(106 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on basic measurement and analysis of eye movements.
No.
This device is intended to provide information to assist in the diagnosis of vestibular disorders by measuring and analyzing nystagmus of the eye, but it provides no diagnoses nor does it provide diagnostic recommendations, and it is not described as providing treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "This device provides no diagnoses nor does it provide diagnostic recommendations."
No
The device description explicitly states it is an "Eye Tracking Device" that facilitates measurement of eye and head movements and is used in combination with "appropriate stimulus generators (rotating or translating devices, visual displays)". This indicates the device includes hardware components beyond just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye." This aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens, including human specimens, to provide information concerning a physiological or pathological state. While the device measures eye movements (which are in vivo), the analysis of these measurements to provide information for diagnosis falls under the scope of IVD.
- Purpose: The device's purpose is to provide data (nystagmus measurements) that is used by qualified medical personnel to assist in the diagnosis of a medical condition (vestibular disorders). This is a key characteristic of an IVD.
- Predicate Devices: The listed predicate devices (Micromedical Technologies Video Eye Monitor, SensoMotoric Instruments 2D VOG-Video-Oculography, Fall Prevention Technologies BalanceBack VNG, DDAT (UK) DDAT OMT, Eye Dynamics House IR/VNG) are all devices used for similar purposes (measuring eye movements for vestibular assessment) and are typically regulated as IVDs.
While the device itself is an instrument that interacts with the patient (in vivo), the output of the device (the measured and analyzed nystagmus data) is used in vitro by the medical professional to assist in making a diagnosis. This is a common characteristic of devices that are considered IVDs even if they have an in vivo component.
Therefore, the Chronos Vision Eye Tracking Device (C-ETD) fits the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Product codes
GWN
Device Description
The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions.
The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of nystagmographs.
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)
Testing was provided which verified system performance using an artificial eye model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964325, K972243, K042529, K050098, K925111
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).
0
K06 2015
Page ① of 2
510(k) Summary for the Chronos Vision Eye Tracking Device (C-ETD)
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Chronos Vision
Wiesenweg 9
12247 Berlin
Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OCT 31 2006 |
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | October 12, 2006 |
| Names | |
Device Name:
Chronos Vision Eye Tracking Device (C-ETD)
Classification Name:
Nystagmograph Product Code: GWN
3. Predicate Devices
The Chronos Vision Eye Tracking Device (C-ETD) is substantially equivalent to a combination of the following devices: Micromedical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IR/VNG (K925111).
4. Device Description
The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions.
The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
1
Page 2 of 2
5. Indications for Use
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
6. Performance Data
..
Testing was provided which verified system performance using an artificial eye model.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
O'Connell Regulatory Consultants, Inc % Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
OCT 3 1 2006
Re: K062015
Trade/Device Name: Chronos Vision Eye Tracking Device (C-ETD) Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 12, 2006 Received: October 13, 2006
Dear Ms. O'Connell:
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.
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.
3
Page 2 - Maureen O'Connell
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.
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K062015
Device Name: ___Chronos Vision Eye Tracking Device (C-ETD) ___________________________________________________________________________________________________________________
Indications for Use:
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, storing, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General,
and Neurological Devices
| 510(k) Number | K062015 | Page 1 of 1 |
|---|---|---|
| --------------- | --------- | ------------- |