(73 days)
The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical or heat disinfection system.
The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a hydrophilic polymer of 2-hydroxyethyl-methacrylate crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 38% water and 62% polymacon by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a spherical conic lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens design begins with a spherical 5.0mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then flattens into the base curve, which is considered the fitting curve of the lens. The cone curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with a peripheral curve to maintain alignment and comfort.
The provided document is a 510(k) summary for the Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.
Therefore, the document does not contain information regarding:
- Acceptance criteria and a study proving the device meets those criteria.
- Sample sizes for a test set, data provenance, or details about training sets.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone (algorithm only) performance studies.
- Specific types of ground truth used in novel studies (e.g., pathology, outcomes data).
Instead, the submission demonstrates substantial equivalence by comparing the Ocu-Flex-38 lens to a predicate device (Harrison Keratoconus Lens PMA #N17976 (hefilcon A) Manufactured By: Paragon Vision Sciences Flexlens Products) based on:
- Intended Use: The intended use of the Ocu-Flex-38 is for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes, for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons, and allows for chemical or heat disinfection. This is compared to the intended use of the Flexlens Harrison Keratoconus Lens.
- Technological Characteristics: Evaluation of manufacturing method, lens function, and material properties.
Here's a table summarizing the comparison, which serves as the basis for demonstrating "acceptance" of substantial equivalence:
| Characteristic | Ocu-Flex-38 (polymacon) Soft Keratoconus Contact lens | Predicate Device: Flexlens Harrison Keratoconus Lens | Assessment of Equivalence (Implicit Acceptance Criteria) |
|---|---|---|---|
| PRODUCTION METHOD | Lathe-cut | Lathe-cut | Equivalent |
| LENS FUNCTION | Keratoconus management. Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism) | Keratoconus management. Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism) | Equivalent |
| MATERIAL | Soft Contact Lens - Group 1, Low Water, Non-ionic polymer | Soft Contact Lens - Group 1, Low Water, Non-ionic polymer | Equivalent Classification |
| a. Water Content | 38% | 45% | Considered Substantially Equivalent in context of overall material group/performance |
| b. Polymer | (polymacon) | (hefilcon A) | Different polymers, but both classified as Group 1, Low Water, Non-ionic |
| c. Oxygen Permeability | 8.41 x 10⁻¹¹ at 35°C | 16 x 10⁻¹¹ at 35°C | Considered Substantially Equivalent despite numerical difference |
| d. Refractive Index | 1.41 | 1.43 | Considered Substantially Equivalent |
| e. Specific Gravity | 1.18 | 1.09 | Considered Substantially Equivalent |
| f. Light Transmission | 96%T | 96%T | Equivalent |
Study to Prove Acceptance Criteria:
The "study" to prove acceptance criteria in a 510(k) submission is primarily the comparison table and the narrative argument for substantial equivalence. The manufacturer asserts that the new device will be manufactured under specified process controls and a Quality Management System (CGMP guidelines), and that its established safety profile (preclinical toxicology and manufacturing/chemistry data) is equivalent to the predicate device.
The FDA's review and subsequent clearance (K992466) signifies their agreement that the Ocu-Flex-38 is "substantially equivalent" to the predicate device and does not raise different questions of safety and effectiveness. This is the "proof" the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. No new clinical safety or effectiveness data from human trials are presented in this summary beyond the comparison to the predicate device's known safety and effectiveness profile.
§ 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.