(203 days)
The PVS Basic™2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic" 2 (migafocon A) and Epic 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D.
The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6. The lenses have the following dimensions and characteristics: Material: migafocon A, Indication: Daily Wear, Water Content:
This document describes the 510(k) summary for the PVS Basic™ 2 and Epic® 2 rigid gas permeable contact lenses. It focuses on demonstrating substantial equivalence to a predicate device, PVS Basics™ (paflufocon E) contact lenses, rather than a clinical study with an acceptance criteria for a new AI/medical device.
Here's the information extracted, re-framed to best fit the categories provided, acknowledging that this is a contact lens submission and not an AI or diagnostic device:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for contact lenses demonstrating substantial equivalence, the "acceptance criteria" are the physical, optical, and chemical properties of the predicate device. The "reported device performance" are the corresponding properties of the new device being submitted. All values for the new device are presented as meeting the implied equivalence to the predicate.
| Parameter | Predicate Device (PVS Basics™ - paflufocon E) | New Device (PVS Basic™ 2 & Epic® 2 - migafocon A) | Comparison / "Acceptance Criteria Met" |
|---|---|---|---|
| Material | paflufocon E | migafocon A | Different material, but deemed equivalent in performance parameters |
| Indication | Daily Wear | Daily Wear | Equivalent |
| Water Content/Absorption |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.