(136 days)
Not Found
No
The description focuses on the physical characteristics and intended use of disposable surface electrodes for signal acquisition, with no mention of AI or ML for signal processing or interpretation.
No
The device is used for stimulating/recording biopotential signals (diagnostics) rather than directly treating a condition (therapy). The predicate device K000870 is a TENS electrode, which is therapeutic, but the description of this device focuses on recording/monitoring/stimulating biopotential signals for diagnostic purposes (EEG, EMG, EP).
Yes
The device aids in recording and monitoring biopotential signals like EEG, EMG, and EP, which are used for diagnostic purposes.
No
The device description clearly outlines physical hardware components (electrodes, lead wires, connectors) and their function in acquiring biopotential signals. It does not describe a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that these electrodes are applied to the patient's skin to record, monitor, and stimulate biopotential signals from the body. This is an in vivo (within the living body) process.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient.
The device is a surface electrode used for physiological monitoring and stimulation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Disposable Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. There are two types of electrodes, one with fixed lead wire and the other without lead wire, tab electrodes. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations. Tab electrode can be connected, using a lead wire with alligator clip, to the gel free contact strip at the electrode end.
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)
Technomed Europe has been bench testing the Cutaneous Electrodes to confirm performance characteristics of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment C:
:
510(k) Summary
| Manufacturer: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands | MAY - 1 2008 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitted by: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands
Tel.: (+31) 43-408 6868
Fax: (+31) 43-408 6888 | |
| Contact person: | Mr. Maurice Roost
Manager Research & Development
E-mail: mroost@technomed.nl | |
| Date: | December 10, 2007 | |
| Proprietary Name: | Cutaneous Electrodes | |
| Common/usual Name: | Disposable Adhesive Surface Electrodes | |
| Classification Name: | Cutaneous Electrode is classified as class II per
21 CFR section 882.1320. Product code GXY. | |
| Substantial Equivalence: | K000870: KM-10 Non-Sterile TENS Electrode
K971914: TECA NCS Electrode System 2000 | |
| Device description: | Disposable Adhesive Surface Electrodes are non-invasive.
Cutaneous devices are used in the acquisition of signals for the
purpose of stimulating, monitoring and recording
Electroencephalograph (EEG), surface Electromyography
(EMG) and Evoked Potentials (EP). The electrodes are
designed for single-patient/multiple application use and are very
flexible. Because of the adhesive nature of the gel, no securing
material is required for fixating the electrode to the patient's
skin.
There are two types of electrodes, one with fixed lead wire and
the other without lead wire, tab electrodes.
The electrodes with lead wire have a safety DIN 42802
connector, several lengths and color combinations. Tab
electrode can be connected, using a lead wire with alligator clip,
to the gel free contact strip at the electrode end. | |
| Intended Use: | The Disposable Adhesive Surface Electrodes are intended for
non-invasive use with recording and monitoring equipment,
(active and reference), of Electromyography (EMG),
Electroencephalograph (EEG) and Evoked Potentials (EP). The
electrodes are designed for single-patient/multiple application
use. | |
| Comparison to predicates: | The design, materials, chemical composition, packaging and
other technological characteristics of the subject device is
equivalent to those of the predicate devices. | |
| Non-clinical data: | Technomed Europe has been bench testing the Cutaneous
Electrodes to confirm performance characteristics of this
device. | |
| Conclusion: | The comparison to the predicate devices demonstrate that the
Disposable Adhesive Surface Electrodes are safe and effective
and are substantially equivalent to the predicate devices. | |
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Technomed Europe % Mr. Maurice Roost Manager Research & Development Amerikalaan 71 6199 AE Maastricht-Airport Limburg The Netherlands
MAY - 1 2008
Re: K073532
Trade/Device Name: Disposable Adhesive Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode. Regulatory Class: Class II Product Code: GXY Dated: April 17, 2008 Received: April 21, 2008
Dear Mr. Roost:
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
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Page 2 - Mr. Maurice Roost
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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.
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 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,
Murk N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073532
:
Device Name:
Disposable Adhesive Surface Electrodes
Indications For Use:
The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nelbo Cyd for 383
(Divis Division of and Neurological Devi
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510(k) Number K073532