(89 days)
The Odyssey Optical Systems S2LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
The S-LO is a medical imaging device utilizing three Class I lasers of different wavelengths (532 nm, 670 nm and 810 nm). Illumination from these lasers can be used independently or collectively to diagnose and monitor diseases and disorders of the posterior pole of the eye. The device operates on a 12 volt power supply and produces 0.8 mW/cm2 of retinal illumination. The non-invasive, non-contact S2LO allows imaging of the posterior segment of the human eye. High resolution images of the posterior segment of the eye can be captured, printed, stored electronically or transmitted for referral purposes.
The provided text (K981640) for the Odyssey Optical Systems S2LO does not contain information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document is a 510(k) summary and subsequent FDA clearance letter for a medical imaging device (Scanning Laser Ophthalmoscope). The core of this submission is a claim of substantial equivalence to legally marketed predicate devices, rather than a demonstration of meeting specific performance acceptance criteria through a new study.
Here's why the requested information cannot be provided from this document:
- No Acceptance Criteria or Performance Study: The document explicitly states: "Performance Data: None. The specifications and indications for use of the Odyssey Optical Systems S-LO are the same or very similar to those of the claimed predicate devices. The Odyssey Optical Systems ScLO has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."
- Substantial Equivalence Pathway: The 510(k) pathway is primarily for demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often relies on comparing technical specifications and intended use, rather than conducting new performance studies that necessitate detailed acceptance criteria and study designs.
Therefore, since no performance study demonstrating the device meets acceptance criteria was conducted or reported in this 510(k) submission, the requested table and study details cannot be filled.
§ 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.