(74 days)
Selecta 1064: photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
Selecta SLT: selective laser trabeculoplasty
Selecta Duo: photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and selective laser trabeculoplasty
The Selecta 1064, Selecta SLT and Selecta Duo Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically, An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
LaserLink S: laser delivery system for use by an ophthalmologist in the treatment of ocular tissue; laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd: YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp.
The Family of Selecta Ophthalmic Lasers, Delivery Device and Accessories consists of the following models:
- Selecta 1064° a Nd: YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-350um in the posterior direction by the physician relative to this convergence of the twin aiming beams.
- Selecta SLT® -- a Nd: YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens.
- Selecta Duo a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
For each Selecta model, the physician controls delivery of laser energy from the Selecta remote control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp delivery adaptor, the LaserLink S, may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation.
The provided text is a 510(k) summary for the Lumenis Family of Selecta Ophthalmic Laser Systems, Delivery Device and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that demonstrates the device meets these criteria in the format specified.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or details about training sets.
- Information on the number or qualifications of experts used to establish ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
Instead, the submission states:
- Rationale for Substantial Equivalence: The primary argument is that the device has "the same intended uses and indications for use as the predicate devices, and have similar technological characteristics as the predicate devices - treatment wavelength, laser media, mode of operation, energy output, pulse duration, pulse settings, spot sizes, aiming beam, cooling system, laser energy delivery control (footswitch/ handswitch), and delivery system." (Section VI)
- Performance Data: "System and software hazard analysis information, software verification and validation information, and clinical literature were submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical characteristics between the Family of Selecta Ophthalmic Laser Systems, Delivery Device and Accessories and the predicate laser systems and the evaluation of the performance data." (Section VII)
This indicates that the performance data submitted was likely focused on technical specifications and safety analyses to demonstrate equivalence, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria for diagnostic or treatment accuracy.
§ 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.