The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.

Device Description

The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Locking Stylet 2". It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain details about specific acceptance criteria, performance studies, or clinical trial data in the way you've outlined.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered based on the available information:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria or report performance metrics from a study against such criteria. The submission is a 510(k) for substantial equivalence, not a clinical trial report.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or study data is mentioned.

3. 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)

Cannot be provided. No ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is described.

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

No. This information is not relevant to a device like a locking stylet, which is a physical instrument, not an AI-powered diagnostic tool. The document describes a physical medical device.

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

No. This is not applicable to a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. No ground truth establishment is described.

8. The sample size for the training set

Cannot be provided. No training set is mentioned as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Cannot be provided. No training set or ground truth establishment is mentioned.

Summary based on the document:

The 510(k) summary states that the Locking Stylet 2 is "similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation." It also mentions "Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated." The basis for substantial equivalence relies on these similarities and the manufacturing processes. The document does not contain data from performance studies or clinical trials to demonstrate specific acceptance criteria.

Summary

{0}------------------------------------------------

510(k) Premarket Notification Locking Stylet 2

K970690

MAY 2 0 1997

510(K) SUMMARY I.

Submitted By:

Neal E. Fearnot, Ph.D., E.E. President MED Institute, Incorporated P.O. Box 2402 West Lafavette, IN 47906 (317) 463-7537 February 24, 1997

Device:

Trade Name:	Locking Stylet 2
Common/Usual Name:	Stylet, Wire Guide Stylet, Catheter RetrievalDevice
Proposed Classification Name:	Predicate devices of this type with similarintended uses have been classified into Class I orClass II.

Predicate Devices:

The Locking Stylet 2 is similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation.

Device Description:

Substantial Equivalence:

The Locking Stylet 2 will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK Vascular™ Incorporated. This device is similar with respect to indications for use, materials, and physical construction to predicate devices in terms of section 510(k) substantial equivalency.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1997

Neal E. Fearnot, Ph.D. President MED Institute, Inc. A Cook Group Company 1400 Cumberland Avenue West Lafayette, Indiana 47906

Re: K970690 Locking Stylet 2 II (two) Requlatory Class: Product Code: DQX Dated: February 24, 1997 February 25, 1997 Received:

Dear Dr. Fearnot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

{2}------------------------------------------------

regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described w in your 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 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:Locking_Stylet_2____________________________________________________________________________________________________________________________________________

Indications For Use:

The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.

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

Concurrence of CORE &ffige of Device Evaluation (ODE)

Tiafik
(Division Sign-Off)

Division of General Restorative Dev 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.