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K Number
K990011
Device Name
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
Manufacturer
CONTINENTAL SOFT LENS, INC.
Date Cleared
1999-05-11

(127 days)

Product Code
LPL
Regulation Number
886.5925
Type
Traditional
Panel
Ophthalmic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Device Description

Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens

AI/ML Overview

This document is a marketing authorization for a contact lens and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the regulatory approval process for the Continental 45 Toric (hefilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information, such as:

  • A table of acceptance criteria and reported device performance.
  • Sample size used, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
  • Information about MRMC studies, standalone performance, or the ground truth used for such studies.
  • Sample size for a training set or how ground truth for a training set was established.

The document is a regulatory approval letter and an "Indications For Use" statement. It does not detail the technical performance or validation studies of the contact lens.

§ 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.