(138 days)
The Bausch & Lomb™ Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.
The Bausch & Lomb, Inc. Sterile Single-Use I/A Handpieces are accessories to the Bausch & Lomb, Inc. Stellaris Vision Enhancement System and the Bausch & Lomb, Inc. PREMIERE (Millennium) Microsurgical System. Both irrigation and aspiration functions are incorporated within one molded plastic handle, and operate simultaneously at a balanced rate to irrigate, maintain proper anterior chamber depth during a procedure, and remove cortical lens material, viscoelastic, and excess BSS used to bathe the anterior chamber. This combination feature allows access through a single incision, thus reducing trauma to the eye and improving surgical control. The Bausch & Lomb, Inc. family of Sterile Single-Use I/A Handpieces (containing the new plastic hand-held handle) currently consists of the models identified in Table 2.
This document is a 510(k) Summary Statement for Bausch & Lomb Sterile Single-Use I/A Handpieces. It describes the device and its intended use, and importantly, details the testing conducted to demonstrate its safety and performance for FDA clearance through substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Sterilization | Validated to a SAL of 10⁻⁶ for ophthalmic organisms (ANSI/AAMI/ISO TR13409) | All tests were conducted on three separate lots of product manufactured at different times. The results indicated that all outcomes were within expected and acceptable limits of the tests. |
| Stability | Seal Integrity Test (dye penetration of radiated product) | The results indicated that all outcomes were within expected and acceptable limits of the tests. |
| Microbial Barrier Test (after accelerated aging at one and five years) | The results indicated that all outcomes were within expected and acceptable limits of the tests. | |
| Biocompatibility | Cytotoxicity (DIN EN ISO 10993-5-12, ISO 9363-1) | The results indicated that all outcomes were within expected and acceptable limits of the tests. |
| Bioburden determination (DIN EN 1174, ISO 11737-1, USP 25 [61]) | The results indicated that all outcomes were within expected and acceptable limits of the tests. | |
| LAL Endotoxin Test (DAB 1999 V.2, USP 25 [85], EP 2001, FDA Guideline) | The results indicated that all outcomes were within expected and acceptable limits of the tests. | |
| Particle Test (USP 25 [788]) | The results indicated that all outcomes were within expected and acceptable limits of the tests. | |
| Functional Performance | Device design control requirements | Performance testing was conducted on the devices and their components... and found to meet requirements set forth in the design control plan. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: For sterilization, stability, and biocompatibility testing, the document states, "All tests were conducted on three separate lots of product manufactured at different times." This indicates a sample size of at least three product lots. For Verification and Validation Testing, the sample size is not explicitly stated but implies testing of "devices and their components."
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be retrospective, as it describes tests conducted on manufactured products to demonstrate compliance with standards. There is no mention of prospective studies or clinical trials with human subjects for this 510(k) submission.
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)
This 510(k) submission describes testing of medical devices against established international and national standards (e.g., ISO, AAMI, DIN, USP, FDA Guidelines). The "ground truth" here is defined by these scientifically recognized and validated standards and their specified acceptable limits, not by expert consensus on specific cases. Therefore, there were no "experts" in the sense of clinical reviewers establishing ground truth for a test set in this context. The experts involved would be the professionals who developed these standards and the qualified laboratory personnel who conducted the tests according to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation of data where adjudication methods (like 2+1 radiologists) would be used. The performance is assessed against quantitative and qualitative benchmarks defined by the referenced standards.
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 submission is for a physical medical device (I/A handpieces) and not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As this is not an AI algorithm, the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is defined by established international and national standards and their pre-defined acceptable limits and specifications. For instance:
- Sterilization: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ as per ANSI/AAMI/ISO TR13409.
- Biocompatibility: Results were within "expected and acceptable limits" of tests like cytotoxicity, bioburden, LAL Endotoxin, and particle tests, all governed by specific ISO, DIN, USP, or FDA guidelines.
- Functional Performance: Met "requirements set forth in the design control plan."
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.