(512 days)
Fiberion Ophthalmic Endolaser Probes are in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached
Fiberion endolaser probes are designed to be connected to ophthalmic laser photocoagulators and to transmit laser energy inside the patient's eye. One end of the probe contains a connector for attachment to the laser unit, the other, a tip section to be introduced inside the eye. Device components are an input connector, a glass fiber optic protected by a buffer coating, a protective tubing, an aluminum handle with a medical grade stainless steel needle. The illuminating endolaser probe has an additional illumination fiber optic.
This document describes the Fiberion Ophthalmic Endolaser Probe. Below is an anaylsis of its acceptance criteria and the study that proves the device meets the criteria.
Note: The provided document is a 510(k) summary for a medical device (Fiberion Ophthalmic Endolaser Probe). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, or expert evaluations as one might find for an AI/ML-based diagnostic device. Therefore, many of the requested fields cannot be directly answered from this document. The responses below are based on the information available and acknowledge the limitations.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench/Lab Testing) | Reported Device Performance |
|---|---|
| Laser Power Transmission: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Beam Divergence: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Beam Density Homogeneity: Equivalent to predicate device | Found to be equivalent to predicate device. |
| Illumination Intensity (for illuminating models): Equivalent to predicate device | Found to be equivalent to predicate device. |
| Illumination Area Diameter (for illuminating models): Equivalent to predicate device | Found to be equivalent to predicate device. |
| Safe Delivery of Intended Output Power: Verified performance | "Fiberion Ophthalmic Endolaser Probes were tested for safe delivery of the intended output power." |
| Sterility: Fulfil requirements | "Found to fulfil the requirements." |
| Biocompatibility (sections in contact with patient): Fulfil requirements | "Found to fulfil the requirements." |
| EO-ECH Residues: EO |
§ 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.