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 MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J".

The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating. This summary outlines the device's characteristics, intended use, and performance data to establish substantial equivalence to predicate devices.

However, the document does not provide the detailed information requested regarding the acceptance criteria for a study proving the device meets those criteria, as typically seen in an AI/Software as a Medical Device (SaMD) context. This is a physical medical device, and the evaluation relies on bench testing and in vivo animal models, rather than a clinical study with human readers and ground truth established by experts.

Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

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

The document states that the device "met the acceptance criteria" and "performed similarly to the predicate devices" for the following functional tests:

Acceptance Criteria / Functional Test	Reported Device Performance
Distal Tip Pull (Tensile Strength)	Met acceptance criteria, performed similarly to predicate devices.
Distal Tip Torque (Tensile Strength)	Met acceptance criteria, performed similarly to predicate devices.
Rotational Accuracy (Torqueability)	Met acceptance criteria, performed similarly to predicate devices.
Tip Flexibility	Met acceptance criteria, performed similarly to predicate devices.
In vivo Performance	Performed comparably to the predicate devices; no new safety or effectiveness issues were raised.

Note: The specific quantitative acceptance criteria values (e.g., "tensile strength > X N") are not provided in this summary.

2. 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: Not specified for the in vitro tests. For the in vivo animal model, the number of animals tested is not specified, only that "two in vivo animal model" studies were conducted.
Data Provenance: Not specified, but given it's an in vivo animal model, it would be prospective data from an animal study.

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. This is a physical device evaluation based on engineering tests and animal models, not a clinical study involving human expert ground truth establishment in the context of diagnostic interpretation.

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

Not Applicable. See point 3.

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. This is not an AI/SaMD product.

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

Not Applicable. This is a physical device. Performance was assessed through standalone bench tests and in vivo animal performance.

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

For in vitro tests: Engineering specifications/standards and comparative performance to predicate devices and their established performance characteristics.
For in vivo animal model: Comparative performance to predicate devices in terms of safety and effectiveness, likely assessed by veterinarians or researchers observing physiological responses and procedural outcomes.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. See point 8.

Summary

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JAN 2 4 :

98
K012534

510(k) SUMMARY

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

1. Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
2. Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95054
3. Telephone:	408-845-3956
4. Fax:	408-845-3743
5. Contact Person:	Joanna Mroz
6. Date Prepared:	July 6, 2001
7. Device Trade Name:	HI-TORQUE MIDDLE SUPPORT™ .012" GuideWire with HYDROCOAT™ Hydrophilic Coating
8. Device Common Name:	Guide Wire
9. Device Classification Name:	Catheter Guide Wire (74DQX)
10. Predicate Devices:	• ACS HI-TORQUE TRAVERSE® Guide Wire withHYDROCOAT™ Hydrophilic Coating• HI-TORQUE BALANCE MIDDLEWEIGHTGuide Wire with HYDROCOAT™ Hydrophilic

Coating

Device Description:

1. 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.

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13. Technological Characteristics:

Comparisons of the new and predicate devices show that the technological characteristics compansons of the new and presign, and intended use are substantially equivalent to the currently marketed predicate devices.

14. Performance Data:

In vitro bench testing and in vivo performance evaluations demonstrated that the HIm varo occión costains and .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similarly to the predicate devices. The Counting functional tests were performed: Distal Tip Pull (Tensile Strength), Distal Tip Tomowing Tailerial torque Strength), Rotational Accuracy (Torqueability), and Tip Flexibility. I unis-to I antare (Torque Buchgan), stons in an in vivo animal model were conducted. The In addition, two performed comparably to the predicate devices and no new safety or effectiveness issues were raised during the testing program Therefore, the HI-TORQUE MIDDLE ISUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating 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 features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Ms. Joanna Mroz Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054-2807

Re: K012534

HI-TORQUE MIDDLE SUPPORT™ 0.012" Guide Wire with HYDROCOAT™ Hydrophilic Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 29, 2001 Received: December 4, 2001

Dear Ms. Mroz:

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. Joanna Mroz

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 premainer nedicate 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) 594-4648. 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,

Dafe Tille

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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Indications for Use Statement

510(k) Number (if known): K012534

HI-TORQUE MIDDLE SUPPORT™ .012" 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)

Prescription Use
(Per 21 CFR 801.109)
✓

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

Dalerteh

Division of Cardiovascular & Respiratory Devices
510(k) Number K012534

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.