Last synced on 25 November 2022 at 11:04 pm

Camera, Ophthalmic, General-Use

Page Type
Product Code
Definition
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
Physical State
PJZ cameras are designed for true color or monochrome imaging in visible spectrum of light and consists of an incoherent light source, image forming lens, aperture, and a sensitive photodetector array (e.g., a CCD array) in the image plane. PJZ excludes cameras that make use of advanced imaging technology (e.g., confocal imaging, adaptive optics, two photon imaging, stroboscopic or scanning illumination). PJZ excludes cameras that feature any special imaging modalities, such as multispectral imaging, fluorescence, autofluorescence, fluorescein angiography, indocyanine green (ICG) angiography, etc. PJZ exclude cameras that designed to contact cornea or any other ocular structure for imaging.
Technical Method
PJZ cameras meet optical performance characteristics stated in the ISO 10940-2009 standard, Ophthalmic instruments— Fundus cameras. PJZ cameras are limited to basic processing of the displayed image (brightness, contrast, white balance) and does not include any advanced software capabilities (e.g., image feature measurements, cup-to-disc ratio analysis, image feature extractions, segmentation, image registration, analysis of oxygen saturation, blood flow velocity) or reference database. Image storage capability should include read-only raw data format. If compressed images are saved, they must be distinguished from and traceable to the raw source image.
Target Area
The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]

Camera, Ophthalmic, General-Use

Page Type
Product Code
Definition
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
Physical State
PJZ cameras are designed for true color or monochrome imaging in visible spectrum of light and consists of an incoherent light source, image forming lens, aperture, and a sensitive photodetector array (e.g., a CCD array) in the image plane. PJZ excludes cameras that make use of advanced imaging technology (e.g., confocal imaging, adaptive optics, two photon imaging, stroboscopic or scanning illumination). PJZ excludes cameras that feature any special imaging modalities, such as multispectral imaging, fluorescence, autofluorescence, fluorescein angiography, indocyanine green (ICG) angiography, etc. PJZ exclude cameras that designed to contact cornea or any other ocular structure for imaging.
Technical Method
PJZ cameras meet optical performance characteristics stated in the ISO 10940-2009 standard, Ophthalmic instruments— Fundus cameras. PJZ cameras are limited to basic processing of the displayed image (brightness, contrast, white balance) and does not include any advanced software capabilities (e.g., image feature measurements, cup-to-disc ratio analysis, image feature extractions, segmentation, image registration, analysis of oxygen saturation, blood flow velocity) or reference database. Image storage capability should include read-only raw data format. If compressed images are saved, they must be distinguished from and traceable to the raw source image.
Target Area
The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]