(90 days)
The Infinit® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
- The AutoSert ™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, as well as approved AcrySof lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.
This is a 510(k) premarket notification for the Infiniti® Vision System. As such, it reports on non-clinical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study with acceptance criteria for a new device's performance.
Therefore, many of the requested categories regarding clinical study design and performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this 510(k) summary.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a non-clinical submission focused on substantial equivalence to existing predicate devices, the "acceptance criteria" are compliance with established medical device standards and demonstrating that the new features do not negatively impact safety or effectiveness. The "reported device performance" is essentially that the device meets these standards and maintains equivalent functionality.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Functional Standards | Device complies with applicable requirements of numerous standards, including: |
- ISO 11135-1:2007 (Sterilization)
- BS EN ISO 11979-3:2006 (Intraocular Lenses Mechanical Properties)
- EN ISO 14971:2007 (Risk Management)
- IEC 60601-1 (General Safety of Medical Electrical Equipment)
- IEC 60601 series (Collateral and Particular Requirements for Medical Electrical Equipment and Ophthalmic Devices)
- BioCompatibility Standards (ISO 10993 series) |
| Material Biocompatibility | Biocompatibility evaluations of patient fluid path materials performed to ISO 10993 standards (Parts 1, 5, 10, 11, 12). |
| Sterilization Efficacy | EtO sterilization process for sterile accessories validated per ISO 11135-1:2007. |
| Reprocessing Instructions | Validated reprocessing instructions (cleaning, sterilization, re-use) provided for reusable handpieces. |
| Manufacturing and Design Control | Developed and manufactured in compliance with 21 CFR 820 (Quality System Regulation) and ISO 14971:2007 (Risk Management). |
| Functional Equivalence | Non-clinical testing demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate device. Technological characteristics affecting clinical performance are similar to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This 510(k) relies on non-clinical testing against established standards and comparison to predicate devices, not on a clinical test set with human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the sense of expert consensus on patient data, is not part of this type of submission. The "ground truth" for non-clinical testing relates to objective measurements against standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication of findings is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a surgical system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware/software medical device used by a human surgeon, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical testing, the "ground truth" is defined by engineering specifications, recognized national and international standards (e.g., ISO, IEC), and established predicate device performance. For biocompatibility, it's the results of standardized biological tests. For sterilization, it's the validation against the specified sterilization cycle.
8. The sample size for the training set:
- Not Applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a dataset for training an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI model is described.
§ 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.