(185 days)
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No
The description focuses on standard signal processing and biofeedback techniques, with no mention of AI or ML terms or methodologies.
Yes.
The device is indicated for relaxation training using biofeedback, which is a therapeutic application.
No
The document states the device is indicated for relaxation training using alpha EEG biofeedback, not for diagnosing any condition.
No
The device description explicitly states it is a "two channel electrophysiological signal acquisition and biofeedback device" and mentions hardware components like the "NRS-2D" and its use with a "standard IBM PC/AT compatible computer and associated peripheral equipment." This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "relaxation training using alpha EEG biofeedback." This involves monitoring and providing feedback on physiological signals (EEG) from the patient's body.
- Device Description: The device acquires "electrophysiological signal acquisition and biofeedback data," specifically EEG.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device directly interacts with the patient's body to acquire signals.
Therefore, the BioLex device, as described, falls under the category of a biofeedback device used for therapeutic or training purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NRS-2D uses Lexicor's BioLex software to perform its intended use.
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The NRS-2D is a two channel electrophysiological signal acquisition and biofeedback device. The product is designed for use with a standard IBM PC/AT compatible computer and associated peripheral equipment. When assembled with the computer, the NRS-2D system will acquire EEG and biofeedback data, perform signal spectral analysis and quantification and provide auditory and/or visual feedback. At the user's discretion the NRS-2D can be factory configured as a single channel device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
NRS-2D 510(k) Notification
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96
OCT 3 1 1996
TABLE OF CONTENTS
| TABLE OF CONTENTS | 6-2 |
|---|---|
| SUBMITTER | 6-2 |
| CONTACT PERSON | 6-2 |
| DEVICE NAME | 6-2 |
| DEVICE DESCRIPTION | 6-3 |
| INTENDED USE | 6-3 |
| PREDICATE DEVICE | 6-4 |
| SUMMARY OF TECHNOLOGICAL CHARACTERISTICS | 6-4 |
SUBMITTER
Lexicor Medical Technology, Inc. 5589 Arapahoe Ave. #206 Boulder, CO 80303 Telephone: 303.443.9944
FAX: 303.443.0591
CONTACT PERSON
Michael M. Shupe Quality and Regulatory Affairs Manager
DEVICE NAME
.
- . Proprietary Name: NRS-2D
- Common Name: Electroencephalograph with an electroencephalogram signal spectrum analyzer and biofeedback options.
- . Classification Names: Electroencephalograph
Analyzer, Spectrum, Electroencephalogram Signal
Device, Biofeedback
1
NRS-2D 510(k) Notification
Section 6
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96 Revised: 7/29/96
DEVICE DESCRIPTION
The NRS-2D is a two channel electrophysiological signal acquisition and biofeedback device. The product is designed for use with a standard IBM PC/AT compatible computer and associated peripheral equipment. When assembled with the computer, the NRS-2D system will acquire EEG and biofeedback data, perform signal spectral analysis and quantification and provide auditory and/or visual feedback. At the user's discretion the NRS-2D can be factory configured as a single channel device.
INTENDED USE
The NRS-2D uses Lexicor's BioLex software to perform its intended use.
BioLex Software
Description
BioLex provides visual and/or auditory feedback based on parameters derived from spectral analysis of the electroencephalogram (EEG) signal.
Indications
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.
Warnings and Contraindications
BioLex is contraindicated in patients with the following conditions:
-
- Individuals who are unwilling or unable to understand the general principles and goals of the feedback used. This includes individuals with excessive behavioral problems or low IQ.
-
- Individuals who experience anxiety or an unpleasant experience associated with EEG biofeedback training.
2
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96
-
- In epilepsy, there may be a causal relationship between EEG training of certain EEG frequencies and incidence of seizure.
Certain patients may be unable to learn to control the EEG through biofeedback. Therapy should be discontinued if periodic monitoring of therapeutic progress indicates that the patient is not learning despite adequate review of instructions for feedback.
- In epilepsy, there may be a causal relationship between EEG training of certain EEG frequencies and incidence of seizure.
Side Effects
There have been clinical reports of dizziness, drowsiness, fatigue and anxiety associated with feedback employing alpha enhancement.
Frequency and Duration of Treatment
Duration of treatment ranges from 1 to 30 sessions and frequency from 1 to 7 times weekly depending on the needs of the patient.
Operation and Usage
Please refer to the Biolex Software Manual for complete operating instructions prior to use.
PREDICATE DEVICE
Lexicor NRS-4, 510(k) K920038
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
System Block Diagram
Image /page/2/Figure/15 description: The image shows a block diagram of a system. The system consists of five blocks: Patient Interface Cable, Acquisition and Preprocessing Unit, Computer Interface Cable, and Personal Computer. Arrows connect the blocks in a sequential manner, indicating the flow of data or signals through the system.
A simple software command will allow the user to check all electrode contacts at any time, while the patient is connected to the NRS-2D without having to disconnect the electrodes from the NRS-2D and check the electrode/skin contact with a separate impedance meter.
3
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96
Patient Interface
When EEG electrodes are used and applied properly, contact impedances below Sk-10k Ohms can be obtained.
Acquisition and Preprocessing Unit
The acquisition and preprocessing unit is a self-contained electrically isolated module which amplifies and filters the subject's EEG signals and converts them from an analog to digital form.
Each of the NRS-2D's channels consists of a continuity checking circuit, followed by a preamplifier and then lowpass, highpass and notch filters.
The notch filter (60 Hz USA) attenuates electrical mains interference noise entering the signal path.
Finally the channels are scanned by a 12 bit combination multiplexer and Analog to Digital converter with Sample and Hold.
A microprocessor in the NRS-2D controls the continuity checking and A/D conversion process, transmits data to, and receives commands from the PC through on-board optical isolators. Communication with the PC is accomplished via a 25 conductor cable which connects to the NRS-2D back panel's DB-25 connector and to any PC parallel printer port.
A binary executable code for the microprocessor handles the communication between the Acquisition and the host software application (BioLex and NeuroLex). The code instructs the card to reset the input multiplexer, read the data into an area of dual-ported memory in the processor and set interrupt vector 7 of the host PC interrupt system. The host software's interrupt routine then reads the data form the processor memory into computer RAM. This process is repeated for each set of input samples of the digitized EEG.
4
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96
Image /page/4/Figure/3 description: This image shows a block diagram of a system. The system starts with a "Continuity Checking" block, which receives input from a patient. The signal then passes through a "Pre-Amp", "Low Pass Filter", "High Pass Filter", and "Optical Interface" in sequence. The signal is then fed into a "Microprocessor" after passing through a "Notch Filter" and "A/D Converter". The microprocessor also handles communication to and from a computer.
NRS-2D Functional Block Diagram
The NRS-2D has a fixed sampling rate of 128Hz, a fixed gain of 8,000 and a built in electrode continuity checking capability.
A simple software command will allow the user to check all electrode contacts at any time, while the patient is connected to the NRS-2D without having to disconnect the electrodes from the NRS-2D and check the electrode/skin contact with a separate impedance meter.
Power
The NRS-2D uses a medical grade single output switching power supply with the following features:
Universal input from 90-264VAC
Power on LED
Overvoltage and short circuit protection Built-in EMI filter-class B
UL-544, CSA-223 and TUV-601 Safety approvals
Output-12 VDC, 2A
A 9.6 VDC rechargeable battery pack is available as an option.
:
5
NRS-2D 510(k) Notification
Section 6
510(k) Summary Lexicor NRS-2D Date Prepared: 4/16/96 Revised: 7/29/96
The following is a table of the NRS-2D specifications.
| Physical
Dimensions | 6" (l) x 3" (w) x
1.125" (h) | AC Power | |
|--------------------------------|---------------------------------|------------------|-----------------------------------|
| Signal Acquisition | | Voltage | 100/240 volts, 30 watts, 50/60 Hz |
| Channels | 1 or 2 | Current | 90 db at 60 Hz | Current | 600 MAH |
| Gain | 8k | Type | Rechargeable |
| Artifact Rejection | manual/automatic | Control Software | |
| Low Pass Filters | 32 Hz | | BioLex |
| High Pass Filters | 0.5 Hz | | |
| Input Impedance | >1 GΩ | | |
| A/D Resolution | 12 bits | | |
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