The Spectre guidewire is intended for use in percutaneous procedures to introduce and position cather interventional devices within the coronary and/or peripheral vasculature.

Device Description

The Spectre guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Spectre guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal tip. The distal end of the Spectre guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Spectre Guidewire." It's a review by the FDA determining substantial equivalence to a predicate device, not a study describing AI performance or complex acceptance criteria for an AI device.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, MRMC study, training set details, ground truth for training) cannot be found in this document because it is not relevant to a typical 510(k) submission for a non-AI medical device.

However, I can extract the acceptance criteria and study information that is present:

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

Acceptance Criteria / Performance Aspect	Reported Device Performance	Study that proves the device meets the acceptance criteria
Indications for Use	Intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.	Substantial equivalence to predicate device (Endura Guidewire, K161702) based on comparison of specifications and bench tests.
Anatomical Location	Coronary and peripheral vasculature	Substantial equivalence to predicate device.
Dimensions	Maximum O.D.: 0.014", Length: 190 cm and 300 cm	Substantial equivalence to predicate device.
Core Wire Material	Nitinol and Stainless Steel	Substantial equivalence to predicate device.
Distal Tip	3 cm radiopaque coil	Substantial equivalence to predicate device.
Lubricious Coatings	Hydrophilic (distal end) and PTFE (proximal end)	Substantial equivalence to predicate device.
Sterility	Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6	Substantial equivalence to predicate device.
Track Force	Met specified acceptance criteria.	Bench tests
Guidewire Support Profile	Met specified acceptance criteria.	Bench tests

Explanation for missing sections:

2. Sample size used for the test set and the data provenance: Not applicable. This device is a guidewire, not an AI or diagnostic tool that uses a "test set" in the context of imagery or clinical data. The "test set" here refers to the guidewire samples used in bench testing. The document does not specify the number of guidewires tested for Track Force or Guidewire Support Profile.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a guidewire's physical properties (like track force) is established through physical measurement, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for physical bench 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: Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical tests like track force and guidewire support profile, the ground truth is based on engineering specifications and physical measurements.
8. The sample size for the training set: Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K163444

Trade/Device Name: Spectre Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 7, 2016 Received: December 9, 2016

Dear Beka Vite:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel
Fernando Aguel
-S

for 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) K163444

Device Name Spectre guidewire

Indications for Use (Describe)

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position cather interventional devices within the coronary and/or peripheral vasculature.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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2 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: December 7, 2016 K163444 510(k) Number:

Submit t er's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person

Beka Vite Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Spectre guidewire
Common / Usual Name	Guidewire
Classification Name	21 CFR 870.1330, Catheter Guidewire (DQX)
Predicate Device	K161702 – Endura guidewire (VSI)

Device Description

Intended Use

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Technological Characteristics Comparison

The table below compares the technological characteristics of the Spectre guidewire.

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	Subject Device	Predicate Device
Characteristic	Spectre Guidewire	Endura Guidewire(K161702, VSI)
Indications for Use	Intended for use in percutaneousprocedures to introduce and positioncatheters and other interventionaldevices within the coronary and/orperipheral vasculature.	Same
Anatomical Location	Coronary and peripheral vasculature	Same
Dimensions	Maximum O.D.: 0.014"Length: 190 cm and 300 cm	Same
Core Wire	Nitinol and Stainless Steel	Same
Distal Tip	3 cm radiopaque coil	Same
Lubricious Coatings	Hydrophilic (distal end) and PTFE(proximal end)	Same
Sterility	Ethylene Oxide (EO) – SterilityAssurance Level (SAL) 10-6	Same

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the Spectre guidewire is substantially equivalent to the predicate device. The Spectre guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

. Track Force
Guidewire Support Profile

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modified Spectre guidewire is substantially equivalent to the predicate device.

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.