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subpart-b—diagnostic-devices/
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Strabismus Detection Device

Page Type
Product Code
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
Physical State
Hardware components are integrated in a housing (e.g., plastic enclosure), which includes the image acquisition optics, the system computer and visual display. User input is limited to only basic device function, such as: “Background” button for background measurements and “Measure” button to perform the measurement of the patient. Device output is conveyed to the operator through LED indicator lights on the surface of the instrument. The device is designed as a non-contact device and is AC powered.
Technical Method
Includes a laser diode (Scanning Laser) that emits a beam of polarized laser light onto the retina based on the principle of retinal birefringence scanning (birefringent nerve fibers that surround the fovea change the polarization state of reflected light). A separate laser diode (Rangefinder light) assists the operator to determine the correct distance of the device from the patient. The patient fixates on a fixation target LED. Photo sensors detect the polarization characteristics of reflected laser light from the fovea. A software algorithm is used to determine whether central fixation is present in both eyes (“Not Refer”), or in only one eye (“Refer”).
Target Area
The target area is the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1342
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
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CFR § 886.1342 Strabismus detection device

§ 886.1342 Strabismus detection device.

(a) Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination).

(2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated:

(i) Verification of lowest detectable amount of deviation; and

(ii) Validation of the accuracy and precision at the lowest detectable amount of deviation.

(3) Software verification, validation, and hazard analysis must be performed.

(4) Optical radiation safety testing must demonstrate the device is safe per the directions for use.

(5) Performance testing must demonstrate the electromagnetic compatibility of the device.

(6) Performance testing must demonstrate the electrical safety of the device.

(7) Labeling must include the following:

(i) Summaries of non-clinical and clinical performance testing;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanation of all user-interface components; and

(iv) Information related to electromagnetic compatibility and optical radiation classification.

[81 FR 65280, Sept. 22, 2016]

FDA Browser

by Innolitics

OP/
subpart-b—diagnostic-devices/
PMW
View Source

Strabismus Detection Device

Page Type
Product Code
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
Physical State
Hardware components are integrated in a housing (e.g., plastic enclosure), which includes the image acquisition optics, the system computer and visual display. User input is limited to only basic device function, such as: “Background” button for background measurements and “Measure” button to perform the measurement of the patient. Device output is conveyed to the operator through LED indicator lights on the surface of the instrument. The device is designed as a non-contact device and is AC powered.
Technical Method
Includes a laser diode (Scanning Laser) that emits a beam of polarized laser light onto the retina based on the principle of retinal birefringence scanning (birefringent nerve fibers that surround the fovea change the polarization state of reflected light). A separate laser diode (Rangefinder light) assists the operator to determine the correct distance of the device from the patient. The patient fixates on a fixation target LED. Photo sensors detect the polarization characteristics of reflected laser light from the fovea. A software algorithm is used to determine whether central fixation is present in both eyes (“Not Refer”), or in only one eye (“Refer”).
Target Area
The target area is the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1342
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
View Source

CFR § 886.1342 Strabismus detection device

§ 886.1342 Strabismus detection device.

(a) Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination).

(2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated:

(i) Verification of lowest detectable amount of deviation; and

(ii) Validation of the accuracy and precision at the lowest detectable amount of deviation.

(3) Software verification, validation, and hazard analysis must be performed.

(4) Optical radiation safety testing must demonstrate the device is safe per the directions for use.

(5) Performance testing must demonstrate the electromagnetic compatibility of the device.

(6) Performance testing must demonstrate the electrical safety of the device.

(7) Labeling must include the following:

(i) Summaries of non-clinical and clinical performance testing;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanation of all user-interface components; and

(iv) Information related to electromagnetic compatibility and optical radiation classification.

[81 FR 65280, Sept. 22, 2016]