RF INTRODUCTION CANNULA

K041021 · Epimed International, Inc. · GXI · Sep 16, 2004 · Neurology

Device Facts

• Record ID: K041021
• Device Name: RF INTRODUCTION CANNULA
• Applicant: Epimed International, Inc.
• Product Code: GXI · Neurology
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Epimed RF Introduction Cannula is a disposable device used in radiofrequency (RF) heat lesion procedures for pain relief. Device consists of a coated stainless steel cannula, stainless steel stylet, and molded plastic hub; available in various lengths, gauges, and tip configurations. Used by clinicians in clinical settings to facilitate RF electrode placement for lesioning. Device functions as a conduit for RF electrodes; does not perform active processing or analysis. Benefits include providing a pathway for targeted thermal tissue ablation to manage chronic pain.

Clinical Evidence

Bench testing only. Performance characteristics were compared to predicate devices to confirm similarity.

Technological Characteristics

Coated stainless steel cannula; stainless steel stylet; molded plastic hub. Available in various lengths, gauges, and tip configurations. Passive device; no energy source or software.

Indications for Use

Indicated for use in radiofrequency (RF) heat lesion procedures for the relief of pain in patients requiring such intervention.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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SEP 1 6 2004

Page 1 of 2

Section II

510(K) Summary

## Company Information:

K 0 4 10 21

Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 [phone] 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:

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.

### 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 [phone]. 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 [phone] or [phone] 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 | ><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| (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/