(30 days)
The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only
Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable
- 트 UNIVERSAL Multi-Electrode Set A (UE-004)
- 0 UNIVERSAL Multi-Electrode Set B (UE-005)
These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities
The provided document is a 510(k) summary for the NeuroMetrix UNIVERSAL Electrodes, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific acceptance criteria based on performance data. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this type of regulatory submission.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. A 510(k) submission for electrodes typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, intended use alignment, and technological characteristics, rather than through detailed performance metrics against specific quantitative acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission does not detail any specific clinical or performance test sets used to generate data for this 510(k). The focus is on substantial equivalence to existing devices rather than a new performance study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. As no specific performance study with a test set is described, there's no mention of ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided. No test set or adjudication process is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. An MRMC study is not mentioned. The 510(k) focuses on the device itself (electrodes), not a diagnostic algorithm that would typically be evaluated in an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
This information is not provided. The device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable.
7. The Type of Ground Truth Used
This information is not provided. No ground truth is described as there's no performance study detailed.
8. The Sample Size for the Training Set
This information is not provided. The document describes an electrode, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See reason for #8).
Summary of the 510(k) Document's Approach to Meeting Regulatory Requirements:
The NeuroMetrix UNIVERSAL Electrodes 510(k) relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove specific performance metrics, the manufacturer asserts that the new electrodes are as safe and effective as previously cleared devices because they share the same:
- Intended Use: For use with electrodiagnostic equipment for recording electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation.
- Clinical Applications.
- Technological Characteristics:
- Surface electrodes that transduce bioelectric signals or provide an interface for stimulation.
- Non-sterile, single-patient use, and disposable.
- Inclusion of multi-electrode sets with various configurations (bar, ring) for stimulation and recording.
- Embedded digital thermometer and ruler for inter-electrode distance measurement.
- Materials, Manufacturing Process, and Packaging: Stated to be the same as NeuroMetrix Biosensors (K060584).
The predicate devices mentioned are:
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate devices. This determination allows the device to be marketed without requiring a new Pre-Market Approval (PMA) application.
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683818
JAN 2 1 2009
510(k) Summary for NeuroMetrıx UNIVERSAL Electrodes
1 SPONSOR
NeuroMetrix, Inc 62 Fourth Avenue Waltham, MA 02451
Contact Person Ramer Maas Telephone (781) 890-9989
Date Prepared
December 19, 2008
2. DEVICE NAME
| Proprietary Name | UNIVERSAL Electrodes |
|---|---|
| Common/Usual Name | Pre-gelled surface electrodes with leads and connector |
| Classification Name | 882 1320 GXY Electrode, Cutaneous |
3 PREDICATE DEVICES
4 INTENDED USE
The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are nonsterile and are for single patient use only
{1}------------------------------------------------
5 DEVICE DESCRIPTION
Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable
- 트 UNIVERSAL Multi-Electrode Set A (UE-004)
- 0 UNIVERSAL Multi-Electrode Set B (UE-005)
These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The two UNIVERSAL Electrodes that are the subject of this 510(k) Premarket Notrfication are substantially equivalent to the predicate UNIVERSAL Electrodes (K081871) The proposed and predicate UNIVERSAL Electrodes share intended use, clinical applications, and technological characteristics
The materials, manufacturing process, and packaging for the two new UNIVERSAL Electrodes are the same as for NeuroMetrix Biosensors (K060584) and are therefore also substantially equivalent to these devices
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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract image of an eagle.
JAN 2 1 2009_ _
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NeuroMetrix, Inc % Mr Rainer Maas 62 Fourth Avenue Waltham, MA 02451
Re K083818
Trade Name UNIVERSAL Electrodes Regulation Number 21 CFR 882 1320 Regulation Names Cutaneous Electrode Regulatory Class II Product Code GXY Dated December 19, 2008 Received December 22, 2008
Dear Mr Maas
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 musbranding and adulteration
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), tt 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 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
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Page 2 - Mr Rainer Maas
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 Brometric'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 Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours.
Mark N Mulhearn
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 UNIVERSAL Electrodes
Intended Use
The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only
Prescription Use X (Part 21 CFR 801 Subparts D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
FOR M.MELKERSON
Division Sign-Off
Division of General, Restorative, and Neurological Devices
-(k) Number K083818
NeuroMetrix, Inc UNIVERSAL Electrodes Special 510(k)
December 19, 2008
Page viu
f
§ 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).