(123 days)
Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT).
The Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaģing patients under anesthesia.
The Envisu™ SDOIS is a non-contact, non-invasive and mobile ophthalmic imaging device that can be used to view ocular tissue physiology and pathology through the interaction of light with the optical scattering properties of structures of the eye.
Like its predicate, the Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) is a nearinfrared scanning imaging medical device designed to capture depth-resolved images of ocular tissue microstructure. It is available in "high (HR)" and "very-high (VHR)" resolution based on the SLED light source chosen. Each option includes an optical engine, a scanning head, an interchangeable lens set, a computer and the InVivoVue™ Clinic software for imaging of ocular tissue microstructures. The smaller system footprint and mobile security cart easily accommodate any clinical environment.
The optical engine includes a low power broadband LED light source with bandwidths of 40 - 100 nm operating in the wavelength range between 760 - 930 nm and a spectrometer that detects backscattered radiation. The scanning head is flexibly designed to be used mounted or handheld for the mutual convenience and comfort of patient and ciinician. Handheld use of the light-weight (
The Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (SDOIS) (K120057) did not involve a clinical study to prove its acceptance criteria. Instead, the submission leveraged non-clinical performance and safety data, as well as a review of existing clinical literature, to establish substantial equivalence to a predicate device (K063343).
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this was a 510(k) submission based on substantial equivalence to a predicate device, the "acceptance criteria" were primarily defined by the performance characteristics of the predicate device. The "reported device performance" refers to the Envisu™ SDOIS meeting or exceeding these characteristics, with specific design modifications noted.
| Acceptance Criteria (Predicate SDOIS) | Reported Device Performance (Envisu™ SDOIS) |
|---|---|
| Method of Operation: SD-OCT | Same as predicate |
| Light Source: SLED | Same as predicate |
| Light Source Class: Class 1 LED | HR: Same as predicate; VHR: Class 1 LED |
| Optical Power: |
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.