RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

K022914 · Rhythmlink International, LLC · GXZ · Dec 20, 2002 · Neurology

Device Facts

• Record ID: K022914
• Device Name: RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
• Applicant: Rhythmlink International, LLC
• Product Code: GXZ · Neurology
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Device Story

Single-use, sterile, disposable subdermal needle electrodes; stainless steel needle with attached lead wire; safety connector prevents AC power outlet connection. Used in clinical settings under physician supervision; interfaces with recording, monitoring, and stimulation equipment to capture biopotential signals (EEG, EMG, nerve potentials). Provides patient contact point for diagnostic or monitoring procedures; facilitates signal acquisition for clinical decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel needle; lead wire with safety connector; sterile; single-patient use; disposable. No active electronic components or software.

Indications for Use

Indicated for patients requiring biopotential signal recording, monitoring, or stimulation, including EMG, EEG, and nerve potential signals. For use under physician supervision.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Various Needle Electrode (K990015)
• Sterile Subdermal Needle Electrodes (K010019)

Submission Summary (Full Text)

{0}------------------------------------------------

K022914 1/2

## Rhythmlink International, LLC

| 9. 510(k) Summary | DEC 2 0 2002 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary of Safety and Effectiveness | |
| Company Name: | Rhythmlink International, LLC<br>2013 Windsor Drive<br>Cayce, SC 29033<br>Phone: [phone]<br>FDA Registration #: PEND80891 |
| Official Contact Person: | Brett L Netherton, President |
| Summary Date: | August 29, 2002 |
| Device Identification: | Proprietary Device Name:<br>Rhythmlink International Subdermal Needle Electrodes<br>Generic Device Name:<br>Subdermal Needle Electrodes<br>Regulatory Class:<br>Class II<br>Classification Name:<br>21 CFR 882.1350, Needle Electrode<br>This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K990015<br>Manufacturer: Technomed Europe<br>Trade Name: Various Needle Electrode<br>Product Code: 89IKT<br><br>510(k) Number: K010019<br>Manufacturer: Nicolet Biomedical<br>Trade Name: Sterile Subdermal Needle Electrodes<br>Product Code: 84GXZ |
| Device Description: | Rhythmlink International Subdermal Needle Electrodes are single<br>patient use, disposable, sterile devices. Electrodes are applied in the<br>study of biopotentials such as electroencephalograph (EEG),<br>electromyograph (EMG), nerve conduction and stimulation/response.<br>Electrodes are invasive as they are placed subcutaneously or in contact<br>with nerve or muscle tissue.<br><br>The electrodes consist of a stainless steel needle with a lead wire<br>attached. The lead wires terminate in a safety connector that cannot be<br>connected to an AC power outlet.<br><br>The electrodes provide the patient contact device. The electrodes<br>connect to the user's recording, monitoring and stimulation/response<br>equipment. The electrodes are used under the supervision of a physician. |

.

•

•

4

{1}------------------------------------------------

- Rhythmlink International Subdermal Needle Electrodes are intended Intended Use: for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only. Technological Characteristics: The electrodes consist of a formed stainless steel needle with a lead wire attached. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The characteristics of Rhythmlink International Subdermal Needle Electrodes are
safety or effectiveness are raised.

substantially equivalent to the predicate devices. No new questions of

This concludes the 510(k) summary.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, arranged in a stacked formation.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2002

Rhythmlink International, LLC Brett L. Netherton President 2013 Windsor Drive Cayce, South Carolina 29033

Re: K022914

Trade/Device Name: Rhythmlink International Subdermal Needle Electrodes Regulation Number: 882.1350 Regulation Name: Needle electrode Regulatory Class: Class II Product Code: GXZ Dated: December 4, 2002 Received: December 11, 2002

Dear Mr. Netherton:

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

{3}------------------------------------------------

Page 2 - Mr. Brett L. Netherton

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.

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 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. Provat

foCelia 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

{4}------------------------------------------------

Page **_ of _**

| 510(k) Number (if known): | SEE BELOW |
|---------------------------|-----------|
| Device Name: | SEE BELOW |
| Indications For Use: | |

.

510(k) Number: K022914

Device Name: Rhythmlink International Subdermal Needle Electrodes

Indications for Use:

Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

712(g) Number K022914