This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Device Description

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, based on the provided text:

Acceptance Criteria and Device Performance (Based on provided text)

The provided text does not contain a detailed table of specific acceptance criteria with numerical targets. Instead, it states a general conclusion about meeting acceptance criteria and performance comparability.

Acceptance Criteria Category	Reported Device Performance
Overall Performance	Met acceptance criteria
Comparability	Performed comparable to the predicate device
Safety and Effectiveness	No new safety or effectiveness issues raised

Study Details:

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: The study was "in vitro bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Therefore, there is no information about country of origin or whether it was retrospective or prospective in the clinical sense.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable/Not specified. This was an in vitro bench test, not an evaluation relying on expert interpretation of clinical data or images.
Adjudication method for the test set:
- Not applicable/Not specified. This was an in vitro bench test, not a study requiring adjudication of expert opinions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a guide wire, not an AI-powered diagnostic or assistive technology. The study was an in vitro bench test.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument (guide wire), not an algorithm. The study was an in vitro bench test of its physical properties and functionality.
The type of ground truth used:
- The "ground truth" for this in vitro bench testing would be established engineering specifications, performance standards, and the performance characteristics of the predicate device. The text indicates the device "met the acceptance criteria" and "performed comparable to the predicate device."
The sample size for the training set:
- Not applicable. This was an in vitro bench test of a physical device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As noted above, this was not an AI study requiring a training set with established ground truth.

Summary

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K072460

510(k) Summary

APR 1 1 2008

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	Abbott Vascular, Cardiac Therapies
2.	Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3.	Telephone	(951) 914-4544
4.	Fax	(951) 914-0339
5.	Contact Person	Michele Walz
6.	Date Prepared	August 30, 2007
7.	Device Trade Name	HI-TORQUE BALANCE MIDDLEWEIGHTUNIVERSAL II Guide Wire
8.	Device Common Name	Guide Wire
9.	Device Classification Name	Catheter Guide Wire (DQX)
10.	Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHTUNIVERSAL Guide Wire (K013833, cleared Jan 162002)

11. Device Description

Indication for Use

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

13. 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 device.

Performance Data

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

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or a series of interconnected human profiles. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Vascular clo Ms. Michele Walz Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92590

APR 1 1 2008

Re: K072460

Trade Name: Hi-Torque Balance Middleweight Universal II Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 24, 2008 Received: March 25, 2008

Dear Ms. Walz:

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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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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. bohner

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

Enclosure

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INDICATION FOR USE

长072460 510(k) Number (if known):

Device Names:

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hum R. vi Ames

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K672460

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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.