(188 days)
The Epoch 2000 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide the health care professionals with information to help access a patient's neurological status during surgery or longterm monitoring in the ICU.
The Epoch 2000 is similar is concept and function to our original product, the Sentinel-4 EEG/EP Intraoperative Monitor (K900482A), a class II device. This instrument is also used to monitor brain function and neurological activity utilizing EEG and multiple modality evoked potential techniques. The additional features incorporated in this product are designed to meet the current and expanding demands of health care professionals for more effective ways to monitor the neurological status of their patients without compromising safety or effectiveness.
The provided documentation describes the Epoch 2000 Neurological Workstation, which is a medical device for neurological monitoring. However, it does not contain specific acceptance criteria, performance metrics, or a dedicated study design that proves the device meets those criteria, as one would expect for an AI-powered device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards.
Therefore, many of the requested sections (2-9) cannot be filled with direct information from the provided text. I will explain what information is available and then address the rest by stating that the information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative acceptance criteria for device performance based on metrics like sensitivity, specificity, accuracy, or similar. Instead, it relies on demonstrating that the Epoch 2000 has the same intended use and capabilities as legally marketed predicate devices, and that it meets established industry and electrical safety standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Industry Standards | Meets or exceeds American Electroencephalograph Society Intraoperative Monitoring guidelines for EEG and evoked response devices. | Claimed: "We claim the device to be safe, effective and substantially equivalent to the predicate devices noted." (Implying adherence to guidelines) |
| Electrical Safety | UL544, IEC 601-1, C22.2 No. 125 | Claimed: Adheres to these standards. |
| Functional Equivalence | Performance of "Epoch 2000" equivalent to predicate devices for various monitoring types (listed below). | Claimed equivalent functionality for all types: Cerebral ischemia, changes in EEG due to neuroactive drugs, long term coma, seizure tracking, electrocorticography, somatosensory evoked potentials, motor evoked potentials, auditory evoked potentials, visual evoked potentials, EMG, Direct Nerve stimulation/EMG. |
| Patient Protection | "Touch proof" female safety electrode connectors, Insulated ABS plastic patient enclosures, Optical & transformer isolation, Line isolation transformer, Built-in software & hardware start-up diagnostics, Software & hardware shutdown protection, Zero average DC electrical stimulation, Hi, medium & low average stimulation intensity limited, Peak stimulation intensity limited, Hi level electrical stimulator disconnected on fault, Preamplifier DC fault limited to safe current (30uA). | Claimed to incorporate these features. |
Study to prove acceptance criteria:
The study proving the acceptance criteria is not a "study" in the traditional sense of a performance evaluation with statistical metrics. Instead, it is a declaration of substantial equivalence to existing predicate devices (Axon Systems Sentinel-4, Moberg Medical Neurotrac II, Nicolet Viking IV) and adherence to recognized standards. The "study" here is the review process by the FDA based on the submitted 510(k) notification.
The document claims:
- "Based upon the documentation stated above and the safety and effectiveness criteria of the design and development process, validated by testing and quality control procedures, we claim the device to be safe, effective and substantially equivalent to the predicate devices noted."
- "The Epoch 2000 is similar is concept and function to our original product, the Sentinel-4 EEG/EP Intraoperative Monitor (K900482A), a class II device."
- The FDA's decision states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This implies that the "proof" is based on comparing the features, intended use, and technological characteristics of the Epoch 2000 to the established predicate devices, and ensuring compliance with general controls and relevant standards for safety.
The following points refer to aspects of a performance study, which are not relevant or applicable to the provided document's content. The provided text focuses on substantial equivalence for regulatory clearance, not on a performance study of an AI algorithm.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. This document does not describe a performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information not provided. This document does not describe a performance study that required expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. This document does not describe a performance study with an adjudication method.
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
- Information not provided. This document describes a standalone neurological monitoring device, not an AI-assisted human reading system, and therefore no MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided in the context of an algorithm's performance. The device itself is a "standalone" monitoring system, but not in the "algorithm-only" sense typically implied by this question for AI products.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided. No ground truth definition is mentioned as there is no specific performance study outlined. The "ground truth" for regulatory clearance is that the device aligns with the functionality and safety of predicate devices.
8. The sample size for the training set
- Information not provided. This document does not describe an AI training process.
9. How the ground truth for the training set was established
- Information not provided. This document does not describe an AI training process.
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NOV 20 1997
Epoch 2000 Supplementary Information K971819
Appendix H Summary of Safety and Effectiveness
The following is a revised Summary of Safety and Effectiveness with requested items removed:
Summary of Safety and Effectiveness
Voluntary regulatory standards Industry:
Meets or exceeds American Electroencephalograph Society Intraoperative Monitoring guidelines for EEG and evoked response devices.
Electrical:
UL544, IEC 601-1, C22.2 No. 125
Additional patient protection & safety features
"Touch proof" female safety electrode connectors Insulated ABS plastic patient enclosures Optical & transformer isolation Line isolation transformer Built-in software & hardware start-up diagnostics Software & hardware shutdown protection Zero average DC electrical stimulation Hi, medium & low average stimulation intensity limited Peak stimulation intensity limited Hi level electrical stimulator disconnected on fault Preamplifier DC fault limited to safe current (30uA)
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| Type of Monitoring | EquivalentDevice | Predicate Devices | ||
|---|---|---|---|---|
| Axon SystemsEpoch 2000 | Axon SystemsSentinel-4DC# 900482A | MobergMedicalNeurotrac IIDC# K914571 | NicoletViking IVDC# K842956DC# K950270 | |
| Cerebral ischemia | Yes | Yes | Yes | Yes |
| Show changes in EEGdue to neuroactivedrugs | Yes | Yes | Yes | Yes |
| Long term coma | Yes | Yes | Yes | Yes |
| Seizure tracking | Yes | Yes | Yes | |
| Electrocorticography | Yes | Yes | Yes | |
| Somatosensory Evokedpotentials | Yes | Yes | Yes | Yes |
| Motor evoked potentials | Yes | Yes | ||
| Auditory evokedpotentials | Yes | Yes | Yes | Yes |
| Visual evoked potentials | Yes | Yes | Yes | Yes |
| EMG | Yes | Yes | Yes | Yes |
| Direct Nervestimulation/EMG | Yes | Yes | Yes | Yes |
Comparison of Intended Use to Predicate Devices
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Based upon the documentation stated above and the safety and effectiveness criteria of the design and development process, validated by testing and quality control procedures, we claim the device to be safe, effective and substantially equivalent to the predicate devices noted.
The Epoch 2000 is similar is concept and function to our original product, the Sentinel-4 EEG/EP Intraoperative Monitor (K900482A), a class II device. This instrument is also used to monitor brain function and neurological activity utilizing EEG and multiple modality evoked potential techniques. The additional features incorporated in this product are designed to meet the current and expanding demands of health care professionals for more effective ways to monitor the neurological status of their patients without compromising safety or effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 20 1997
Mr. Howard Bailin Vice President, General Manager Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788
K971819 Re : Epoch 2000 Neurological Workstation Trade Name: Requlatory Class: II (two) 84 GWF Product Code: September 9, 1997 Dated: September 10, 1997 Received:
Dear Mr. Bailin:
.. .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
Image /page/3/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three distinct lines. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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Page 2 - Mr. Howard Bailin
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of_ 1_
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Epoch 2000 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide the health care professionals with information to help access a patient's neurological status during surgery or longterm monitoring in the ICU.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971819 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use__ | |
| (Optional Format 1-2-96) |
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).