(188 days)
Not Found
No
The summary describes a device for neurological monitoring using standard techniques (EEG, evoked potentials, EMG) and explicitly states that mentions of AI, DNN, or ML were "Not Found". The description focuses on traditional signal processing and monitoring, similar to predicate devices.
No
The device is described as a monitoring and assessment tool, providing information to healthcare professionals about a patient's neurological status. It does not actively treat or intervene to improve a medical condition.
Yes
Explanation: The Epoch 2000 is intended for "neurological monitoring and assessment" and uses techniques (EEG, evoked potentials, EMG) to "provide the health care professionals with information to help access a patient's neurological status." This aligns with the definition of a diagnostic device, as it provides information for determining a medical condition or state.
No
The device description explicitly states "The instrument uses EEG, evoked potentials and EMG techniques" and refers to it as an "instrument," implying hardware components are involved in acquiring these physiological signals. The comparison to the predicate device, described as an "Intraoperative Monitor," further suggests a hardware-based system.
Based on the provided information, the Epoch 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for neurological monitoring and assessment in the operating room and critical care areas. It uses techniques like EEG, evoked potentials, and EMG to provide information about a patient's neurological status during surgery or long-term monitoring.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description reinforces that the device monitors brain function and neurological activity using electrical signals (EEG, evoked potentials, EMG). This is a direct measurement of physiological activity, not an analysis of a sample taken from the body.
The Epoch 2000 is a device that directly measures and monitors physiological signals from the patient's body, which falls under the category of in vivo diagnostics or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals / operating room and critical care areas (ICU)
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.
K900482A, K914571, K842956, K950270
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
§ 882.1870 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).
0
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)
1
| Type of Monitoring | Equivalent
Device | Predicate Devices | | |
|----------------------------------------------------|----------------------------|-------------------------------------------|--------------------------------------------------|----------------------------------------------------|
| | Axon Systems
Epoch 2000 | Axon Systems
Sentinel-4
DC# 900482A | Moberg
Medical
Neurotrac II
DC# K914571 | Nicolet
Viking IV
DC# K842956
DC# K950270 |
| Cerebral ischemia | Yes | Yes | Yes | Yes |
| Show changes in EEG
due to neuroactive
drugs | Yes | Yes | Yes | Yes |
| Long term coma | Yes | Yes | Yes | Yes |
| Seizure tracking | Yes | Yes | Yes | |
| Electrocorticography | Yes | | Yes | Yes |
| Somatosensory Evoked
potentials | Yes | Yes | Yes | Yes |
| Motor evoked potentials | Yes | | | Yes |
| Auditory evoked
potentials | Yes | Yes | Yes | Yes |
| Visual evoked potentials | Yes | Yes | Yes | Yes |
| EMG | Yes | Yes | Yes | Yes |
| Direct Nerve
stimulation/EMG | Yes | Yes | Yes | Yes |
Comparison of Intended Use to Predicate Devices
2
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.
3
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.
4
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
5
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) |