(196 days)
The NeuroMetrix Bioamplifier is intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.
The NeuroMetrix Bioamplifier ("Bioamplifier") is a one channel wireless electromyography amplifier. This device is intended to differentially measure, amplify, digitize, and wirelessly transmit bioelectrical signals from peripheral nerves and muscles transduced by surface electrodes, which are provided separately. The Bioamplifier consists of the following components: Amplifier/Digitization Unit, Battery, RF Trigger, and Bluetooth. The Bioamplifier is typically used with a host device that controls the operation of the Bioamplifier and may provide other functionality such as a user interface, electrical or other stimuli, data analysis, data storage, and document generation.
This 510(k) summary for the NeuroMetrix Bioamplifier primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics. Therefore, much of the requested information regarding specific acceptance criteria, performance data, sample sizes, expert involvement, and ground truth derivation is not explicitly provided in this document.
However, I can extract and infer some information based on the premise of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Formal, quantifiable acceptance criteria with corresponding reported device performance metrics are not explicitly stated in this 510(k) summary. The document focuses on demonstrating comparable functionality and validation of components to a predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Amplification & Digitization: Equivalent ability to measure, amplify, and digitize bioelectrical signals from peripheral nerves and muscles. | "performance of all Bioamplifier system components has been validated." (General statement, no specific metrics provided) |
| Wireless Transmission: Equivalent ability to transmit digitized data to a host device. | Bluetooth wireless link successfully provides communication to a host device. |
| Power Source: Comparable reliable power source. | Powered by a high-capacity rechargeable Li-polymer battery. |
| RF Trigger functionality: Equivalent ability to precisely trigger data acquisition. | Includes an RF receiver that allows a host device to precisely trigger data acquisition. |
| Safety & Effectiveness: No new safety or effectiveness issues raised compared to the predicate. | "Therefore any differences in system component technologies do not raise new safety or effectiveness issues." |
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not provide information on a specific "test set" in the context of a clinical performance study. The validation mentioned ("performance of all Bioamplifier system components has been validated") likely refers to engineering and bench testing, not a clinical study with human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. Since there's no mention of a clinical test set requiring a ground truth determination for diagnostic accuracy, there's no information on experts or their qualifications.
4. Adjudication Method
Not applicable/Not provided. As there's no clinical test set for diagnostic accuracy, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This 510(k) summary does not describe an MRMC comparative effectiveness study, as it's a device for signal amplification and transmission, not an AI diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a hardware component (bioamplifier) with embedded software, not a standalone algorithm in the sense of AI. While its components' performance was validated, it wasn't a "standalone algorithm" performance study.
7. Type of Ground Truth Used
Not applicable/Not provided. For a hardware device focused on signal acquisition and transmission, the "ground truth" would relate to the accuracy of the signal capture and transmission, likely evaluated through instrumentation and bench testing against known calibration signals, rather than clinical outcomes or pathology. This document does not detail the specifics of such testing.
8. Sample Size for the Training Set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." Its software components relate to the device's operational control, amplification, and digitization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set for an AI/ML algorithm, this information is not relevant.
In summary, the NeuroMetrix Bioamplifier 510(k) emphasizes substantial equivalence to a predicate device by comparing their intended use, system components, and functionality. It states that "the performance of all Bioamplifier system components has been validated," implying internal testing to ensure the device performs as intended and comparably to the predicate. However, it does not provide detailed specific performance metrics or clinical study data that would typically be described when proving adherence to quantitative acceptance criteria for a diagnostic accuracy claim.
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510(k) Summary for NeuroMetrix Bioamplifier
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- SPONSOR
MAY 27 2009
- SPONSOR
न्द
- NeuroMetrix. Inc. 62 Fourth Avenue Waltham. MA 02451
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 314-2781 |
| Date Prepared: | May 11, 2009 |
2. DEVICE NAME
| Proprietary Name: | Bioamplifier |
|---|---|
| Common/Usual Name: | One channel wireless electromyography amplifier |
| Classification Name: | 890.1375 Electromyograph. Diagnostic |
PREDICATE DEVICES 3.
- EB Neuro S.p.A. NeMus PC Peripheral (K073415) o
4. INTENDED USE
The NeuroMetrix Bioamplifier is intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.
5. DEVICE DESCRIPTION
Bioamplifier ("Bioamplifier") is a one channel wireless NeuroMetrix The electromyography amplifier. This device is intended to differentially measure, amplify. digitize, and wirelessly transmit bioelectrical signals from peripheral nerves and muscles transduced by surface electrodes, which are provided separately,
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The Bioamplifier consists of the following components:
- 5.1 Amplifier/Digitization Unit. The electronic circuitry and software required to measure, amplify and digitize bioelectrical signals generated by nerves and muscles.
- 5.2 Battery. The Bioamplifier is powered from a high capacity re-chargeable Li-polymer battery.
- 5.3 RF Trigger. The Bioamplifier includes an RF receiver that allows a host device to precisely trigger data acquisition in order to synchronize to events such as stimuli.
- 5.4 Bluetooth. The Bioamplifier is equipped with Bluetooth wireless technology that provides communication between it and a host device.
The Bioamplifier is typically used with a host device that controls the operation of the Bioamplifier and may provide other functionality such as a user interface. electrical or other stimuli, data analysis, data storage, and document generation.
(). BASIS FOR SUBSTANTIAL EQUIVALENCE
The Bioamplifier, which is the subject of this 510(k) Premarket Notification. is substantially equivalent to the predicate EB Neuro S.p.A. NeMus PC Peripheral as previously cleared for marketing. The two devices have similar indications for use. which is the recording of bicelectrical activity from peripheral nerves and muscles using surface electrodes, converting these signals into digital form, and transmitting this data to a host device. The two devices have comparable system components. They both have amplifier and digitization circuits. They both have a DC power source which in the Bioamplifier is provided by an embedded rechargeable battery and in the NeMus PC Peripheral by an AC/DC adapter. They both have a wired connector to surface Finally, they both have a digital link to an external device. In the electrodes. Bigamplifier this is accomplished through a Bluetooth wireless link while in the NeMus PC Peripheral it is provided via a wired Ethernet cable. Although the technology used in some system components is different (c.g., battery vs. AC/DC adapter: wireless vs. wired link). the functionality is comparable. Furthermore, the performance of all Bioamplifier system components has been validated. Therefore any differences in system component technologies do not raise new safety or effectiveness issues.
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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 of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
MAY 27 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NeuroMetrix, Inc. % Rainer Maas . 62 Fourth Avenue Waltham, Massachusetts 02451
Re: K083322
Trade/Device Name: Bioamplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: April 1, 2009 Received: April 3, 2009
Dear Rainer Mass:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Rainer Maas
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K083322
Device Name: Bioamplifier
Intended Use:
The NeuroMetrix Bioamplifier us intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
and the contraction of the comments of the country of the country of
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083322
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).