(41 days)
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than -2.00 diopters that does not interfere with visual acuity.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses may be prescribed for daily wear. The eye-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting systems.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):
- plano to -10.00D Asphere .
- . with center thickness from 0.025mm to 0.40mm
- . with base curves of 8.00mm to 9.20mm
- . with diameter of 12.00mm to 18.00mm
The lens material is the same as the one BIOMEDICS® UV described in submission PMA890023/S4 and S7, K982947, K984046, K012425.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum cage thickness and This front optical surface allows for correction of visual acuity in non-aphakic persons with noncontour. diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.
The provided text describes a 510(k) Premarket Notification for the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens. This notification seeks to establish substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through clinical studies of the proposed device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional acceptance criteria and device performance as measured in a clinical study for a de novo device, this submission relies on demonstrating substantial equivalence to predicate devices by comparing various characteristics.
| Characteristic | Predicate Device (BIOMEDICS® UV Sphere) Reported Performance | Subject Device (BIOMEDICS® UV Asphere) Reported Performance | Substantial Equivalence Basis |
|---|---|---|---|
| Production Method | Cast molded process | Cast molded process | Same |
| Intended Use | Extended and daily wear, Correction of ametropia | Daily wear, Correction of ametropia (With added UV protection statement) | Similar (adjusted wear time, added UV protection) |
| Material (ocufilcon D) | 55% water content | 55% water content | Same |
| Material Type | Group IV | Group IV | Same |
| Color additive | Vat Blue 6 Dye, CFR 130-20-1 | Vat Blue 6 Dye, CFR 130-20-1 | Same |
| UV additive | Yes | Yes | Same |
| Dk/Harmonic thickness (Minus powers -10.00 to -0.25D) | $15.9 \times 10^{-9}$ | $15.9 \times 10^{-9}$ | Same |
| Dk/Harmonic thickness (Plus powers Plano to +8.00D) | $12.2 \times 10^{-9}$ | $12.2 \times 10^{-9}$ | Same |
| Oxygen transmissibility (-3.00D) | $18.8 \times 10^{-9}$ | $19.5 \times 10^{-9}$ | Similar (within expected range) |
| Light transmittance (Tv, % @ 20°C, 380-780nm) | 97.8% (Labeled: >95%) | 98.2% (Labeled: >95%) | Meets or exceeds predicate's labeled spec |
| Base Curve, mm (-3.00 D) | Measured: 8.61 (Labeled: 8.60) | Measured: 8.59 (Labeled: 8.60) | Similar |
| Diameter, mm (-3.00 D) | Measured: 14.19 (Labeled: 14.20) | Measured: 14.20 (Labeled: 14.20) | Similar |
| Power, D (Predicate BIOMEDICS® UV Sphere, -3.00 D) | Measured: -1.37 (Labeled: -1.50) | Measured: -1.64 (Labeled: -1.75) | Similar (different lens powers for comparison, but demonstrating equivalence in design/manufacturing) |
| Power, D (Predicate FREQUENCY Asphere, -3.00 D) | Measured: -1.44 (Labeled: -1.75) | Measured: -1.68 (Labeled: -1.75) | Similar (different lens powers for comparison, but demonstrating equivalence in design/manufacturing) |
The acceptance criteria for this 510(k) submission are not defined as specific clinical thresholds, but rather the demonstration of substantial equivalence to legally marketed predicate devices in terms of material, design, physical, chemical, and optical properties, and intended use, such that it does not raise new questions of safety or effectiveness. The reported device performance is explicitly compared against the predicate devices to support this claim.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "It was determined that Clinical Studies were not warranted in order to establish the safety and efficacy of the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses."
Therefore, there is no test set of human subjects to report a sample size for, nor any data provenance related to clinical testing. The assessment is based on non-clinical studies including manufacturing information, finished lens parameters, physicochemical properties, and labeling information, with reference to previous PMA/510(k) submissions for the predicate devices. These are laboratory/manufacturing data, not data derived from human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical studies were performed on the subject device, there was no "ground truth" derived from expert assessment of patient outcomes or conditions for the subject device. The ground truth for the predicate devices (BIOMEDICS® UV Sphere and Frequency 55 Asphere) would have been established during their respective approval processes (PMA890023/S4, S7, K982947, K984046, K012425, K000384), but this information is not provided for the current submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies with a test set of human subjects were conducted for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical studies were performed, and thus no MRMC study comparing human readers with or without AI assistance was conducted. This device is a contact lens, not an AI diagnostic tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a contact lens, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this submission is effectively the established safety and efficacy profiles and characteristic specifications of the identified predicate devices, as confirmed by their previous regulatory approvals (PMAs and 510(k)s). This relies on:
- Physical and chemical property measurements.
- Manufacturing process consistency.
- Toxicology data (referenced from predicate device submissions).
- Microbiology data (referenced from predicate device submissions).
- Previous clinical data that supported the predicate devices (though details aren't included here).
8. Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI system that requires a "training set." The data provided are related to manufacturing characteristics and comparisons to predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a contact lens, not an AI system.
§ 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.