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510(k) Data Aggregation
(300 days)
Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is indicated for daily wear for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eyecare professional. When prescribed for frequent/planned replacement wear. The contact lens may be disinfected using chemical (not heat) disinfection system.
The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 %). `.te hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) Ind methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is tinted blue using C.I Reactive blue 19 to make the lens more visible for handling In the Discon Plus Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics for Discon Plus lens are less than 5% in the UVB range of 280nm - 315nm and less than 30% in the UVA range of 316nm - 380nm. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
This document describes the Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker. It is important to note that this 510(k) submission primarily relies on substantial equivalence to previously cleared predicate devices, rather than an independent de novo study with acceptance criteria being met by the device itself.
1. Table of Acceptance Criteria (Technological Characteristics) and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate devices. The "reported device performance" refers to the characteristics of the Discon Plus lens, which are shown to be substantially equivalent to the predicates.
| Characteristic | Acceptance Criteria (Predicate: Discon (K051129) & Acuvue (K962804)) | Reported Device Performance (Discon Plus) |
|---|---|---|
| FDA group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | Etafilcon A | Etafilcon A |
| Production method | Predicate 1 (Discon): Spin-casting Predicate 2 (Acuvue): Cast-molded | Spin-casting |
| %Water content | 58 | 58 |
| Refractive index | 1.40 | 1.40 |
| Oxygen permeability (edged corrected) @ 35°C | Predicate 1 (Discon): $24 \times 10^{-11}$ Predicate 2 (Acuvue): $26 \times 10^{-11}$ | $24 \times 10^{-11}$ |
| Power, Diopters | Predicate 1 (Discon): +6.0D~-12.0D Predicate 2 (Acuvue): +20.0D~-20.0D | +20.0D~-20.0D |
| %Light transmission @381~700 nm | 93 minimum (for Discon) / 85 minimum (for Acuvue) | 93 minimum |
| %Light transmission @316~380 nm (UVA) | avg <30% (for Acuvue) | avg <30% |
| %Light transmission @280~315 nm (UVB) | avg <5% (for Acuvue) | avg <5% |
Note regarding "Acceptance Criteria": For this 510(k) submission, the "acceptance criteria" are not explicit numerical targets set for the new device in a de novo study. Instead, the new device (Discon Plus) is deemed acceptable if its characteristics are shown to be "substantially equivalent" to the existing predicate devices. Therefore, the predicate device characteristics serve as the de facto acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Therefore, no clinical data is required for this submission." This indicates that no dedicated clinical test set was used for the Discon Plus lens in this specific submission. The clinical safety data is referenced from the predicate device (K051129).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no dedicated clinical test set was used for the Discon Plus lens in this submission, no experts were used to establish ground truth for a test set. The reliance is on prior approvals and established safety profiles of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical test set was used for the Discon Plus lens in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed for this device. This submission focuses on chemical composition and physical properties for substantial equivalence, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a contact lens and does not involve an algorithm or AI.
7. Type of Ground Truth Used (for "test set")
As stated, no dedicated clinical test set with a newly established ground truth was used for the Discon Plus lens in this submission. The "ground truth" for safety and effectiveness is derived from the previously established safety and effectiveness profiles of the predicate devices (Discon K051129 and Acuvue K962804) and non-clinical testing.
8. Sample Size for the Training Set
Not applicable. This device is a contact lens and does not involve AI or algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set was used.
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