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. The HI-TORQUE WHISPER DS/DS CS-J and EDS/EDS CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.0145" maximum diameter and a length of 190 cm. These guide wires are all labeled as 0.014". 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 a guide wire. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics against pre-defined acceptance criteria in the same way a new drug or a more complex AI/ML device would.

Therefore, the structure of the acceptance criteria and study information will differ from what might be expected for an AI-powered diagnostic device. The study described focuses on verification testing to ensure the device performs equivalently to the predicate, meeting established internal criteria for safety and function, rather than demonstrating a specific clinical performance improvement.

Here's an analysis based on the provided text:

Acceptance Criteria and Study Information for HI-TORQUE® WHISPER™ LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values in the manner typically seen for clinical endpoints or AI/ML model metrics. Instead, the "Performance Data" section broadly states:

Acceptance Criteria Category	Reported Device Performance
Overall Performance	"The HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device."
Safety and Effectiveness	"No new safety or effectiveness issues were raised during the testing program."
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."

Note: For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. The specific internal engineering and performance criteria used for verification testing are typically not disclosed in the 510(k) summary, but are part of the detailed submission to the FDA. These would likely include criteria for mechanical properties (e.g., tensile strength, kink resistance, pushability, torqueability, tip flexibility), lubricity, and biocompatibility, all demonstrated to be comparable to or within acceptable limits relative to the predicate.

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

The document does not explicitly state the sample size (e.g., number of guide wires tested, number of simulated procedures) used for the verification testing. This information would be part of the more detailed submission to the FDA but is not included in the public K030019 summary.

Data Provenance: Not specified in the summary, but given the nature of a guide wire, the "test set" would primarily consist of in vitro (laboratory) testing, and potentially in vivo animal model testing. Human patient data is not the primary test set for this type of device clearance for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable in the context of this 510(k) submission. This device is a physical medical instrument, not an interpretive diagnostic tool requiring expert ground truth for image or data analysis. The "ground truth" for its performance is established through objective engineering and usability testing, not expert consensus on medical findings.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth for subjective interpretations, primarily in diagnostic studies involving image or data review. The verification testing for this guide wire would involve objective measurements and comparisons against technical specifications, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with vs. without AI assistance, which is irrelevant for a guide wire. The study described is verification testing against a predicate device, not a human-in-the-loop performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable. This device is not an algorithm; it is a physical medical instrument.

7. The Type of Ground Truth Used

The "ground truth" for a device like a guide wire is established through objective engineering measurements and functional testing to ensure it meets pre-defined specifications and performs safely and effectively as intended. This includes evaluations of:

Mechanical properties: (e.g., tensile strength, pushability, torque response, tip flexibility, kink resistance)
Dimensional accuracy: (e.g., diameter, length)
Material compatibility: (e.g., biocompatibility)
Sterility:
Lubricity: (for hydrophilic coating)
Visual inspection:

The comparison is made against the established performance characteristics of the predicate device and internal design specifications.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

This question is not applicable, as there is no "training set" for physical medical devices in this context.

Summary

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K030019

JAN 2 4 2003

510(K) SUMMARY

Submitter's Name:	Guidant CorporationCRM Division
Submitter's Address:	4100 Hamline AvenueMail Stop F330St. Paul, Minnesota 55112
Telephone:Fax:	(651) 582-5011(651) 582-5134
Contact Person:	Kristine M. Teich
Date Prepared:	January 2, 2003

Device Trade Name:

HI-TORQUE® WHISPER™ LS (Light Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6726

HI-TORQUE® WHISPER™ MS (Medium Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6737

HI-TORQUE® WHISPER™ MS CS-J (Medium Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6738

HI-TORQUE® WHISPER™ ES (Extra Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4482

HI-TORQUE® WHISPER™ ES CS-J (Extra Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4483

HI-TORQUE® WHISPER™ DS (Distal Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4581

HI-TORQUE® WHISPER™ DS CS-J (Distal Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4586

HI-TORQUE® WHISPER™ EDS (Extra Distal Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4583

HI-TORQUE® WHISPER™ EDS CS-J (Extra Distal Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4588

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 HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS 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/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS 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/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS 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; 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

Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Ms. Kristine M. Teich Principal Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul. MN 55112

Re: K030019

Trade Name: Hi-Torque Whisper DS/DS CS-J, and EDS/EDS 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: January 2, 2003 Received: January 3, 2003

Dear Ms. Teich:

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.

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Page 2 -- Ms. Kristine M. Teich

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 (OS) 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

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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2. Indications for Use Statement

510(k) Number (if known)
Device Name	HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS 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 Sign-Off)

Division of Cardiovascular

510(k) Number	4030019
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Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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Anidat CRM HI-TORQUE WHISPER Guide Wire
Guidant CRM II Octor Special 5 I0(k): Device Modification

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.