The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Epimed RF Introduction Cannula," and as such, it does not detail acceptance criteria and a study proving device performance in the way a clinical trial or AI device study would. Instead, it demonstrates substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Demonstrated by "Bench Testing performed on the Epimed RF Introduction cannula to compare performance characteristics to the predicate device(s) confirmed that the performance of the RF Introduction Cannula is similar to the predicate device(s)." This similarity to legally marketed predicate devices (K980430, unknown K# for Cotop) implies meeting existing safety and effectiveness standards for RF cannulae.
Similar Physical and Technical Characteristics	The device "has similar physical and technical characteristics to the predicate device(s)."
Similar Intended Use	The device "has a similar intended use to the predicate device(s)," which is "for use in radiofrequency (RF) heat lesion procedures for the relief of pain."

2. Sample size used for the test set and the data provenance

Not Applicable. This document describes a bench testing comparison to predicate devices, not a clinical study with a "test set" in the context of AI or clinical efficacy. The "test set" here refers to the Epimed RF Introduction Cannula itself, which was subjected to bench tests.
Data Provenance: The data comes from "Bench Testing performed on the Epimed RF Introduction cannula." No information on country of origin or retrospective/prospective nature is given beyond being bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of expert consensus or clinical outcomes is not relevant for this type of regulatory submission, which relies on bench testing comparisons for substantial equivalence. The "ground truth" for the bench testing would be the measured physical and technical characteristics of the device and its predicate.

4. Adjudication method for the test set

Not Applicable. No explicit adjudication method is mentioned. The comparison seems to be direct measurements of physical/technical characteristics against those of predicate devices.

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, not done. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

Not Applicable. This is a physical medical device (cannula), not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical data, the ground truth was the measured physical and technical characteristics of the Epimed RF Introduction Cannula and the referenced predicate devices, assessed through bench testing.

8. The sample size for the training set

Not Applicable. This is not an AI device with a training set.

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

Not Applicable. This is not an AI device with a training set.

Summary of the Study (Bench Testing):

The study performed was Non-Clinical Bench Testing. This testing aimed to compare the performance characteristics of the Epimed RF Introduction Cannula to its predicate devices. The conclusion from this bench testing was that the performance of the Epimed RF Introduction Cannula is "similar to the predicate device(s)," leading to the determination of substantial equivalence in terms of safety and effectiveness. The specific parameters measured during these bench tests are not detailed in this summary.

Summary

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SEP 1 6 2004

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Section II

510(K) Summary

Company Information:

K 0 4 10 21

Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of RA/QA

Trade Name:

Epimed RF Introduction Cannula

Common Name:

Disposable Cannula for Radiofrequency Electrode

Product Class/Classification:

Class II

Predicate Device(s):

Radionics Disposable RF Cannulae (K980430) Cotop International RF Cannula (K# unknown)

Description:

Intended Use:

The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

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Comparison to Predicate:

The Epimed RF Introduction cannula has similar physical and technical characteristics to the predicate device(s) and a similar intended use to the predicate device(s).

Non-Clinical Data:

Bench Testing performed on the Epimed RF Introduction cannula to compare performance characteristics to the predicate device(s) confirmed that the performance of the RF Introduction Cannula is similar to the predicate device(s).

Conclusion:

The testing performed and comparison to the predicate device(s) demonstrates that the Epimed RF Introduction cannula is safe and effective and is substantially equivalent to the predicate device(s).

Very truly yours,

Epimed International, Inc.

Chall

Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

SEP 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance Epimed International, Inc. 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095

Re: K041021

Trade/Device Name: Epimed RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: September 1, 2004 Received: September 7, 2004

Dear Mr. Lake:

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. Christopher B. Lake

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K04:021

510(k) Number (if known): unk

Device Name: Epimed RF Cannula

Indications for Use:

The Epimed RF Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain

Prescription Use	>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number_Ko4102/

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).