(159 days)
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.50mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ± 0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) |
This is an FDA 510(k) summary for a rigid gas permeable contact lens. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against predefined acceptance criteria for a novel device through clinical trials. Therefore, much of the information you requested regarding acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, training set details) is not applicable to this type of submission.
Here's a breakdown of what is available in the document related to acceptance criteria and performance, and why other elements are absent:
Context: This 510(k) submission is for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. The manufacturer is not introducing a new type of device or technology but is demonstrating that their product is "substantially equivalent" to existing, legally marketed predicate devices. For this type of submission, extensive clinical studies and a complex acceptance criteria framework (as would be seen for a novel AI device, for example) are generally not required. The focus is on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate devices.
Acceptance Criteria and Device Performance (as evident from the document):
The acceptance criteria are implicitly based on demonstrating that the device's physical properties and manufacturing quality fall within acceptable ranges and meet the standards set by the predicate devices and relevant industry standards (like ANSI Z80.20 for lens specifications).
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance (as stated or implied) |
|---|---|
| Bench Testing: Manufacturing Verification | The manufacturer demonstrated the ability to produce lenses from fluoroxyfocon A blanks to a variety of prescribed parameters. All manufactured lenses met established finished product specifications within the ANSI Z80.20 tolerance. |
| Bioburden Testing: Colony Forming Units (CFU) per lens | The acceptance criterion was less than 100 CFU per lens. The testing demonstrated that the product met this established acceptance criterion. |
| Biocompatibility Testing: |
- In-Vitro Cytotoxicity
- Systemic Toxicity
- Acute Ocular Irritation | 1. In-Vitro Cytotoxicity: Per ISO 10993-5, results indicated that the finished lenses are not cytotoxic.
- Systemic Toxicity: Per ISO 10993-11, the finished lenses met the requirements of the systemic injection test, and extracts did not induce acute systemic toxicity.
- Acute Ocular Irritation: Per ISO 10993-23, extracts did not induce ocular irritation. |
| Physical Properties (Matching Predicate and Industry Standards) | Specific values are listed, demonstrating they are within typical ranges for such lenses and comparable to predicate devices:
- Refractive Index: 1.430
- Modulus (MPa): 1194
- Hardness (Shore D): 78
- Specific Gravity: 1.18
- Oxygen Permeability (Dk): 200 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
- Water Content:
§ 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.