| Device |
digital amsler grid |
| Regulation Description |
Amsler grid. |
| Definition |
A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients. |
| Physical State |
Digital Amsler Grid may be implemented as a standalone software device or web-based system. The test algorithms are delivered by software, which can run on a dedicated hardware platform or on a standard computer platform such as PC, Tablet, smartphone, etc. The software utilizes a visual display, either a commercially available one or proprietary one. The visual display may be a head-mounted display, a tablet, smartphone, a computer screen, etc. |
| Technical Method |
The device presents an Amsler grid and fixation target on a digital display located at a predetermined distance from the patient. The test distance may be determined by the device. The patient self-administers the test, with or without the aid of an eye care provider, by characterizing the perceived image of the visual stimulus interactively. Based on the patient’s responses, the device provides an assessment of visual perception in the central visual field. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QTW |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
886.1330
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
