(171 days)
K930080, K905435B
K905435B
No
The description focuses on data acquisition, storage, and display of raw EEG waveforms, with no mention of AI or ML processing.
No
The device is described as an EEG recording and display system for review and interpretation, not for treating a disease or condition.
Yes
The device is described as providing "tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals," which is indicative of a diagnostic function.
No
The device description explicitly lists several hardware components as part of the system, including electrodes, headpiece, patient module, fiber optic cable, DSP Interface Card, and computer hardware. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the device is an EEG system. It acquires, preserves, displays, and prints EEG waveform data. EEG data is electrical activity measured from the scalp, not a specimen taken from the body.
- Intended Use: The intended use is for preserving and displaying EEG waveform data for review and interpretation by healthcare professionals. This is a diagnostic tool, but it operates on electrical signals from the body, not on in vitro specimens.
Therefore, the Equinox™ Digital EEG System, as described, falls under the category of a medical device used for physiological monitoring and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Equinox™ System has the same intended use as the Neuro Concepts UNIQUANT™ System, that is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals. The Physiometrix Equinox™ System has the same intended use as the predicate devices described in K905435B, UNIQUANT™ System, which is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing the waveforms for analysis and interpretation by trained health care professionals.
Product codes
Not Found
Device Description
This submission describes an EEG recording system that is comprised of a combination of components described in two separate 510(k) submissions. The system components are Biosensor electrodes, e-Net Headpiece, Patient Module, Fiber Optic Cable, DSP Interface Cable, Computer Hardware and Software Application. The Equinox™ Digital EEG System incorporates products produced by Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K930080, K905435B
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
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Kg62447
Physio netrix, Inc. 510(k), Premarket Notification
Equinox™ Digital E-3G System
DEC 1 2 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | June 21, 1996 |
|---|---|
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| Contact: | Dawn E. Frazer |
| Director, Regulatory Affairs & Quality Assurance | |
| (508) 670-2422 | |
| (800) 474-9746 | |
| Subject Device: | Equinox ™ Digital EEG System |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| K905435B UNIQUANT ™ System | |
| This submission describes an EEG recording system that is comprised | |
| of a combination of components described in two separate 510(k) | |
| submissions. The system components are Biosensor electrodes, e-Net | |
| Headpiece, Patient Module, Fiber Optic Cable, DSP Interface Cable, | |
| Computer Hardware and Software Application. | |
| The first three items were originally discussed in Physiometrix | |
| Premarket Submission K930080, HydroDot NeuroMonitoring System. | |
| Subsequently several modifications have been submitted to the FDA | |
| for review. This file, Physiometrix Premarket Submission K962157, | |
| NeuroLink NeuroMonitoring System, is pending substantial equivalence | |
| decision. Therefore, all applicable items contained in K962157 have | |
| been duplicated in this submission. | |
| The last two items, the computer hardware and software application | |
| are described in Neuro Concepts K905435B, UNIQUANT ™ System. | |
| The software application described in this submission is called the | |
| Administrator. A business agreement has been arranged between | |
| Physiometrix and Neuro Concepts, Inc. whereby the Administrator | |
| software application will be incorporated into the Physiometrix System | |
| by Neuro Concepts, Inc. | |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Class II, 21 CFR Part 882.1400, Electroencephalograph | |
| Class II, 21 CFR Part 882.1835, Physiological Signal Amplifier |
1
Physiometrix, Inc. 510(k), Premarket Notification Equinox™ Digital EEG System
The Equinox™ Digital EEG System incorporates products produced by Description: Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data. The Equinox™ System has the same intended use as the Neuro Intended Use: Concepts UNIQUANT™ System, that is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals. The Physiometrix Equinox™ System has the same intended use as the Technology: predicate devices described in K905435B, UNIQUANT™ System, which is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing the waveforms for analysis and interpretation by trained health care professionals. The Equinox™ System is similar to the UNIQUANT™ System in that they use identical computer hardware and software applications. The Equinox™ System differs mainly from the UNIQUANT™ in that the Equinox™ is comprised of all the components necessary to acquire and display waveforms. The UNIQUANT™ system does not include electrodes or electrode placement tools that are a part of the Equinox™ System. These components are described in the Physiometrix K930080. The requirements of the Equinox™ System are consistent with the Conclusion: basic functionality of the predicate devices as well as conventional EEG machines that acquire and display EEG records on paper. Since there is no change in intended use from either of the predicate devices, there are no failure modes or latent design flaws in the software that would be expected to result in physical injury to the patient Thus, the software that controls this device poses no
2
Physiometrix, Inc. 510(k), Premarket Notification Equinox™ Digital EEG System
substantial risk or danger to the patient. It therefore meets the criteria for minor concern as outlined in the FDA Draft Reviewer Guidance for Computer Controlled Products. The concern is minor because even if there is an inadvertent misuse of the software, there is no risk or danger to the patient.