(27 days)
DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes.
DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES® lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution.
Here's a breakdown of the acceptance criteria and study information for the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens, based on the provided document:
This document is a 510(k) Summary of Safety and Effectiveness for a "parametric release" of the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens. It's crucial to understand that a parametric release means the device itself is not new, but rather a change in the sterilization release criteria is being submitted. Therefore, the "study" described focuses on validating the sterilization process, not the clinical performance of the contact lens.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Sterilization) | Reported Device Performance (Sterilization) |
|---|---|
| Sterilization cycle: chamber temperature of 121 to 124°C for 45 consecutive minutes, with chamber pressure of 2.6 ± 0.2 bar. | A successful sterilization cycle includes these parameters. (Note: This is the description of the validated process, which by definition "meets" the criteria if the process is followed). |
| Deliver sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival. | The sterilization cycle is "based on an overkill approach, delivering sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival regardless of the number and heat resistance of the naturally occurring microorganisms." |
| Typical Sterility Assurance Level (SAL) obtained during validation study. | Consistently greater than 10⁻³². |
| Production bioburden levels (pre-sterilization). | Consistently below both 1000 vegetative CFU and 20 spore forming CFU over a 4-month period. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set for device performance. Instead, it focuses on the sterilization process.
- Test Set Description: The "test set" in this context refers to the samples used to validate the sterilization process and monitor bioburden.
- Sample Size (Sterilization Validation): Not explicitly stated in terms of a number of devices. The validation is described as an "overkill approach" implying robust testing. The SAL of 10⁻³² is a result of extensive validation.
- Sample Size (Bioburden Monitoring): "Results obtained from measurement of product bioburden over a 4-month period" suggests continuous monitoring, but a specific number of samples taken during this period is not provided.
- Data Provenance: The document is from CIBA Vision Corporation, located in Duluth, GA, USA. The data would therefore be assumed to be from their manufacturing facilities. The nature of the data is prospective for both initial sterilization validation and ongoing bioburden monitoring.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. There is no human expert "ground truth" involved in evaluating the performance of the sterilization process; it's based on objective physical measurements and microbiological assays. The "ground truth" is established by adherence to microbiological sterility standards.
4. Adjudication Method for the Test Set
Not applicable. There's no subjective assessment requiring adjudication in the context of sterilization validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a material/process change related to sterilization, not an assessment of the clinical effectiveness or diagnostic performance of the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (contact lens) and a manufacturing process (sterilization), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is:
- Sterilization Validation: Microbiological testing (e.g., spore strips, lethality calculations) demonstrating the destruction of a specified number of microorganisms, and physical monitoring of autoclave parameters (temperature, pressure, time). The target microbial reduction (12-log) and probability of survival (10⁻⁶) are established industry standards for sterility.
- Bioburden Monitoring: Direct measurement of CFU (colony-forming units) of vegetative and spore-forming bacteria from product samples. This is a direct, objective microbiological measurement.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the validation of a manufacturing process against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML device. For the sterilization validation, the ground truth is established by:
- Engineering principles and scientific validation protocols for steam sterilization processes.
- Microbiological testing, often involving inoculation of representative product with a known challenge organism and subsequent culturing to demonstrate inactivation.
- Adherence to regulatory standards and guidance (e.g., from FDA, ISO) for sterile medical devices.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.