(54 days)
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (referred to as PeroxiClear) is a sterile, buffered solution containing 3% hydrogen peroxide (which contains a phosphonic acid stabilizer), potassium chloride, propylene glycol, carbamide (urea), a citrate/phosphate buffer system, and a poloxamer (P-181) surfactant. The sterile solution is aseptically filled and packaged in ethylene oxide (EtO) sterilized plastic bottles with a tamper-evident seal and labeled with a lot number and expiration date. A special lens case, containing a platinum-coated neutralizing disc, is provided with each bottle of PeroxiClear. This is the same lens case as provided with the previously cleared device.
The solution and lens case combined are considered a lens care system. As with the previously cleared device, the solution requires the use of the provided lens case specifically designed for neutralization of the peroxide and cannot be used in combination with any other lens case. The system is designed to clean and disinfect contact lenses by filling solution into the provided lens case and allowing the lenses to soak for a minimum of four hours. During the soaking period, the hydrogen peroxide is neutralized by a platinum-coated disc, thereby allowing the lenses to be safely inserted in the eye.
The provided submission describes a contact lens cleaning and disinfecting solution, not an AI/ML-driven device. Therefore, many of the requested criteria, such as number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness through non-clinical testing.
Here's an analysis of the provided information, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The relevant acceptance criteria are based on microbiological requirements for contact lens care products. The "device performance" refers to the solution meeting these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| EN ISO 14729:2001/AMD.1:2010(E) Microbiological requirements (Disinfection) | Met (demonstrated through non-clinical testing) |
| EN ISO 147302000(E) Antimicrobial preservative efficacy | Met (demonstrated through non-clinical testing) |
| Stability studies | Met (demonstrated through non-clinical testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for the microbiological and stability testing. Standardized tests (like ISO 14729 and 14730) typically involve specific numbers of microbial samples and product batches.
- Data Provenance: The studies were non-clinical (laboratory-based) tests, not involving human subjects or real-world patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the studies are non-clinical (microbiological and stability testing) against established scientific standards. The "ground truth" is defined by the performance criteria outlined in the ISO standards, not by expert consensus on clinical images or data.
4. Adjudication Method for the Test Set
Not applicable, as the tests are objective laboratory measurements against predefined microbial reduction and preservative efficacy standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. This submission is for a contact lens cleaning solution.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a chemical solution, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical studies is defined by established scientific standards and accepted microbiological performance criteria as set forth in the EN ISO standards (14729 and 14730). For stability studies, the ground truth would be the maintenance of the product's chemical and physical properties over time within specified limits.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system and does not involve training data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Study Demonstrating Acceptance Criteria:
The study demonstrating the device meets acceptance criteria was a series of non-clinical laboratory studies, specifically:
- Microbiological testing performed according to EN ISO 14729:2001/AMD.1:2010(E), which outlines ophthalmic optics standards for contact lens care product microbiological requirements and test methods for hygienic management of contact lenses. This would assess its disinfection efficacy against specified microorganisms.
- Antimicrobial preservative efficacy testing performed according to EN ISO 147302000(E), which provides guidance on determining discard dates and ensures the solution remains effective over its shelf-life.
- Stability studies to confirm the product's physical and chemical integrity and efficacy over its intended shelf life.
The submission states that "The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device." This implies that the device successfully met the performance thresholds set by these international standards, thus confirming its safety and effectiveness for its intended use.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”