(234 days)
The IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cvclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810 laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments |
| Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma | |
| (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy; |
| Transscleral Cyclophotocoagulation | |
| (TSCPC) | |
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation |
| (TSRPC); Focal and Grid Laser | |
| Treatments | |
| Lattice Degeneration | PRP; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | |
| with Choroidal Neovascularization (CNV) | Focal and Grid Laser Treatments |
| Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments |
| Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser |
| Treatments | |
| Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments |
The IQ 810 is a semiconductor diode laser system that delivers infrared 810 nm laser light intended to be used for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. Visible red (630-650 nm) semiconductor diode laser is used for aiming.
The provided document is a 510(k) premarket notification decision letter from the FDA regarding the IRIS Medical® IQ 810 Diode Laser. This type of document establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- No acceptance criteria table or reported device performance is present.
- No sample sizes for test sets, data provenance, or details about the ground truth establishment for a study are provided. This is because no such study is described.
- No information on experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is included.
- No training set details are mentioned.
The document states:
- "Non-Clinical performance Data: None"
- "Clinical performance Data: None"
The substantial equivalence determination is based on the device's technological characteristics and its intended use being similar to predicate devices, namely the IRIDEX Corporation's IRIS Medical OcuLight SLx Laser Photocoagulator (K020374). The letter concludes that the IQ 810 is "substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy."
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.