(69 days)
BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Biomedics® UV Colors Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with ultraviolet absorbing additive (benzophenone based) and marketed in four colors: Blue, Green, Hazel and Grey in the power range of -20.00 to +10.00 diopters for sphere, with center thickness from 0.025mm to.40mm, with base curves of 8.00mm to 9.20mm, with diameter of 12.00mm to 15.00mm.
The lenses are made by affixing a color pigment on the front surface of the lens, which corresponds to the iris. The colored pigments consist of Iron Oxide (Black, Russet & Yellow), Titanium Dioxide (White), Cartozole The colored piginents consist of from Onle (Green), Chromium Oxide (Green). All colored additives used are listed in 21 CFR 73 subpart D and 74 subpart D.
This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/S4 and S7, 510(K) K984046.
The provided text is a 510(k) Premarket Notification for the BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. As such, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the traditional sense of a performance study for a new medical device.
Instead, the submission aims to show that the new device (BIOMEDICS® UV Colors) is as safe and effective as already legally marketed devices. This is done by comparing its characteristics and performance to those of the predicate devices.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size) are not applicable or not explicitly detailed in the provided document, as a head-to-head clinical performance study against pre-defined acceptance criteria for a novel device is not the primary objective of this type of submission.
However, I can extract information related to the comparisons made to establish substantial equivalence, which serves a similar purpose to demonstrating "meeting acceptance criteria" in the context of a 510(k).
Here's a breakdown based on the provided text, addressing the applicable points:
1. Table of "Acceptance Criteria" (Predicate Device Metrics) and Reported Device Performance
In the context of a 510(k) for substantial equivalence, the "acceptance criteria" are effectively the characteristics and performance of the predicate devices. The "reported device performance" is how the new device compares to these predicates.
| Characteristic Comparison | Predicate Device: BIOMEDICS® UV Sphere (ocufilcon D) (Where applicable) | Predicate Device: FRESHLOOK Colorblends (phere (Hydrophilic) (Where applicable for colored lens aspects) | Subject Device: BIOMEDICS® UV Colors (ocufilcon D) |
|---|---|---|---|
| Material | ocufilcon D (Group IV) | Phemfilcon A | ocufilcon D (Group IV) |
| Production Method | Cast molded process | Cast molded | Cast molded process |
| Intended Use | Extended and Daily wear, Correction of ametropia | Extended and Daily Wear | Daily wear, Correction of ametropia, Enhance/alter eye color, UV protection |
| Color Additive | Vat Blue 6 Dye (for tint) | Iron Oxides, Titanium Dioxide, Copper Phthalocyanine Blue/Green, Chrome Oxide, Carbazole Violet | Iron Oxides, Titanium Dioxide, Copper Phthalocyanine Blue/Green, Chrome Oxide, Carbazole Violet |
| UV Additive | Yes | Not specified, but UV blocking for predicate BIOMEDICS® UV | Yes |
| Water Content % @ 20°C (Labeled) | 55 | Not specified | 55 |
| Water Content % @ 20°C (Measured) | 54.1 | Not specified | 53.8 |
| Refractive Index @ 20°C (Labeled) | 1.41 | Not specified | 1.41 |
| Refractive Index @ 20°C (Measured) | 1.405 | Not specified | 1.405 |
| Dk permeability, ISO 9913-1 @ 35°C x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) (Labeled) | 19.6 | Not specified | 19.6 |
| Dk permeability, ISO 9913-1 @ 35°C x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) (Measured) | 17.4 | Not specified | 17.4 |
| Elongation at break, % @ 20°C (Measured) | 80 | Not specified | 80 |
| Mechanical strength, Mpa @ 20°C (Measured) | 0.52 | Not specified | 0.52 |
| Light transmittance, Tv, % @ 20°C (Labeled) | 97% | Not specified | 97% |
| Light transmittance, Tv, % @ 20°C (Measured) | 97.4 | Not specified | 97.8 |
| Base Curve, mm (-7.00D) (Labeled) | 8.60 | Not specified | 8.60 |
| Base Curve, mm (-7.00D) (Measured) | 8.55 ± 0.021 | Not specified | 8.49 ± 0.027 |
| Diameter, mm (-7.00D) (Labeled) | 14.20 | Not specified | 14.20 |
| Diameter, mm (-7.00D) (Measured) | 14.13 ± 0.03 | Not specified | 14.20 ± 0.008 |
| Power, D (-7.00D) (Labeled) | -7.00 | Not specified | -7.00 |
| Power, D (-7.00D) (Measured) | -7.48 ± 0.087 | Not specified | -7.34 ± 0.123 |
| Tint Process | Not specified for base BIOMEDICS® UV | Pad Printing | Pad Printing |
| Print Zone | Not applicable | corresponds to the iris | corresponds to the iris |
| Location of print | Not applicable | Front surface | Front surface |
2. Sample size used for the test set and the data provenance
- Material properties and physical characteristics (Tables 1 & 2): The measurements for "Characteristics comparison, -7.00 D" state "40 lenses" for both predicate and subject devices for Base Curve, Diameter, and Power. Other material properties likely involved similar or different sample sizes, but it's not explicitly stated for each property.
- Data Provenance: The document does not specify the country of origin of the data. It implies laboratory testing rather than human subject testing for these physical properties. The studies are "Non-clinical studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The submission focuses on comparing physical, chemical, and design characteristics of the subject device to predicate devices, and conducting non-clinical toxicology and materials testing. There is no "ground truth" established by experts in the context of diagnostic accuracy or clinical judgment, as would be relevant for an AI/CADe device.
4. Adjudication method for the test set
- Not applicable as there is no "test set" requiring adjudication in the context of clinical judgment or diagnostic accuracy.
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 an AI/CADe device, and no MRMC study was conducted. The submission specifically states: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Colored lenses."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a contact lens, not an algorithm/AI.
7. The type of ground truth used
- For material properties and physical characteristics (Tables 1 & 2): The "ground truth" is measured physical and chemical properties and specifications, comparing the subject device's adherence to its own specifications and its similarity to predicate device specifications/measurements.
- For toxicology studies: Standardized ISO guidelines for biological evaluation (e.g., cytotoxicity, acute systemic injection, ocular irritation) are used. The "ground truth" are the established biological safety endpoints defined by these standards (e.g., absence of cytotoxicity, no systemic toxicity, no irritation).
- For chemistry studies (residual monomers, color extraction, shelf life): The "ground truth" is established analytical chemistry detection limits and stability protocols.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Overall Study/Demonstration:
The submission demonstrates substantial equivalence through a series of non-clinical studies and comparisons to predicate devices.
- Chemical and Physical Property Comparisons: The subject device's material properties (e.g., water content, refractive index, Dk, mechanical strength, light transmittance) and physical parameters (base curve, diameter, power) were measured and compared to those of the predicate BIOMEDICS® UV Sphere lenses. The results showed "substantial equivalence."
- Toxicology Studies:
- Cytotoxicity Test: Conducted according to ISO 10993: Part 5. Result: "test articles were not cytotoxic."
- Acute Systemic Injection Test: In mice, according to ISO 10993: Part 11. Result: "Each test article met the test requirements" (i.e., no systemic toxicity).
- Ocular Eye Irritation Test: In rabbits, according to ISO 10993: Part 10. Result: "the test article extracts are not considered irritants to the ocular tissue of rabbits."
- The "worst case scenario" of Blue and Red Printed lenses were used for these toxicology studies.
- Chemistry Studies:
- Material property data were generated and found "substantially equivalent."
- Residual monomer levels were determined and found "substantially equivalent" to the predicate.
- A color extraction study was conducted, and pigments were not detected in saline extracts above detection limits, indicating color fastness.
- Shelf life stability protocols were included.
- Solution Compatibility: Tested with Allergan Complete and Essilor (OSL) Concerto, finding no adverse interaction.
- Design and Intended Use Comparison (Colored Lenses): The colored lens design aspects (pigments, tint process, print zone, location of print, manufacturing method) were compared to the FRESHLOOK Colorblends predicate device and found to be "equivalent."
The conclusion drawn from these studies is that the BIOMEDICS® UV Colors lenses are equivalent in optical, chemical, and physical properties to the predicate devices and do not raise new questions of safety or effectiveness.
§ 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.