Facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MAN™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are 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 Guide Wires with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of .010",014" and .018"and available in 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. The wires are constructed from a stainless steel core wire. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration 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 a summary of the acceptance criteria and the study details for the HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating, based on the provided text:

Acceptance Criteria and Device Performance Study Summary

The provided document describes a 510(k) submission for guide wires, focusing on demonstrating substantial equivalence to predicate devices, particularly regarding a new hydrophilic coating. The study primarily involves bench testing to compare the performance of the new device with its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Accelerated Aging	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating.
Distal Tip Pull Test	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating.
Distal Tip Turns-to-Failure Test	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating.
Rotational Accuracy Test	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating.
Tip Flexibility Test	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating.
Coating Adherence/Integrity	Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate and the ChoICE™ PT Plus Guide Wire.	Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating and substantially equivalent to the ChoICE™ PT Plus Guide Wire.

Overall Conclusion: The results from the bench tests showed that the new ACS HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE® Guide Wire with MICROGLIDE® Coating and the ChoICE™ PT Plus Guide Wire. No new safety or effectiveness issues were raised.

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

Sample Size: Not specified in the provided text. The document states "Bench testing was performed," but does not give specific numbers of devices or tests conducted for each category.
Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a controlled laboratory environment by the manufacturer. It is not clinical data (e.g., from specific countries, nor is it explicitly called retrospective or prospective patient data).

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

This information is not applicable as the study described is bench testing of physical device properties, not a study involving interpretation of data by human experts (e.g., radiologists, pathologists) to establish a "ground truth" for diagnostic or clinical performance. The "ground truth" for these tests would be the measured physical properties of the devices themselves, compared against engineering specifications or predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data that requires consensus or expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical images or data, which is not relevant to the described bench testing of guide wire physical characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical guide wire, not a software algorithm or AI tool. Performance is evaluated directly through bench tests of its physical properties.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on the measured physical and mechanical properties of the guide wires during bench testing (e.g., pull strength, rotational accuracy, flexibility, coating adherence). These measurements are then compared against established engineering specifications or the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as the described study is a bench testing and comparison of physical devices, not an AI/machine learning model that would require a "training set."

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

This information is not applicable for the same reason as above (no AI/ML training set).

Summary

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194773

167

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.	MAR 1 3 1998
	Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
	Telephone:	408-235-3995
	Fax:	408-235-3743
	Contact Person:	Margaret Anderson
	Date Prepared:	December 19, 1997

1. Device Trade Name:
HI-TORQUE FLOPPY® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TOROUE STANDARD® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TOROUE INTERMEDIATE® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE APPROACH® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE FLOPPY II® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic . Coating
HI-TORQUE FLOPPY® EXTRA SUPPORT Guide Wire with HYDROCOAT™ . Hydrophilic Coating
HI-TORQUE FLOPPY II ® EXTRA SUPPORT Guide Wire with HYDROCOAT™ . Hydrophilic Coating
ACS HI-TORQUE IRON MAN® Guide Wire with HYDROCOAT™ Hydrophilic Coating .

Device Common Name: Guide Wire

Device Classification Name: Catheter Guide Wire (74DQX)

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Predicate Device: 3.

HI-TORQUE FLOPPY® Guide Wire with MICROGLIDE® Coating .
HI-TORQUE STANDARD® Guide Wire with MICROGLIDE® Coating .
HI-TORQUE INTERMEDIATE® Guide Wire with MICROGLIDE® Coating .
HI-TORQUE APPROACH® Guide Wire with MICROGLIDE® Coating .
HI-TORQUE FLOPPY II® Guide Wire with MICROGLIDE® Coating .
HI-TORQUE TRAVERSE® Guide Wire with MICROGLIDE® Coating .
ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with MICROGLIDE® Coating ' .
HI-TORQUE FLOPPY® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating .
HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating .
ACS HI-TORQUE IRON MAN® Guide Wire with MICROGLIDE® Coating .
ChoICE™ PT Plus Guide Wire .
Device Description: 4.

క. Intended Use:
The HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ 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 ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with . HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MANTM Guide Wire with HYDROCOAT™ Hydrophilic Coating are also intended to facilitate the placement of equipment such as atherectomy, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
Technological Characteristics: 6.

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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 devices. The design feature that distinguish the new guide wires from that of the predicate wires is the new hydrophilic coating.

7. Performance Data:

Bench testing was performed to demonstrate that the ACS HI-TORQUE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. 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

The results from the bench tests showed that the new ACS HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE® Guide Wire with MICROGLIDE® Coating and the ChoICE™ PT Plus 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, design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE® Guide Wires with MICROGLIDE® Coating. Additionally, the new guide wires performed substantially equivalent with regards to coating adhesion integrity to the ChoICETM PT Plus Guide Wire therefore, we conclude the new guide wire may be considered substatntially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR | 3 1998

Ms. Margaret Anderson Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054

Re: K974773 HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating Regulatory Class: II (two) 74 DQX Product Code: December 19, 1997 Dated: Received: December 22, 1997

Dear Ms. 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 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 Regulations, 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 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 regulation may result in requlatory action. In addition, FDA may publish further announcements 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.

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Page 2 - Ms. Margaret Anderson

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) 594-4648. 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. Callahan

Thomas J. Callahan, 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:

HI-TORQUE FLOPPY® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE STANDARD® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE INTERMEDIATE® Guide Wire with HYDROCOAT™ Hydrophilic . Coating
HI-TORQUE APPROACH® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE FLOPPY II® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating .
ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic . Coating
HI-TORQUE FLOPPY® EXTRA SUPPORT and HI-TORQUE FLOPPY II ® EXTRA . SUPPORT Guide Wire with HYDROCOAT™ Hydrophilic Coating
ACS HI-TORQUE IRON MAN® Guide Wire with HYDROCOAT™ Hydrophilic Coating .

Indications for Use:

· Facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MAN™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are 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)

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

Tu A. A

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

K974773 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.