The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.

The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the EASYTRAK® 2 Stylet, focusing on acceptance criteria and study information:

Based on the provided document (K052965), the information about acceptance criteria and the study that proves the device meets them is very limited. This is typical for 510(k) submissions, especially for devices seeking substantial equivalence where extensive clinical trials with detailed performance metrics are often not required if the device is sufficiently similar to a predicate.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria."
Not specified	"No new safety or effectiveness issues were raised during the testing program."

Explanation: The document states that testing was performed and the device met the acceptance criteria. However, it does not explicitly list what those acceptance criteria were or provide specific quantitative results for the device performance beyond a general statement of compliance. This typically means the tests related to engineering performance (e.g., tensile strength, flexibility, material compatibility, dimensional accuracy) and possibly simulated use, which are usually compared against internal design specifications derived from the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified. Given the nature of a 510(k) for a stylet, the testing would almost certainly be internal, non-clinical (benchtop) testing. There is no indication of clinical data, animal studies, or data from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the studies described are not clinical studies requiring expert ground truth for interpretation (e.g., image reading, disease diagnosis). The testing would have focused on engineering specifications and physical properties.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials involving human interpretation of data, where discrepancies need to be resolved. This document describes non-clinical engineering and performance testing.

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

This is not applicable. MRMC studies are related to evaluating diagnostic devices, often AI-driven, and involve multiple human readers interpreting cases. The EASYTRAK® 2 Stylet is a mechanical accessory, not a diagnostic or AI-powered device.

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

This is not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

This is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For engineering testing, "ground truth" would be established by validated test methods and reference standards against which the device's physical and functional properties are measured. For example, a "pull test" might have an acceptance criterion of "withstands X Newtons of force," and the ground truth for whether the device passes is an objective measurement of the force it withstood.

8. The sample size for the training set

This is not applicable as 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

This is not applicable for the same reason as point 8.

Summary

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K052965

510(K) SUMMARY 5.

Owner:	Guidant Corporation
	Cardiac Rhythm Management (CRM)
	4100 Hamline Avenue North
	St. Paul, Minnesota 55112-5798
Contact:	Linda Kleinsasser, RAC
	Senior Regulatory Affairs Associate
	Telephone:	(800) 227-3422, x24106 or direct (651) 582-4106
	Fax:	(651) 582-5134
	Email:	linda.Kleinsasser@guidant.com
Date of Summary:	October 20, 2005
Common Name:	Stylet
Trade Name:	EASYTRAK® 2 Stylet
Classification Name:	Class II
	Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel
Predicate:	Stylet Accessory, Model 6602, K905674, cleared January 30, 1991
	IRONMAN Guide Wire, Model 6725, K021285,
		cleared May 2, 2002

DEVICE DESCRIPTION 5.1.

The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.

Gaetan Carpersona

way.guidant.com

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5.2. INTENDED USE

The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant The EASYTRAK® 2 implantable venous lead in the coronary venous vasculature.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 5.3.

Comparisons of the EASYTRAK® 2 Stylet and the predicate devices show that the Comparisons of the Eristics such as Intended Use, material, packaging, shelf life and technological enaracteristion satin alles and and the currently marketed predicate devices.

5.4. TESTING

Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK® 2 Stylet may be considered substantially equivalent to the predicate devices.

5.5. CONCLUSION

The Guidant EASYTRAK® 2 Stylet are substantially equivalent to the currently marketed The Saccessory, Model 6602 (K905674, cleared 1/30/1991) and the IRONMAN Guide Wire, Model 6725 (K021285, cleared 5/2/2002).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

FEB 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Ms. Linda Kleinsasser, RAC Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K052965 Trade Name: EASYTRAK® 2 Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: January 9, 2006 Received: January 10, 2006

Dear Ms. Kleinsasser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of re(s) pe device is substantially equivalent (for the indications felerenced above and nave determined is a aveces marketed predicate devices marketed in interstate for use stated in the enerosale) to regary the Medical Device Amendments, or to Commerce prices that have been reclasion with the provisions of the Federal Food. Drug. de vices marchave been recuire approval of a premarket approval application (PMA). and Costinctle recry too, that do nover copied to the general controls provisions of the Act. The I ou may, dierelove, market 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), If your device is classified (566 acre) in the s. Existing major regulations affecting your device . FFA it may to subject to back as a segulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Linda Kleinsasser, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a basevice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of any I ecolar statutes and regulations and limited to: registration and listing (21 Compry with an the Fee brequirements)01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) rogans (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro hereins (oveting your device as described in your Section 510(k) This letter will anow you to ogin maneting your antial equivalence of your device to a legally prematication. "The PDTP Intentig seriestion 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 If you ucate specific advice for Jour as not on a more as note the regulation written, Contact the Office of Comphalled as (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2011 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blymmman for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 4.

INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K052965

Device Name: Stylet

Indication for Use:

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The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

(PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

College of the country of the state of the same of the state and the comments of the comments with and

Bhumma

Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kos 1965 Company Controller Concession Comer Collection Comer College Comer College Comments of Concession Comers of Concession Comparis Comments of Concession Comers of Concession of

EASYTRAK® 2 Stylet Guidant Corporation Confidential October 20, 2005

Regulation Number and Section

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).