RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT

K072736 · Rhythmlink International, LLC · ETN · Jan 22, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K072736
• Device Name: RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
• Applicant: Rhythmlink International, LLC
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jan 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only.

Device Story

The Rhythmlink International Monopolar Stimulating Instrument is a sterile, single-use surgical tool designed for nerve location and identification. It consists of a stainless steel wire with biocompatible electrical insulation on selected portions and a proximal connector for attachment to a monopolar stimulator. The distal tip remains non-insulated to facilitate tissue stimulation. Used by surgeons during procedures to identify cranial, peripheral, and spinal nerve roots, the device delivers electrical stimulation to elicit a motor response, aiding in nerve mapping and preservation. It functions as a passive conduit for electrical signals from an external stimulator to the patient's tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel wire with biocompatible electrical insulation; proximal connector for monopolar stimulator; distal non-insulated tip for stimulation. Meets IEC 60601-1:1988/A1:1991/A2:1995 Clause 56.3(c) for protected pin design. Sterile, single-use.

Indications for Use

Indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. For use in surgical settings.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Stimulation/Dissection Instruments (K031003)

Submission Summary (Full Text)

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K07236

## 5. 510(k) Summary

| | 510(k) Summary of Safety and Effectiveness |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | Rhythmlink International, LLC<br>1256 First Street South Extension<br>Columbia, SC 29209 |
| | Phone: [phone] |
| | FDA Registration #: 1067162 |
| | JAN 22 2008 |
| Official Contact Person: | James M. Mewborne, Engineering and Regulatory Manager |
| Summary Date: | September 21, 2007 |
| Device Identification: | Proprietary Device Name:<br>Rhythmlink International Monopolar Stimulating Instrument (Trade<br>names have not been finalized at this time) |
| | Generic Device Name:<br>Nerve Stimulator/Locator |
| | Regulatory Class: Class II |
| | Classification Name: 21 CFR 874.1820, Surgical nerve<br>stimulator/locator |
| | This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K031003 |
| | Manufacturer: Medtronic Xomed |
| | Trade Name: Stimulation/Dissection Instruments |
| | Product Code: 874.1820 |
| Device Description: | The design of the Rhythmlink International Monopolar Stimulating<br>Instrument is similar to existing stainless steel stimulating instruments.<br>The device consists of a stainless steel wire with biocompatible<br>electrical insulation applied to selected portions, and proximal<br>connector provided to attach the instruments to a monopolar stimulator.<br>The distal surface of the instrument is non-insulated stainless steel to<br>provide for tissue stimulation. The Rhythmlink International<br>Monopolar Stimulating Instrument with cable assembly is a protected<br>pin design and meets requirements of IEC 60601-1:1988 /A1:1991<br>/A2:1995 Clause 56.3(c) per 21 CFR 898.12. |
| Indications for Use: | Rhythmlink International Monopolar Stimulating Instrument is<br>indicated for stimulation of cranial and peripheral motor nerves for<br>location and identification during surgery, including spinal nerve roots.<br>The Rhythmlink International Monopolar Stimulating Instrument is<br>sterile and for single use only. |

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

JAN 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rhythmlink International, LLC c/o James Mewborne Engineering and Regulatory Manager 1256 First Street South Extension Columbia, SC 29209

Re: K072736

Trade/Device Name: Rhythmlink Monopolar Stimulating Instrument Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: December 21, 2007 Received: December 26, 2007

Dear Mr. Mewborne:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Malina B. Eyler, ud

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use Statement

## Indications for Use

510(k) Number (if known):

Device Name: Rhythmlink International Monopolar Stimulating Instrument

Indications For Use: Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kouett. booke

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K072736

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