(80 days)
CIBA VISION® (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
CIBA VISION® Toric (lotrafilcon B) 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 6.00 diopters (D) or less of astigmatism.
CIBA VISION® Multifocal (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 of astigmatism.
CIBA VISION® Multifocal Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of refractive and/or corneal astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
CIBA VISION® spherical (lotrafilcon 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 and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
CIBA VISION® toric (lotrafilcon 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 10.00 diopters (D) or less of astigmatism.
CIBA VISION® multifocal (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 of astigmatism.
CIBA VISION® multifocal toric (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
In addition, CIBA VISION® (lotrafilcon A) lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.
The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lenses contain the color additive phathalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.
Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal 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: -20.00D to +20.00D
• Center Thickness: varies with design and power (0.08 mm for -3.00D spherical)
Lenses have the following properties:
- Refractive index: 1.4217 (hydrated)
- Light transmittance: > 94 %
- Water content : 33% by weight in normal saline
- Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)} measured at 35°C (intrinsic Dk-Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845.
The lens material is 24% water and 76% lotrafilcon A, a fluoro-silicone containing hydrogel which is surface treated. Lenses may be clear or contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.
Lotrafilcon A lens designs include spherical, toric, multifocal and toric multifocal 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: -20.00D to +20.00D
- Center Thickness: varies with power (0.080 mm for -3.00D spherical)
Lenses have the following properties:
- Refractive index: 1.4271 (hydrated)
- Light transmittance: > 94 %
- Water content : 24% by weight in normal saline
- Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845.
The provided text describes Lotrafilcon B and Lotrafilcon A Soft Contact Lenses. The "acceptance criteria" discussed are primarily tied to demonstrating substantial equivalence to predicate devices through non-clinical testing. This is not a study proving a device meets specific performance criteria in the way a clinical trial for a diagnostic AI might, but rather demonstrating that a modified version of an already approved device maintains its safety and effectiveness.
Here's an attempt to structure the information based on your request, understanding that the nature of this submission (510(k) for contact lenses) is primarily about equivalence rather than novel AI performance.
Acceptance Criteria and Study for Lotrafilcon B and Lotrafilcon A Soft Contact Lenses
The primary acceptance criterion for the Lotrafilcon B and Lotrafilcon A soft contact lenses, as described in these 510(k) summaries, is Substantial Equivalence to their respective predicate devices. This means that the modified devices (lenses packaged with saline additive) must demonstrate that they are as safe and effective as the previously cleared versions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Demonstrating Substantial Equivalence via Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Not toxic and non-irritating (Material and Extracts Biocompatibility) | The lens material and extracts of the modified devices (Lotrafilcon B and Lotrafilcon A) are equivalent to the predicate and remain non-toxic and non-irritating. (Tested in accordance with GLP regulation 21 CFR Part 58). |
| Consistent physical and material properties | Lens physical and material properties of the modified devices (Lotrafilcon B and Lotrafilcon A) are consistent with industry marketed lenses, and equivalent or better than the predicate lens. |
| Compatibility with common lens care products | Finished lenses (Lotrafilcon B and Lotrafilcon A) are compatible with commonly available lens care products. (Note: Disinfection must be chemical, not heat). |
| Water Content | Lotrafilcon B: 33% water, equivalent to predicate and similar to other daily wear soft contact lenses. |
| Lotrafilcon A: 24% water, equivalent to predicate and similar to other daily wear soft contact lenses. | |
| Ionic Characteristics | Both Lotrafilcon B and Lotrafilcon A: FDA Group I (low water, nonionic), equivalent to predicate and similar to other daily wear soft contact lenses. |
| Indications for Use | Both Lotrafilcon B and Lotrafilcon A: Indications for use are equivalent to the predicate and similar to other daily wear soft contact lenses. These include correction of refractive ametropia (myopia and hyperopia) for spherical, toric, multifocal, and multifocal toric lenses. |
| Additionally for Lotrafilcon A: Therapeutic use as a bandage to protect the cornea and relieve pain in specific ocular pathologies and post-surgical conditions. | |
| Shelf-Life/Sterility/Package Integrity | Compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products. Packaged lenses are effectively steam sterilized in a validated autoclave. Expiration date established through stability studies. Shelf-life studies are ongoing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of individual patient data or image datasets with sample sizes. The testing largely involved non-clinical laboratory evaluations of the device materials and properties.
- Sample Size for Test Set: Not applicable in the context of individual patient data; refers to materials testing.
- Data Provenance: The studies were non-clinical, conducted in accordance with regulations like GLP (Good Laboratory Practice) (21 CFR Part 58). Based on the submitter information, CIBA VISION Corporation is located in Duluth, Georgia, USA, implying testing was likely conducted in the USA or supervised according to US regulations. The studies are by nature prospective (i.e., conducted for the purpose of this submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not explicitly provided. For "ground truth" in non-clinical materials testing, it would typically be established by laboratory standards and validated analytical methods, not by human experts adjudicating individual cases.
4. Adjudication Method for the Test Set
Not applicable. The testing was non-clinical and involved laboratory analyses and measurements of material properties against established standards and comparison to a predicate device, rather than subjective evaluation requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These are contact lenses, not a diagnostic AI device requiring human reader performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm, which is not applicable here as the device is a physical medical device (contact lenses), not an AI/software device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Established standards and validated analytical methods for material properties (e.g., Dk, water content, refractive index, light transmittance).
- Biocompatibility testing guidelines (e.g., ISO 10993 series, implicitly followed by GLP compliance) to determine toxicity and irritation.
- Comparison to the known properties and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
§ 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.