To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of equipment such as compatible stent devices during other diagnostic or therapeutic intravascular procedures.

Device Description

The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating is a steerable guide wire with a nominal diameter 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 is tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, cleared September 4, 1990). The proximal shaft of this guide wire is coated with polytetrafluoroethylene (PTFE) and the distal working end is coated with Microglide® Coating, a silicon based material. The distal end has a 3 cm, flexible, radiopaque tip that is provided either as a straight, shapeable configuration or as a preshaped J configuration. These guide wires have proximal markers at 90 and 100 cm from the distal tip.
Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire:

The provided document describes a 510(k) submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical analysis as might be seen for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but unfortunately, it does not explicitly state the specific quantitative acceptance criteria for each test. Instead, it states that the device "met acceptance criteria" and "performed similar to the predicate" or "performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014″ Guide Wire."

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated (implied to be parity/non-inferiority to predicate)	Bench Tests: Met acceptance criteria and performed similar/equivalent to the predicate device in: - Distal Tip Pull Test - Distal Tip Turns-to-Failure Test - Rotational Accuracy Test - Tip Flexibility Test
Not explicitly stated (implied to be parity/non-inferiority to predicate)	In vivo animal testing: Performed in a manner equivalent to the predicate guide wire in a canine model with healthy coronary arteries.

2. Sample Size Used for the Test Set and Data Provenance

Bench Tests: The specific sample sizes for each of the four bench tests (Distal Tip Pull, Distal Tip Turns-to-Failure, Rotational Accuracy, Tip Flexibility) are not provided in the summary.
Animal Testing: The sample size (number of animals) for the canine model testing is not provided.
Data Provenance:
- Bench Tests: Performed in a laboratory setting. No country of origin is specified, but given the submitter's address in Temecula, CA, USA, it's highly likely to be U.S.-based. This would be considered a controlled prospective test.
- Animal Testing: Conducted in a canine model with healthy coronary arteries. This is an in vivo animal study, not human data. The specific location and whether it was retrospective or prospective is not stated, but animal studies are typically prospective by design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and therefore not provided in the context of this device submission. The tests performed are engineering/performance-based (bench tests) and animal studies, which do not typically involve human experts establishing clinical "ground truth" in the way a diagnostic AI device would. The "ground truth" in this context would be the objective measurements from the bench tests and observations from the animal study.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As explained above, for engineering performance tests and animal studies, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study involving subjective interpretation.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. This device is a guide wire, which is an interventional tool, not a diagnostic AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical instrument (guide wire), not an algorithm or AI software. All performance tests are inherently standalone in the sense that they evaluate the physical properties and performance of the guide wire itself, without human-in-the-loop interaction as a performance variable.

7. Type of Ground Truth Used

Bench Tests: The ground truth for the bench tests would be the established engineering specifications and measurement standards for guide wire performance (e.g., specific force required for pull, number of turns to failure, degree of rotational accuracy, flexibility measurements).
Animal Testing: The ground truth for the animal testing would be direct observation of the guide wire's performance in vivo within the canine coronary anatomy, assessed through methods like fluoroscopy or necropsy, and compared against the control (predicate device).

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical product, not an AI/machine learning model that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device.

Summary

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K 11011/2

510(k) SUMMARY

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

1.	Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
	Submitter's Address:	26531 Ynez RoadTemecula, CA 92591-4628
	Telephone:	909-914-2400	AUG 25 1997
	Fax:	909-914-6690
	Contact Person:	Wayne R. Hohman
	Date Prepared:	June 5, 1997
2.	Device Trade Name:	ACS HI-TORQUE ALL STAR™ 0.014" GuideWire with Microglide® Coating
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Device:	ACS HI-TORQUE EXTRA S'PORT™ 0.014"Guide Wire with Microglide® Coating(K950156, cleared April 5, 1995, andK942066, cleared July 18, 1994)

Device Description: 4.

Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.

1. Intended Use:
  The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating has the following intended uses:

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To facilitate the placement of balloon dilatation catheters during . percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of equipment such as compatible stent . devices during other diagnostic or therapeutic intravascular procedures

The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating has the following contraindications:

Use in cerebral vasculature. .
. Use with atherectomy devices.

NOTE: The predicate guide wire is indicated for use with atherectomy devices; the new guide wire is contraindicated for use with atherectomy devices.

Technological Characteristics: 6.
Comparison of the new and predicate devices shows 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. Two design features distinguish the new guide wire: an added segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire just proximal to the 3 cm tip and a more flexible 3 cm tip. The TFE shrink tubing provides a continuous working diameter of 0.014″ in this distal portion of the guide wire. The decreased coefficient of friction of the TFE layer facilitates movement of the guide wire within 0.014" devices. The more flexible tip is designed to be more atraumatic in coronary vessels.
1. Performance Data:
  Bench testing was performed to demonstrate that the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating met acceptance criteria and performed similar to the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire with Microglide "Coating. Four tests were performed as follows:
. Distal Tip Pull Test
. Distal Tip Turns-to-Failure Test
. Rotational Accuracy Test
Tip Flexibility Test .

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In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire in comparison to the predicate guide wire. The results showed that the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014" Guide Wire.

The results from the four bench tests plus the animal testing showed that the new ACS HI-TORQUE ALL STAR™ Guide Wire met acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE EXTRA S'PORT™ 0.014″ 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 (minus the atherectomy indication), similar design and technological characteristics, no new materials, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE ALL STAR™ Guide Wire with Microglide® Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with Microglide Coating.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Wayne R. Hohman Senior Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems 26531 Ynez Road, P.O. Box 9810 Temecula, California 92591-4628

AUG 25 1997

K972142 Re: ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating Requlatory Class: II (two) Product Code: DOX Dated: June 5, 1997 Received: June 6, 1997

Dear Mr. Hohman:

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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4648. 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/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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide Coating

Indications for Use:

. To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of equipment such as compatible stent devices . during other diagnostic or therapeutic intravascular procedures.

Contraindications:

Use in cerebral vasculature. .
. Use with atherectomy devices.

(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

signature

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number	K972142
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(Optional Format 1-1-96)
120

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.