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 WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic The II - Ore Quide 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 extendable lengths and a 500 em enemange compression 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 wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides tapes in diamover to the up. Thathew re- wire is jacketed with a polyurethane coating that is coated with a hyrophilic coating. The proximal section of the wire is coated with 13 couted with a hyropinias countal tips of the guide wires are available either as a straight tip that is shapeable, or as a pre-shaped "J".

AI/ML Overview

This submission (K013092) is for a guide wire, and the performance data provided focuses on in-vitro bench testing. Therefore, many of the requested criteria related to human studies (e.g., sample size for test set, expert qualifications, MRMC study, human-in-the-loop performance) are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Guide wires meet acceptance criteria.	In vitro bench testing demonstrated that the HI-TORQUE WHISPER™ Guide Wires met the acceptance criteria and is acceptable for clinical use.

Details of the Study

A table of acceptance criteria and the reported device performance:
(See table above)
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The text only mentions "in vitro bench testing."
- Data Provenance: The study was "in vitro bench testing," meaning laboratory testing, not human or animal studies. No country of origin is specified for this type of testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was in vitro bench testing, not a study requiring expert clinical assessment for ground truth.
Adjudication method for the test set:
Not applicable, as this was in vitro bench testing.
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:
Not applicable. This device is a guide wire, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical instrument, not an algorithm. The "performance" here refers to the physical properties and functionality of the guide wire itself during bench testing.
The type of ground truth used:
The ground truth would be established through engineering specifications and predefined pass/fail criteria for the various bench tests performed on the guide wires (e.g., tensile strength, lubricity, torqueability, tip flexibility, etc.). This information is not detailed in the summary but is implied by "met the acceptance criteria."
The sample size for the training set:
Not applicable. This is not a machine learning device that requires a training set.
How the ground truth for the training set was established:
Not applicable. This is not a machine learning device.

Summary

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DEC 1 3 2001

K013092

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:	September 14, 2001
7. Device Trade Name:	HI-TORQUE WHISPER™ LS and MS Guide Wireswith Hydrocoat Hydrophilic Coating
8. Device Common Name:	Guide Wire
9. Device Classification Name:	Catheter Guide Wire (74DQX)
10. Predicate Device:	HI-TORQUE WHISPER™ LS and MS Guide Wireswith Hydrocoat Hydrophilic Coating (K002206)

11. Device Description:

12. Intended Use:

To facilitate the placement of balloon dilatation catheters during percutaneous ro raomate the pracement of one of CA) 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:

There are no changes to the technological characteristics.

Performance Data:

In vitro bench testing demonstrated that the HI-TORQUE WHISPER™ Guide Wires met
the acceptance criteria and is acceptable for clinical use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Ms. Jennifer Pae Riggs Sr. Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA 92589-9018

K013092 Re:

K013092
HI-TORQUE™ WHISPER LS and MS Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 14, 2001 Received: September 17, 2001

Dear Ms. Riggs:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premained is substantially equivalent (for the indications felerenced above and nave determined the arredicate devices marketed in interstate for use stated in the ciclosure) to regally names of the Medical Device Amendments, or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been icclassified in acceraanse was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The I ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of the reviles, 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 IT your device is classified (500 a0010) als. Existing major regulations affecting your device can inay be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may or found in the Oous cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that I Dris issualites our device complies with other requirements of the Act that I DT has made a active and regulations administered by other Federal agencies. You must of any I cacial statutes and regaranents, including, but not limited to: registration and listing (21 compy with an tale 110 (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,

K. Donka Telle

am 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

KO13092 510(k) Number (if known): _ HI-TORQUE WHISPER™ LS (Light Support) Guide Wire with Device Names: . Hydrocoat Hydrophilic Coating

HI-TORQUE WHISPER™ MS (Middle Support) Guide Wire . with Hydrocoat Hydrophilic Coating
To facilitate the placement of balloon dilatation catheters during Indications PTCA), 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 of Cardiovascular & Respiratory Devices
510(k) Number K015092

Prescription Use
(Per 21 CFR 801.109)

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

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.