(359 days)
The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
59% Extreme H2O (hioxifilcon A) soft contact lenses are hemispherical shells and are available as spherical (G59 S-Thin and G59 S-Xtra) or toric (G59 Toric) lens designs. The 59% Extreme H2O (hioxifilcon A) soft contact lens is fabricated from hioxifilcon A, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).
The provided text is a 510(k) Premarket Notification for a soft contact lens and does not contain information about acceptance criteria, device performance metrics, or a study evaluating such performance.
Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, I cannot provide the requested information.
Here's why and what's missing:
- No Acceptance Criteria or Performance Metrics: The document describes the device, its intended use, and argues for its substantial equivalence to another cleared product. It does not list specific performance criteria (e.g., visual acuity targets, comfort scores, lens fit parameters) that the new toric lens must meet, nor does it report data on how the device performed against such criteria.
- No Study Described: There is no mention of a clinical trial or a formal study designed to assess the performance of the 59% Extreme H2O (hioxifilcon A) toric soft contact lens. The clearance is based on its similarity to an existing spherical lens, assuming similar safety and effectiveness.
- No Information on Experts, Sample Sizes, or Ground Truth: Since no performance study is described, there is no information regarding sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, or the type of ground truth used.
- No MRMC or Standalone Performance: These terms are relevant to assessing the performance of AI/CAD systems, which is not the subject of this 510(k) submission.
Summary of what can be extracted related to the device:
- Device Name: 59% Extreme H2O (hioxifilcon A) toric soft contact lens
- Intended Use: Correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism of 10.00 Diopters or less.
- Predicate Device: 59% Extreme H2O (hioxifilcon A) spherical lens (K992692)
- Basis for Clearance: Substantial Equivalence to the predicate device, differing only in design (toric vs. spherical).
To answer the questions posed, a document detailing a clinical or non-clinical performance study of the 59% Extreme H2O toric soft contact lens would be required.
§ 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.