(46 days)
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
EVERLIFE, Various Models of Self Adhesive Electrodes, AP series
The provided text is a 510(k) summary for the EVERLIFE Self Adhesive Electrodes. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use and existing safety/effectiveness data for similar products. It does not contain information about a study proving specific performance acceptance criteria for the EVERLIFE electrodes.
Therefore, many of the requested elements for describing an acceptance criteria study cannot be found in the provided text.
Here is an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for the electrical performance (e.g., impedance levels, signal-to-noise ratio) of the EVERLIFE Self Adhesive Electrodes, nor does it report specific device performance data against such criteria.
The closest to "acceptance criteria" are the biocompatibility tests performed, which are inherently "pass/fail" or "meet standard X" criteria.
| Acceptance Criteria (related to biocompatibility) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | |
| - Cytotoxicity study (ISO 10993-5) | Performed |
| - Skin irritation study (ISO 10993-10) | Performed |
| - Skin sensitization study (ISO 10993-10) | Performed |
The summary states, "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." This is a qualitative statement about performance relative to the predicate, but it does not specify quantitative acceptance criteria or report measured impedance levels.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No performance study data is presented for the EVERLIFE electrodes related to signal recording or electrical stimulation. The biocompatibility tests, while involving samples, do not align with a "test set" in the context of diagnostic or AI device performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is relevant for studies establishing ground truth, typically in AI/diagnostic imaging, which is not the subject of this 510(k) submission.
4. Adjudication Method
Not applicable. No expert-based adjudication process is described in the context of device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not pertain to an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant or mentioned.
6. Standalone (Algorithm Only) Performance
No. This device is a medical accessory (electrodes), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" here is implied by the successful completion of the biocompatibility tests according to ISO standards, and the claim of substantial equivalence based on the predicate device's established safety and effectiveness. For the biocompatibility, the "ground truth" would be the standard biological reactions or lack thereof as defined by the ISO guidelines.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI or machine learning product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this information is irrelevant.
In summary, the provided 510(k) document is for a medical accessory (self-adhesive electrodes) and primarily relies on substantial equivalence to a legally marketed predicate device, along with successful biocompatibility testing. It does not describe a performance study with quantitative acceptance criteria, test sets, or expert-adjudicated ground truth as would be seen for a diagnostic or AI-driven device.
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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.
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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.
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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
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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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§ 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).