(89 days)
The Boston® Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.
The Boston® Liquid Enzymatic Cleaner is a sterile, aqueous, buffered solution containing proteolytic enzyme (subtilisin) as the cleaning agent, and glycerol. Preservative-free.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
Please note: This document is from 1997 and refers to guidance documents from that era. Modern regulatory submissions often have more detailed and quantitative acceptance criteria and study reporting.
Acceptance Criteria and Device Performance Study for Boston® Liquid Enzymatic Cleaner
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the acceptance criteria are largely implicit in the types of tests performed and the statement of "acceptable" or "substantially equivalent" results. Specific numerical performance targets are not explicitly stated in this high-level summary, which is common for 510(k) submissions of this vintage.
| Criterium Category | Acceptance Criteria (Implicit from Testing) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Toxicology: Must not be toxic or ocular irritant. | "The results of these tests demonstrate that the product and packaging components are not toxic." |
| Microbiology - Sterility: Must be sterile. | Studies demonstrated sterility. | |
| Microbiology - Biostatic Efficacy: Must demonstrate acceptable biostatic activity against specified microorganisms over time (up to 98+ days, with rechallenge). | "The biostatic activity of Boston® Liquid Enzymatic Cleaner was determined..." (Implies success as no negative findings reported). | |
| Microbiology - Disinfection Efficacy: Must meet disinfection efficacy requirements for a combination product. | "The results from these tests support that the product has acceptable antimicrobial activity." | |
| Lens/Solution Compatibility: Must be compatible with specified contact lens materials. | "The results of these tests demonstrate the compatibility of the proposed regimens with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses." | |
| Performance/Efficacy | In-Vitro Cleaning: Must demonstrate cleaning efficacy substantially equivalent to the predicate device. | "The results of these tests demonstrate that the cleaning efficacy of the product is substantially equivalent to the predicate device." |
| Clinical Safety & Efficacy: Must be substantially equivalent in safety and efficacy to the predicate device in human use. | "The clinical study used to support this premarket notification was carried out to determine that the...Boston® Liquid Enzymatic Cleaner is substantially equivalent in safety and efficacy when compared to the currently marketed Alcon OPTI-ZYME Enzymatic Cleaner..." | |
| Shelf Life | Must establish appropriate expiration dating based on stability testing. | Expiration dating was established. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set:
- Total Patients: 103 (206 eyes)
- Boston® Liquid Enzymatic Cleaner Group: 69 patients (64 eyes)
- Alcon OPTI-ZYME® Enzymatic Cleaner Group (Predicate): 32 patients (64 eyes)
- Completed Study: 95 subjects
- Discontinued: 12 subjects (none due to adverse reactions)
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically prospective and often multi-site within the US. The six investigational sites suggest a prospective, multi-center US study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number or qualifications of experts for establishing ground truth in the clinical study. It is a comparative study, implying that the clinical outcomes observed by the investigators (e.g., visual acuity, irritation) would be the "ground truth" for safety and efficacy comparison, rather than an independent expert panel interpreting data.
4. Adjudication Method for the Test Set
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study data or endpoints. Clinical studies for device approval rely on the observations and assessments of the participating investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, this was not an MRMC study. MRMC studies are typically used when multiple human readers interpret diagnostic images or data, and the device is an AI-powered diagnostic aid. This device is a contact lens cleaning solution, so an MRMC study design is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No, this concept (standalone algorithm performance) is not applicable to this medical device. This is a physical product (liquid cleaner) that is used by patients (human-in-the-loop activity, though not AI-assisted).
7. The Type of Ground Truth Used
- For the Clinical Study: The "ground truth" was established through direct clinical observation and patient outcomes as assessed by the investigators over a three-month period. This would include parameters like visual acuity, ocular irritation, lens condition, and patient subjective experiences, compared between the investigational and predicate device groups.
- For Pre-Clinical Studies:
- Toxicology: In vitro (cell culture reactivity) and in vivo (rabbit ocular irritation) tests with established biological reactivity and irritation scales/observations.
- Microbiology: Direct colony counting (cfu/mL) for biostatic and disinfection efficacy against specific challenge organisms, with defined reduction criteria.
- In-Vitro Cleaning: Protein level determination (likely quantitative protein assays on lenses) and Image Analysis to compare cleaning efficacy.
- Sterility, Shelf Life, Compatibility: Laboratory testing with defined pass/fail criteria based on accepted standards (e.g., USP).
8. The Sample Size for the Training Set
- This is not applicable as 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
- As mentioned above, this is not applicable for this type of medical 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.”