The SUPPORTRAK Finishing Wire is intended to facilitate the positioning of a Guidant over-the wire left ventricular coronary venous pace/sense lead. The finishing wire is inserted into the lumen of the implanted lead and serves to stabilize the lead as the guide catheter is removed. A mechanical stop engages with the terminal pin of the lead and controls the position of the wire relative to the lead.

Each finishing wire model is specific to a particular lead length and hence, the location of the mechanical stop along the core wire varies for each SUPPORTRAK model. Also, the proximal end of the wire is formed into a loop to prevent incorrect insertion of the finishing wire in the lumen of the lead.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SUPPORTRAK Finishing Wire:

Acceptance Criteria and Device Performance

The provided 510(k) summary for the SUPPORTRAK Finishing Wire does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format.

Instead, it offers a general statement:

"Testing demonstrated that the SUPPORTRAK Finishing Wire met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program."

This indicates that while acceptance criteria were in place and met, the document does not disclose them in detail. The primary "performance" reported is that the device was found substantially equivalent to its predicate devices.

Given the information provided, a table of acceptance criteria and reported device performance would look like this:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
General Performance	(Not explicitly stated)	Met acceptance criteria; no new safety or effectiveness issues. Substantially equivalent to predicate devices.
Technological Characteristics	(Not explicitly stated beyond "substantially equivalent" comparisons)	Demonstrated substantial equivalence in Intended Use, Material, Assembly, Design, Package, and Sterilization to predicate devices.

Study Details from the Provided Text:

Unfortunately, the provided 510(k) summary is very high-level and does not contain the detailed information required for points 2 through 9 regarding the study that "proves the device meets the acceptance criteria."

Here's an assessment of what can and cannot be extracted from the text for each point:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information in text: Not available. The document states "Testing demonstrated...", but provides no details on the sample size of devices tested or the nature of the data (e.g., in vitro, animal, human).
- Conclusion: Unknown.
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):
- Information in text: Not applicable. This device is a mechanical medical instrument (finishing wire), not an AI or diagnostic imaging device that would typically involve expert ground truth for a "test set" in the way described. The "testing" referred to appears to be engineering and design verification/validation against pre-defined performance specifications, rather than clinical efficacy assessed by experts.
- Conclusion: Not applicable/Unknown.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information in text: Not applicable for the same reasons as point 3.
- Conclusion: Not applicable/Unknown.
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:
- Information in text: No. This is a medical device (finishing wire), not an AI diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.
- Conclusion: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information in text: Not applicable. As a mechanical device, there is no "algorithm only" performance. The device is used by a human clinician.
- Conclusion: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information in text: Not explicitly stated. For a mechanical device, "ground truth" would likely relate to objective engineering measurements and performance specifications (e.g., tensile strength, flexibility, dimensions, biocompatibility, force required for insertion/removal, etc.) rather than clinical endpoints or expert consensus in a diagnostic sense.
- Conclusion: Not specified, but likely based on engineering and performance specifications.
The sample size for the training set:
- Information in text: No "training set" is mentioned as this is not an AI/machine learning device. The testing likely involved design verification and validation.
- Conclusion: Not applicable.
How the ground truth for the training set was established:
- Information in text: Not applicable for the same reasons as point 8.
- Conclusion: Not applicable.

Summary of Missing Information: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices. It provides a high-level overview but lacks the granular technical and study design details (like specific test data, sample sizes, expert involvement, or adjudication methods) that would be found in a comprehensive study report or detailed technical file. The "testing data" section is very brief and only states that acceptance criteria were met.

Summary

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

AUG = 6 2004 510(K) SUMMARY

SPONSOR

Guidant Corporation Cardiac Rhythm Management (CRM) 4100 Hamline Avenue North St. Paul, Minnesota 55112-5498

CONTACT PERSON

Jennifer X. Tang, Phone: 800-CARDIAC or direct 651-582-6746 Fax: 651-582-5134 jennifer.tang(@guidant.com

DATE OF THE SUMMARY

June 28, 2004

PREDICATE DEVICE

Stylet Accessory, K905674, cleared on 1/30/1991 .
. HI TORQUE WHISPER Guide Wire, K023300, cleared on 10/28/2002

DEVICE TRADE NAME

Finishing Wire® SUPPORTRAK®

DEVICE COMMON NAME

Finishing Wire

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DEVICE DESCRIPTION

INTENDED USE

The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Comparisons of the SUPPORTRAK Finishing Wire and the predicate devices show that the technological characteristics such as Intended Use, Material, Assembly, Design, Package, and Sterilization are substantially equivalent to the currently marketed predicate devices.

TESTING DATA

Testing demonstrated that the SUPPORTRAK Finishing Wire met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The SUPPORTRAK Finishing Wire may be considered substantially equivalent to the predicate devices.

CONCLUSION

The Guidant SUPPORTRAK Finishing Wires are substantially equivalent to the currently marketed Stylet Accessory (K905674, cleared 1/30/1991) and HI TORQUE WHISPER Guide Wire (K023300, cleared 10/28/2002).

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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2004

Guidant Corporation c/o Ms. Jennifer X. Tang Senior Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K041762

K041702
Trade Name: SUPPORTRAK Finishing Wire, Models 6681-85 and 6667-69 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: June 29, 2004 Received: June 30, 2004

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your Section > ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally maketed predicate devices marketed in interstate for use stated in the cherosule) to regars mannent date of the Medical Device Ameral Food. Drug commerce prior to May 28, 1976, the encontent and othe provisions of the Federal Food, Drug, devices that have occh recuise in assessmed in assessment of a premarket approval application (PMA). and Cosmelle Act (Act) that do not require approvince of the general controls provisions of the Act. The You may, therefore, market the device, basyer of the more of registration, listing of
general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classifica (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroling may of one 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi be found in the Oous ocements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 -- Ms. Jennifer X. Tang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a succession of the requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decidination that Jour Correst by other Federal agencies. You must or any Federal statutes and regulations adminding, but not limited to: registration and listing (21 l
ess set comply with all the Act s requirements, merceive and acturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good manage (200); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (occions of 7 - evice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to location to local I his letter will anow you to begin mancellig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket nothication. The PDA midning of backannal reporterine 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
rs the results of the more and 1610 - 11 to the results to regulation entit if you desire specific advice for your ac novel as a look of the regulation entitled, white in the move obtain contact the Office of Complance at (301) of the Part 807.97). You may obtain " Misbranding by reference to premarket nouthean in the Act from the Division of Small other general information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number on any armanial Manufacturers, International and Ochschhttp://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil Rt. Ogle

Dr. 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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Indications for Use

510(k) Number (if known):_K041762

Device Name:_Finishing Wire

Indications For Use:

The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Srogl
Division Sign-Off
307

ivision of Cardiovascular Devices

510(k) Number K041762

Page 1 of

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.