(30 days)
The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.
The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.
The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.
The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.
The BREVIO device is a hand-held nerve conduction velocity measurement device intended for use in the diagnosis and monitoring of peripheral neuropathies. The 510(k) summary provides limited details on formal acceptance criteria or detailed study results. Based on the provided text, the device's performance was evaluated through bench testing and comparative human testing against a predicate device.
Here's an attempt to organize the information based on your request, with significant limitations due to the brevity of the study description in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Meets design controls. | "Bench testing has been done with this device demonstrating that it meets design controls." (No specific quantitative criteria or results provided for individual design control elements.) |
| Latency Correlation | High correlation with predicate device. | "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency...". (No specific correlation coefficient or statistical measure of "high correlation" is provided.) |
| Amplitude Correlation | High correlation with predicate device. | "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for... amplitude comparison." (No specific correlation coefficient or statistical measure of "high correlation" is provided.) |
| Motor Response Min Detection | Detect signals down to 100 microvolts (covering motor and F wave responses). | "The BREVIO is capable of detecting motor response signals down to 100 microvolts covering motor and F wave responses." (This is a statement of capability, not performance from a test, but implies it meets this threshold during testing). |
| Sensory Response Min Detection | Detect signals to 5 microvolts. | "Sensory signal responses can be detected to 5 microvolts." (Similar to motor response, a statement of capability implying it meets this threshold). |
| Latency Detection Range | Covers time range from 0 to 45 milliseconds. | "Latency detection capability covers the time range from 0 to 45 milliseconds." (Similar to above, a statement of capability.) |
| Amplitude Detection Range | Detects 5 to 10,000 microvolts. | "Amplitudes of signal responses can be detected in the range of 5 to 10,000 microvolts." (Similar to above, a statement of capability.) |
| Automated Latency/Amplitude Selection | Ability to automatically pick out latency and amplitude of waveforms. | "The BREVIO has incorporated a change in the software that allows the device to automatically pick out the latency and amplitude of waveforms presented to determine the values associated with them." (This is a design feature description, not a performance metric from a test validating its accuracy or efficiency.) |
| Manual Adjustment Capability | User-adjustable automated values. | "These automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change or adjustment based upon the user's experience or analysis." (This is a design feature description.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "comparative human testing." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for this human testing. Given the context of a 510(k) submission in the US, it is implied the testing was likely conducted in the US, but this is not explicitly stated. The testing seems to be prospective in nature, given its description as "comparative human testing" conducted to demonstrate correlation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth in the "comparative human testing." The testing was a comparison between the BREVIO device and a predicate device, implying the predicate device's readings served as a comparative reference.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance. The "comparative human testing" described seems to be a direct comparison of device measurements, not a study of human readers using the device with and without AI assistance. Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported.
6. Standalone (Algorithm Only) Performance
The device is implicitly standalone in its measurement capability, as it "automatically picks out the latency and amplitude of waveforms." The "comparative human testing" involved comparing the BREVIO device's measurements directly against a predicate device, which inherently implies standalone performance of the BREVIO in generating those measurements. However, no specific "standalone" study, separated from human involvement in interpretation or adjudication of those measurements, is explicitly detailed. The statement that "These automatically chosen values may be manually adjusted by the user" indicates that while the algorithm provides initial values, human-in-the-loop interaction is an expected part of its use.
7. Type of Ground Truth Used
For the "comparative human testing," the "ground truth" was established by the measurements obtained from a legally marketed predicate device. The document states, "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison." This implies the predicate device acted as the reference standard.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This suggests that the device's automatic latency and amplitude detection capabilities might have been developed through internal engineering and testing, rather than a formal, disclosed machine learning training paradigm with a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is also not provided.
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510(k) Summary
Trade Name: BREVIO
Common/Classification Name: Nerve Conduction Velocity Measurement Device 21 CFR 882.1550
Neurotron Medical, Inc. 1590 Reed Rd., Suite 102B Pennington, NJ 08534 800-367-1238
Contact: Jack Guldalian, President
Prepared: June 29, 2001
LEGALLY MARKETED PREDICATE DEVICES A.
K963208 NervePace Nerve Conduction Viewscope (VS 200) Neurotron Medical, Inc.
K843924 Digital Electroneurometer (S-100) Neurotron Medical, Inc.
DEVICE DESCRIPTION B.
The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.
The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.
The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.
C. INTENDED USE
The BREVIO is intended for use for the measurement of nerve response
" : ,
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Neurotron Medical Inc. 510(k) Notification
latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.
Indication for use:
The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the potontial. The onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The BREVIO is a medical device that has the same indication, intended use and target population as the legally marketed predicate devices.
The BREVIO has the same technological characteristics as the predicate devices.
The BREVIO has incorporated a change in the software that allows the device to automatically pick out the latency and amplitude of waveforms presented to determine the values associated with them. These automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change or adjustment based upon the user's experience or analysis. In addition the BREVIO has incorporated the mechanical features of both the NERVEPACE® ViewScope™ (200 VS) and Digital Electroneurometer S-100 into a single device.
TECHNOLOGICAL CHARACTERISTICS E.
The BREVIO operates utilizing four AA Alkaline batteries with an output of 9V. It has a graphical LCD display format of 128 x 112 pixels displaying motor and sensory nerve responses.
The BREVIO is capable of detecting motor response signals down to 100 microvolts covering motor and F wave responses. Sensory signal
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Neurotron Medical Inc. 510(k) Notification
responses can be detected to 5 microvolts. Latency detection capability covers the time range from 0 to 45 milliseconds. Amplitudes of signal responses can be detected in the range of 5 to 10,000 microvolts. Once the waveform is recorded the system will determine in the case of motor responses the onset latency value and baseline peak amplitude. For sensory responses, the peak latency value and baseline to peak amplitude value will be reported. These values will appear on the screen display and in the printed report.
The memory of the device is capable of storing up to 28 waveform responses.
The maximum stimulator output is 300 volts, pulse width 250 microseconds.
F. TESTING
Bench testing has been done with this device demonstrating that it meets design controls.
Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison.
G. CONCLUSIONS
Design specifications, comparison to predicate device specifications and testing has demonstrated that this BREVIO device meets design requirements and is equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. The text is in all capital letters and is arranged to follow the curve of the circle.
1 2001 AUG
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neurotron Medical, Inc. c/o Mr. T. Whit Athey C. L. McIntosh & Associates 12300 Twinbrook Parkway Suite 230 Rockville, Maryland 20852
Re: K012069
Trade/Device Name: BREVIO Regulation Number: 882.1550 Regulatory Class: II Product Code: JXE Dated: July 2, 2001 Received: July 2, 2001
Dear Mr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave acterificated predicate devices marketed in interstate commerce stated in the energials, to regary and date of the Medical Device Amendments, or to devices that provisions of the reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosments for (110). - Tot Ine)y and controls provisions of the Act include requirements for annual provisions of the Frea - Process, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ipps of ally to the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopelvestity the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. T. Whit Athey
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N. Mikkelsen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
1 012069 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: BREVIO
Indications For Use:
The BREVIO is intended to be used as a waveform display nerve conduction monitor. It The DIGITO is intension derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete value in miniscoonals from als argust in derived and this is delivered to the digital storage oscilloscope for compete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The The facelley varies is interestine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
R. Masha OR. Melson Over-The-Counter Use
Division Sign-Off
. Restorative
510(k) Number
00256
§ 882.1550 Nerve conduction velocity measurement device.
(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).