NEURO PULSE II,III

• K Number: K971143
• Device Name: NEURO PULSE II,III
• Manufacturer: AARON MEDICAL INDUSTRIES
• Date Cleared: 1997-06-06 ( 70 days)
• Product Code: ETN
• Regulation Number: 874.1820
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document snippets, I cannot extract the specific details about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the Neuro Pulse II and Neuro Pulse III devices, indicating that they are substantially equivalent to pre-amendments devices.

The information provided outlines:

• The FDA's decision regarding K971143 (Neuro Pulse II and Neuro Pulse III).
• The regulatory class and procode.
• The general controls provisions of the Act.
• The indication for use: "as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance studies.
7. Type of ground truth used in such studies.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This type of information would typically be found in the actual 510(k) submission document itself, or a summary of it, not in the FDA's clearance letter.

Summary

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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 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 assumply 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 does not affect any obligation you might have under sections 51 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

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Image /page/1/Picture/0 description: The image shows the logo for AARON MEDICAL INDUSTRIES, INC. The word "AARON" is in a stylized font, with the two A's connected at the top. Below the word "AARON" is the text "MEDICAL INDUSTRIES, INC." in a smaller, sans-serif font. The logo is in black and white.

RECEIVED

30 APR 97 12 07

FDA/CDRH/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 h. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971163

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.