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 wire is also intended to facilitate the placement of equipment such as . atherectomy, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.

Device Description

The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires 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, approved September 4, 1990).

The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

AI/ML Overview

The provided 510(k) summary (K973494) describes the performance testing for the HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire." Similarly, for in vivo testing, it states "The results showed that the new wires performed in an equivalent manner to the predicate devices." And finally, "The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."

However, the specific quantitative acceptance criteria or detailed numerical performance results for each test were not explicitly provided in the summary. The acceptance criterion appears to be general equivalence or similarity to the predicate device.

Test Performed	Acceptance Criteria (as implied)	Reported Device Performance (as stated)
Accelerated Aging	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Distal Tip Pull Test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Distal Tip Turns-to-Failure Test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Rotational Accuracy Test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Tip Flexibility Test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Hypotube Junction Pull Test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Hypotube Junction Maximum Torque test	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
Coating Adherence/Integrity	Equivalent to predicate device	Met acceptance criteria and performed similar/equivalent to the predicate device.
In vivo animal testing	Equivalent to predicate device	Performed in an equivalent manner to the predicate devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify the exact number of units or animals used in the bench tests or the in vivo animal testing. It generally refers to "bench testing" and "in vivo animal testing in a canine model."

Data Provenance:

Bench tests: Not explicitly stated, but typically conducted internally by the manufacturer.
In vivo animal testing: Performed in a "canine model," which implies an experimental, prospective study. The country of origin is not specified but is presumably where the manufacturer (Guidant Corporation) is based or where their testing facilities are located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided document. The performance testing described (bench tests and animal studies) involves physical and mechanical properties, not interpretation or diagnosis requiring human experts or ground truth in the context of diagnostic accuracy. The "ground truth" here is the objective measurement of physical properties or observed physiological responses in the animal model.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) to establish a consensus ground truth. The device's performance was evaluated through objective bench tests and animal studies, not through human interpretation 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

This question is not applicable. The device is a medical guidewire, not an AI or imaging device that would be subject to MRMC studies or human reader comparisons. Performance was assessed through physical testing and animal models, not human interpretation.

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

This question is not applicable. The device is a physical guidewire, not an algorithm, so standalone algorithm performance is not relevant. The performance tests described (bench and animal) are inherently "standalone" in the sense that they evaluate the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" would be the objectively measured physical properties and performance characteristics against predefined engineering specifications (implied to be equivalent to the predicate device). For the in vivo animal testing, the "ground truth" would be the observed physiological responses, device maneuverability, and safety outcomes within the healthy coronary arteries of the canine model, compared to the predicate device.

8. The sample size for the training set

This question is not applicable. The device is a physical guidewire, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

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

Summary

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K-173494

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. DEC 12 1997
	Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
	Telephone:	408-235-3995
	Fax:	408-235-3743
	Contact Person:	Margaret Anderson
	Date Prepared:	September 13, 1997
2.	Device Trade Name:	HI-TORQUE BALANCE™ Guide Wire withHYDROCOAT™ Hydrophilic CoatingACS HI-TORQUE BALANCE MIDDLEWEIGHT™Guide Wire with HYDROCOAT™ Hydrophilic Coating
	Device Common Name:	Guide Wire
	Device Classification Name:	Catheter Guide Wire (74DQX)
3.	Predicate Device:	HI-TORQUE BALANCE™ Guide Wire(K925381, approved February 12, 1993)ACS HI-TORQUE BALANCE MIDDLEWEIGHT™Guide Wire (K971815, approved July 9, 1997)ChoICE™ PT Plus Guide Wire(K950216, approved June 22, 1995)
4.	Device Description:

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from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

Intended Use: ર્જ
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 wire is 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.

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

Performance Data: 7.
Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® 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
Hypotube Junction Pull Test ●
Hypotube Junction Maximum Torque 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 HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHTTM 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 new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ 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 HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate HI-TORQUE BALANCE® Guide Wire and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire respectively.

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Rockville MD 20867

DEC 1 2 1997

Ms. Margaret Anderson Requlatory Affairs Guidant Corporation 3200 Lakeside Drive, P.O. Box 58167 Santa Clara, California 95052-8167

K973494 Re : HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating II (two) Requlatory Class: Product Code: DQX Dated: September 13, 1997 Received: September 15, 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 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 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the

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Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation 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, 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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ા રત

Indications for Use Statement

510(k) Number (if known):

Device Name:

HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating

ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating ...

Indications for Use:

The ACS HI-FORQUE BALANCE MIDDLEWEIGHTM Could Vire is a seeeeeble wite intended to facilitate the placement of balloon dilatation catheres during percurancous. intended to facilitate the placement of onliness on transitionin' angioplasy (PTA).
transluminal coronary angloplasy (PTCA) and perculances attensioning as atterectomy. IVUS transluminal coronary angloplash (r r Ca) and percedent such as atherectony, IVUS and
The wire is also intended to facilitate the passioned intravacular procedures, The wire is also intended to facinate die pracement of organism intravascular 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)	OR	Over-The-Counter(Optional Format 1-1-96)
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(Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices	K973494
510(k) Number

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.