(343 days)
Not Found
No
The description focuses on standard signal processing techniques (noise filtering, artifact rejection, frequency and time domain analysis) and statistical measures, with no mention of AI or ML algorithms.
No
The device is described as an electrophysiological system that generates stimuli and records VEP signals for study and analysis of central visual functions, not for treatment.
Yes
The device is described as generating stimuli and recording, processing, and analyzing signals (VEP) for the study of central visual functions, indicating its use in assessing a physiological state. It also mentions "diagnostic" and "disease" in the context of its predicate devices, further supporting its diagnostic nature.
No
The device description explicitly states it is an "electrophysiological device that generates photic stimuli" and utilizes a "stimulus monitor" and "medical-rated EEG electrodes" (even if not included in the device package, they are integral to the system's function). This indicates the system includes hardware components beyond just software.
Based on the provided information, the Neucodia system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Neucodia system analyzes electrical signals (VEP) generated by the human body in response to stimuli. It's a physiological measurement device, not a device that tests biological samples like blood, urine, or tissue.
- The intended use describes studying central visual functions through electrophysiological measurements. This aligns with in vivo testing (testing within a living organism), not in vitro testing (testing outside of a living organism).
- The device description focuses on presenting stimuli and recording electrical signals from the scalp. This is characteristic of electrophysiological devices like EEG systems, not IVDs.
Therefore, the Neucodia system falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Neucodia system is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions.
Product codes
GWE
Device Description
Visual stimuli are presented to the patient on the stimulus monitor. Visual evoked potentials are extracted from EEG epochs recorded via medical-rated EEG electrodes (not included in the device) attached to the scalp of the patient. Once the recording is complete, the digitized EEG data are processed by the software algorithm for noise filtering, artifact rejection, frequency and time domain analysis. The results are displayed on the user's monitor: EEG epochs, spectrum, Fourier components, and statistical measures (e.g., means, deviations, and signal to noise ratio).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Normal observers, individuals at-risk for visual pathway dysfunction or with confirmed ophthalmic disorders
Intended User / Care Setting
Intended users: Vision researchers, neurologists, eye-care professionals, and trained medical technicians
Site of use: Hospital, clinics, physicians' offices, and research laboratories
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: Clinical testing
Sample size: Not specified
Key results: VEP multi-variable statistics and signal to noise ratio were measured to produce system repeatability and reproducibility. 10 repeated sequential tests were performed on each subject to obtain repeatability performance data. In addition, each subject had three visits for the same repeated tests using different devices and with different operators and reapplication of electrodes to obtain reproducibility performance data. The clinical test results are described in Section 4.2.18, User's Manual and Section 5.2.3, Device Description.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).
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Page 1 of 2
Premarket Notification 510(k) Submission
VeriSci Corp.
04/24/2009
510(k) Summary 2
| Submitter: | VeriSci Corporation
106 Anderson Street
Raritan, New Jersey 08869-1514
Telephone: (908) 725-5213
Fax: (908) 725-4617 MAY 15 2009 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | George Hu, Ph.D.
CEO |
| Trade Name: | Neucodia |
| Classification Name: | Stimulator, Photic, Evoked Response |
| Regulation Number: | 882.1890 |
| Classification Product Code: | GWE |
| Regulatory Class: | II |
Identification of Legally Marketed Predicate Devices 2.1
The Neucodia system is substantially equivalent to Roland Consult's RETI-Port-Scan (K023525) and LACE Elettronica's GLAID Ocular Electrophysiology Device (K043367). The Neucodia device features are substantially equivalent to the predicate devices with respect to the device's general design concept, operational procedure, data processing methodology, data acquisition conditions, and indications for use. All the devices are electrophysiological (EEG) test systems that consist of electrical hardware and software to produce visual stimuli, EEG signal recording and processing for extraction of visual evoked potentials (VEPs). All the devices are intended to be used by trained medical professionals for the study of central visual functions.
2.2 Device Description
Visual stimuli are presented to the patient on the stimulus monitor. Visual evoked potentials are extracted from EEG epochs recorded via medical-rated EEG electrodes (not included in the device) attached to the scalp of the patient. Once the recording is complete, the digitized EEG data are processed by the software algorithm for noise filtering, artifact rejection, frequency and time domain analysis. The results are displayed on the user's monitor: EEG epochs, spectrum, Fourier components, and statistical measures (e.g., means, deviations, and signal to noise ratio).
Indications for Use 2.3
The Neucodia system is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions
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VeriSci Corp.
Page. ② of 2
04/24/2009
Substantial Equivalence 2.4
| Predicate Devices | Submission Device | |||||
|---|---|---|---|---|---|---|
| Product Name | Roland Consult | |||||
| RETI-Port-Scan | ||||||
| (K023525) | LACE Elettronica | |||||
| GLAID Ocular | ||||||
| (K043367). | VeriSci | |||||
| Neucodia | ||||||
| Indications for use | ||||||
| Electrophysiological device that | ||||||
| measures and processes | ||||||
| electroencephalographic signals | ||||||
| elicited by visual stimuli presented | ||||||
| on electronic display for the study | ||||||
| of visual function | Yes | Yes | Yes | |||
| Intended users | ||||||
| Vision researchers, neurologists, | ||||||
| eye-care professionals, and trained | ||||||
| medical technicians | Yes | Yes | Yes | |||
| Intended population | ||||||
| Normal observers, | ||||||
| individuals at-risk for visual | ||||||
| pathway dysfunction or with | ||||||
| confirmed ophthalmic disorders | Yes | Yes | Yes | |||
| Site of use | ||||||
| Hospital, clinics, physicians' | ||||||
| offices, and research laboratories | Yes | Yes | Yes | |||
| Data collected | ||||||
| EEG signals | Yes | Yes | ||||
| Stimuli | ||||||
| Patterns on screen displayed in | ||||||
| periodical functions | Yes | Yes | Yes | |||
| Data processing | ||||||
| Frequency domain and time | ||||||
| domain analysis, statistical | ||||||
| analysis | Yes | Yes | Yes | |||
| Hardware for signal | ||||||
| amplification and AD converting | ||||||
| (Filter bandwidth, sampling rate, | ||||||
| AD converting accuracy, Gain, | ||||||
| CMRR, input impedance, | ||||||
| input/output voltage range) | Yes | Yes | Yes |
Performance and Validation 2.5
Software: Verification and validation
Safety test: UL 60601-1, IEC 60601-2-26, EN60601-1-2, ISO15004-2 System: Bench testing for power supply requirement, amplifier gain and CMRR Clinical testing:
VEP multi-variable statistics and signal to noise ratio were measured to produce system repeatability and reproducibility. 10 repeated sequential tests were performed on each subject to obtain repeatability performance data. In addition, each subject had three visits for the same repeated tests using different devices and with different operators and reapplication of electrodes to obtain reproducibility performance data. The clinical test results are described in Section 4.2.18, User's Manual and Section 5.2.3, Device Description.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
MAY 15 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
VeriSci Corporation % George Hu, Ph.D. 106 Anderson Street Raritan, New Jersey 08869
Re: K081591
Trade/Device Name: NEUCODIA Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Codc: GWE Dated: April 24, 2009 Received: April 29, 2009
Dear Dr. Hu:
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 adulteration.
Please he 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.
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Page 2- George Hu, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark H. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification 510(k) Submission
VeriSci Corp.
04/24/2009
1 Indications for Use
Device Name: NEUCODIA
Indications for Use:
The Neucodia system is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of 1
Orthopedic, Division or Sugies and Restorative D. rices
§10(k) Number K081541
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