To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

Device Description

The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires guide wires with a 0.014'' diameter 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. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the HI-TORQUE BALANCE® guide wires:

It's important to note that the provided text is a 510(k) summary for a medical device (guide wires), not a scientific paper detailing a clinical study for an AI/ML powered medical device. Therefore, many of the requested categories are not applicable or the information is not present within this type of regulatory submission. The "device" in this context is a physical medical instrument, not a software algorithm.

Acceptance Criteria and Reported Device Performance

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

The document states: "The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device."

However, the specific acceptance criteria (e.g., tensile strength, fracture resistance, lubricity values) and the quantitative reported performance of the device against these criteria are not provided in this 510(k) summary. It only states that the device "meets the established acceptance criteria."

Acceptance Criteria	Reported Device Performance
Not specified	Meets established criteria; performs equivalently to predicate device.

Study Details (as inferable for a non-AI medical device submission)

Given this is a physical medical device and not an AI/ML product, many of the AI-specific questions are not applicable. The "study" here refers to pre-clinical verification testing and a demonstration of substantial equivalence to a predicate device.

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

Sample Size for Test Set: Not specified. Verification testing would involve testing a certain number of guide wire samples, but the exact quantity is not detailed in this summary.
Data Provenance: Not applicable in the sense of patient data. The "data" comes from physical engineering and performance tests on the manufactured guide wires. There's no country of origin of "data" in this context, as it's product testing.
Retrospective or Prospective: Not applicable for device verification testing.

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)

Number of Experts & Qualifications: Not applicable. For a physical medical device, "ground truth" isn't established by expert consensus on patient data. It's established by engineering specifications, material standards, and performance test protocols. The "experts" would be the engineers and quality assurance personnel performing and validating the tests, but these roles and numbers are not specified.

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

Adjudication Method: Not applicable. Adjudication methods like 2+1 are used for human review of clinical data, typically in AI/ML validation. For device verification, engineers follow defined test methods and specifications.

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. This is a physical guide wire, not an AI-powered diagnostic or assistive tool.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. There is no algorithm to run in standalone mode.

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

Type of Ground Truth: For this type of device, the "ground truth" would be defined by the pre-established engineering specifications, material properties, and functional performance benchmarks (e.g., specific thresholds for torqueability, tip flexibility, lubricity, radiopacity, tensile strength, etc.) that the device must meet.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

Ground Truth for Training Set: Not applicable. There is no training set for this device.

Summary

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510(k) SUMMARY

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

Submitter's Name:	Guidant CorporationVascular Intervention
Submitter's Address:	26531 Ynez RoadTemecula, CA 92591
Telephone:Fax:	(909) 914-4581(909) 914-0339
Contact Person:	Jennifer Pae Riggs
Date Prepared:	April 17, 2002
Device Trade Name:	HI-TORQUE BALANCE®HI-TORQUE BALANCE MIDDLEWEIGHTTMHI-TORQUE BALANCE HEAVYWEIGHT™HI-TORQUE BALANCE TREKTMHI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALTM
Device Common Name:	Guide Wire
Device Classification Name:	Guide Wire Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are substantially equivalent with regard to these features in their predicate device.

Device Description:

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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. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

Intended Use:

Technological Characteristics:

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.

Performance Data:

The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.

Conclusions:

The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires have the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are substantially equivalent to the predicate devices.

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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 eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Ms. Jennifer Pae Riggs, RAC Sr. Regulatory Affairs Associate Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

K021228 Re:

HI-TORQUE Balance® Balance Middleweight™, Balance Heavyweight™, Balance TrekTM and Balance Middleweight Universal™ Guide Wires Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated: April 17, 2002 Received: April 18, 2002

Dear Ms. Riggs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Jennifer Pae Riggs

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

NOahtill

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory 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)	K021228
Device Name	HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and the BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires
Indications for Use	To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K021225

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.