(90 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 recording, they transduce bioelectric 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 peripheral nerves. Surface electrodes are used in the performance of nerve conduction studies (NCS). They are provided non-sterile and are designed and intended to be for single patient use only and are disposable.
- l UNIVERSAL Stimulator Bar Electrode (UE-001)
- UNIVERSAL Tab Electrode Set (UE-002) 트
- 트 UNIVERSAL Ring Electrode Set (UE-003)
These individually placed electrodes are not configured for specific nerves, limbs, or clinical applications. The Stimulator Bar Electrode (UE-001) is for stimulation of peripheral nerves and consists of two electrodes in a bar configuration. The Tab Electrode Set (UE-002) and the Ring Electrode Set (UE-003) each consist of three distinct electrodes that are individually placed by the user.
This 510(k) summary for NeuroMetrix UNIVERSAL Electrodes does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance.
This document primarily focuses on establishing substantial equivalence to predicate devices based on shared intended use, clinical applications, and technological characteristics, rather than presenting a performance study with specific acceptance criteria and detailed results.
Here's an analysis of what can be extracted from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. The summary states that "testing data presented, support a finding of substantial equivalence," but it does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the reported device performance metrics were against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. There is no mention of any specific test set, its sample size, or the provenance of any data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given 510(k) summary. Given the absence of a described test set, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided in the given 510(k) summary. MRMC studies are typically for evaluating the impact of an AI algorithm on human reader performance, which doesn't appear to be the focus of this submission for surface electrodes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided in the context of this device. The NeuroMetrix UNIVERSAL Electrodes are physical surface electrodes, not an AI algorithm. Therefore, "standalone" performance in the sense of an algorithm is not relevant. The document implies performance testing of the physical electrodes (e.g., electrical properties, skin compatibility, durability), but details are absent.
7. The Type of Ground Truth Used
This information is not provided in the given 510(k) summary. For physical electrodes, ground truth would likely relate to objective physical and electrical measurements (e.g., impedance, signal-to-noise ratio, material biocompatibility), rather than expert consensus on diagnostic interpretations.
8. The Sample Size for the Training Set
This information is not provided in the given 510(k) summary. As these are physical electrodes, the concept of a "training set" in the machine learning sense is not directly applicable. If "training set" refers to data used to design or optimize the electrode, those details are not present.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given 510(k) summary for the reasons mentioned above.
Summary of Missing Information:
This 510(k) summary largely relies on demonstrating substantial equivalence to existing predicate devices (Axon Systems Pre-gelled Surface Electrodes and NeuroMetrix Biosensors) rather than providing a detailed performance study with explicit acceptance criteria and results. The text states:
- "A comparison of the UNIVERSAL Electrodes to the predicate Axon Systems Pre-gelled Surface Electrodes (K062198), along with testing data presented, support a finding of substantial equivalence."
- "The UNIVERSAL Electrodes and these predicate electrodes share similar intended use, clinical applications, and technological characteristics."
This indicates that any "testing data" was likely used to confirm that the new electrodes perform similarly to the predicates, thereby not raising new questions of safety or effectiveness. The specific details of that testing, including numerical acceptance criteria, sample sizes, and empirical results, are not included in this publicly available portion of the submission. For a device like surface electrodes, performance "acceptance criteria" generally relate to electrical characteristics (e.g., impedance, noise levels), biocompatibility, adhesion, and durability, but these are not quantified or presented here.
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510(k) Summary for NeuroMetrix UNIVERSAL Electrodes
1. SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 890-9989 ext. 2781 |
Date Prepared:
August 22, 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. PRÉDICATE 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 non-sterile and are for single patient use only.
August 22, 2008
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5. DEVICE DESCRIPTION
Surface electrodes are the interface medium between neurodiagnostic equipment and the When used for recording, they transduce bioelectric signals into electronic patient. 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 peripheral nerves. Surface electrodes are used in the performance of nerve conduction studies (NCS). They are provided non-sterile and are designed and intended to be for single patient use only and are disposable.
- l UNIVERSAL Stimulator Bar Electrode (UE-001)
- UNIVERSAL Tab Electrode Set (UE-002) 트
- 트 UNIVERSAL Ring Electrode Set (UE-003)
These individually placed electrodes are not configured for specific nerves, limbs, or clinical applications. The Stimulator Bar Electrode (UE-001) is for stimulation of peripheral nerves and consists of two electrodes in a bar configuration. The Tab Electrode Set (UE-002) and the Ring Electrode Set (UE-003) each consist of three distinct electrodes that are individually placed by the user.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
A comparison of the UNIVERSAL Electrodes to the predicate Axon Systems Pre-gelled Surface Electrodes (K062198), along with testing data presented, support a finding of substantial equivalence. The UNIVERSAL Electrodes and these predicate electrodes share similar intended use, clinical applications, and technological characteristics.
The UNIVERSAL Electrodes include a connector, an electronic serial number (UE-001 only), EEPROM memory (UE-001 only), and the measurement of patient skin-surface temperature (UE-001). These technological characteristics are substantially equivalent to the NeuroMetrix Biosensors (K060584).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
SEP 2 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NeuroMetrix, Inc. c/o Mr. Rainer Maas 64 Fourth Avenue Waltham, MA 02451
Re: K081871
Trade/Device Name: Universal Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 22, 2008 Received: September 3, 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 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); Iabeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - 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) 276-0115. 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 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
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):
UNIVERSAL Electrodes Device Name:
Indications for 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 Subpart 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)
Peblhora
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k)Page 1 of 1 K041871
NeuroMetrix, Inc. Universal Electrodes 510(k) June 27, 2008
CONFIDENTIAL Page x
§ 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).