(334 days)
AMO brand Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product as recommended by your eye care practitioner to:
- Chemically (NOT HEAT) Disinfect ●
- Clean ●
- Rinse ●
- Store
- Remove Protein ●
- Condition
AMO Brand Multi-Purpose Disinfecting Solution is a sterile and buffered aqueous solution containing disinfectants / preservatives, buffers, a surfactant, a chelating agent, other ancillary agents, and purified water. The solution is packaged in tamper-resistant multi-dose plastic bottles with controlled dropper tips.
Here's an analysis of the provided text, outlining the acceptance criteria and the studies that prove the device meets them:
Acceptance Criteria and Device Performance for AMO Brand Multi-Purpose Disinfecting Solution
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical and clinical studies conducted to demonstrate the safety and effectiveness of the AMO Brand Multi-Purpose Disinfecting Solution. The acceptance criteria are largely implied by the successful outcomes ("meets requirements," "compatible," "equivalent," "well tolerated," "not cytotoxic," "no ocular irritation").
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Solution Compatibility | Compatibility with various soft contact lenses, including silicone hydrogel lenses. | Demonstrated product is compatible with soft contact lenses, including silicone hydrogel lenses (Groups 1, 4, and four representative silicone hydrogel lenses). Tests primarily followed FDA Guidelines, Premarket Notification (510(k)) Guidance Documents for Contact Lens Care Products, May 1, 1997. |
| Protein Removal | Ability to passively and effectively remove lysozyme protein from contact lens surfaces, comparable to the predicate device. | Demonstrated ability to passively and effectively remove protein from soft (hydrophilic) contact lenses, including silicone hydrogels, comparable to the predicate device. |
| Wettability | Equivalent wettability, conditioning, and moisturizing of soft contact lenses (including silicone hydrogels) compared to the predicate device. | Demonstrated equivalence to Opti-Free® RepleniSH® in soft (hydrophilic) contact lens, including silicone hydrogels, wettability, conditioning, and moisturizing (based on contact angle measurements). |
| Microbiological Efficacy | Meets current FDA requirements for disinfection against bacteria, yeast, and mold at low shelf specifications. Meets USP sterility test requirements. | Product meets current FDA requirements for disinfection of contact lenses against bacteria, yeast, and mold at low shelf specifications for the disinfectant/preservative system. Formulated with dual-disinfection technology. Meets USP sterility test requirements. All tests used solution at low shelf specifications. |
| Stability | Remains stable for the labeled shelf-life. | Accelerated testing indicates the solution will remain stable for the labeled shelf-life. |
| Biocompatibility | - Not cytotoxic to mouse fibroblasts. |
- No dermal sensitization reactions.
- No 1-day acute ocular irritation in rabbits.
- Well-tolerated in 22-day ocular safety studies with contact lenses in rabbits.
- No acute oral toxicity in rats.
- Less cytotoxic with pre-soaked contact lenses compared to predicate. | - Neither cytotoxic to mouse fibroblasts cells after 24 hours (for test formulation and predicate).
- No dermal reactions from either test or control in sensitization study.
- 1-day acute ocular irritation study in rabbits demonstrated no ocular irritation.
- Treatment was well tolerated in rabbits over 22 days (with PureVision™ or Acuvue® 2 lenses).
- Neither caused an adverse effect when administered to rats in a single oral dose.
- Overall results showed MPDS 9608X was less cytotoxic than the predicate device (with pre-soaked contact lenses). Tests followed FDA Guidance (1997) and Pre-IDE 1080487 (2008). |
| Clinical Safety & Performance | Safe and effective for soft contact lens wearers, including silicone hydrogel. Comparable to predicate in patient acceptability, lens wearing comfort, and corneal staining. | Demonstrated to be safe and effective for soft (hydrophilic) contact lenses, including currently marketed silicone hydrogel lenses. Comparable to the predicate device in terms of patient acceptability, lens wearing comfort, and corneal staining (PureVision™ lenses). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for most non-clinical tests.
- Solution Compatibility: Tested with "conventional Group 1 and Group 4 soft (hydrophilic) contact lenses" and "four (4) representative marketed silicone hydrogel lenses."
- Protein Removal: Tested using AMO Brand MPDS and the predicate device.
- Wettability: Tested using "four (4) representative silicone hydrogel contact lenses and FDA Group IV contact lenses."
- Microbiological Studies:
- Disinfection: Evaluation against "bacteria, yeast, and mold." The specific number of organisms or replicates is not stated.
- Sterility: No specific sample size given for USP test.
- Biocompatibility:
- Cytotoxicity: Mouse fibroblasts (number not specified).
- Sensitization: Dermal reactions (number of subjects/animals not specified).
- Ocular Irritation: Rabbits (number not specified, but typically 3-6 per group for acute irritation).
- 22-day Ocular Safety: Rabbits (number not specified, but uses "control" and "test formulation" with two lens types: PureVision™ or Acuvue® 2).
- Acute Oral Toxicity: Rats (number not specified).
- Cytotoxicity with pre-soaked contact lenses: Mouse fibroblasts (number not specified).
- Clinical Trials:
- Multi-center clinical trial: "Soft contact lenses, including silicone hydrogel lens wearers." No specific number of participants.
- Single-center clinical trial: Used "PureVision™ lenses at specified time points over a period of four days." No specific number of participants.
Data Provenance: The studies appear to be prospective as they were conducted to test the specific device for regulatory submission. The country of origin is not explicitly stated for the test data, but the submitter (Abbott Medical Optics) is based in Santa Ana, CA, USA, and the submission is to the US FDA, implying the studies were conducted to US regulatory standards, likely within the US or by internationally recognized laboratories.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. For laboratory-based non-clinical studies, "ground truth" is typically established by laboratory standards and protocols, not expert consensus in the same way it would be for clinical image interpretation. Clinical trials would involve ophthalmologists or optometrists for evaluations (e.g., corneal staining, adverse events), but their specific qualifications and number are not detailed.
4. Adjudication Method
This information is not applicable to most of the non-clinical tests described (e.g., microbiological, chemical analysis, animal studies) where results are quantitative or based on defined criteria. For the clinical trials, the document does not specify any adjudication method (e.g., 2+1, 3+1) for participant observations or outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices. The AMO Brand Multi-Purpose Disinfecting Solution is a contact lens care product, not a diagnostic imaging device.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This concept is also primarily relevant for AI/ML-based diagnostic devices. The device described is a chemical solution; its "performance" is assessed through its physical, chemical, and biological interactions, not by an algorithm's output.
7. Type of Ground Truth Used
The "ground truth" for the various tests was established through:
- Laboratory Standards and Protocols:
- Microbiological: Quantitative measurements of microbial kill (against specific bacteria, yeast, mold) as per FDA guidelines and USP for sterility.
- Chemical/Physical: Measurement of protein removal, contact angles for wettability, stability metrics.
- Biocompatibility: Observation of cytotoxicity, dermal reactions, ocular irritation, oral toxicity in animal models against defined endpoints (e.g., cell viability, irritation scale).
- Clinical Observations: For the clinical trials, the "ground truth" for safety and performance (e.g., patient acceptability, comfort, corneal staining, adverse events) would be based on direct patient feedback and objective examinations by trained healthcare professionals (e.g., ophthalmologists, optometrists).
8. Sample Size for the Training Set
Not applicable. The device is a chemical solution, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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.”