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 ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide with a 200 cm exchange length and lengths of 175 cm and 190 cm and 190 and lengths of 175 cm and 190 cm extendation of the are a soland tapered so that it has The proximal end of the 175 cm and 190 cm models and one Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges.

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is constructed from astable wire consists of an HYDROCOAT™ Hydropinne Coating is course in consists of the wire consists of an ewith a nominal oute with a nominal outer diameter of 0.017 . The wire is coated with polytetrafluoroethylene (PTFE) and the distal, segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

The distal tip coil has a radiopaque length of 4.5 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The 190 cm and 300 cm guide wires have markers located 90cm and 100 cm from the distal tip.

AI/ML Overview

The provided 510(k) summary for the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating describes the performance data and conclusions based on bench testing. However, it does not include information related to human user studies, expert involvement, or training data for an AI/algorithm-based device. This is because the device described is a physical medical device (a guidewire), not an AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD studies (sections 2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this submission.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Test Performed	Acceptance Criteria	Reported Device Performance
Distal Tip Pull Test	Not explicitly stated, but implied to be sufficient for intended use.	Met acceptance criteria and performed similar to the predicate device.
Distal Tip Turns-to-Failure Test	Not explicitly stated, but implied to be sufficient for intended use.	Met acceptance criteria and performed similar to the predicate device.
Rotational Accuracy Test	Not explicitly stated, but implied to be sufficient for intended use.	Met acceptance criteria and performed similar to the predicate device.
Tip Flexibility Test	Not explicitly stated, but implied to be sufficient for intended use.	Met acceptance criteria and performed similar to the predicate device.

The document states: "The results from the bench tests showed that the new ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a physical medical device. The "test set" refers to the guidewire samples used in the bench tests. The document does not specify the number of guidewires tested for each bench test.

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)

This information is not applicable. Ground truth is not established by human experts for the performance evaluation of this physical device in bench testing. Performance is measured against engineering specifications and comparison to a predicate device.

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

This information is not applicable. Adjudication methods are relevant for human interpretation tasks, not for bench testing of a physical device.

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 information is not applicable as this is a physical medical device and not an AI/SaMD.

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

This information is not applicable as this is a physical medical device and not an AI/SaMD.

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

The "ground truth" for this device's performance is based on engineering specifications and performance equivalence to a legally marketed predicate device as demonstrated through bench testing. There is no biological or clinical "ground truth" as would be found in diagnostic AI studies (e.g., pathology, outcomes).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/SaMD based on machine learning.

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

This information is not applicable. There is no "training set" in the context of this device.

Summary

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K982083

SEP 1 1 1998

510(k) SUMMARY

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

Prepared By:

Lorna Tsuda Regulatory Affairs Coordinator

Address:

GUIDANT CORPORATION

Advanced Cardiovascular Systems, Inc. 3200 Lakeside Drive Santa Clara, CA 95054 408-235-3995 Telephone: 408-235-3743 Fax: June -- , 1998 Date Prepared:

Device Trade Name:	ACS HI-TORQUE BALANCE HEAVYWEIGHT™ GuideWire with HYDROCOAT™ Hydrophilic Coating
Device Common Name:	Guide Wire
Device Classification Name:	Catheter Guide Wire, 74DQX
Predicate Device:	ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire

Device Description:

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with The ACS HI-TORQUE BALANCE IIIEA + With a puice with a nominal diameter of 0.014"
HYDROCOAT™ Hydrophilic Coating is a guide with a 200 cm exchange length HYDROCOAT™ Hydrophilic Coating is a gelec while and a 300 cm exchange length.
and lengths of 175 cm and 190 cm and 190 and lengths of 175 cm and 190 cm extendation of the are a soland tapered so that it has The proximal end of the 175 cm and 190 cm models and one Wire Extension. This the ability to fit into the nypotube portion of the Fred D of this guide wire to facilitate catheter
enables the physician to extend the working length of this guide wire to exchanges.

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with The ACS HI-TORQUE BALAINCE IILA-T THEICH Tom stainless steel proximal core
HYDROCOAT™ Hydrophilic Coating is constructed from astable wire consists of an HYDROCOAT™ Hydropinne Coating is course in consists of the wire consists of an
with a nominal outer diameter of 0.014". The first wire is consists of an
ewith a nominal oute with a nominal outer diameter of 0.017 . The wire is coated with

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polytetrafluoroethylene (PTFE) and the distal, segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

Intended Use:

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 devices. The design feature that distinguishes the new guide wires from that of the predicate wires is the tapered distal coil.

Performance Data:

Bench testing was performed to demonstrate that the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. The following tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.

The results from the bench tests showed that the new ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

Conclusions:

Since the new guide wires have the same intended use, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Ghide Wire.

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SED 11 1938

Ms. Lorna Tsuda Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems, Inc. 3200 Lakeside Dr. P.O. Box 58167 Santa Clara, CA 95054-2807

Re: K982083

Trade Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating Regulatory Class: II Product Code: DQX Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Tsuda:

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 aqainst 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

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Page 2 - Ms. Lorna Tsuda

assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

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) 594-4586. 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 regulation 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. Callahan, Ph.D. Director Division of Cardiovascular, Respirator 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 BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Punge
(Division Sign-Off)

(Division Sign-Off) Cardiovascular, Respiratory,
and Neurological Devices and Neurological Devices 510(k) Number

K982083

Prescription Use (Per 21 CFR 801.109)

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

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.