(59 days)
Boston Original Cleaner is indicated for use to clean silicone acrylate and fluoro silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston Original Conditioning Solutions is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) of fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Boston Original Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate and silica gel as cleaning agents, titanium dioxide and fragrance.
Boston Original Conditioning Solutions is a sterile, aqueous buffered, solution containing a cellulosic viscosifier, cationic cellulose derivative polymer and polyvinyl alcohol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.006%) and edetate disodium (EDTA) (0.05%).
The provided document is a 510(k) Premarket Notification for Bausch + Lomb Boston Original Cleaner and Boston Original Conditioning Solutions. It focuses on demonstrating the substantial equivalence of a modified regimen for using these existing contact lens care products, specifically replacing a water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution.
Therefore, the acceptance criteria and supporting studies are related to proving the safety and effectiveness of this modified regimen, not a new device.
Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or explicitly stated for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the modified regimen) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Microbiology - Antimicrobial Preservative Efficacy (for discard dating): Meet requirements of ISO 14730, Annex C. | Both Boston Original Cleaner and Boston Original Conditioning Solutions (test articles) met the requirements of ISO 14730, Annex C for antimicrobial preservative efficacy testing and guidance on determining discard date, initially and after simulated use for the proposed 90-day discard dates. |
| Microbiology - Regimen Evaluation: Meet FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products, when used in a 10-second rub, 5-second rinse (per lens side) regimen. Also meet ISO Standard 14729:2001/Amd. 1:2010 (E) for regimen testing. | The modified regimen (replacing tap water with Sensitive Eyes Plus Saline Solution) met the FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance. The products used in this regimen also met the performance criteria established in ISO Standard 14729:2001/Amd. 1:2010 (E) for regimen testing. (Note: Regimen testing was previously reviewed as part of K170483 for Sensitive Eyes Plus Saline Solution.) |
| Biocompatibility: (Implied need to ensure continued biocompatibility of the lens care system) | Biocompatibility tests were deemed "unnecessary for this application" as previous data submitted for K980133 (Boston Original Conditioning Solutions) and P820069 (Boston Original Cleaner) were still applicable. This indicates that the predicate device's biocompatibility was accepted as sufficient for the modified regimen. |
| Lens Compatibility: Ensure the modified regimen is compatible with gas permeable contact lenses. | The results of lens compatibility studies per ISO 11981 demonstrate that replacing water with Bausch + Lomb Sensitive Eyes Plus Saline Solution as part of the regimen is compatible with gas permeable contact lenses. |
| Clinical Data: (Implied need to ensure the modified regimen is safe and effective in vivo) | Clinical studies were "unnecessary for this application." The submission states, "This Cleaner - Conditioning System has been commercially available in the market for almost 20 years with well demonstrated safety and efficacy." This implies that extensive real-world usage of the existing products, coupled with the lab testing on the modified regimen, was sufficient to demonstrate substantial equivalence without new human clinical trials for this specific change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual microbiological and lens compatibility test sets. It refers generally to "studies" and "results."
- Data Provenance: The studies were preclinical (laboratory testing). The specific country of origin for the lab work is not stated, but given it's a US FDA submission for a US-based company, it's likely conducted in the US or by a contracted lab. The studies are prospective for the modified regimen comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this submission. The "ground truth" for these types of tests (microbiology, lens compatibility) is established by adherence to specific, validated international standards (ISO standards) and FDA guidance documents. There isn't a need for expert consensus on individual results in the way there would be for, say, image interpretation in a diagnostic AI device.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." For laboratory tests like those described, the results are quantitative and objective, measured against predefined acceptance criteria from standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human readers (e.g., AI for medical imaging). The submission addresses chemical solutions and their compatibility/efficacy, which are not evaluated through MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the submission is not for an AI/algorithm-based device. The "device" here refers to contact lens cleaning and conditioning solutions.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these solutions is established through:
- Adherence to International Standards (ISO): Specifically ISO 14730 (Antimicrobial preservative efficacy), ISO 14729 (Regimen testing), and ISO 11981 (Lens compatibility).
- Adherence to FDA Guidance Documents: "Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997."
- Validated Laboratory Methods: Results are compared against specific quantitative thresholds defined by these standards and guidance.
- Historical Data: The "almost 20 years" of commercial availability of the existing products with "well demonstrated safety and efficacy" serves as substantial baseline "ground truth" for the system as a whole, negating the need for new clinical trials for a modified rinse step.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set."
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”