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 procedures.

Device Description

The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HI-TORQUE BALANCE TREK™ Guide Wires:

There are no specific acceptance criteria or performance metrics quantified in the provided text. The document describes a medical device submission (510(k)) where the focus is on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific quantitative performance targets.

The study described is not a typical clinical trial or AI performance study. It's a series of in vitro bench tests and in vivo performance evaluations designed to show the new device performs similar to a predicate device.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Performs similar to the predicate device (ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating)	"met the acceptance criteria and performed similar to the predicate device"
Meeting acceptance criteria in functional tests: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test, and Tip Flexibility Test	"The results from the tests demonstrated that the new The HI-TORQUE BALANCE TREK™ Guide Wires met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE HEA VYWEIGHT™ Guide Wire."
No new safety or effectiveness issues raised	"No new safety or effectiveness issues were raised during the testing program."

Important Note: The document does not provide numerical acceptance criteria (e.g., "distal tip pull strength must be >X Newtons") nor does it provide quantitative results from the tests (e.g., "distal tip pull strength measured Y Newtons"). The primary "acceptance criteria" is stated as performing "similar to" or "equivalent to" the predicate device.

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

Sample Size: The document does not specify the sample size used for the in vitro bench testing or in vivo performance evaluations.
Data Provenance: The data provenance is not specified (e.g., country of origin, retrospective or prospective). Given it's a 510(k) submission focused on bench and "in vivo performance evaluations," it's likely a mix of laboratory testing and potentially animal studies or early human use if the "in vivo performance evaluations" refer to that, though details are absent. It is not explicitly stated as retrospective or prospective human patient data.

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

Number of Experts: Not applicable. This study focuses on device engineering performance, not interpretation of clinical data by experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "tests" are functional engineering performance tests, not clinical assessments requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable. This is not an AI-assisted device.

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

Standalone Performance: Not applicable. This is a physical medical device (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" here is the functional performance of the predicate device and established engineering specifications for guide wires. The new device's performance was compared against the predicate's performance in specific functional tests. The goal was to show similarity/equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Ground Truth for Training Set: Not applicable.

Summary

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4/29/99

K991152 31

ATTACHMENT 4

510(k) Summary

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

1.	Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
2.	Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95054
3.	Telephone:	408-235-3995
4.	Fax:	408-235-3743
5.	Contact Person:	Margaret Anderson
6.	Date Prepared:	April 5, 1999
7.	Device Trade Name:	HI-TORQUE BALANCE TREKTM Guide Wires withHYDROCOATTM Hydrophilic Coating
8.	Device Common Name:	Guide Wire
9.	Device Classification Name:	Catheter Guide Wire(74DQX)
10.	Predicate Device:	ACS HI-TORQUE BALANCE HEAVYWEIGHTTM GuideWire with HYDROCOATTM Hydrophilic Coating (K982083)

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1. Device Description:
  The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
1. Intended Use:
  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 procedures.
1. Technological Characteristics:
  Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate device. The design modifications of the new guide wire compared to that of the predicate wire are the modified core and tip coils.
1. Performance Data:
  In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate device. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.

The results from the tests demonstrated that the new The HI-TORQUE BALANCE TREK™ Guide Wires met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

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15. Conclusions

Since the new guide wire has the same intended use, materials, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE BALANCE HEA VYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Ms. Marqaret Anderson Regulatory Affairs Guidant Corporation P.O. Box 58167 Santa Clara, CA 95052

Re: K991152

HI-TORQUE BALANCE TREK™ Guide Wires with Trade Name: HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DOX Dated: April 5, 1999 Received: April 6, 1999

Dear Mr. Anderson:

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 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to

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Page 2 - Ms. Margaret Anderson

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.

This letter will allow you to beqin 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) 594-4586. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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. Callahan

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

Enclosure

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ATTACHMENT 2

Indications for Use Statement

510(k) Number (if known)
Device Name	HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating
Indications for Use	The intended use for the HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating is: 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 procedures.

510(k) Number (if known)

Device Name

HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating

Indications for Use

The intended use for the HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating is: 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 procedures.

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)

Use

Over-The-Counter

A. Wetteng

(Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Device 510(k) Number

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.