(221 days)
The Sauflon New Day® (methafilcon A) Soft (hydrophilic) Visibility tinted contact lens is a daily disposable lens indicated for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.
The SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lenses are available in an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the lens consists of 45% HEMA and 55% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with weight of summe inimelod in his meller on the well and one UV absorbing monomer is used to block UV radiation. Sauflon New Day lenses are daily disposable lenses. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380nm. The SAUFLON New Day Daily Disposable Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.
This 510(k) summary describes a contact lens, the SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lens, and aims to establish its substantial equivalence to a predicate device, the SAUFLON 55UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649).
The acceptance criteria relate to demonstrating that the new device is as safe and effective as the predicate device. The study presented is a comparison of physical, optical, and chemical properties, as well as manufacturing processes and safety tests, between the two contact lenses. No clinical effectiveness study with human readers or AI assistance is mentioned as this is a medical device approval for a contact lens.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implicitly that the new device (SAUFLON New Day) demonstrates properties, materials, and manufacturing processes that are identical or equivalent to the legally marketed predicate device (SAUFLON 55UV), and where differences exist (e.g., lens design or modality), these differences do not affect safety or efficacy.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (SAUFLON New Day) |
|---|---|
| Material Composition: Methafilcon A | Identical (Methafilcon A) |
| Physical/Optical Properties (e.g., Water Content, Transmittance, Dk): | Identical across a range of specified measurements (Water Content: 55%, %Transmittance @590nm: 94.61%, %Transmittance @280-315nm: 9.41%, %Transmittance @316-380nm: 36.00%, Dk @35°C: 22.0 x 10^-11, Refractive Index: 1.4020, Tensile Strength: 1.47, Modulus: 0.52, Elongation at Break: 280, Toughness: 1.39) |
| Powers: -20.00 to +20.00 D | Identical |
| Color: Aquamarine Visibility | Identical |
| Chemical Composition of Finished Lens: Co-polymer of 2-hydroxyethylomethacrylate and methacrylic acid cross-linked with ethyleneglycol dimethacrylate, with benzophenone type UV absorbing monomer, CI Reactive Blue Dye 4, CI Reactive Yellow Dye 86. | Identical |
| Raw Material Specifications: Approved in K013649 | Identical |
| Manufacturing Process: Cast Moulding | Identical |
| Tinting Process: 'In monomer' tinting | Identical |
| Packaging Materials: Injected molded polypropylene blisters, aluminum foil laminate, printed cartons | Identical |
| Lens Packing Solution: 0.9%w/v sodium chloride solution buffered at pH 7.5 to 7.8 with sodium hydrogen carbonate and containing 0.005% w/v poloxamer 407 | Identical |
| Packaging Method: Hermetically sealed blister pack | Identical |
| Sterilization Method: Steam Sterilization | Identical |
| Shelf-life: 5 years (based on stability studies of predicate) | Identical (Applicable from predicate studies due to identical materials and processes) |
| Toxicology (Lens Material Methafilcon A): Non-toxic, non-irritating (cytotoxicity, systemic toxicity, ocular irritation tests) | Identical (Toxicity data applicable due to identical material) |
| Toxicology (Blister Packs): Non-toxic (cytotoxicity, systemic toxicity, ocular irritation tests) | Identical (Toxicity data applicable due to identical materials) |
| Residual Monomers: Below detection limits | Data applicable due to identical material |
| Leachable Color Additives: No detectable amounts | Data applicable due to identical dyes |
| Indications for Use: Myopia, Hyperopia, Astigmatism in aphakic and non-aphakic persons with non-diseased eyes, astigmatism up to 2.00 Dioptres not interfering with visual acuity. | Identical |
| Difference in Lens Design: Spherical (predicate) | Aspherical (subject device) - "This design alteration does not affect the safety or the efficacy of the lens." |
| Difference in Modality: Daily Wear (predicate) | Daily Disposable wear (subject device) - Labeling adapted accordingly; noted as a "convenient alternative" with reduced risk due to limited exposure. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of tested units for each property. The "test set" here refers to the SAUFLON New Day lens, for which various properties were measured and compared. The data provenance is from Sauflon Pharmaceuticals Ltd., United Kingdom. The studies appear to be prospective in that new measurements were taken for the subject device to compare against the known predicate device. For some aspects (e.g., stability, leachability, toxicology), the data from the predicate device's prior approval (K013649) was deemed applicable due to identical materials and processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable for this submission. The "ground truth" for contact lens properties like water content, transmittance, Dk, etc., is established through standardized physical, optical, and chemical testing methods, not through expert consensus on interpretation. Toxicology and leachability tests also follow established laboratory protocols.
4. Adjudication method for the test set
Not Applicable. As mentioned above, the "ground truth" is derived from objective physical, optical, and chemical measurements and standard laboratory tests, not from subjective expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a submission for a medical device (contact lens), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the comparison is based on:
- Standardized physical, optical, and chemical measurements: For properties like water content, transmittance, Dk, refractive index, tensile strength, etc.
- Laboratory test results: For toxicology (cytotoxicity, systemic toxicity, ocular irritation), residual monomers, and color leachability studies.
- Manufacturing process documentation: To confirm identical processes.
- Reference to prior FDA clearance (K013649): For established safety and efficacy of the predicate device's materials and processes.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device. The ground truth for the comparison was established through objective, standardized testing and the documented equivalence to a previously cleared device.
§ 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.