®, Hi-Torque S'Port-T™ and the Medi-tech Amplatz Super Stiff Guide Wires.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 20 1998

Susan Silavin, Ph.D. Senior Requlatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems, Inc. 3200 Lakeside Drive Santa Clara, CA 95054

510 (k) Number K980119 Re : Trade Name: ASC HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire Regulatory Class: II Product Code: DQX Dated: January 12, 1998 Received: January 13, 1998

Dear Dr. Silavin:

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 to 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 requlatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Reqister. this

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Page 2 - Dr. Silavin

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 regulation (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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Thomas J. Callahon

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

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire

Indications for Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	✓ OR Over-The-Counter ______
	(Optional Format 1-1-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices
510(k) Number	K980119

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.