(78 days)
The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.
The Bausch + Lomb VIS100 Injector System is a sterile, single-use device used to fold and insert an IOL into the human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
The provided document describes a 510(k) submission for the Bausch + Lomb VIS100 Injector System. Here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria:
The Bausch + Lomb VIS100 Injector System is a sterile, single-use device designed to fold and insert an intraocular lens (IOL) into the human eye. The submission aims to demonstrate substantial equivalence to a predicate device (K113852, Bausch + Lomb IOL Injector).
The acceptance criteria for this device primarily revolve around bench testing for mechanical properties and biocompatibility testing. There were no clinical studies performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Mechanical Properties | ISO 11979-3 | Bench testing was performed to determine compliance with ISO 11979-3 (Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods). (Implicitly met standards for substantial equivalence) |
| Biocompatibility | ISO 10993-5 | Biocompatibility testing was performed. The device was found to be biocompatible as per ISO 10993-5 (Biological Evaluation of medical devices – Part 3: Tests for in vitro cytotoxicity). |
| Biocompatibility | ISO 10993-10 | Biocompatibility testing was performed. The device was found to be biocompatible as per ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10 - Tests for Irritation and Skin Sensitization). |
| Sterility | (Implied) | Sterile, Method of Sterilization: Ethylene oxide, Sterility assurance level: 10-6. (Compliant with established medical device sterility standards) |
| Single Use | (Implied) | Single use (Matches predicate device) |
| Shelf Life | (Implied) | 1 month (Compared to predicate's 12 months, this is a difference, but within acceptable limits for substantial equivalence given the context of a sterile, single-use device for a surgical procedure). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the bench testing or biocompatibility testing. It only states that these tests were "performed."
The data provenance is from non-clinical laboratory testing (bench and biocompatibility tests). There is no information about country of origin, and the data is inherently prospective for these types of tests (new tests performed on the device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The ground truth for mechanical and biocompatibility testing is established by adherence to recognized international standards (ISO). There are no "experts" in the context of clinical interpretation or image review for this particular device's submission.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or diagnosis, which were not conducted for this device. The results of the bench and biocompatibility tests are objective measurements against established standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "A clinical study was not performed on the Bausch + Lomb VIS100 Injector System." This type of study is associated with AI-assisted interpretation or diagnostic tools, which this device is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The Bausch + Lomb VIS100 Injector System is a mechanical device for IOL insertion, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established international standards for medical device mechanical properties (ISO 11979-3) and biocompatibility (ISO 10993-5, ISO 10993-10), as well as general medical device requirements for sterility and single-use functionality.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm. Hence, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
§ 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.