The BMW Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

Device Description

The BMW Guide Wire is a steerable guide wire available in a nominal diameter of 0.14" in two lengths: a 190 centimeter extendible length (extendible to 335cm using the DOC® Guide Wire Extension) and a 300-centimeter exchange length.

AI/ML Overview

The provided text describes a 510(k) summary for the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. This document focuses on demonstrating substantial equivalence to a predicate device for a labeling modification, rather than evaluating a new device's performance against specific acceptance criteria in a detailed clinical study.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully extracted as such information is not typically part of a 510(k) submission for a labeling change on a pre-existing device.

However, I can provide the limited information that is present regarding testing:

Key Takeaways from the Provided Text:

Focus: The 510(k) is primarily for a labeling modification to change the indications for use of an already marketed device (ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire, K971815).
No Changes to Device: There are "no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device." This significantly reduces the scope of required testing compared to a new device.
Substantial Equivalence: The primary goal is to show substantial equivalence to the MicroVena Niner Nitinol Guide Wire (K952860) for the modified indication and to the existing BMW Guide Wire (K971815) for all other aspects.

Information Extracted from the Text:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The text does not explicitly state quantitative acceptance criteria for the device performance in the context of this 510(k) submission. The acceptance was primarily based on demonstrating substantial equivalence to predicate devices and the results of a single animal study.

Reported Device Performance:

Performance Metric	Reported Performance
Performance in Coronary Vein (In Vivo Animal Study)	"acceptable within the coronary vein when used with a compatible lead system."
Design, Materials, Manufacturing, Packaging, Sterilization, Shelf Life	Stated to be identical to the currently marketed BMW Guide Wire (K971815).
Intended Use Equivalence	Equivalent to MicroVena Niner Nitinol Guide Wire (K952860) for intended use.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The text mentions "An animal study was conducted," but does not specify the number of animals (sample size) used.
- Data Provenance: The study was an "In Vivo Testing" and "animal study." No specific country of origin is mentioned for the study. It is a prospective study as it was conducted to evaluate performance.
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 provided in the text. The animal study results are reported as "acceptable," implying an evaluation by experts, but their number and qualifications are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a guide wire, not an AI-assisted diagnostic tool, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical medical instrument (guide wire), not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the animal study appears to be a clinical assessment of acceptability based on the performance of the guide wire within the coronary vein, likely by veterinary or medical experts involved in the study. Details are not provided on whether this included specific pathological findings or long-term outcomes for the animals.
The sample size for the training set:
- This question is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- This question is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

Summary

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NOV I 0 1998 CONFIDENTIAL

K983033¹⁴

510(k) Summary

1. Device Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire
1. Devices to Which Equivalence is Claimed: MicroVena Niner Nitinol Guide Wire (K952860, cleared December 3, 1995) with regard to intended use and all other aspects of the proposed BMW Guide Wire are identical to the currently marketed BMW Guide Wire (K971815, cleared July 9, 1997).
1. Intended Use: The BMW Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
1. Device Description: The BMW Guide Wire is a steerable guide wire available in a nominal diameter of 0.14" in two lengths: a 190 centimeter extendible length (extendible to 335cm using the DOC® Guide Wire Extension) and a 300-centimeter exchange length.
1. Summary of Technological Characteristics: This notification concerns a labeling modification to modify the indications for a currently marketed device. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device.
1. Summary of Substantial Equivalence: This notification concerns a labeling modification to modify the indications for the currently marketed device. The indications are equivalent to the currently marketed MicroVena Niner Nitinol Guide Wire (K952860, cleared December 3, 1995) and all other aspects of the proposed BMW Guide Wire are identical to the currently marketed BMW Guide Wire (K971815, cleared July9, 1997).

7. Testing Data:

In Vivo Testing

An animal study was conducted to evaluate the performance of the ACS Hi-Torque Floppy II® (K887897) and the BMW (K971815) Guide Wire when the devices were used within the coronary vein. The results of the in vivo animal evaluation show that the BMW Guide Wire is acceptable within the coronary vein when used with a compatible lead system. See Appendix B for the in vivo study.

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1. Conclusion: This BMW Guide Wire with the modified indication is substantially equivalent to the currently marketed MicroVena Niner Nitinol Guide Wire (K952860, cleared December 3, 1995) with regard to intended use and all other aspects of the proposed BMW Guide Wire are identical to the currently marketed BMW Guide Wire (K971815, cleared July 9, 1997).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1998

Ms. Jennifer Pae Riggs Sr. Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems 26531 Ynez Road P.O. Box 9018 Temecula, CA 92591

K983033 Re : Trade Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire Requlatory Class: II Product Code: DQX Dated: August 28, 1998 Received: August 31, 1998

Dear Ms. Riggs:

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 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 regulatory In addition, FDA may publish further announcements concerning action.

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Page 2 - Ms. Jennifer Pae Riggs

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 requlation (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-Also, please note the regulation entitled, "Misbranding by 4639. 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, 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): K983033

Device Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire

Indications for Use:

Current:

All ACS HI-TORQUE® Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Proposed:

The HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary and peripheral vasculature during diagnostic and/or therapeutic procedures.

Ta lu fa

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(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)

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.