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K Number
K021720
Device Name
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
Manufacturer
SOFLEX ISRALENS CONTACT LENS LTD.
Date Cleared
2002-08-12

(80 days)

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

The MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 0.75 diopters. The lens may be disinfected using a chemical disinfection system.

Device Description

MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested.

The document is a 510(k) clearance letter from the FDA for a contact lens. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance. However, it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details about a specific study, including sample sizes, data provenance, number and qualifications of experts, or adjudication methods.
  • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used or how ground truth was established for training data.

§ 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.