(126 days)
The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters.
Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments.
The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate).
Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm).
The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation.
Wire crimped to Cup Electrode using Tin plated copper tubing.
Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.
This document describes a 510(k) summary for the DE-48-Plus Disposable Electrodes, a non-invasive cutaneous device for physiological signal acquisition. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study. Therefore, many of the requested criteria for a clinical study are not applicable or explicitly stated.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resistance (Electrical Property) | "found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes." |
| Model Surface (Physical/Material Property) | "found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes." |
| Impedance (Electrical Property) | "found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes." |
| Frequency Response (Electrical Property) | "found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes." |
| Material Composition | "same or equivalent to the Rhythmlink predicate" (e.g., ABS Plastic with Ag/AgCl coating, 28AWG stranded Tin Copper conductor, Alex crimp type terminal). |
| Design | "same/equivalent design as the predicate Disc Electrodes" (circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl)). |
| Electrical Safety Conformance | Conforms to DIN 42-802. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "appropriate testing" but does not detail the number of electrodes or tests conducted for Resistance, Model Surface, Impedance, and Frequency Response.
- Data Provenance: Not explicitly stated, but it's implied that the testing was conducted by Grass Technologies as part of their submission process. Given the nature of a 510(k) for a medical device, this would typically involve laboratory testing, not human clinical trials. It's likely retrospective in the sense that it compares features and performance to existing, legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For this type of device (electrodes for acquiring physiological signals), ground truth isn't established by expert consensus on clinical findings. Instead, the "truth" is based on objective measurements of physical and electrical properties compared against established product specifications or the properties of predicate devices.
4. Adjudication method for the test set
- Not Applicable. As there's no clinical "ground truth" to adjudicate, this concept does not apply to the device's testing for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is an electrode, not an AI diagnostic tool or system that assists human readers. Therefore, an MRMC study and AI-related effectiveness are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (electrode), not an algorithm or software. "Standalone performance" in this context would refer to its physical and electrical characteristics, which were assessed as described in the "Performance Data" section.
7. The type of ground truth used
- The "ground truth" for demonstrating substantial equivalence was the established characteristics and performance of the identified predicate devices: the Rhythmlink Disc Electrodes (K061148) and Grass Technologies' Gold Electrodes (marketed prior to 1976).
- For the technical characteristics (Resistance, Model Surface, Impedance, Frequency Response), the ground truth would be the measured values from the predicate devices which the DE-48-Plus aimed to match or be "substantially equivalent" to.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
Summary of the Study:
The "study" referenced in the document is not a traditional clinical trial but rather a series of bench tests and comparative analyses conducted by Grass Technologies to demonstrate that the DE-48-Plus Disposable Electrodes are "substantially equivalent" to legally marketed predicate devices.
The tests focused on physical and electrical performance characteristics such as Resistance, Model Surface, Impedance, and Frequency Response. The results of these tests, although not numerically detailed in the summary, reportedly showed that the DE-48-Plus electrodes were "found, through appropriate testing to be substantially equivalent" to the Rhythmlink Disc Electrodes and existing Grass Technologies' Gold Electrodes. Material composition and design were also compared directly to the predicates.
The purpose of this submission (510(k)) is to demonstrate that the new device is as safe and effective as a legally marketed device, not to prove novel performance through a clinical trial with human subjects.
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APR 2 4 2013
510(k) SUMMARY (as required by 21 CFR 807.92)
Device Name:
DE-48-Plus Disposable Electrodes
12 123915
COMPANY:
Grass Technologies Division of Astro-Med, Inc. 53 Airport Park Drive Rockland, MA 02370 Establishment Registration Number: 1218414
CONTACT:
Steven G. Holbrook 401-828-4000 (phone) 401-822-2430 (fax)
TRADE NAME: DE-48-Plus Disposable Electrodes COMMON NAME: Non-invasive Disc Electrodes CLASSIFICATION NAME: Electrode, Cutaneous REGULATION NUMBER: 882.1320 PRODUCT CODE: GXY
SUBSTANTIAL EQUIVALENCE
Grass Technologies believes that the DE-48-Plus Disposable Electrodes are substantially equivalent to the Rhythmlink Disc Electrodes as marketed under K061148 by Rhythmlink International, FDA Reg# 1067162 and to Grass Technologies' Gold Electrodes as marketed by Grass Technologies in the US prior to 1976.
DEVICE DESCRIPTION
The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters.
Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded
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connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments.
The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate).
Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm).
The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation.
Wire crimped to Cup Electrode using Tin plated copper tubing.
Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.
INDICATIONS FOR USE
The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)
The Grass and Predicate Surface Disk Electrodes are non-invasive, cutaneous devices used for the acquisition of signals from the body for the purpose of monitoring and recording EEG, EMG and Evoked Potentials (EP). The Grass DE-48-Plus Disk electrodes are manufactured from ABS Plastic with an AG/AgCl coating; with lead wire manufactured from 28AWG stranded tin copper conductor with soft PVC insulation; electrode to wire crimp with tin plated copper tubing; and an Alex crimp type terminal (24-30 AWG Brass, tin plated, molded in Palprene) which conforms to DIN 42-802 for electrical safety and is the same/equivalent design as the predicate Disc Electrodes. Skin contact materials do not include the use of any color additives.
PERFORMANCE DATA
Product performance characteristics [Resistance, Model Surface, Impedance and Frequency Response] of the Grass DE-48-Plus electrode was found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
April 24,2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Grass Technologies, Inc. Mr. Phillio Soares 53 Airport Park Drive Rockland, MA 02370
Re: K123915
Trade/Device Name: DE48-Plus Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: January 27, 2013 Received: February 21, 2013
Dear Mr. Soares:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53)-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Phillip Soares
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices · Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123915
Device Name: _DE48-Plus Disposable Electrodes
Indications For Use:
The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
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)
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(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
K123915 510(k) Number
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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).