The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

Device Description

The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel.

The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to help facilitate smoother passage.

The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.

AI/ML Overview

The provided text is a 510(k) summary for the HyTek Guidewire. It discusses the device's substantial equivalency to predicate devices based on non-clinical tests. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically required for AI/ML-based medical devices.

Instead, this document describes a traditional medical device (a guidewire) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already approved predicate devices through bench testing.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's the breakdown of what can be extracted from the provided text, and what cannot:

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

Acceptance Criteria (Implied)	Reported Device Performance
Functionality and performance comparable to currently marketed predicate devices.	"The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device." (K991898, Section 6. Non-Clinical Tests)
Specific performance characteristics tested (bench tests)	Torque, flexibility, and coating adherence. (K991898, Section 6. Non-Clinical Tests)

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

Not applicable / Not provided. The "tests" mentioned are non-clinical bench tests. Sample sizes for these types of engineering tests are rarely specified in 510(k) summaries as they are not human subject studies. Data provenance (country, retrospective/prospective) is irrelevant for bench testing of a physical device.

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)

Not applicable / Not provided. "Ground truth" in the context of AI/ML usually refers to human expert annotations or clinical outcomes. For physical device bench testing, the "ground truth" is typically established by engineering specifications and direct measurement, not human experts in the clinical sense.

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

Not applicable / Not provided. Adjudication is a concept for resolving discrepancies in human expert opinions for ground truth establishment. This is not relevant for bench testing a physical device.

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 / Not provided. MRMC studies are for evaluating the impact of AI on clinical reader performance. This device is a physical guidewire, not an AI algorithm.

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

Not applicable / Not provided. This is a physical medical device, not an algorithm.

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

Not applicable / Not provided. The "ground truth" for the bench tests would be the physical properties and performance measured against engineering specifications, which are implicitly derived from the predicate device's characteristics and industry standards.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

Not applicable / Not provided. There is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study consisted of non-clinical tests designed to demonstrate that the HyTek Guidewire's functionality and performance characteristics are comparable to the currently marketed predicate device (K943390 and K991194).

These tests specifically included:

Torque
Flexibility
Coating adherence

The document states that "The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device." This statement, along with the detailed comparisons to predicate devices in the full 510(k) submission (which is summarized here), was sufficient for the FDA to determine substantial equivalence and clear the device for market. The specific methodology, detailed results, and quantitative acceptance thresholds for these bench tests are not provided in this summary but would have been part of the full 510(k) submission.

Summary

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K991898

Special 510(k) Summary

HyTek™ Guidewire (Prepared in accordance with 21 CFR part 807.92)

510(k) Number: This application

Submitter: Prepared and Submitted by: 1. MICROVENA Corporation Angela Mallery Sr. Regulatory Affairs Associate 651-7777-6700 1861 Buerkle Road White Bear Lake, MN 55110
Device Name: Guidewire 2. Trade Name: HyTek Guidewire Classification Name: Wire, Guide, Catheter Classification Code: 74 DQX
Substantial Equivalency: The HyTek guidewire is substantially equivalent 3. to K943390 and K991194.
Device Description and Intended Use: 4. The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel.

The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.

Technological Characteristics ഗ് MICROVENA's HyTek guidewire have the same indications for use and are otherwise technically the same as the predicate device.
1. Non-Clinical Tests

The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device. These tests included: torque, flexibility, and coating adherence.

1. Conclusions Based on information presented in this 510(k) premarket notification, MICROVENA guidewires are considered substantially equivalent to the currently marketed predicate device.
  HyTek 510(k) Special 510(k) Summary - 1

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

JUN 16 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Angela Mallery Sr. Regulatory Affairs Associate MICROVENA Corporation 1861 Buerkle Road White Bear Lake, MN 55110

Re: K991898 HyTek™ Guidewire Trade Name: Requlatory Class: II Product Code: DQX Dated: June 3, 1999 Received: June 4, 1999

Dear Ms. Mallery:

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 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). 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 reqistration, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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

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Page 2 - Ms. Angela Mallery

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 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 807.97). Other general 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application

HyTek Guidewire

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	for Callahan
(Division Sign-Off)
F of Cardiovascular, Respiratory,
logical Devices
K(k) Number	K991898

Prescription Use(Per 21 CRF 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

HyTek 510(k)Indications for Use - 1

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.