(35 days)
Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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. Eye care practitioners may prescribe Frequency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.
The Frequency 38 and Silver 07 (polymacon) Hydrophilic Contact Lens for Daily Wear (tinted) is available as a single vision lens. The lens material, polymacon is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate (62%) and water (38%). Frequency 38 and Silver 07 (polymacon) Hydrophilic Contact Lenses for Daily Wear are tinted for visibility purposes from edge to edge using color additive Blue No. 4. Frequency 38 is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera with the following dimensions: Diameter: 14.0 mm to 15.0 mm, Base Curve: 8.4 mm to 9.0 mm, Center Thickness: 0.03 mm to 0.40 mm (varies with power), Powers: -20.00 to +20.00 D. The physical properties of the lens are: Refractive Index: 1.43, Light Transmittance: >97%, Specific Gravity: 1.17, Water Content: 38%, Oxygen Permeability: 8.0 x 10-11 (cm²/sec)(mi 02/ml x mmHg) at 35°C (Fatt method for determination of oxygen permeability).
The CooperVision Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses were evaluated for substantial equivalence to a predicate device, the Frequency 38 & Silver 07 Post-Hydration Tint (K971049). The study did not involve a direct assessment of clinical performance against specific acceptance criteria for a new device, but rather a comparison to the established predicate device based on material, physical properties, and toxicology.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly matching the characteristics and performance of the legally marketed predicate device.
| Characteristic | Predicate Device (K971049) Reported Performance | New Device (In-Monomer Tint) Reported Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Material | Polymacon | Polymacon | Match predicate material |
| Material Classification | Hydrophilic Lens Group 1 | Hydrophilic Lens Group 1 | Match predicate classification |
| Indications for Use | Daily wear for correction of refractive ametropia (myopia & hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, exhibiting up to 2.00 diopters astigmatism that doesn't interfere with visual acuity. Frequent replacement wear with cleaning, disinfecting, and scheduled replacement. | Daily wear for correction of refractive ametropia (myopia & hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, exhibiting up to 2.00 diopters astigmatism that doesn't interfere with visual acuity. Frequent replacement wear with cleaning, disinfecting, and scheduled replacement. | Match predicate indications for use |
| Water Content | 38% | 38% | Match predicate water content |
| Light Transmittance | >97% | >97% | Match predicate light transmittance |
| Dk (35° C) (Oxygen Permeability) | $8.0 \times 10^{-11}$ | $8.0 \times 10^{-11}$ | Match predicate Dk (oxygen permeability) |
| Refractive Index | 1.43 | 1.43 | Match predicate refractive index |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00 D | Match predicate power range |
| Dye | C.I. Reactive Blue #4 | C.I. Reactive Blue #4 | Match predicate dye |
| Manufacturing Method | Cast Molded | Cast Molded | Match predicate manufacturing method |
| Toxicology | Non-toxic (for predicate) | Non-toxic | Demonstrate non-toxicity and equivalence to predicate |
| Leachable Dye (Color Fastness) | Not explicitly stated for predicate, but implied acceptable. | Below 1 ppm leaching of Blue 4, no significant difference in absorbance pre/post extraction. | Demonstrate acceptable color fastness (matching or better than predicate expectation) |
2. Sample Size Used for the Test Set and the Data Provenance
The submission does not detail specific "test set" sample sizes in the way a clinical trial would. For the preclinical studies:
- Toxicology testing: The sample size for ocular irritation, cytotoxicity, and systemic toxicity tests is not specified in the provided text. The data provenance is "in-house evaluation."
- Physical properties evaluation: The sample size is not specified. The data provenance is "in-house evaluation."
- Leachable study: The sample size for the "test lenses" is not specified, but multiple "three extraction solutions" were used to assess the color fastness. The data provenance is "in-house evaluation."
The data provenance is presented as "in-house evaluation" by CooperVision. The country of origin is not explicitly stated for individual study data, but CooperVision Manufacturing, Ltd. is located in Southampton, UK. The studies appear to be retrospective analyses and comparisons to the predicate device's established properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission is for substantial equivalence and relies on material and chemical characterization, as well as comparison to an existing device, rather than expert-derived ground truth from a clinical test set. The determination of "non-toxic" would be based on standard toxicological protocols and expert interpretation within CooperVision and potentially by regulatory bodies.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in the context of this submission. The determination of substantial equivalence was based on a comparison of device characteristics and preclinical data.
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 a contact lens submission, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contact lens submission, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence claim is effectively the established and accepted characteristics and performance of the predicate device (Frequency 38 & Silver 07 Post-Hydration Tint, K971049).
- For toxicology, the ground truth is the established safety profiles for contact lens materials and dyes.
- For physical and chemical properties, the ground truth is the measured values of the predicate device and accepted industry standards for those properties.
- For the leachable study, the ground truth is the acceptable level of leached dye, which was interpreted as "below 1 ppm" and "no significant difference" in absorbance.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.