(316 days)
Not Found
No
The summary describes a hardware-based system for measuring eye movements using infrared light and laser projectors. It mentions a "saccade detection algorithm" but provides no indication that this algorithm utilizes AI or ML techniques. The performance studies focus on traditional metrics like linearity, resolution, and reliability, not metrics typically associated with AI/ML performance (e.g., AUC, sensitivity/specificity on a large dataset). There is no mention of training or test sets in the context of model development, which is characteristic of AI/ML.
No
The device measures temporal characteristics of saccadic refixation responses and identifies individual time delays of eye movements, indicating it is a diagnostic or measurement tool, not a therapeutic device.
Yes
The device measures temporal characteristics of saccadic refixation responses and identifies individual time delays of eye movements, which are physiological parameters used to assess neurological function. The intended use of "measuring temporal characteristics of saccadic refixation responses" and "identifying the individual time delays of moving the eyes toward the stimuli" points to gathering information about the body's functional state, which is indicative of a diagnostic device.
No
The device description explicitly states that the system is composed of "proprietary hardware and firmware," an "examination control unit," an "eye movement sensor with integrated miniature laser spot projectors," and an "optical fiber to USB data transmitter," in addition to the software application. This indicates the device includes significant hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Saccadometer system measures eye movements in response to visual stimuli. It does this by analyzing infrared light reflected from the eye orbit. This is a measurement of a physiological response in vivo (within the living body), not an examination of a specimen in vitro (outside the living body).
- Intended Use: The intended use is to measure temporal characteristics of saccadic refixation responses and identify time delays of eye movements. This is a functional assessment of the oculomotor system, not a diagnostic test performed on a biological sample.
- Device Description: The description details hardware that interacts with the eye and head, not equipment for analyzing biological specimens.
- Input Modality: The input modality is infrared light reflected from the eye, not a biological sample.
Therefore, the Saccadometer system, as described, falls outside the definition of an In Vitro Diagnostic device. It is a device that measures a physiological function directly from the patient.
N/A
Intended Use / Indications for Use
Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
Product codes (comma separated list FDA assigned to the subject device)
HLL
Device Description
The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution
§ 886.1510 Eye movement monitor.
(a)
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with a stylized wing-like shape extending from the top profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
Ober Consulting Sp. Z.o.o. Mr. Jan Krzysztof Ober Brzechwy 6, 60-195 Poznan Poland
Re: K152890 Trade/Device Name: Saccadometer Plus and Saccadometer Advanced Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: July 8, 2016 Received: July 11, 2016
Dear Mr. Ober:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152890
Device Name Trade / family name: Saccadometer model name: Plus, Advanced
Indications for Use (Describe)
Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
06 July 2016
I. SUBMITTER
Submitter's contact: Mr. Jan Krzysztof Ober Submitter's name: Ober Consulting sp. z o.o. Submitter address and contact data: Brzechwy 6, 60-195 Poznan Poland +48 505940787 info@ober-consulting.com
II. DEVICE
There is no prior submission for the device. The assigned 510(k) number is K152890/S001.
Proprietary name: Saccadometer Plus, Saccadometer Advanced
Common or usual name: Saccadometer
Classification name: EYE MOVEMENT MONITOR (21 CFR 886.1510)
Classification code: HLL
III. PREDICATE DEVICE
Permobil Meditech, Ober2, K902954
VI. DEVICE DESCRIPTION
The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution