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

Device Description

The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.

AI/ML Overview

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire. However, it does not contain the detailed performance study information required to answer all the posed questions. The text explicitly states:

"In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices."

This is a general statement and lacks the specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement that are typically associated with performance studies involving AI or complex medical device efficacy.

Therefore, for many of your questions, the answer will be "Information not provided in the input text."

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text. The text only states that the device "met the acceptance criteria."	"met the acceptance criteria and performed similarly to the predicate devices." (General statement, no specific metrics provided)

Study Details

Here's what can and cannot be answered based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the input text. The text only mentions "In vitro bench testing performance evaluations."
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)
- Not applicable / Not provided in the input text. The study described is "in vitro bench testing," which would not typically involve human experts establishing ground truth in the way described for clinical or imaging data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided in the input text. This is not relevant for an in vitro bench testing study.
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. The device is a guide wire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related information is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The "in vitro bench testing" represents a standalone evaluation of the physical device's performance against pre-defined criteria, without human intervention in the performance measurement itself (though humans design and conduct the tests). However, this is not an "algorithm" in the context of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in the input text, but inferred from "in vitro bench testing." The "ground truth" would likely be objective measurements of physical properties (e.g., tensile strength, friction, flexibility, torque transmission, coating integrity) against engineering specifications or established industry standards for guide wires, rather than medical "ground truth" like pathology or clinical outcomes.
The sample size for the training set
- Not applicable / Not provided in the input text. The concept of a "training set" is typically for machine learning algorithms, which this device is not. For a physical device, manufacturing and process validation would involve numerous samples, but these aren't "training sets" in the AI sense.
How the ground truth for the training set was established
- Not applicable / Not provided in the input text. (See point 7).

In summary, the provided document is a 510(k) summary for a medical device (a guide wire), not for an AI diagnostic tool. Therefore, many of the questions asked, particularly those related to AI performance, human readers, and clinical data/expert consensus, are not applicable or the information is not present in this type of regulatory submission summary. The "study" described is limited to "in vitro bench testing."

Summary

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K031678

AUG 2 6 2003

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the SMDA of 1990.

1. Submitter's Name:	Guidant Corporation
	Vascular Intervention
2. Submitter's Address:	26531 Ynez Road
3. Telephone:	(909) 914-2676
4. Fax:	(909) 914-0339
5. Contact Person:	Bruce Cerwin
6. Date Prepared:	May 28, 2003
7. Device Trade Name:	HI-TORQUE BALANCE UNIVERSAL™ Guide
	Wires with Hydrocoat Hydrophilic Coating
8. Device Common Name:	Guide Wire
9. Device Classification Name:	Catheter Guide Wire (74DQX)
10. Predicate Device:	HI-TORQUE BALANCE MIDDLEWEIGHT (BMW)
	UNIVERSAL™ Guide Wire with Hydrocoat
	Hydrophilic Coating (K013833)

11. Device Description:

Intended Use:

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 compatible stent devices during therapeutic intravascular procedures.

Technological Characteristics:

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.

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1031678

14. Performance Data:

In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2003

Guidant Corporation c/o Mr. Bruce Cerwin Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628

Re: K031678

HI-TORQUE Balance Universal™ Guide Wire with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Introducer Regulatory Class: Class II Product Code: DQX Dated: July 1, 2003 Received: July 3, 2003

Dear Mr. Cerwin:

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.

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Page 2 -- Mr. Bruce Cerwin

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 forth in the quality systems (OS) 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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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,

sincerrity, 8 ms,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

HI-TORQUE BALANCE UNIVERSAL™ Guide Wire with Device Names: Hydrocoat Hydrophilic Coating

To facilitate the placement of balloon dilatation catheters during Indications percutaneous transluminal coronary angioplasty (PTCA), for Use: 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)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K031675
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter(Optional Format 1-1-96)
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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.