(30 days)
The Centurion™ Vision System (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection.
The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal.
The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF. SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Alcon's CENTURION™ Vision System is an ophthalmic surgical instrument designed to provide cataract extraction using the CENTURION™ OZil™handpiece, the CENTURION™ Active Sentry™ handpiece, and the INFINITI™ OZil™ handpiece.
The CENTURION™ Vision System is intended for use in small incision cataract extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the eye, while replacing aspirated fluid and lens material with balanced salt solution (BSS™). This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration vacuum, and the flow of BSS™ irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.
I'm sorry, but the provided text from the FDA 510(k) summary for the Centurion™ Vision System (Active Sentry™) (K233902) does not contain the detailed information required to answer your request.
Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or details about retrospective/prospective studies.
- Information on the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Details about a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This 510(k) summary states that the current submission (K233902) is for a modification to add a new Warning statement in the labeling for the TurboSonics™ ultrasonic tips. It explicitly states that "Non-clinical testing was previously performed in the predicate device and can be referenced in K161794." Therefore, this document focuses on demonstrating substantial equivalence based on the minor labeling change, rather than presenting new performance data from a comprehensive clinical or non-clinical study.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.