The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).

The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.

AI/ML Overview

This document describes the ACUITY™ Steerable Stylet Accessory, a Class II medical device, and its substantial equivalence to predicate devices. The information provided is for regulatory clearance and focuses on device characteristics and testing to meet acceptance criteria, rather than a detailed study comparing its performance against specific clinical metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. The information focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific clinical safety and effectiveness through quantified performance targets.

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Testing Data" section broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria" without detailing the nature or scope of this testing.

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

This information is not provided. The document is concerned with the physical and functional characteristics of a medical device (a stylet) for regulatory clearance, not with image interpretation or diagnostic performance that would typically involve establishing ground truth by medical experts.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the evaluation does not involve diagnostic interpretation or human reader performance that would necessitate an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable and not provided. The device is a mechanical accessory (a stylet), not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of AI assistance for human readers is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable and not provided. The device is a physical stylet, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

This information is not provided. Given the nature of the device (a stylet), "ground truth" as typically understood in a diagnostic study (e.g., pathology, clinical outcomes) is not the primary focus. The focus is on physical and functional characteristics, and comparison to predicate devices, implying engineering and material testing rather than clinical outcome studies for establishing "ground truth."

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set or ground truth for its development.

Summary of the Study and Acceptance Criteria (Based on the Provided Text):

The "study" described is a premarket notification (510(k)) submission to the FDA, not a clinical trial or performance study as might be conducted for an AI diagnostic device. The core assertion made is of "substantial equivalence" to legally marketed predicate devices.

Acceptance Criteria (Implied): The implied acceptance criteria are that the ACUITY™ Steerable Stylet Accessory possesses "technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life" that are substantially equivalent to the predicate devices and that it meets unspecified internal "acceptance criteria" from internal testing. The ultimate acceptance criterion for the FDA is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
Reported Device Performance: The document states, "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." It also lists the technological characteristics that were found to be substantially equivalent to the predicate devices. No specific quantitative performance metrics are provided.
Study Type: This is a pre-market regulatory submission demonstrating substantial equivalence, not a clinical effectiveness study. It mentions internal "testing" but does not detail the methodology, sample sizes, or specific results of this testing. The focus is on comparing the new device's characteristics to those of established, legally marketed devices.

Summary

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SFCTION 21: OTHER

MAR 3 2006

K053019

510(K) SUMMARY

Submitter:	Guidant CorporationCardiac Rhythm Management (CRM)4100 Hamline Avenue NorthSt. Paul, Minnesota 55112-5498
Contact:	Jennifer X. TangSenior Regulatory Affairs AssociateTelephone: (800) 227-3422 or direct (651) 582-6746FAX: (612) 582-5134Email: jennifer.tang@guidant.com
Date of Summary:	February 20, 2006
Common Name:	Stylet
Trade Name:	ACUITY™ Steerable Stylet Accessory
Classification Name:	Class IIPer 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel
Predicate:	Firm Straight 0.016 Stylet, Model 6602, K905674, cleared January 30, 1991 Tapered 0.016 Stylet, Model 6583, K843060, cleared September 20, 1984

DEVICE DESCRIPTION 1.1.

1.2. INTENDED USE

For use with compatible, transvenous, left ventricular, pace/sense leads.

page 1 of 2

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 1.3.

Comparisons of the ACUITY Steerable Stylet and the predicate devices show that the technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life are substantially equivalent to the currently marketed predicate devices.

TESTING DATA 1.4.

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

CONCLUSION 1.5.

The Guidant ACUITY Steerable Stylets are substantially equivalent to the currently marketed Firm Straight 0.016 Stylet, Model 6602 (K905674, cleared 1/30/1991) and Tapered 0.016 Stylet, Model 6583 (K843060, cleared 9/20/1984).

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Image /page/2/Picture/11 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 2006

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

Re: K053019

Trade Name: ACUITYTM Steerable Stylet Accessory Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: February 06, 2006 Received: February 07, 2006

Dear Ms. Tang:

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 interstatc 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 cl 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, MLA شھر publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jennifer X. Tang

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Bffimmumator

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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INDICATION FOR USE STATEMENT

510(k) Number (if known):	K053019
Device Name:	ACUITY™ Steerable Stylet Accessory
Indications For Use:	For use with compatible, transvenous, left ventricular, pace/sense leads
Prescription Use: (Part 21 CFR 801 Subpart D)	X 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)

Bflimmmon

(Division Sign-Division of Caraiovascular Devices 510(k) Number k05 3019

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).