(189 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML, and the device description (EMG Recording Ring Electrode) is a standard medical device component.
No
The device is described as an "EMG Recording Ring Electrode". Recording electrodes are diagnostic tools, not therapeutic devices. Therapeutic devices deliver energy or substances to treat a condition.
No
The device description "EMG Recording Ring Electrode" indicates it is used for recording electrical signals, which is typically a data collection tool rather than a device that interprets or diagnoses conditions. There is no information in the provided text that suggests it performs a diagnostic function.
No
The device description explicitly states "EMG Recording Ring Electrode," which is a hardware component used for recording electrical signals. This indicates the device is not software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without an intended use related to analyzing biological samples, it doesn't fit the definition of an IVD.
- Device Description: The description "EMG Recording Ring Electrode" indicates a device used for recording electrical activity from muscles (Electromyography). This is a physiological measurement taken directly from the body, not an analysis of a biological specimen in vitro.
- Lack of other IVD indicators: The absence of information about image processing, AI/ML, input imaging modality, anatomical site, patient age range, intended user/care setting, training/test sets, performance studies, key metrics, and predicate/reference devices further supports that this is not an IVD. These elements are often present in submissions for devices that involve analysis or interpretation of data, which is common for IVDs.
In summary, an EMG Recording Ring Electrode is a device used for physiological measurement in vivo, not for the in vitro examination of biological specimens. Therefore, it does not meet the definition of an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
84 GXY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with the words "A Human Services USA" arranged in an arc shape. Below the text, there are three thick, diagonal lines that are parallel to each other. The logo appears to be a simple design, possibly representing a company or organization related to human services in the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Sarvice
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1996
RE
Richard Kaiser, CEO Chalgren Enterprises, Inc. 8021 Carmel Street Gilroy, California 95020
Re: K953356 EMG Recording Ring Electrode Regulatory Cass: II (two) Product Code: 84 GXY Dated: October 16, 1995 October 23, 1995 Received:
Dear Mr. Kaiser:
We have reviewed your Section 510(k) notification in market the device We have reviewed your section 510(K) notreaded is subscantlally couivalent 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 You may, therefore, market the device, subject to the general controls (Act). The general controls provisions of the Act include provisions of the Act. provisions of the net. The gencian, listing of devices, good manufacturing requirements for annual registions 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. of class fly (regulations affecting your device can be found in the Code of Exting major regulacions arres 800 to 895. A subscanting Breachice for Medical determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic Devices: General (onr) regulacion (rug Administration (FDA) will regulatory Failure to comply with the GMP regulation may result in regulatory assumptions. In addition, FDA may publish further announcements concerning your action. accion. In addiction, Rogister. Please note: this response to your premarke notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Sections 531 childing one or other Federal Laws or Regulations.
This letter will immediately allow you to begin marketing your device as Ints Tecter will premarket notification. An PDA finding of substantial equivalence of your device to a legally marketed predicated to the market equivalence on your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, your may not but it does not mean that for approved your its labeling as being georged by If you desire specific advice for your device on our labeling regulation EDA . (21 CFR Part 801 and additionally 809.10 for in xi consideres , reconcion and (2) CFR Part 801 and adolerone ontact the Office of Compliance, Promotion and promotion, of advertising prease and 301) 594-4639. Other general information
1
. j ... .. .pomaro.clicles ander the hel may be vinding the Olvision of Small . . Juli :: sponstorers and their coll free number (800) 638-2041 or at (301) 443.6597.
Sincerely yours.
Thomas J. Carlin
Thomas J. Calimhan, Ph.D. Acting Director Division of Cardiovascular. Rospiracory, and Neurological Devices Office of Device Evaluation Cencer for Devices and Radiological Health
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