(141 days)
The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.
BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).
Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSTON ES®, BOSTON EO®, and BOSTON® XO Rigid Gas Permeable Contact Lenses.
It's important to note that this document is a 510(k) summary, which often points to prior submissions and substantial equivalence rather than detailing a new comprehensive clinical study for the specific device being cleared.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to a predicate device (BOSTON® II itafocon A). This means that the new devices are considered safe and effective because they are as safe and effective as a legally marketed device.
The "performance" for these new devices is presented not as a comparison against specific numerical targets, but as their fundamental physical and optical properties, which are then implicitly considered acceptable because they fall within the parameters of what is deemed safe and effective for rigid gas permeable contact lenses, similar to the predicate.
| Acceptance Criteria Category (Implicit) | Specific Criteria (from predicate/general RGP lens standards) | Reported Device Performance (BOSTON ES, EO, XO) |
|---|---|---|
| Substantial Equivalence to Predicate Device | Safety and efficacy equivalent to BOSTON® II (itafocon A) lens. | Achieved through similarity in materials, indications for use, and general design. |
| Material Composition | Appropriate for RGP contact lenses, including UV absorber. | BOSTON ES/EO: aliphatic fluoroitaconate siloxanyl methacrylate copolymer with UV absorber. |
| BOSTON XO: siloxanyl fluoromethacrylate copolymer with UV absorber. | ||
| Color additives conform to 21 CFR Part 74/73. | ||
| Physical/Optical Properties | Within acceptable ranges for RGP lenses (specific gravity, refractive index, light transmittance, water content, oxygen permeability). | BOSTON ES: |
| Specific Gravity: 1.22 | ||
| Refractive Index: 1.443 | ||
| Light Transmittance: C.I.E. Y value - at least % |
§ 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.