(70 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use describes a nerve stimulator, which is a different type of technology.
No
The device is used to assist in the location of nerves during reconstructive surgery, which is a diagnostic or procedural aid function, not a direct therapeutic intervention.
No
The device is described as a nerve stimulator to assist in the location of motor nerves during surgery, which is a therapeutic or positioning aid function, not a diagnostic one.
No
The device is described as a nerve stimulator, which is inherently a hardware device that delivers electrical impulses. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery." This describes a device used in vivo (within a living organism) to interact with the body directly for surgical assistance.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed in vitro (outside the body).
The device's function as a nerve stimulator for surgical guidance clearly falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
77 ETN
Device Description
Neuro Pulse II and Neuro Pulse III
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand and facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes, which are often interpreted as representing the human form or the flow of services.
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 (301) 594-4591 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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)