(139 days)
The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.
The Eclipse Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas.
The Eclipse Neurological Workstation can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols.
The main Eclipse system components include: computer, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Eclipse also provides support for the Nonin XPod pulse oximeter module and high impedance preamplifier module to allow recording from high impedance electrodes.
Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. The electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators. The computer controls the user interface for setting parameters and the display of processed data.
A built-in pulse oximeter provides pulse rate and oxygen saturation measures. Data from external devices, such as vital signs or other physiological monitors, can be imported to the Eclipse display screen, allowing the operator to correlate changes in neurological function with the patient's systemic measurements. In addition, a display window may be opened to observe the surgeon's microscope view or other video input. The Eclipse is network compatible for data review within the hospital and permits secure information access over the Internet.
The provided text is a 510(k) summary for the Eclipse Neurological Workstation. It outlines the device's intended use, classification, and substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text.
The information given primarily focuses on:
- Identifiant: K050798
- Device Name: Eclipse Neurological Workstation / Eclipse Lite Neurological Workstation
- Applicant: Axon Systems, Inc.
- Contact: Howard Bailin
- Common Name: Electroencephalograph (EEG Monitor), Evoked Potential (SEP, BAEP, AEP, VEP, MEP) System, EMG Monitor
- Classification Name: Electroencephalograph, Evoked Response, Electromyograph
- Regulation Numbers: 21 CFR 882.1400, 21 CFR 882.1420, 21 CFR 882.1870, 21 CFR 882.1570, 21 CFR 882.1620, 21 CFR 882.1900
- Product Codes: GWQ, GWS, GWF, GWE, GWJ, CAB
- Predicate Devices: Axon Systems - EpochXP (K032741), Digitimer - D185 (K020400), NuVasive - Neurovision JJB (K032083), Grass Telefactor - AS40 Amplifier (K021807)
- Device Description: Provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit using EEG, EMG, and evoked potential test protocols. It includes a computer, controller, digital preamplifiers, various stimulators, and support for pulse oximetry and external device data import.
- Indications for Use: Intended for use to monitor sensory and motor pathways in the operating room and critical care areas. It uses EEG, EMG, motor and sensory evoked potentials, and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.
- Conclusion: The device is claimed to be safe, effective, and substantially equivalent to the predicate device(s).
To answer your full request, you would need access to the full 510(k) submission, which typically includes detailed performance data, verification, and validation studies.
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15 510(k) Summary AUG 1 5 2005
This 510(k) summary of safety and effectiveness is being submitted in
t and effective and effect of OED 807 00 This 910(K) Summary of Sammary of CFR 807.92.
| Name: | Howard BailinVice President, C.O.O. |
|---|---|
| Address: | Axon Systems, Inc.400-2200 Oser AveHauppauge, NY 11788 |
| Phone: | 631 436 5112 |
| Fax: | 631 436 5141 |
| Email: | hbailin@axonsystems.com |
| Proprietary Name: | Eclipse Neurological WorkstationEclipse Lite Neurological Workstation |
| Common Name: | Electroencephalograph (EEG Monitor), EvokedPotential (SEP, BAEP, AEP, VEP, MEP) System, EMGMonitor |
| Classification Name: | Electroencephalograph, Evoked Response, Electromyograph |
| Classification: | Class II (Performance Standards)Panels: Neurology, AnesthesiologyNumber: 882.1400 Electroencephalograph882.1420 Electroencephalograph (EEG)Signal Spectrum AnalyzerElectromyograph MonitorStimulator, Electrical, Evoked ResponseStimulator, Photic, Evoked ResponseStimulator, Sonic, Evoked ResponseProcodes: GWQ, GWS, GWF, GWE, GWJ, CAB |
| Predicate Devices | Axon Systems - EpochXP (K032741)Digitimer - D185 (K020400)NuVasive - Neurovision JJB (K032083)Grass Telefactor - AS40 Amplifier (K021807) |
| Description: | The Eclipse Neurological Workstation provides continuousmonitoring of brain and neural pathways intraoperatively or inthe intensive care unit. The system has been designed tomeet the requirements for comprehensive neurologicalmonitoring in the operating room and critical care areas.The Eclipse Neurological Workstation can be used to monitorneurological data using either individual or multimodality EEG,EMG and evoked potential test protocols. |
| The main Eclipse system components include: computer,controller, digital preamplifiers, direct nerve, sensory andmotor evoked potential electrical stimulators, stimulatorextension modules, LED goggles and insert earphones. TheEclipse also provides support for the Nonin XPod pulseoximeter module and high impedance preamplifier module toallow recording from high impedance electrodes. | |
| Recording electrodes detect spontaneous or stimulus evokedelectrophysiological activity and are used as inputs to thedigital preamplifier. The electrophysiological signals areamplified, filtered, optically isolated and digitized. Thedigitized data is then routed to the digital signal processor(DSP) located in the Eclipse controller. The DSP processesthe data and controls timing for the electrical, audio and visualstimulators. The computer controls the user interface forsetting parameters and the display of processed data. | |
| A built-in pulse oximeter provides pulse rate and oxygensaturation measures. Data from external devices, such asvital signs or other physiological monitors, can be imported tothe Eclipse display screen, allowing the operator to correlatechanges in neurological function with the patient's systemicmeasurements. In addition, a display window may be openedto observe the surgeon's microscope view or other videoinput. The Eclipse is network compatible for data reviewwithin the hospital and permits secure information access overthe Internet. | |
| Based on the technical information provided in this 510(k) andthe safety and effectiveness criteria of the design anddevelopment process, validated and verified, we claim theEclipse Neurological Workstation to be safe, effective andsubstantially equivalent to the predicate device(s) noted. |
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Public Health Service
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard Bailin Vice President, C.O.O. Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788
Re: K050798
Trade/Device Name: Eclipse Neurological Workstation Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: August 1, 2005 Received: August 2, 2005
Dear Mr. Bailin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty premier is substantially equivalent (for the indications felerenced above and nave develomes and and marketed predicate devices marketed in interstate for use stated in the encrosale) to regars and the Medical Device Amendments, or to commerce prior to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent of the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is olassified (600 wor 70) als. Existing major regulations affecting your device can Inay of subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may oe found in the Our cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a availations administered by other Federal agencies. You must or any i caeral statutes and registents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 607); accems (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.
.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your artial equivalence of your devertire your dever devi premarket nothication. The PDA miding of backand for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2 CFR Part 801), please If you desire specific advice for your accessed on one and the regulation entitled, and contact the Office of Complaned at (210) = i & cation" (21CFR Part 807.97). You may obtain " Misoranung by Icierchee to premainters with the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s C29 AA other general information on your responses Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octable so http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Barbara Buehmd
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Koso798
Indications for Use Statement
| 510(k) Number | K050798 |
|---|---|
| Device Name | Eclipse Neurological Workstation |
| Indications for Use | The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)
.
:
AND/OR Over-The-Counter
Barbara for
(Division Sign-Off) Melkers
Division of General, Restoratio
and Neurological Devices
510(k) Number: K050798
§ 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).