(212 days)
The BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +20.00 to -20.00 D.
The BIOLENS Toric (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +20.00 to -20.00 D and a cylinder power range up to -10.0D.
The BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +20.00 to -20.00 D and have near add requirements up to 3.25 D.
The BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +20.00 to -20.00 D, a cylinder power range up to -4.00 D and an add requirement up to +3.25 D.
BIOLENS lenses may be disinfected using chemical (not heat) disinfecting systems.
BIOLENS UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, toric, multifocal, and toric-multifocal designs. Specifically, the BIOLENS models are hemispheric flexible shells of the following parameters:
Diameter(s): 12.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 8.0 mm - 9.5 mm
Powers: -20.00 D to +20.00 D
Cylinder Powers: Not Applicable (N/A) for Sphere and Multifocal; Up to -10.00 D in steps of 0.25 D for Toric; Up to -4.00 D in steps of 0.25 D for Toric Multifocal
Axis: Not Applicable (N/A) for Sphere and Multifocal; 1° to 180° for Toric and Toric Multifocal
Add Powers: N/A for Sphere and Toric; +0.50D to +3.25D for Multifocal and Toric Multifocal
All BIOLENS lenses are plasma treated in the dry state prior to initial hydration.
The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
This document is a 510(k) Premarket Notification from the FDA regarding the BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. It details how the device demonstrates substantial equivalence to predicate devices, focusing on its physical and chemical properties and non-clinical performance data.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics against a defined threshold. Instead, it demonstrates substantial equivalence by comparing the BIOLENS properties to those of two legally marketed predicate devices (LSH and iO2, both made of mangofilcon A). The "reported device performance" in this context refers to the physicochemical properties and other characteristics of the BIOLENS and its predicates.
| Characteristic | BIOLENS (subject device) | LSH (1° predicate) | iO2 (2° predicate) |
|---|---|---|---|
| USAN | Mangofilcon A | Mangofilcon A | Mangofilcon A |
| Device Class | II | II | II |
| FDA Product Code | LPL | LPL | LPL |
| Regulation | 21 CFR 886.5925 | 21 CFR 886.5925 | 21 CFR 886.5925 |
| Manufacturing Method | Lathe-cut | Lathe-cut | Lathe-cut |
| Plasma Treatment? | Yes | Yes | Yes |
| Water Content | 49% | 49% | 49% |
| Oxygen Transmissibility (Dk) | 49 (ISO/Fatt) | 49 (ISO/Fatt) | 49 (ISO/Fatt) |
| Refractive Index (Dry) | 1.470 | 1.470 | 1.470 |
| Refractive Index (Hydrated) | 1.413 | 1.413 | 1.413 |
| Specific Gravity (Dry) | 1.112 | 1.112 | 1.112 |
| Specific Gravity (Hydrated) | 1.109 | 1.109 | 1.109 |
| Shore D Hardness | ≥ 83 | > 83 | > 83 |
| Tensile Strength | 3.07 M Pa | 3.07 M Pa | 3.07 M Pa |
| Elongation at Break | 470% | 470% | 470% |
| Light Transmittance (Clear) | 96%T | 96%T | 96%T |
| Light Transmittance (Tinted) | >70%T | >70%T | >70%T |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify a "test set" or its "sample size" in a clinical trial context. This submission focuses on physicochemical characterization and non-clinical performance, comparing the new device against existing predicate devices. Therefore, the data provenance is derived from the testing of the BIOLENS (mangofilcon A) and the properties of the predicate devices, which are also mangofilcon A lenses. It's an engineering and material science assessment rather than a clinical study with a patient test set. No country of origin for specific "data" is mentioned, but the submission is to the US FDA. The data would be considered retrospective in the sense that it relies on existing knowledge and characterization of the material (mangofilcon A) and the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The submission is a 510(k) premarket notification for a Class II medical device (contact lenses) and relies on demonstrating substantial equivalence through non-clinical data (i.e., material properties and performance characteristics), not on clinical "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable. There is no explicit "adjudication method" described, as there isn't a test set that requires expert interpretation or clinical outcome assessment in this submission.
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
This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This is not applicable. The device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established physicochemical properties and performance characteristics of the mangofilcon A material and the predicate devices, as determined through various non-clinical tests (e.g., Dk measurements, refractive index, tensile strength). It's based on material science and engineering characterization data. No pathology, expert consensus on clinical images, or outcomes data is mentioned as a "ground truth" source in this context.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an AI/machine learning model. The submission is for a physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no "training set" for this 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.