(77 days)
COMPLETE® brand Lubricating and Rewetting Drops are indicated to lubricate and rewet soft (hydrophilic) contact lenses during lens wear.
COMPLETE® brand Lubricating and Rewetting Drops are used to lubricate and rewet soft (hydrophilic) contact lenses before application and during lens wear.
COMPLETE® brand Lubricating and Rewetting Drops are a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand Lubricating and Rewetting Drops contain no chlorhexidine or thimerosal and no other mercury containing ingredients. Both current and reformulated products are clear, colorless solutions packaged in plastic bottles with controlled dropper tips.
The provided 510(k) summary for "COMPLETE® brand Lubricating and Rewetting Drops" does not include a detailed table of acceptance criteria with specific quantitative thresholds or a singular study explicitly designed to "prove" the device meets these criteria in the typical sense of a diagnostic device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (the existing formulation of the product and other contact lens multi-purpose, lubricating and rewetting solutions) through a series of non-clinical and limited clinical studies. The "acceptance criteria" are implied by the successful outcomes of these tests, showing the new formulation is as safe and effective as the predicate.
Here's a breakdown of the information based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, a formal table of quantitative acceptance criteria is not present in the provided text. The "acceptance criteria" are implicitly met when the device performs comparably or better than the predicate/controls in various safety and effectiveness tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Microbiological Safety: | |
| - Preservative Effectiveness (USP Modified criteria) | Meets USP Modified criteria for Preservative Effectiveness. |
| - Sterility (USP Sterility test requirements) | Meets USP Sterility test requirements. |
| Toxicology/Biocompatibility: | |
| - Cytotoxicity (Cell damage assessment) | Neutral Red Retention Assay: New COMPLETE® exhibited better neutral red retention than benzalkonium chloride (BAK) and at least comparable to ReNu MultiPlus. Indicates potentially less damaging to cells than old COMPLETE® after 3 hours. |
| CHO Clonal Growth Assay: New COMPLETE® showed significantly better survival rate of Chinese hamster ovary cells than old COMPLETE® and ReNu MultiPlus. Higher relative survival than negative control. Indicates potentially less damaging to eye cells. | |
| - Sensitization (Allergic reaction potential) | No dermal reactions observed in test or control groups in a guinea pig maximization test, indicating comparability to the marketed formulation. |
| - Acute Oral Toxicity (Systemic toxicity from ingestion) | No treatment-related effects or deaths, and no adverse effects when administered to rats at a single oral dose of 20 mL/kg. |
| - Ocular Safety (Irritation, long-term eye health with use) | In a 28-day rabbit study (4X/day instillations, 8 hours/day lens wear): No clinically significant ocular discomfort, conjunctival irritation, changes in corneal thickness, conjunctival/uveal/corneal abnormalities, or apparent ocular changes. Histopathological exams revealed no treatment-related changes. Concluded as "safe for use with hydrophilic contact lenses". |
| Clinical Performance (Indirect for Lubricating Drops): | |
| - Safety (Adverse events, ocular findings during lens wear) | No adverse device effects reported. No statistically significant differences in clinically significant slit lamp findings. Statistically significant differences in maximum severity grades for injection and tarsal anomaly, with more severe findings in the predicate (COMPLETE® MPS) group than the investigational group. Other safety variables similar. |
| - Acceptability (Patient comfort/symptoms) | Statistically significant difference with higher maximum severity score for symptoms of discomfort in the Investigational MPS group. However, overall incidence of symptoms was low and not regimen-related, thus not clinically relevant. No statistically significant difference in the number of examinations with clinically significant ocular symptoms of discomfort. Unremarkable findings for other variables. |
| Equivalence to Predicate | The safety, efficacy, and performance of the Investigational product is substantially equivalent to the approved formulation currently on the market. |
| Stability (Expiration Date Establishment) | Stability testing using the protocol approved in K981168 will be completed prior to marketing. (This is a future action, not a completed criterion at the time of submission, but indicates a planned acceptance criterion). |
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical/Toxicology Studies:
- Cytotoxicity: Not specified, but involved comparisons between new COMPLETE®, old COMPLETE®, ReNu MultiPlus, and BAK.
- Sensitization: 25 female Hartley guinea pigs.
- Acute Oral Toxicity: 40 (20 male and 20 female) CD albino rats.
- 28-Day Ocular Safety Study: 12 female New Zealand white rabbits.
- Clinical Study (referenced from K981168, used for multi-purpose solution):
- Total subjects: 124
- Investigational MPS group: 62 (2 disqualified, leaving 60 evaluable)
- Control (COMPLETE® MPS) group: 62 evaluable
- Data Provenance: The animal studies were conducted in rabbits, guinea pigs, and rats. The clinical study was conducted with human subjects. The country of origin is not specified but implicitly in the USA as it's an FDA submission. The clinical study was prospective, as it involved enrolling subjects and following them. The animal studies are also implicitly prospective evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" establishing a ground truth in the context of diagnostic performance for this device. This product is a lens care solution, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for safety and performance comes from direct observation (e.g., ocular irritation, cell survival, animal health) and clinical findings by investigators.
4. Adjudication Method for the Test Set
Not applicable. This is not a diagnostic device with ambiguous readings requiring adjudication. Clinical observations and measurements were performed and analyzed statistically.
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 is not a diagnostic device or an AI-assisted interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not a software algorithm; it's a physical product (liquid solution).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on a combination of:
- Microbiological assays: Meeting established USP modified criteria and test requirements.
- Cell cultures: Direct observation of cell survival and neutral red retention.
- Animal models: Direct observation of dermal reactions, survival rates, detailed ocular examinations (pachometry, slit lamp, ophthalmoscopy), and histopathological evaluations. These are considered direct evidence of physiological response to the product.
- Clinical observations: Direct observation of adverse events, slit lamp findings, and patient-reported symptoms of discomfort by clinical investigators. These are considered outcomes data relevant to the product's safe use and patient acceptability.
8. The Sample Size for the Training Set
Not applicable. This product does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this 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.”