(261 days)
No Reference Device(s) K/DEN number found.
No
The summary describes a passive electrode device and explicitly states that AI, DNN, or ML mentions were "Not Found".
No
The device is used to record physiological signals (e.g., EEG, EMG), not to provide therapy. It is a diagnostic tool, not a therapeutic one.
Yes
The device is described as recording "physiological signals" like EEG, EMG, nerve conduction velocity, and evoked potential, which are used to assess the function of the nervous and muscular systems, thereby aiding in diagnosis.
No
The device description explicitly states it is a "cutaneous electrode," which is a physical hardware component applied to the skin. The intended use also describes recording physiological signals, which requires a physical interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography." These are all measurements taken directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The device is described as a "cutaneous electrode," which is applied to the skin to pick up electrical signals. This is consistent with in vivo (within the body) measurement.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for direct physiological measurement on the patient.
N/A
Intended Use / Indications for Use
The SLE Electrodes and Accessories device is intended to be used in direct application the patient's skin to record physiological to signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
Product codes
GXY
Device Description
The SLE Electrodes and Accessories device is a cutaneous electrode.
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
KC/804/C
510(K) SUMMARY
Specialised Laboratory Equipment A. Manufacturer: Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom
Ferguson Medical Submitted By: Consultant to Specialised Laboratory Equipment Limited
- Phone: 44 181 681 1414 ਸ -Contact Information: 44 181 649 8570 FAX:
C. Classification Name: Electrode, cutaneous Common/Usual Name: Electrode, surface electrode, skin Burface electrode, electrode, etc.
SLE Electrodes and Accessories Proprietary Name:
- D. Classification Number: 80GXY
- E. Substantial Equivalence: Electrode, PNS, NDM Corp. (K760213), Cutaneous Electrode, Medicotest, Inc. (K931430), Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801), and others.
- P. Device Description: The SLE Electrodes and Accessories device is a cutaneous electrode.
- G. Intended Use: The SLE Electrodes and Accessories device is intended to be used in direct application the patient's skin to record physiological to signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
- Technological Characteristics: The design, materials, ਮ . composition, energy source, chemical and other technological characteristics of the subject device considered to be the same as the technological are characteristics of the predicatc devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 1998
Mr. Frank Ferquson Official Correspondent Consultant for Specialized Laboratory Equipment Limited Ferquson Medical 2581 California Park Drive, Suite 269 Chico, California 95928
Re: K980410 SLE Electrodes and Accessories Trade Name: Requlatory Class: II Product Code: GXY Dated: July 3, 1998 Received: July 28, 1998
Dear Mr. Ferguson:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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.
2
Page 2 - Mr. Frank Ferguson
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 your 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) 594-4659. 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 gener 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page r of 1
510(k) Number: K980410
Device Name: SLE Electrodes and Accessories
Indications For Use:
SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF HEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcolleto
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)