(81 days)
The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge, Injector. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
The Lenstec Injector System for Tetraflex™ Intraocular Lenses (K050638) is a Class I medical device, and as such, clinical tests were not required for its premarket notification. The device's approval was based on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and shared technological characteristics.
Therefore, the following information, typically found in a clinical study report proving device performance against acceptance criteria, is not available or applicable for this submission:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance study results
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Instead, the submission focused on non-clinical aspects and established substantial equivalence based on:
- Technological Characteristics: The device consists of a reusable titanium injector and single-use polypropylene cartridges. The submission details the nominal incision sizes and power ranges of the Tetraflex™ intraocular lenses used with the system.
- Biocompatibility: All contact materials were tested for biocompatibility.
- System Testing: The Lenstec Injector System was tested with Tetraflex™ intraocular lenses to ensure compatibility and functionality.
- Comparison to Predicate Devices: The Lenstec Injector System was deemed substantially equivalent to the Medicel MultiJect Injector for IOLs and MicroGlide Cartridge (K040837) and the STAAR Surgical Foam Tip™ Injector System (K980696) in terms of safety and efficacy.
In summary, for K050638:
- Acceptance Criteria & Device Performance: Not explicitly detailed as clinical performance metrics. The implicit acceptance criteria were that the device performs its intended function (inserting IOLs) safely and effectively, as demonstrated through non-clinical testing and comparison to predicate devices.
- Study Type: Non-clinical tests, primarily biocompatibility and functional testing with the intended IOLs.
- Clinical Studies: "Not required" as explicitly stated in the submission.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.