(142 days)
Not Found
No
The document describes standard signal processing and data display, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used to monitor sensory and motor pathways and to provide information on blood flow, which helps guide surgery and assess a patient's neurological and vascular status; it does not directly treat or alleviate a condition.
Yes
The device is intended to "provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status," which implies providing information to make a diagnosis or inform diagnostic decisions.
No
The device description explicitly lists multiple hardware components including a computer, internal or external Doppler, controller, digital preamplifiers, stimulators, LED goggles, insert earphones, and support for external modules like a pulse oximeter. This indicates it is a hardware-based system with accompanying software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 Function: The described device monitors physiological signals (EEG, EMG, evoked potentials, nerve potentials) and uses Doppler analysis to assess blood flow. These are all measurements taken directly from the patient's body using external sensors and probes.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient.
Therefore, the device falls under the category of a medical device used for physiological monitoring and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The systems are intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GWS, GWF, GWE, GWJ, IKN, IYN, ITX
Device Description
The Eclipse Neurological Workstation with TCD and vascular Description: Doppler, Eclipse TCD Neurovascular Workstation and CardioMon (The Systems) provide continuous monitoring of brain and neural pathways and intracranial and extracranial vascular blood flow 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 Systems can be used to monitor neurological and vascular data using either individual or multimodality EEG, EMG, evoked potential and Doppler test protocols.
The Systems main components include: computer, internal or external Doppler, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Systems also provide support for the Nonin XPod pulse oximeter module and a high impedance preamplifier module to allow recording from micro electrodes.
Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. 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. The computer also provides the hardware and software Doppler interface.
The TCD and vascular Doppler provide blood flow information using a spectral display and audible Doppler signal.
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 systems display screen, allowing the operator to correlate changes in neurological function with systemic changes.
In addition, a display window may be opened to observe the surgeon's microscope view or other video inputs. The systems are network compatible for data review within the hospital and permits secure information access over the Internet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed Doppler, Ultrasonic
Anatomical Site
Brain, neural pathways, intracranial and extracranial vascular arteries
Indicated Patient Age Range
Adults
Intended User / Care Setting
Health care professionals. Operating room and critical care areas.
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)
The Systems were tested functionally using accepted laboratory test procedures.
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.
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
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1
11. 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.
| Summary Date: | June 6, 2006 | |||||
|---|---|---|---|---|---|---|
| Submitter's | ||||||
| Information: | Howard Bailin | |||||
| Vice President, C.O.O. | ||||||
| Axon Systems, Inc. | ||||||
| 400-2200 Oser Ave | ||||||
| Hauppauge, NY 11788 | ||||||
| P: 631 436 5112 | ||||||
| F: 631 436 5141 | ||||||
| hbailin@axonsystems.com | NOV | 1 2006 | ||||
| Trade Names: | Eclipse TCD Neurovascular Workstation | |||||
| Eclipse Neurological Workstation with TCD and vascular Doppler | ||||||
| CardioMon | ||||||
| Common Name: | Electroencephalograph (EEG Monitor), Evoked Potential | |||||
| (SEP, BAEP, AEP, VEP, MEP) System, EMG Monitor, | ||||||
| Transcranial and Vascular Doppler, Diagnostic | ||||||
| Ultrasound Transducer | ||||||
| Classification | ||||||
| Name: | Electroencephalograph, Evoked Response, Electromyograph, | |||||
| System, Imaging, Pulsed Doppler, Ultrasonic, Diagnostic | ||||||
| Ultrasound Transducer | ||||||
| Classification: | Class II (Performance Standards) | |||||
| Panels: | Neurology, Physical Medicine, Radiology | |||||
| Number: | 882.1400 | Electroencephalograph | ||||
| 882.1420 | Electroencephalograph (EEG) Signal | |||||
| Spectrum Analyzer | ||||||
| 890.1375 | Electromyograph | |||||
| 882.1870 | Stimulator, Electrical, Evoked | |||||
| Response | ||||||
| 882.1890 | Stimulator, Photic, Evoked Response | |||||
| 882.1900 | Stimulator, Auditory, Evoked | |||||
| Response | ||||||
| 892.1550 | System, Imaging, Pulsed Doppler, | |||||
| Ultrasonic | ||||||
| 892.1570 | Diagnostic Ultrasound Transducer | |||||
| Procodes: | GWQ, GWS, GWF, GWE, GWJ, IKN, IYN, ITX |
1
Image /page/1/Picture/0 description: The image shows a black and white abstract drawing. The drawing appears to be a signature or some type of symbol. The lines are thick and dark, and they overlap each other in a chaotic manner.
Image /page/1/Picture/1 description: The image shows the logo for Axon Systems. The logo is in a sans-serif font and is in all caps. Above the logo, the text "Page 2 of 3" is handwritten. The number 2 is circled.
- Predicate Devices Axon Systems - Eclipse Neurological Workstation (K050798) Multigon Industries – 500P Pocket Transcranial and Vascular Doppler Spectrum Analyzer (K051739)
- The Eclipse Neurological Workstation with TCD and vascular Description: Doppler, Eclipse TCD Neurovascular Workstation and CardioMon (The Systems) provide continuous monitoring of brain and neural pathways and intracranial and extracranial vascular blood flow 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 Systems can be used to monitor neurological and vascular data using either individual or multimodality EEG, EMG, evoked potential and Doppler test protocols.
The Systems main components include: computer, internal or external Doppler, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Systems also provide support for the Nonin XPod pulse oximeter module and a high impedance preamplifier module to allow recording from micro electrodes.
Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. 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. The computer also provides the hardware and software Doppler interface.
The TCD and vascular Doppler provide blood flow information using a spectral display and audible Doppler signal.
A built-in pulse oximeter provides pulse rate and oxygen saturation measures.
2
Image /page/2/Picture/0 description: The image shows the logo for Axon Systems. The logo is in black and white and features the word "AXON" in large, stylized letters. Below the word "AXON" is the word "SYSTEMS" in smaller letters. At the top left of the image, the text "Page 3 of 13" is written in cursive.
Data from external devices, such as vital signs or other physiological monitors, can be imported to the systems display screen, allowing the operator to correlate changes in neurological function with systemic changes.
In addition, a display window may be opened to observe the surgeon's microscope view or other video inputs. The systems are network compatible for data review within the hospital and permits secure information access over the Internet.
The Systems were tested functionally using accepted laboratory test procedures.
Technologically, The Systems are similar to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Axon Systems, Inc. % Mr. Howard Bailin Vice President 400-2200 Oser Avenue Hauppauge, New York 11788
NOV 1 2006
Re: K061639
Trade/Device Name: Eclipse TCD Neurovascular Workstation Eclipse Neurological Workstation with TCD and Vascular Doppler CardioMon Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF, IYN Dated: October 16, 2006 Received: October 17, 2006
Dear Mr. Bailin:
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 application (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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
4
Page 2 – Mr. Howard Bailin
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Melkerson
Dep D. Diederich
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number | K061639 |
|---|---|
| Device Name | Eclipse TCD Neurovascular Workstation |
| Eclipse Neurological Workstation with TCD and Vascular Doppler | |
| CardioMon | |
| Indications | |
| for Use | The systems are intended for use to monitor sensory and motor |
| pathways and to provide information to determine the state of blood | |
| flow in the intracranial and extracranial vascular arteries in adults. | |
| The instrument uses electroencephalography (EEG), | |
| electromyography (EMG), motor and sensory evoked potentials | |
| and nerve potentials and Doppler analysis. Transcranial stimulation | |
| techniques for motor evoked potentials are used to assess for | |
| acute dysfunction in axonal conduction of the corticospinal tract. | |
| The system is used in the operating room and critical care areas to | |
| provide health care professionals with information to guide surgery | |
| and to assess a patient's neurological and vascular status. |
Doppler analysis is not to be used for Obstetrics.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Division Sign-Off)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061639