The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Device Description

The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping.

The HI-TORQUE WHISPER LS, MS/MS CS-J and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically guide wires. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and AI performance metrics. Therefore, much of the requested information regarding AI performance, specific acceptance criteria for a study, sample sizes for training/test sets, expert adjudication methods, and MRMC studies is not present in the provided text.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the "results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device."

Without specific numerical or qualitative acceptance criteria defined in the provided text, a table cannot be fully populated. The "reported device performance" is broadly stated as meeting these unspecified criteria and being equivalent to the predicate device. The performance characteristics that were compared include "materials, performance characteristics, sterilization and packaging."

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (as stated in document)
(Implicit: Conformity to predicate device's features, performance characteristics, and material properties for safety and effectiveness)	"Meet the established acceptance criteria and perform in a manner equivalent to the predicate device."
(Implicit: No new safety or effectiveness issues)	"No new safety or effectiveness issues were raised during the testing program."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "verification testing" but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in a detailed study report, not usually in a 510(k) summary focused on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable or not provided. The document describes a medical device (guide wire) and its mechanical/material performance, not an AI or diagnostic tool that relies on expert interpretation for ground truth.

4. Adjudication Method

This information is not applicable or not provided. As above, the context is device performance testing, not diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not performed or at least not reported in this 510(k) summary. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device here is a guide wire, which is a tool used by a physician, not a diagnostic algorithm. Therefore, there's no mention of AI assistance or effect size on human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This information is not applicable or not provided. The device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device (a guide wire) would be based on engineering and performance specifications, material science properties, and direct functional testing (e.g., lubricity, flexibility, torque transmission, guidewire trackability, structural integrity after use). The document states that "performance data" and "verification testing" were conducted, implying these types of objective tests. There is no mention of "expert consensus, pathology, or outcomes data" in the context of establishing ground truth for the device's performance.

8. Sample Size for the Training Set

This information is not applicable or not provided. Since this is not an AI/ML device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or not provided. As there is no training set for an AI/ML model, there's no ground truth to establish for it in this context.

Summary

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GUIDANT

and the state of the research and

and the may

..............................................................................................................................................................................

OCT 2 8 2002

K023300

7. 510(K) SUMMARY
Submitter's Name:	Guidant CorporationCRM Division
Submitter's Address:	4100 Hamline AvenueMail Stop F330St. Paul, Minnesota 55112
Telephone:	(651) 582-6691
Fax:	(651) 582-5134
Contact Person:	Janell A. Colley
Date Prepared:	October 1, 2002
Device Trade Name:	HI-TORQUE® WHISPER™ LS (Light Support) GuideWire with Hydrocoat Hydrophilic Coating,Model 6726HI-TORQUE® WHISPER™ MS (Medium Support) GuideWire with Hydrocoat Hydrophilic Coating,Model 6737HI-TORQUE® WHISPER™ MS CS-J (Medium SupportCoronary Sinus J) Guide Wire with Hydrocoat HydrophilicCoating,Model 6738HI-TORQUE® WHISPER™ ES (Extra Support) Guide Wirewith Hydrocoat Hydrophilic Coating,Model 4482HI-TORQUE® WHISPER™ ES CS-J (Extra SupportCoronary Sinus J) Guide Wire with Hydrocoat HydrophilicCoating,Model 4483
Device Common Name:	Guide Wire
Device Classification Name:	Catheter Guide Wire
Device Classification:	Class II

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Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER Guide Wires (K020340/March 1, 2002, and K021285/May 2, 2002).

Device Description:

Intended Use:

The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Technological Characteristics:

Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed device.

Performance Data:

The results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.

Conclusions:

The Guidant CRM HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires have the same intended use, materials, technological characteristics, performance properties, and use identical sterilization processes as the Guidant VI Whisper LS and MS (Enhanced Radiopacity) guidewires and the Guidant CRM HI-TORQUE guidewires; therefore, there are no new safety or effectiveness issues. The modified HI-TORQUE WHISPER Guide Wires are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

OCT 28 2002

Guidant Corporation c/o Ms. Janell A. Colley Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline North St. Paul. MN 55112-5798

Re: K023300

Trade Name: Hi-Torque Whisper LS, MS, MS CS-J, ES, and ES CS-J Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX

Dated: October 1, 2002 Received: October 3, 2002

Dear Ms. Colley:

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Janell A. Colley

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 (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) 594-4646. 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). 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,

Odell Tun

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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Indications for Use Statement

510(k) Number (if known)
Device Name	HI-TORQUE WHISPER LS, MS, MS CS-J, ES, and ES CS-J Guide Wires with Hydrocoat Hydrophilic Coating
Indications for Use	The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

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 K023300

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109) Guidant CRM HI-TORQUE WHISPER Guide Wire

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.