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.

Device Description

The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL 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 BMW™ 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 MIDDLEWEIGHT™ UNIVERSAL Guide Wire. The information necessary to fully populate the requested table regarding acceptance criteria and study details is limited. However, based on the available text, here's what can be extracted and inferred:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of specific numerical thresholds or benchmarks. The general criteria is that the device should perform "similarly to the predicate devices" and "meet regulatory requirements for safety and effectiveness."	In vitro bench testing: Met acceptance criteria.In vivo performance evaluations: Met acceptance criteria.Overall: Performed similarly to predicate devices. No new safety or effectiveness issues were raised during the testing program.

2. Sample size 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 in the provided text.
Data Provenance: The text states "in vitro bench testing" and "in vivo performance evaluations." It doesn't specify the country of origin for these tests or whether they were retrospective or prospective. Typically, "in vitro" implies laboratory testing, and "in vivo" refers to testing in living organisms (animal or human), which, in a 510(k), would usually be animal studies or clinical data gathered as part of a substantial equivalence claim.

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)

Not applicable/Not specified. This information is typically relevant for studies involving human interpretation (e.g., imaging studies assessed by radiologists), which is not the nature of this device's testing as described. The performance evaluations here are likely functional and mechanical tests.

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

Not applicable/Not specified. Adjudication methods are typically used when there are multiple reviewers assessing an outcome or image, which is not indicated for the type of testing described (bench and in vivo performance).

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to devices, particularly AI-powered ones, that assist human readers in interpreting data (e.g., medical images). This device is a guide wire, which is a physical tool, not an interpretive aid.

6. 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 or software. Therefore, the concept of "standalone" performance for an algorithm is not relevant.

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

The "ground truth" for a medical device like a guide wire would typically be established through engineering specifications, established performance standards, and clinical outcomes related to its intended use and safety. For the provided text, the "ground truth" seems to be aligned with:
- Predicate device performance: The new device must perform "similarly to the predicate devices."
- Acceptance criteria: These would be pre-defined performance thresholds for various mechanical, material, and functional tests (though not explicitly detailed in the summary).
- Safety and effectiveness: Demonstrated through the in vitro and in vivo testing program.

8. The sample size for the training set

Not applicable. This device is a physical medical tool, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this type of device.

Study Description based on the provided text:

The study involved in vitro bench testing and in vivo performance evaluations to demonstrate the substantial equivalence of the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire to its predicate devices. The specific tests performed and their methodologies are not detailed in the summary, but they were sufficient to show that the new device "met the acceptance criteria and performed similarly to the predicate devices" and raised "no new safety or effectiveness issues." This implies a battery of tests designed to assess the guide wire's mechanical properties, lubricity, steerability, and biocompatibility, likely against established industry standards or the performance benchmarks of the predicate devices.

Summary

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JAN 1 6 2002

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 CorporationVascular Intervention
2. Submitter's Address:	26531 Ynez Road
3. Telephone:	(909) 914-4581
4. Fax:	(909) 914-0339
5. Contact Person:	Jennifer Pae Riggs
6. Date Prepared:	November 16, 2001
7. Device Trade Name:	HI-TORQUE BALANCE MIDDLEWEIGHTTMUNIVERSAL Guide Wires with HydrocoatHydrophilic Coating
8. Device Common Name:	Guide Wire
9. Device Classification Name:	Catheter Guide Wire (74DQX)
10. Predicate Device:	HI-TORQUE BALANCE MIDDLEWEIGHTTM GuideWire with Hydrocoat Hydrophilic Coating (K973494)HI-TORQUE WHISPERTM MS Guide Wire withHydrocoat Hydrophilic Coating (K002206)

Device Description:

12. Intended Use:

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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Performance Data:

In vitro bench testing and in vivo performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ 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 MIDDLEWEIGHT™ UNIVERSAL Guide Wire may be considered 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 and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines that converge to form the shape of a bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2002

Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

Sr. Regulatory Affairs Coordinator

Ms. Jennifer Pae Riggs

Re: K013833

HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 16, 2001 Received: November 19, 2001

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 forth in the quality

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Page 2 - Ms. Jennifer Pae Riggs

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 promated notificate 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,

Dalle Tuth

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

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known): _ KO/ 3833

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

Indications To facilitate the placement of balloon dilatation catheters during for Use: percutaneous transluminal coronary angioplasty (PTCA), 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)

Prescription Use
(Per 21 CFR 801.109) ✓

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

Nalle Teh
Division of Cardiovascule & Respiratory Devices
510(k) No K013833

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.