(166 days)
MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.
The provided text is a 510(k) summary for the Vortex Surgical MAXReach Laser Probe. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information related to software-driven device performance, clinical study acceptance criteria, or a study proving device performance against such criteria.
The document primarily focuses on:
- Regulatory information: 510(k) number, regulation details, classification, and general controls.
- Device description: Physical characteristics, materials, and compatibility with laser systems.
- Comparison to a predicate device: Highlighting similarities in indications for use, intended use, wavelength, optical fiber, and other technical characteristics.
- Non-clinical bench testing: This testing involved laser output, laser spot size, laser compatibility, ophthalmic cannula interface, and handle actuation testing. The conclusion states these tests indicate the device operates similarly to the predicate and is safe and effective.
- Risk management: Compliance with ISO 14971.
- Biocompatibility, sterilization, and shelf-life testing.
Therefore, I cannot provide the requested table of acceptance criteria and study details because the provided text does not describe a study proving the device meets acceptance criteria. The document focuses on showing substantial equivalence to a predicate device through engineering and bench testing, not through a clinical performance study with human subjects, which would typically involve the type of acceptance criteria and study design elements you've asked about.
The "study" referenced in the text is "Non-Clinical Bench Testing," which is distinct from a clinical study assessing reader performance.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.