NEURO PULSE II,III

K971143 · Aaron Medical Industries · ETN · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971143
• Device Name: NEURO PULSE II,III
• Applicant: Aaron Medical Industries
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The subject device of this premarket notification submission (K-971143) is indicated for use as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery.

Device Story

Neuro Pulse II and Neuro Pulse III are nerve stimulators used during hand and facial reconstructive surgery. Device assists surgeons in locating individual motor nerves by providing electrical stimulation. Operated by surgeons in clinical/surgical settings. Output allows identification of motor nerves via muscle response to stimulation, aiding surgical navigation and nerve preservation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nerve stimulator; electrical stimulation output for motor nerve localization. Class II device (21 CFR 874.1820).

Indications for Use

Indicated for use as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery. 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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 6 1997

J. Robert Saron
President
AARON Medical Industries, Inc.
7100 30th Avenue North
St. Petersburg, FL 33710-2902

Re: K971143
Neuro Pulse II and Neuro Pulse III
Dated: March 26, 1997
Received: March 28, 1997
Regulatory Class: II
21 CFR 874.1820/Procode: 77 ETN

Dear Mr. Saron:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{1}

AARON
MEDICAL INDUSTRIES, INC.
RECEIVED
30 APR 97 12 07
FDA/CORH/ODE/DMC

# INDICATION FOR USE

The subject device of this premarket notification submission (K-971143) is indicated for use as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery.

David M. Segman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971143

Prescription Use ☑
(Per 21 CFR 801.109)

7100 - 30th Avenue North, St. Petersburg, FL 33710-2902
[phone] Fax: [phone]