(62 days)
The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.
The provided document is a 510(k) summary for the FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens for Daily Wear. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a new device meets predefined acceptance criteria through a traditional clinical study with statistical significance targets. Instead, the "study" is a comparison to the predicate device to show it performs similarly and is thus safe and effective.
Here's an analysis of the provided information in the context of acceptance criteria and the "study" that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are generally that the new device's properties are either identical or "substantially equivalent" to the predicate device, and any differences do not raise new questions of safety or effectiveness. The document effectively presents a comparison of the new device's properties against the predicate device.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (FREQUENCY UV™) | Comparison / Result |
|---|---|---|---|
| Material | Etafilcon A | Etafilcon A | Equivalent |
| Indication for use | Myopia, hyperopia, and astigmatism | Myopia, hyperopia, and astigmatism | Equivalent |
| Water content | 58% | 58% | Equivalent |
| % transmittance @ 593nm | 96.42% | 93.91% | Similar (within acceptable range for visibility) |
| % transmittance @ 280-315 nm | 2.4% (with UV Blocker) | 9.5% (with benzotriazole UV absorbing monomer) | Similar (both block UV-B) - stated "less than 10%" in description as a target |
| % transmittance @ 316-380 nm | 15.55% (with UV Blocker) | 7.86% (with benzotriazole UV absorbing monomer) | Similar (both block UV-A) - stated "less than 10%" in description as a target |
| Dk (35 °C) (Edge Corrected) | 15.09 X 10" | 15.62 X 10" | Similar (Oxygen Permeability) |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00 D | Equivalent |
| Color | Clear and blue visibility | Clear and aqua visibility | Different tint color (visibility aid, not functional difference) |
| Specific gravity | 0.98-1.12 | 0.98-1.12 | Equivalent |
| Refractive index | 1.4 | 1.39 | Similar |
| Tensile strength | 0.64 | 1.12 | Different, but likely within acceptable limits for a contact lens |
| Modulus | 0.22 | 0.35 | Different, but likely within acceptable limits for a contact lens |
| Elongation at Break | 228 | 249 | Different, but likely within acceptable limits for a contact lens |
| Toughness | 0.74 | 1.12 | Different, but likely within acceptable limits for a contact lens |
| Manufacturing method | Cast Molding | Cast Molding | Equivalent |
| Toxicology Testing | Non-toxic (for Acuvue, implicit by marketing clearance) | Non-toxic (cytotoxicity, systemic toxicity, ocular irritation) | Equivalent |
| Residual Monomer & Color Leach | Acceptable levels (for Acuvue, implicit) | Not contain leachable color nor significant levels of residual monomers | Equivalent |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in the way a clinical trial would. For material property comparisons, it implies laboratory testing of samples from the device production.
- Data Provenance: The data for the FREQUENCY UV™ comes from direct testing of the device itself ("Preclinical Testing" and "COMPARISON OF PHYSICAL/OPTICAL PROPERTIES" sections). The predicate device data (Acuvue) is presented as established characteristics for a previously cleared product. The data is likely from the United Kingdom (Aspect Vision Care, Ltd.'s location) for the new device, and presumably from the US for the predicate's marketing clearance. This is retrospective for the predicate and prospective for the tests performed on the FREQUENCY UV™ to demonstrate substantial equivalence.
3. Number of Experts for Ground Truth and Qualifications
- This type of submission (510(k) for contact lenses) does not typically involve expert consensus for "ground truth" in the diagnostic sense, as it focuses on material properties and performance equivalence.
- The "experts" involved would be the engineers, chemists, and statisticians who designed and conducted the physical, chemical, and biological compatibility tests, along with the regulatory review team at the FDA (Division of Ophthalmic Devices). Their qualifications are implicit in their professional roles and adherence to regulatory standards for device testing.
4. Adjudication Method
- Not applicable in the conventional sense of a clinical trial where image interpretations or clinical outcomes are adjudicated. The "adjudication" here is the FDA's review process, where their experts assess whether the presented data for the new device demonstrates substantial equivalence to the predicate, and whether any differences raise new safety or effectiveness concerns.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an imaging algorithm or diagnostic tool that requires human interpretation of outputs.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a physical medical device (contact lens), not an algorithm or AI.
7. Type of Ground Truth Used
- The "ground truth" for this submission are the established physical, chemical, and biological properties of the contact lens material and design, as measured by standard laboratory tests (e.g., water content, Dk, transmittance, tensile strength, cytotoxicity). For the predicate device, its 'truth' is its FDA clearance (K962804) based on similar prior testing. The overall "ground truth" is that the device is safe and effective when its properties are substantially equivalent to a legally marketed predicate.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a contact lens.
§ 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.