(25 days)
The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears and detachments:
- retinopathy of prematurity;
- Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
This document describes a 510(k) premarket notification for a modified medical device, the Ellex Integre LP561 ophthalmic laser. The submission aims to demonstrate substantial equivalence to a predicate device, the Ellex Integre Duo LP1RG. As such, it focuses on comparing the modified device to the predicate device and other commercially available equivalents, rather than presenting a standalone study with defined acceptance criteria and performance results in the typical sense for a brand new device.
Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria," does not directly apply in the context of this 510(k) submission. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to the predicate device, especially concerning safety and effectiveness. The "study" proving this is primarily the comparison tables and narrative provided within the 510(k) submission itself, highlighting technological similarities and equivalent intended use.
Here's an attempt to extract and frame the information according to your request, with caveats reflecting the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In a 510(k) for a modified device, the "acceptance criteria" are implicitly the characteristics and performance of the predicate device. The "reported device performance" is the characteristics and expected performance of the modified device, ideally showing it is at least as safe and effective as the predicate.
| Characteristic compared (as "Acceptance Criteria" implicit from Predicate) | Ellex Integre Duo LP1RG (Predicate Performance) | Integre LP561 (New Device Performance) |
|---|---|---|
| Intended Use | Photocoagulation of both anterior and posterior segments of the eye for conditions like diabetic retinopathy, choroidal neovascularization, retinal tears, glaucoma. | Substantially Equivalent (same intended use as the predicate, confirmed with minor rephrasing) |
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) |
| Laser Wavelength | 532 nm (green), 670 nm (red) | 561 nm (yellow) |
| Laser Power | 50-2000 mW (green), 50-1500 mW (red) | 50-1500 mW (yellow) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments |
| Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm |
| Aiming Laser Type | Semi conductor laser diode | Semi conductor laser diode |
| Aiming Laser Power |
§ 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.