(59 days)
TOTAL30™ (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.
TOTAL30™ Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and byperopia) in phakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded with a new pair each month, or more often, if recommended by the eye care professional.
The subject device, TOTAL30™ (lehfilcon A) soft contact lenses, are made from a surface treated, silicone containing hydrogel lens material that is approximately 55% water and 45% lehfilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edgeto-edge color to make it easier to see when handling. The lenses contain two benzotriazole monomers to block UVA and UVB radiation and, additionally, reduce transmittance in the range from 380 nm to 450 nm.
Lehfilcon A represents a Group 5B silicone hydrogel contact lens material ("enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows:
Group Suffix: 5B
Hydrogel Material: High water subgroup
Description: A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8
Lehfilcon A lens designs include spherical, asphere, toric, multifocal toric contact lenses in the following parameter ranges:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00 D to +20.00 D
Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical)
Cylinder Power (Toric) -0.25 D to -10.00 D
ADD Power (Multifocal) LO, MED, HI
Lenses have the following properties:
Refractive index: 1.40 (hydrated)
Water content: 55% by weight in normal saline
Surface water content: ≥ 90%
Oxygen permeability: 123 x 10 -11 [(cm2/sec)(ml O2 /ml.mmHg)] measured at 35 °C (normalized Dk-Polarographic method)
Light transmittance: >85%
UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 315 to 380 nm for the entire power range.
Lehfilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.
The provided document is a 510(k) Premarket Notification for Alcon's TOTAL30 contact lenses. It details the steps taken to demonstrate substantial equivalence to a predicate device, CooperVision Biofinity.
Here, we will synthesize the information to describe the acceptance criteria and the study that proves the device meets them, focusing on aspects relevant to device performance and ground truth establishment.
Based on the provided document, the acceptance criteria and proof of adherence are primarily demonstrated through a comparison against a predicate device and adherence to established ISO standards and FDA guidance for contact lenses, rather than a typical AI/software device evaluation with specific performance metrics like sensitivity, specificity, etc.
However, we can infer "acceptance criteria" as meeting the safety and performance standards demonstrated by the predicate device and relevant industry standards. The "study that proves the device meets the acceptance criteria" refers to the nonclinical and clinical performance testing.
1. A table of acceptance criteria and the reported device performance:
Since this is a contact lens submission (medical device), the "acceptance criteria" are not reported as specific numerical thresholds for metrics like accuracy, sensitivity, or specificity as would be common for an AI/software device. Instead, they relate to demonstrating comparable safety, effectiveness, and performance to a legally marketed predicate device and compliance with applicable standards. The "reported device performance" is largely qualitative and comparative.
Here's an interpretation based on the document:
| Acceptance Criterion (Inferred from Regulatory Requirements/Predicate Comparison) | Reported Device Performance (TOTAL30 Lehfilcon A) |
|---|---|
| Safety: | |
| Biocompatibility (non-toxic, non-irritating, non-sensitizing) | Confirmed through cytotoxicity, ocular irritation/toxicity (rabbits), sensitization, acute systemic toxicity (mice), and genotoxicity testing. Concluded to be non-toxic, non-irritating, and non-sensitizing. Existing biocompatibility data for packaging materials also applies. |
| Sterility and Stability | Supplied sterile in sealed blister packs. Ongoing stability study demonstrates lenses remain sterile and stable for the labeled expiration date. |
| Compatibility with Lens Care Products | Confirmed compatibility with commonly available cleaning/disinfection solutions (peroxide, MPDS), preserved/unpreserved saline, and rewetting drops per ISO 11981:2017. Uptake/release of preservatives (PQ, Aldox, PHMB, alexidine) comparable to control lenses per ISO 11986:2017. |
| Effectiveness/Performance: | |
| Comparable Clinical Performance (Vision, Comfort, Fit, Handling, Health) | Clinical study showed similar clinical performance between TOTAL30 (lehfilcon A) and the predicate Biofinity (comfilcon A) in clinically relevant areas of vision, comfort, fit, handling, and health when worn on a daily wear basis. Primary effectiveness endpoint (Snellen VA at distance) showed similar performance. |
| Physical-Chemical Properties | Established per GxP conditions and ISO 18369-2, -3, -4 for: Refractive Index (1.40), Oxygen Permeability (123 x 10^-11), Ion Permeability, Mechanical Properties, Wetting Contact Angle, Transmittance Properties (>85% light, |
§ 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.