(35 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is used to locate and identify nerves, which is a diagnostic or procedural aid function, not a therapeutic intervention to treat a disease or condition.
Yes
The device is described as locating and identifying cranial motor nerves, which is a diagnostic function to determine the presence and location of these nerves during surgical procedures. Even though it's used during a procedure, its primary function is to provide information for diagnosis or to guide surgical intervention.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To locate and identify cranial motor nerves during ENT and intra-cranial procedures." This describes a device used during a surgical procedure to interact with the patient's body in real-time.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The provided description doesn't mention any specimen collection or analysis.
Therefore, this device appears to be a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
Product codes
ETN
Device Description
Neurosign Nerve Monitor, Models Neurosign 400 and Neurosign 800
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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 and 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, curved shapes that resemble an abstract caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
The Magstim Company LTD c/o Mr. Chris Lewis Spring Gardens Whitland, Dyfed Wales United Kingdom SA34 OHR
Re: K053141
Trade/Device Name: Neurosign Nerve Monitor, Models Neurosign 400 and Neurosign 800 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 1, 2005 Received: November 9, 2005
Dear Mr. Lewis:
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.
1
Page 2 - Mr. Chris Lewis
This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictier will anow you to ogin maneness your alence of your device of your device to a legally prematics notification: "The PDF intemsgssification 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 If you desire spocents at (301) 827-8910. Also, please note the regulation entitled, Comation of Compilance and (set notification" (21CFR Part 807.97). You may obtain Milsoranding of reference to premiers on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Neurosign Motor Nerve Monitor Special 510(k)
Indications for Use
510(k) Number (if known): K053141
Device Name: ___ Neurosign Motor Nerve Monitor
Indications for Use:
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
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)
. . . . . ... . . . . . . . . . . . Section and the considered Concurrence of CDRH, Office of Device Evaluation (ODE)
and and the security the country and the comments of
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
sion of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K053171