(70 days)
The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
Acceptance Criteria and Study for OCULAR SCIENCES BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens
This document describes the acceptance criteria and supporting evidence for the Ocular Sciences BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens, based on the provided 510(k) summary (K984046).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to previously cleared devices and outlining the optical and physical properties of the contact lens. The acceptance criteria are implicitly met by demonstrating these properties are equivalent to the predicate devices and conform to regulatory guidelines for daily wear contact lenses, particularly regarding UV blocking.
| Acceptance Criteria Category | Specific Criteria/Performance Goal | Reported Device Performance | Study/Evidence Provided |
|---|---|---|---|
| Material Equivalence | Substantially equivalent to predicate device material (ocufilcon D) | The BIOMEDICS 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4, and K972303. | Comparison to predicate devices (K942214, P890023/S26, P890023/S4, K972303). |
| Optical Properties | Equivalence of physical, optical, and chemical properties to clear and tinted versions of BIOMEDICS 55 (ocufilcon D) ocufilcon D cast molded contact lenses. | The subject contact lens is equivalent and has the same characteristics and properties as the clear BIOMEDICS® 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26. | Comparison to predicate devices (K942214, P890023/S26). |
| Indication for Use | Daily wear for myopic, hyperopic, or astigmatic conditions, with specific power ranges. | Indicated for daily wear in normal eyes (myopic, hyperopic, or astigmatic) in powers from -20.00 to +20.00 Diopters and astigmatic corrections from -0.25 to -10.00 Diopters. | Stated indications for use in the 510(k) summary. |
| UV Blocking | UV transmittance profile comparable to or better than predicate devices and relevant human ocular structures. | Demonstrated typical transmittance profiles for Ocufilcon D Hydrophilic Contact Lens with UV, including comparison to human cornea and crystalline lens. | Graphs showing UV transmittance curves (pages 3, 4, 5). |
| Lens Group Classification | Classified within FDA's Lens Group IV (high water ionic group). | This lens is in the Lens Group IV high water ionic group as established by the FDA. | Statement in the 510(k) summary, referencing FDA guidance. |
| Manufacturing Process | Approval for cast molding process. | The cast molding process was approved under P890023/S4. | Reference to predicate device (P890023/S4). |
| Disinfection Regimen | Compatible with chemical disinfection. | The lens may be disinfected only with a chemical disinfection regimen. | Stated in the Indications for Use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly describe a separate "test set" in the context of a clinical trial or algorithm evaluation with a specific sample size. The primary evidence presented is a comparison to predicate devices and specifications, along with transmittance curves.
- Sample Size: Not applicable in the context of a traditional test set for performance evaluation. The data provenance for the transmittance curves is not specified (e.g., how many lenses were tested to generate the "typical" profiles).
- Data Provenance: The document does not specify the country of origin for any specific data, nor whether it is retrospective or prospective. The human cornea and lens data used for comparison in the transmittance graphs are from "24-year-old" and "25-year-old" individuals, respectively, without further detail on their origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided in the context of this 510(k) summary. The summary focuses on manufacturing processes, material equivalence, and physical/optical properties, not on diagnostic accuracy tasks that would require expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no description of a test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document is for a medical device (contact lens) and does not involve human readers evaluating cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the claims in this submission is established through:
- Predicate Device Equivalence: The primary method for establishing that the new device meets acceptance criteria is by demonstrating its substantial equivalence in materials, manufacturing processes, and intended use to previously cleared devices. The "truth" here is built upon the regulatory acceptance of those predicate devices.
- Physical and Chemical Properties Measurement: Laboratory measurements of properties like hydrogel composition, water content, oxygen permeability (implied by material group), and UV transmittance.
- Regulatory Grouping: Classification within FDA's established Lens Group IV.
No clinical outcomes data or pathology results are presented as ground truth for this 510(k) in the usual sense of a diagnostic device.
8. The Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a contact lens, not an AI/ML algorithm that requires a training set.
§ 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.