(182 days)
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals
This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for "Self-Adhesive Electrodes" and primarily focuses on establishing substantial equivalence to predicate devices, regulatory information, and intended use.
The text explicitly states that no clinical investigation was performed: "Therefore, we need not perform clinical investigation. And, the safety and performance of Adhesive Electrodes is verified." This means there would be no study to describe in the context of device performance against specific acceptance criteria.
The document refers to "Testing reports, analysis" and "Performance Characteristics (If/when applicable) — 1. See the Exhibits." However, the actual content of these reports or exhibits, which would contain detailed performance data and acceptance criteria, is not included in the provided text.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided input.
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Koro276
510(K) SUMMARY
AUG - 4 2008
[as required by 807.92(c)]
- A. 510k Number:
- B. Applicant:
Company name: Cathay healthcare equipment manufacturing. Inc Address: Taoyuan Village,Changtang Town, Shangyu City, Zhejiang Province, China Tel: +86 575 8259988 Fax: +86 575 8259977
- C. Proprietary and Established Names: Cathay healthcare equipment manufacturing. Inc
- D. Regulatory Information -Product name: Self-Adhesive electrodes
-Classification: Class 2
-Product cord : GXY
-Regulation Number : 882.1320
-
E. Intended use
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals -
F. Device Description
This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured. -
G. Substantial Equivalence Information
-SOF-PACH Reusable Neurostimulation Electrodes/ TOP-RANK ADHESIVE ELECTRODE -Classification : Class 2
-Product cord : GXY
-Requlation Number : 882.1320
- Comparison with predicate
From the above clinical evidence, we can conclude that Clinical evidence is
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demonstrated by way of
- · Comparison chart of predicate device
- . Experience from previous use
- o Testing reports, analysis
Therefore, we need not perform clinical investigation.
And, the safety and performance of Adhesive Electrodes is verified.
Based on the above, we conclude that the Adhesive Electrodes are substantially equivalent to the marketed predicate device, and do not raise any new issues of safety or effectiveness.
H. Standard / Guidance Document Referenced (if applicable)
| 1) | ISO 9001 | 2000 | Quality management system -requirements |
|---|---|---|---|
| 2) | EN ISO 14971 | 2001 | Medical devices — Application of riskmanagement to medical devices |
| 3) | EN 980 | 2003 | Graphic Symbols for use in the labeling of medical device |
| 4) | EN 1041 | 1998 | Terminology, Symbols and Information with Medical Devices;Information supplied by the manufacturer with medical devices |
| 5) | EN ISO 10993-5 | 1999 | Biological Evaluation of Medical Devices - Part 5: Tests for In VitroCytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994 |
| 6) | EN ISO 10993-10 | 2002 | Biological evaluation of medical devices - Part 10: Tests forirritation and delayed-type hypersensitivity ISO 10993-10:2002 |
- Performance Characteristics (If/when applicable) ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
-
- See the Exhibits.
-
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cathay Healthcare Equipment Manufacturing, Inc. % Pats Corporation Mr. Brandon Choi Representative
Flemington Court, Suite 155 La Mirada, California 90638
Re: K080276
Trade/Device Name: Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: July 24, 2008 Received: July 29, 2008
Dear Mr. Choi:
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
AUG - 4 2008
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Page 2 - Mr. Brandon Choi
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.
This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Millican
Mark N. Melkerson 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
510(k) Number (if known):
Device Name: SELF-ADHESIVE ELECTRODES
Indications For Use: The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals
Prescription Use X (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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark M. Milliken
(Division Sign (Division Sign-off General, Restorative, Division of of Call Devices
510(k) Number
§ 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).