(136 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria with numerical targets or performance metrics for the device. Instead, it focuses on the device's adherence to intended use and its substantial equivalence to predicate devices, supported by bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-invasive use with recording and monitoring equipment | Intended for non-invasive use with recording and monitoring equipment |
| Suitable for stimulating/monitoring/recording EEG, sEMG, and EP | Used for stimulating, monitoring, and recording EEG, surface EMG, and EP |
| Designed for single-patient/multiple application use | Designed for single-patient/multiple application use |
| Requires no securing material for fixation | Because of adhesive gel, no securing material required |
| Performance characteristics confirmed through bench testing | Bench testing conducted to confirm performance characteristics |
| Substantially equivalent to predicate devices for safety/effectiveness | Comparison to predicate devices demonstrates substantial equivalence for safety and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing" was performed, but no details on the number of samples or specific test cases are provided.
- Data Provenance: The testing was conducted by Technomed Europe, which is based in The Netherlands. It is implied to be internal (bench) testing, not necessarily human subject data. The study is retrospective in the sense that it's a summary of testing already performed, rather than a prospective trial design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish a ground truth for any test set. The evaluation focuses on the physical and functional characteristics of the electrodes through bench testing and comparison to predicate devices, not on diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication is mentioned or implied, as the study relies on bench testing and comparison to predicate devices for electrode performance, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- No MRMC study was done. This device (Cutaneous Electrodes) is a hardware component used in medical procedures, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of AI assistance or human reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This is a hardware device (electrodes), not an algorithm or software. Its performance is assessed through physical and functional bench testing, not as an "algorithm only" study.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily engineering and manufacturing specifications, along with performance characteristics defined by relevant standards and the performance of the predicate devices. For example, the adhesive qualities, conductivity, material safety, and signal acquisition capabilities would be objectively measured without requiring a clinical "ground truth" like pathology or expert consensus.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, there's no ground truth established for one.
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Attachment C:
:
510(k) Summary
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands | MAY - 1 2008 |
|---|---|---|
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 | |
| Contact person: | Mr. Maurice RoostManager Research & DevelopmentE-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 per21 CFR section 882.1320. Product code GXY. | |
| Substantial Equivalence: | K000870: KM-10 Non-Sterile TENS ElectrodeK971914: TECA NCS Electrode System 2000 | |
| Device description: | Disposable Adhesive Surface Electrodes are non-invasive.Cutaneous devices are used in the acquisition of signals for thepurpose of stimulating, monitoring and recordingElectroencephalograph (EEG), surface Electromyography(EMG) and Evoked Potentials (EP). The electrodes aredesigned for single-patient/multiple application use and are veryflexible. Because of the adhesive nature of the gel, no securingmaterial is required for fixating the electrode to the patient'sskin.There are two types of electrodes, one with fixed lead wire andthe other without lead wire, tab electrodes.The electrodes with lead wire have a safety DIN 42802connector, several lengths and color combinations. Tabelectrode 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 fornon-invasive use with recording and monitoring equipment,(active and reference), of Electromyography (EMG),Electroencephalograph (EEG) and Evoked Potentials (EP). Theelectrodes are designed for single-patient/multiple applicationuse. | |
| Comparison to predicates: | The design, materials, chemical composition, packaging andother technological characteristics of the subject device isequivalent to those of the predicate devices. | |
| Non-clinical data: | Technomed Europe has been bench testing the CutaneousElectrodes to confirm performance characteristics of thisdevice. | |
| Conclusion: | The comparison to the predicate devices demonstrate that theDisposable Adhesive Surface Electrodes are safe and effectiveand 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
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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
§ 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).