(62 days)
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.
The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye care practitioners may prescribe the lens for either single-use disposable wear or 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 only.
The device description does not change from that cleared under K983912.
The provided 510(k) submission (K991163) for the VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses does not describe a study involving acceptance criteria and device performance in the typical sense of a new medical device efficacy study. Instead, this submission is a labeling modification for an already cleared device (K983912).
Therefore, the following information is largely not applicable or directly extractable from the provided text, as the focus is on the equivalence of the device and its existing data to support new indications, rather than a de novo study demonstrating meeting new acceptance criteria.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of acceptance criteria or new device performance data. The core of this 510(k) is that the device material and manufacturing process are unchanged from a previously cleared device (K983912). The only new "performance" mentioned relates to UV blocking, which was also established in a prior submission or existing data.
- UV Blocking:
- UVA: 95%
- UVB: 99.9%
- Acceptance Criteria for UV Blocking: Not explicitly stated in this document, but implied to be met based on the reported values. Generally, contact lenses classified as UV-blocking must meet certain FDA-defined percentages for UVA and UVB absorption.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Description: Not applicable, as no new clinical or non-clinical studies were conducted specifically for this 510(k) to establish performance against new acceptance criteria.
- Data Provenance: The submission explicitly states: "There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K983912 supports the clinical safety of the subject device." This means any performance data supporting the indications would stem from studies related to K983912. The provenance for those original studies is not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable, as no new test set was created for a study mentioned in this 510(k). The clinical safety is supported by prior data.
4. Adjudication Method for the Test Set
- Not applicable, as no new test set was created for a study mentioned in this 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a contact lens, and the 510(k) is for an expanded indication statement, not for an AI diagnostic or interpretive device. Therefore, a human reader improvement effect size is not relevant.
6. Standalone Performance Study (Algorithm Only)
- No standalone performance study was done. This device is a contact lens. The concept of an "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
- For the original submission (K983912) that established the safety and efficacy of the lens material, the "ground truth" would have likely been based on clinical outcomes data from human subjects wearing the contact lenses (e.g., visual acuity, comfort, adverse events, fit characteristics, etc.) as evaluated by optometrists or ophthalmologists.
- For the UV blocking claim, the ground truth would be based on laboratory measurements of UV transmission through the lens material.
8. Sample Size for the Training Set
- Not applicable. This 510(k) is not for a machine learning or AI device that requires a training set. The clinical data from K983912 would have involved a cohort of human subjects. The details of that sample size are not in this document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this 510(k). For the original clinical data from K983912, the ground truth would have been established by clinical investigators (eye care professionals) assessing patient outcomes and device performance against defined endpoints in clinical trials.
§ 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.