The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided text describes a submission for a medical device (Selectiva™ Guidewire) to the FDA, seeking substantial equivalence to a predicate device. This document is a 510(k) Premarket Notification, a process used to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. This type of submission relies on comparisons to an existing device rather than presenting novel clinical study data to establish acceptance criteria and performance against those criteria in the way one might for a new drug or an AI-powered diagnostic tool.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this type of device submission. The "acceptance criteria" here are fundamentally about demonstrating equivalence to the predicate device in specific functional and safety aspects.

Here's an attempt to answer the questions based on the provided text, indicating "N/A" (Not Applicable) where the information is not present or relevant to a 510(k) submission for a guidewire, which is not an AI/diagnostic device.

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

Acceptance Criteria (based on predicate device)	Reported Device Performance (Selectiva™ Guidewire)
Functional Equivalence	Demonstrated equivalency in all functional tests.
Dimensional Specifications	Successfully compared.
Visual Inspection	Successfully compared.
Tip Flexibility	Successfully compared.
Tensile Strength	Successfully compared.
Torqueability	Successfully compared.
Coating Durability	Successfully compared.
Safety Equivalence	Demonstrated equivalency in all safety tests.
Biocompatibility	Successfully completed testing of finished devices.
Independent Laboratory Material Equivalence	Demonstrated equivalence of materials.

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

Sample Size: Not specified for individual tests. The submission refers to a comparison of "all functional and safety tests."
Data Provenance: Not specified. The testing was conducted by the submitter (NeoMetrics, Inc.) and potentially independent laboratories. The country of origin of the data is not mentioned, but the submitter is based in Plymouth, MN, USA.
Retrospective or Prospective: Not explicitly stated, but device testing of this nature is generally prospective for the specific tests performed to support a 510(k).

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)

N/A. This type of information is not relevant to demonstrating substantial equivalence for a physical medical device like a guidewire. Ground truth is established by objective engineering and biocompatibility testing standards, not expert consensus on diagnostic images.

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

N/A. Adjudication methods are typically employed in clinical studies where subjective human interpretation or diagnostic accuracy is being assessed. For physical device performance tests, the results are typically objective measurements or pass/fail criteria against established specifications.

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

N/A. This context relates to AI-powered diagnostic tools. The Selectiva™ Guidewire is a physical device, not an AI or diagnostic tool, and therefore, an MRMC study is not relevant.

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

N/A. This applies to AI algorithms. The Selectiva™ Guidewire is a physical medical device.

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

The "ground truth" for this device's performance is established by:

Pre-defined engineering specifications and performance standards for functional characteristics (e.g., tensile strength, flexibility, torqueability).
Biocompatibility testing against ISO standards or equivalent for safety to demonstrate the device is non-toxic and compatible with the human body.
Characteristics of the predicate device (Lake Region Manufacturing Mandrel Guidewire Assembly K011084) serve as the primary reference for demonstrating "substantial equivalence."

8. The sample size for the training set

N/A. There is no "training set" in the context of a 510(k) submission for a physical guidewire; this term refers to machine learning.

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

N/A. As there is no training set, this question is not applicable.

Summary

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Section 8 Summary of Safety and Effectiveness

K013024

Submitter

NeoMetrics, Inc. 15301 Highway 55 West DEC 0 4 2001 Plymouth, MN 55447 Telephone: (763) 559-4440 Fax: (763) 559-7676 Contact Person: Gene Champeau, President Date: August 31, 2001

Product

Classification Name: Common Name: Trade/Proprietary Name:

Catheter Guidewire (21 CFR 870.1330) Guidewire, catheter guidewire, and wire guide Selectiva™ Guidewire

Substantially Equivalent Product

Lake Region Manufacturing Mandrel Guidewire Assembly (K011084).

Description

Indications for Use

To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

Physical Characteristics

The Selectiva™ Guidewire and the predicate device were compared in all functional and safety tests including dimensional, visual, tip flexibility, tensile strength, torqueability, and coating durability, to demonstrate equivalency in terms of safety and effectiveness. Biocompatibility testing of finished devices has been successfully completed in addition to the independent laboratory testing demonstrating equivalence of materials.

Conclusion

Based on performance data and comparisons of intended use, labeling, and design, the Selectiva™ Guidewire is considered substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed within a circle, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gene Champeau President NeoMetrics, Inc. 15301 Highway 55 West Plymouth, MN 55447

DEC 0 4 2001

Re: K013024 Seletiva™ Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 6, 2001 Received: September 7, 2001

Dear Mr. Champeau:

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gene Champeau

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough maing of substantial equivalence of your device to a legally prematication. The PDF intently sification 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 If you desire specific acriso as for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 007.10 Additionally, for questions on the promotion and advertising of Compliance it (301) 591-1800. The of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general information 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,

Vatty Hill

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

Enclosure

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Section 3
Indications for Use ~ K013074

The NeoMetrics Selectiva™ Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.

for thaghostic and interves are not intended for PTCA use.

Division of Cardiovascular & Respiratory Devices
510(k) Number K013624

Prescription Use
(Per 21 CFR 801.109)

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.