RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

K112435 · Rhythmlink International, LLC · ETN · Sep 22, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K112435
• Device Name: RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
• Applicant: Rhythmlink International, LLC
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Special
• 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

Monopolar Stimulating Instrument used during surgery to locate and identify cranial and peripheral motor nerves, including spinal nerve roots. Device delivers electrical stimulation to target tissues. Operated by surgeons or clinical staff in surgical settings. Single-use, sterile instrument. Facilitates nerve identification to assist in surgical decision-making and minimize risk of nerve damage during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate device.

Technological Characteristics

Monopolar stimulating probe; sterile, single-use. Design and materials are identical to the predicate device (K072736).

Indications for Use

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

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

• Rhythmlink International Monopolar Stimulating Instrument (K072736)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD-20993-0002

Rhythmlink International, LLC. c/o Mr. James Mewborne Manager of Regulatory Affairs 1140 First Street South Columbia, SC 29209

SEP 2 2 2011

Re: K112435

Device Trade Name: Monopolar Stimulating Instrument Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: August 22, 2011 Received: August 24, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Earle. Clements

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

Enclosure

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## Attachment 2 - Indications for Use Statement

## Indications for Use Statement

## 510(k) Number K072736

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 X (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 if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

R. Mathe

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

510(k) Number K112435

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