(167 days)
The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.
OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Daily Wear Contact Lenses.
This letter is a medical device approval from the FDA, and as such, it does not contain the detailed technical study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
To provide the information you've requested about acceptance criteria and study details, I would need access to the actual 510(k) summary or the full submission for K081178, which would typically contain performance data and clinical study details if they were required for the specific device type.
§ 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.