(281 days)
The Component Neuromonitoring System™ is intended to monitor the state of the brain by recording and displaying EEG signals, and can also receive and display a variety of vital signs and other measurements from third-party monitoring devices (such as ICP, ECG, SpO2, and others). It also has the optional capability to record and display patient video.
The Component Neuromonitoring System is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.
The Component Neuromonitoring System (CNS) is a portable, computer based system that can continuously record, display, store, and analyze physiological data from multiple monitoring sources in real-time. Electroencephalographic (EEG) data can be recorded from up to 16 electrode locations using the included EEG amplifier. Video can be recorded using an optional video camera. Other data can be recorded from interfaces to third-party monitoring devices, or can be manually entered.
The CNS Monitor consists of the following main physical components: a color flat-panel touchscreen display, an integrated computer system, a Device Interface Module, and an EEG Arnolifier. All hardware components of the monitor are mounted on a wheeled pole stand to provide a compact design, convenient use, and ease of transportation. An Ethernet port is located at the base of the system to allow the archival of patient data to a network. A storage basket can hold electrone supplies, and can also hold the EEG amplifier when the system is not in use.
The Device Interface Module contains six digital serial interfaces for connecting to external monitoring devices and four MDport™ (USB) interfaces used for connecting to other CNS components (such as the EEG Amplifier) or to electrically isolated, USB-based, external monitoring devices. The Device Interface Module also contains a CD/DVD drive for archiving patient recordings, for updating the system software, and for other data storage or retrieval purposes.
The EEG Amplifier is small and lightweight and connects to the Device Interface Module with a flexible 15' cord. It has 19 inputs (including Reference, Ground, and auxiliary inputs) and can record from up to 16 EEG electrode sites. Up to 6 inputs can be used as differential pairs for other physiological signals (e.g.: ECG, EOG, respiration, etc.). Continuous impedance checking automatically detects any electrodes that become loose or detached.
Data can be viewed on the CNS Monitor using a variety of display types: waveform, trend, numeric readout, compressed spectral array (CSA), and density spectral array (DSA). Combinations of multiple display types can be configured in a variety of screen layouts to allow the comparison of different measurements or different time periods from the recording.
The CNS Monitor can compute processed parameters from the EEG data, including: Amplitude Integrated EEG (aEEG), Total Power, Spectral Edge Frequency, EEG Band Power Percentages (delta, theta, alpha, beta), Envelope Amplitude, % Asymmetry, % Suppression, and Inter-Burst Interval (IBI).
The CNS Monitor also has several features to enable ease-of-use. It employs monitoring protocols that can step the user through a monitoring procedure and configure a group of settings for the recording (including EEG electrode sites & montage, collected measurements, and display settings). Pre-configured protocols are included on the system and the user can also create their own customized protocols. Embedded reference content can be viewed on the CNS Monitor to assist the user with system features, device connections, electrode application, and other topics.
Here's a breakdown of the acceptance criteria and study information for the Moberg Research, Inc. Component Neuromonitoring System, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Safety | Compliance with all applicable requirements of IEC60601-1 and IEC60601-1-4. Compliance with particular requirements for the safety of electroencephalographs established in IEC60601-2-26. |
| Electromagnetic Compatibility (EMC) | Compliance with all applicable requirements of IEC60601-1-2. Compliance with particular requirements for the safety of electroencephalographs established in IEC60601-2-26. |
| Design Requirements (General) | Undergone validation and verification testing to ensure conformance to all design requirements. |
| Calculation and Display of aEEG | Undergone comparison testing to ensure the substantial equivalence of the calculation and display of the aEEG. |
Important Note: The document does not provide specific quantitative or qualitative performance metrics (e.g., sensitivity, specificity, accuracy, specific thresholds for signal-to-noise ratio, drift, etc.) that would typically constitute detailed acceptance criteria. The acceptance criteria are described in terms of compliance with regulatory standards and general verification/validation.
Regarding the study that proves the device meets the acceptance criteria:
The document describes the performed testing in a general way, rather than detailing a specific, single study with a defined sample size, ground truth, or adjudication method.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. It refers to "validation and verification testing" and "comparison testing," but provides no details on the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The document does not mention the use of experts for establishing ground truth in its performance testing summary.
4. Adjudication method for the test set:
- Not specified in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned in the provided text. The device is an "EEG Monitor" that records, displays, stores, and analyzes physiological data. It computes parameters from EEG data, but the submission focuses on its equivalence to other neuromonitoring systems, not on assisting human readers in interpretation. Therefore, a study of this nature would not be directly relevant to the described performance testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes the system as continuously recording, displaying, storing, and analyzing physiological data. It "computes processed parameters from the EEG data," such as aEEG, Total Power, Spectral Edge Frequency, etc. The performance testing included "comparison testing to ensure the substantial equivalence of the calculation and display of the aEEG." This implies that the algorithm's output (calculated parameters) was evaluated for equivalence. However, the document doesn't explicitly frame this as a "standalone algorithm performance study" with specific metrics against absolute ground truth. It's more focused on equivalence to predicate devices for the calculation and display.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies a "ground truth" based on the performance of predicate devices for the comparison testing of aEEG calculation and display. For other aspects (safety, EMC, general design requirements), the ground truth is adherence to international standards (IEC 60601 series). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the device's analytical outputs.
8. The sample size for the training set:
- Not applicable/Not specified. The document describes a medical device, an EEG monitor, which performs signal acquisition, display, and computation of derived parameters. It does not describe a machine learning or AI model that would typically require a "training set" in the conventional sense. The "analysis" capabilities are likely based on established signal processing algorithms rather than learned models from a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set for a machine learning model is mentioned.
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510(k) Summary
| Submitter: | Moberg Research, Inc.224 South Maple WayAmbler, PA 19002Phone: (215) 283-0860Fax: (215) 283-0859 | NOV - 5 2008 |
|---|---|---|
| Contact Person: | Damon Lees | |
| Device Trade Name: | Component Neuromonitoring System™ | |
| Common Name: | EEG Monitor | |
| Classification Name: | Electroencephalograph (21CFR882.1400, Product Code: GWQ) | |
| Date of Preparation: | September 22, 2008 |
Substantially Equivalent Devices:
| Product Name | 510(k) Number | Manufacturer / Submitter |
|---|---|---|
| A-2000 EEG Monitor with BIS | K974496 | Aspect Medical |
| Bravo Multi-Modality System | K991054 | Nicolet Biomedical |
| BRM2 Brain Monitor | K033010 | BrainZ Instruments |
| CFM 6000 | K031149 | Olympic Medical |
| HARMONIE-Schwarzer EEG System | K010728 | Stellate Systems |
| Integra Mobius Multi-Modality System | K061640 | Integra NeuroSciences |
| Nervus Monitor | K021185 | Taugagreining HF |
| Neurotrac II-EP | K960170 | Moberg Medical |
| Lectromed Cerebral Function MonitorSystem | K983229 | Olympic Medical |
Indications for Use:
The Component Neuromonitoring System™ is intended to monitor the state of the brain by recording and displaying EEG signals, and can also receive and display a variety of vital signs and other measurements from third-party monitoring devices (such as ICP, ECG, SpO2, and others). It also has the optional capability to record and display patient video.
The Component Neuromonitoring System is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.
Device Description:
The Component Neuromonitoring System (CNS) is a portable, computer based system that can continuously record, display, store, and analyze physiological data from multiple monitoring sources
| Moberg Research, Inc. | ||
|---|---|---|
| -- | ----------------------- | -- |
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Page 2 of 3
in real-time. Electroencephalographic (EEG) data can be recorded from up to 16 electrode locations using the included EEG amplifier. Video can be recorded using an optional video camera. Other data can be recorded from interfaces to third-party monitoring devices, or can be manually entered.
The CNS Monitor consists of the following main physical components: a color flat-panel touchscreen display, an integrated computer system, a Device Interface Module, and an EEG Arnolifier. All hardware components of the monitor are mounted on a wheeled pole stand to provide a compact design, convenient use, and ease of transportation. An Ethernet port is located at the base of the system to allow the archival of patient data to a network. A storage basket can hold electrone supplies, and can also hold the EEG amplifier when the system is not in use.
The Device Interface Module contains six digital serial interfaces for connecting to external monitoring devices and four MDport™ (USB) interfaces used for connecting to other CNS components (such as the EEG Amplifier) or to electrically isolated, USB-based, external monitoring devices. The Device Interface Module also contains a CD/DVD drive for archiving patient recordings, for updating the system software, and for other data storage or retrieval purposes.
The EEG Amplifier is small and lightweight and connects to the Device Interface Module with a flexible 15' cord. It has 19 inputs (including Reference, Ground, and auxiliary inputs) and can record from up to 16 EEG electrode sites. Up to 6 inputs can be used as differential pairs for other physiological signals (e.g.: ECG, EOG, respiration, etc.). Continuous impedance checking automatically detects any electrodes that become loose or detached.
Data can be viewed on the CNS Monitor using a variety of display types: waveform, trend, numeric readout, compressed spectral array (CSA), and density spectral array (DSA). Combinations of multiple display types can be configured in a variety of screen layouts to allow the comparison of different measurements or different time periods from the recording.
The CNS Monitor can compute processed parameters from the EEG data, including: Amplitude Integrated EEG (aEEG), Total Power, Spectral Edge Frequency, EEG Band Power Percentages (delta, theta, alpha, beta), Envelope Amplitude, % Asymmetry, % Suppression, and Inter-Burst Interval (IBI).
The CNS Monitor also has several features to enable ease-of-use. It employs monitoring protocols that can step the user through a monitoring procedure and configure a group of settings for the recording (including EEG electrode sites & montage, collected measurements, and display settings). Pre-configured protocols are included on the system and the user can also create their own customized protocols. Embedded reference content can be viewed on the CNS Monitor to assist the user with system features, device connections, electrode application, and other topics.
Comparison of Technological Characteristics to Predicate Devices:
The Component Neuromonitoring System has the combined technological characteristics of the specified predicate devices. The system can record and display both digital EEG and video. compute various processed parameters from the EEG, and digitally interface to third-party monitoring devices for the collection and storage of other measurements.
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Summary of Performance Testing:
The Component Neuromonitoring System has undergone validation and verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the aEEG.
To ensure safety, the Component Neuromonitoring System will comply with all applicable requirements of IEC60601-1 and IEC60601-1-4, and will also comply with the uparticular requirements for the safety of electroencephalographs established in IEC60601-2-26.
To ensure electromagnetic compatibility, the Component Neuromonitoring System will comply with all applicable requirements of IEC60601-1-2, and will also comply with the particular requirements for the safety of electroencephalographs established in IEC60601-2-26.
Conclusion of Substantial Equivalence:
The comparison of technological characteristics and performance testing of the Component Neuromonitoring System demonstrate that its safety, effectiveness, and performance are equivalent to the specified predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Moberg Research, Inc. c/o CITECH Mr. Robert Mosenkis 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
APR - 9 2012
Re: K080217 Trade/Device Name: Component Neuromonitoring System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, GWQ, OLT, MUD, MHX, ORT Dated (Date on orig SE ltr): October 20, 2008 Received (Date on orig SE ltr): October 21, 2008
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of November 5, 2008.
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 (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 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.
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Page 2 - Mr. Robert Mosenkis
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use
510(k) Number (if known):
Device Name: Component Neuromonitoring System
Indications For Use:
The Component Neuromonitoring System™ is intended to monitor the state of the brain by recording and displaying EEG signals, and can also receive and display a variety of vital signs and other measurements from third-party monitoring devices (such as ICP, ECG, SpO2, and others). It also has the optional capability to record and display patient video.
The Component Neuromonitoring System is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter Arvan
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
11/4/08
510(k) Number K080217
Moberg Research, Inc.
Component Neuromonitoring System The 510(k) Application
Section 4, Page 1
§ 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).