(90 days)
Not Found
None
No
The summary describes a disposable needle electrode for recording muscle activity, a standard medical device without any mention of AI or ML processing.
No
The device is used for recording muscle activity for Electromyography (EMG) applications, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used for "Recording muscle activity for Electromyography (EMG) applications," and EMG is a diagnostic procedure used to assess the health of muscles and the nerve cells that control them.
No
The device description explicitly states "Neuroline Disposable Monopolar Needle Electrode," which is a physical hardware component used for recording muscle activity. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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 used to examine these samples outside of the body.
- Device Function: The intended use of this device is "Recording muscle activity for Electromyography (EMG) applications." This involves inserting a needle electrode into the muscle to measure electrical signals directly from the tissue within the body.
- Lack of Sample Analysis: There is no mention of analyzing a sample taken from the body. The device is used for direct measurement of physiological activity in vivo.
Therefore, this device falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
Product codes
GXZ
Device Description
Neuroline Disposable Monopolar Needle Electrode
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Ms. Emalee G. Murphy C/O McKenna & Cuneo, L.L.P. 1900 K Street, Northwest Washington, D.C. 20006
Re: K983597
Trade Name: Neuroline Disposable Monopolar Needle Electrode Regulatory Class: II Product Code: GXZ Dated: October 9, 1998 Received: October 13, 1998
Dear Ms.Murphy:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 – Ms. Emalee G. Murphy
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 vour 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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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意味和几几次儿的儿儿儿儿儿 1177. 0
Page 1 of l
510 (k) Number (if known):
Neuroline Disposable Monopolar Needle Electrode Device Name:
人983597
Indications For Use:
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)
(Divi ion Sign-Off) Division of General Restorative Devices 510(k) Number