Search Results
Found 1 results
510(k) Data Aggregation
(147 days)
The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia.
The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoroitaconate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
In the ENFLU 18 (enflufocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for ENFLU 18 averages > 98% in the UVB range of 280nm - 315nm and >83% in the UVA range of 316 - 380mm.
The ENFLU 18 (enflufocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C red No. 17.
The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "M Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (enflufocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.
The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The provided document describes the ENFLU 18 (enflufocon A) Daily Wear Contact Lens, a rigid gas permeable (RGP) contact lens, and its substantial equivalence to predicate devices, thus demonstrating its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the ENFLU 18 device in the format of a pre-defined threshold vs. actual performance data. Instead, it demonstrates substantial equivalence by comparing the ENFLU 18's physical properties and performance characteristics to those of predicate devices. The "reported device performance" are the physical properties listed for ENFLU 18. The "acceptance criteria" are implied by the properties of the predicate devices for which the new device is deemed substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Boston ES) | Acceptance Criteria (Predicate Optimum GP) | Reported Device Performance (ENFLU 18 Uncoated) | Reported Device Performance (ENFLU 18 Tangible™ Hydra-PEG Coated) |
|---|---|---|---|---|
| Material USAN Name | enflufocon A | roflufocon C, D, E | enflufocon A | enflufocon A |
| Water Content (%) | <1% | <1% | <1% | <1% |
| Specific Gravity (g/cm³) | 1.220 | Roflufocon C: 1.178, D: 1.166, E: 1.155 | 1.221 | 1.221 |
| Oxygen Permeability (Dk) | 22 x 10⁻¹¹ | Roflufocon C: 65x10⁻¹¹, D: 100x10⁻¹¹, E: 125x10⁻¹¹ | $21.03 \times 10^{-11}$ | $23.96 \times 10^{-11}$ |
| Wettability (Sessile Drop Contact Angle) | 87.5° | Roflufocon C: 40.28°, D: 40.40°, E: 36.90° | 86.5° (Average, n=30) | 48.0° (Average, n=30) |
| Refractive Index (dry) | Not explicitly listed for predicate | Not explicitly listed for predicate | 1.4436 | 1.4432 |
| Light Transmission (@380-780nm) | Not explicitly listed for predicate | Not explicitly listed for predicate | >90% | >90% |
| UVA Transmission (@316-380nm) | Not explicitly listed for predicate (Yes UV Blocker) | Not explicitly listed for predicate (Yes UV Blocker) | <17% | <14% |
| UVB Transmission (@280-315nm) | Not explicitly listed for predicate (Yes UV Blocker) | Not explicitly listed for predicate (Yes UV Blocker) | <2% | <1% |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Wettability Testing: 30 lenses (
n=30) were used for the sessile drop contact angle measurements for both uncoated and Tangible™ Hydra-PEG coated ENFLU 18 lenses. - Data Provenance: The document states that "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed". It also mentions that "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." This implies a controlled laboratory setting. The country of origin for the data is not explicitly stated. The study is described as "preclinical" and "in vitro and in vivo," indicating a mix of laboratory and potentially animal or human (for biocompatibility) testing. The document also states "The clinical safety and effectiveness has been previously established for contact lenses manufactured from (enflufocon A) and contact lenses treated with Tangible ™ Hydra-PEG," indicating that the clinical data for these materials are retrospective from prior research.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies mentioned are primarily technical and laboratory-based, focusing on material properties, toxicology, and biocompatibility, rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as the described studies are not based on subjective interpretation or a diagnostic assessment requiring adjudication. They focus on objective measurements of physical, chemical, and biological properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (contact lens) and its substantial equivalence submission. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed, nor is it applicable. The device is an RGP contact lens, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the various non-clinical tests described were:
- Objective measurements: For physical properties like refractive index, light transmission, specific gravity, oxygen permeability, and wettability (sessile drop contact angle).
- Established scientific protocols/standards: For toxicology, biocompatibility, and microbiological testing (e.g., GLP regulations, bioburden acceptance criteria).
- Predicate device characteristics: The acceptance that the ENFLU 18 is substantially equivalent relies on its properties being comparable to those of the legally marketed predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the document describes the testing of a medical device (contact lens), not the development of an artificial intelligence or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as #8.
Ask a specific question about this device
Page 1 of 1