(46 days)
Not Found
No
The summary describes standard self-adhesive electrodes for recording physiological signals or applying electrical stimulation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The predicate device is also a standard electrode.
No
The device is used to record physiological signals or apply electrical stimulation, which are often diagnostic or functional applications rather than directly therapeutic in themselves.
No
The device is described as electrodes used to record physiological signals or apply electrical stimulation, which are actions for data collection or therapy, not for diagnosing a condition.
No
The device description explicitly states "Various Models of Self Adhesive Electrodes," which are hardware components applied to the skin. The intended use also describes recording physiological signals and applying electrical stimulation, which requires physical electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be applied directly to a patient's skin to record physiological signals or apply electrical stimulation. This is a direct interaction with the patient's body for diagnostic or therapeutic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The device is described as "Self Adhesive Electrodes," which are external devices applied to the skin.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside that definition.
N/A
Intended Use / Indications for Use
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Product codes
GXY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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)
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
KOSO
5. 510(K) STATEMENT
and and the mail of the station to the mail of the see of the state of the state of the states of the states of the states of the states of the states of the states of the st
MAY 1 9 2005
510(k) SUMMARY "
Submitter's Name: EVERLIFE Medical Instrument Co., Ltd. No. 58, Fu-Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
Date summary prepared:
March 18, 2005
Device Name:
EVERLIFE, Various Models of Self Adhesive Electrodes, Proprietary Name: AP series Self Adhesive Electrodes Common or Usual Name:
Classification Name:
21 CFR 882.1320
GXY, Class II
Indications for Use:
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Biocompatibility Testing:
- Cytotoxicity study ISO 10993-5 .
- Skin irritation study ISO 10993-10
- Skin sensitization study ISO 10993-10
Legally marketed device for substantial equivalence comparison:
HOME CARE Various Models of Self-Adhesive Electrodes, K022917
Summary for substantial equivalence comparison:
The intended uses for the two devices are almost the same, because the new device can also be used for EEG, ECG, EMG, TENS, and Muscle stimulation cases. Though the gel ingredients or the conductive films for the two devices may be different, the effect of impedance levels for the intended situations is assured for both of the devices, and the safety and effectiveness hazards are not present, and they are considered to be substantially equivalent.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2005
Everlife Medical Instrument Co., Ltd. C/o: Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City China (Taiwan) 300
Re: K050788
Trade/Device Name: EVERLIFE, Various Models of Self Adhesive Electrodes, AP series Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: March 18, 2005 Received: March 28, 2005
Dear Dr. Jen, Ke-Min:
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 for association 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, de rios mat have 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 r ou mayy are a 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 may or saily of 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 I loase oc advised that rermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 (21 CFR Part 820); and if applicable, the electronic forth in adiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Dr. Jen, Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in yourse finding of substantial equivalence of your device to a legally premaired predicated. The 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), please If you desire specific darroliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational 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,
Sincerely yours,
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
State of the States
510 (K) Number (If Known ):___________________________________________________________________________________________________________________________________________________
Device Name: EVERLIFE, Various Models of Self Adhesive Electrodes, AP series 1
Indications for Use:
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. ---
| Prescription Use | AND/OR | Over-The-Counter Use | √ |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of General, Restorative, and Neurological Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)
| 510(k) Number | K050788 |
|---|---|
| --------------- | --------- |
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