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510(k) Data Aggregation
(178 days)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. - Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate) | Reported Device Performance (Aquamax Etafilcon A) |
|---|---|---|
| Technological Characteristics | ||
| Production Method | Cast-Molded (K120028, K962804, K991134) | Cast-Molded |
| USAN Name | Etafilcon A (K120028, K962804, K991134) | Etafilcon A |
| Material Classification | Group 4 (High Water Ionic) (K120028, K962804, K991134) | Group 4 (High Water Ionic) |
| Water Content (%) | 58% (K120028, K962804, K991134) | 58% |
| Refractive Index | 1.402 (K120028), 1.40 (K962804, K991134) | 1.402 |
| Oxygen Permeability (Dk) (x 10⁻¹¹ (cm²/sec)(ml O₂/ml-mmHg) @ 35°C) (edge corrected) | 19.73 (K120028), 26 (K962804), 26.3 (K991134) | 19.73 |
| Percent Transmittance (% T) at 593nm | > 95% (K120028), > 85% (K962804, K991134) | > 95% |
| Percent Transmittance (% T) at 380-315nm (UVA) | < 50% (K120028), < 30% (K962804, K991134) | < 50% |
| Percent Transmittance (% T) at 315-280nm (UVB) | < 5% (K120028, K962804, K991134) | < 5% |
| Lens Design | Spherical, Aspherical (K120028); Spherical, Toric, Multifocal, Toric Multifocal (K962804); Spherical, Bifocal, Toric, Toric Bifocal (K991134) | Spherical, Aspherical, Toric, Multifocal |
| Packaging Solution | Borate buffered saline (K120028), N/A (K962804, K991134) | Borate buffered saline (with Tween 80, Sodium hyaluronate and Polyethylene Glycol) |
| Biocompatibility | Negative responses for standard tests | Negative responses for all tests |
| Microbiology | Minimum SAL of 10⁻⁵ | Steam sterilization validated to deliver minimum SAL of 10⁻⁵ |
| Shelf-life Sterility | Stereo through expiration date claimed | Lenses remained sterile for 5 years (accelerated conditions) |
| Bacteriostatic Validation | Microorganisms killed under tested conditions vs. control | Steam sterilizer effective, tested microorganisms killed |
| Leachability | No leachable monomers and additive residues at detection levels | No leachable monomers and additive residues at detection levels |
| pH and Osmolality of Packaging Solution | Within normal range for commercial soft lens (Consistent with K120028) | Within normal range, consistent with K120028 |
| Manufacturing Verification (for Toric & Spherical Multifocal) | Meet prescribed specifications with established tolerances for diameter, power, and base curve (per 1994 FDA Guidance) | Verification studies conducted and ensured lenses met specifications/tolerances |
2. Sample Sizes Used for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for most tests in quantitative terms (e.g., number of lenses, number of animals). The document indicates "All tests were conducted" and "Studies were conducted to determine leachable materials," implying standard testing protocols were followed, which would inherently involve specific sample sizes per test type (e.g., for cytotoxicity, sensitization, ocular irritation, material property measurements) but these numbers are not detailed in this summary.
- Data Provenance: The studies were conducted by Pegavision Corporation (Taiwan). The report implies that these were internal studies to support the 510(k) submission. Therefore, it is retrospective in the sense that the data was generated to support the application, but the tests themselves would have been conducted prospectively on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided in the summary. For non-clinical tests (biocompatibility, material characteristics, microbiology), "ground truth" is typically established by laboratory standards and validated methods rather than expert consensus on individual observations. For manufacturing verification, engineers and quality control personnel would assess against specifications.
4. Adjudication Method for the Test Set
- This information is not applicable in the context of these non-clinical, objective tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, patient-reported outcomes) from multiple readers or clinicians require reconciliation for ground truth establishment.
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, an MRMC comparative effectiveness study was not done.
- This device is a physical medical device (contact lenses), not an AI/software device that assists human readers. Therefore, this type of study is completely irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done.
- As established above, this is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
- For the non-clinical tests described:
- Material properties: Measured values compared against established standards and values of predicate devices.
- Biocompatibility: Negative responses (absence of toxicity, sensitization, irritation) based on standardized in vitro and in vivo models.
- Microbiology/Sterility: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validation studies using microbiological indicators and established protocols.
- Leachability: Absence of detectable levels of specific substances using analytical chemistry methods.
- Manufacturing Verification: Conformance to engineering specifications and tolerances for physical dimensions (diameter, power, base curve).
8. The Sample Size for the Training Set
- Not applicable. This device is a manufactured product, not an AI model requiring a training set. The term "training set" is typically associated with machine learning and AI algorithms.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
Summary of the Study per the Document:
The study presented in this 510(k) summary is a series of non-clinical, laboratory-based tests designed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) contact lenses and their substantial equivalence to legally marketed predicate devices. The "study" encompasses:
- Technological Characteristics Comparison: Direct comparison of material properties and design specifications with three predicate devices (K120028, K962804, K991134). The current device largely matches the most relevant predicate (K120028) for key properties like oxygen permeability and percentage transmission, and is in acceptable ranges for others.
- Biocompatibility Testing: According to standard cytotoxicity, maximization sensitization, and ocular irritation tests.
- Microbiology and Sterilization Validation: Validation of the steam sterilization process to ensure a minimum SAL of 10⁻⁵ and demonstration of sterility throughout the shelf life.
- Bacteriostatic Validation: Testing of the steam sterilizer's effectiveness in killing microorganisms.
- Leachability Studies: To confirm the absence of leachable monomers and additive residues.
- Manufacturing Verification Studies: For the new toric and multifocal lens designs, ensuring they meet specified tolerances for key parameters like diameter, power, and base curve.
The overarching "study" proves adherence to the "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses" (May 1994) and establishes substantial equivalence based on these non-clinical tests. Clinical studies were deemed "not required" due to the well-documented safety and effectiveness of etafilcon A lenses and the similarity to predicate devices.
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(71 days)
NaturalVue (etafilcon A) Sphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for single-use disposable wear.
The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
The provided text is a 510(k) summary for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. This document does not describe a study that uses AI or machine learning to determine performance against acceptance criteria. Instead, it describes non-clinical tests to demonstrate the safety and effectiveness of the contact lenses.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as they relate to AI/ML device evaluations.
However, I can extract the acceptance criteria and reported device performance from the non-clinical studies described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are based on demonstrating substantial equivalence to a predicate device (K140025 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses) and compliance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses. Where specific numerical acceptance criteria are not explicitly stated, the equivalence to the predicate device serves as the implicit acceptance criterion.
| Characteristic | Acceptance Criteria (Implicitly: Equivalent to Predicate K140025 or regulatory standards) | Reported Device Performance (NaturalVue (etafilcon A)) | Meets Acceptance Criteria? |
|---|---|---|---|
| Material Properties | |||
| Production Method | Cast-Molded (per predicate) | Cast-Molded | Yes |
| USAN Name | etafilcon A (per predicate) | etafilcon A | Yes |
| Material Classification | Group 4 high water ionic (per predicate) | Group 4 high water ionic | Yes |
| Water Content (%) | 58% (per predicate) | 58% | Yes |
| Refractive Index | 1.4023 (per predicate) | 1.4023 | Yes |
| Oxygen Permeability | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C (per predicate) | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C | Yes |
| % Transmittance at 593nm | > 95% (per predicate) | > 95% | Yes |
| % Transmittance at 380-315nm | < 30% (per predicate) | < 30% | Yes |
| % Transmittance at 315-280nm | < 5% (per predicate) | < 5% | Yes |
| Biocompatibility | Negative responses for cytotoxicity, maximization, and ocular irritation (per predicate). Validity of blister packaging (passing standard extraction tests). | Negative responses for all tests. Blister packaging validity demonstrated. | Yes |
| Microbiology | Minimum SAL of 10-9 for steam sterilization. Sterility maintained through expiration. | Validated to deliver SAL of 10-9. Shelf-life stability supports sterility. | Yes |
| Bacteriostatic Validation | Uniformity of temperature in sterilizer; Tested microorganisms killed. | Demonstrated uniformity of temperature; Tested microorganisms killed. | Yes |
| Shelf-Life | Lenses remain sterile and packages remain tight for claimed expiration. | Lenses remained sterilized with no microbial growth for 4 years (accelerated conditions). Seal remained tight for 4 years (accelerated conditions). | Yes |
| Leachability | No leachable monomers and additive residues at detection levels. | No leachable monomers and additive residues at detection levels. | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML device. For non-clinical material property testing, the sample sizes are not explicitly stated. The biocompatibility, microbiology, and leachability studies were conducted on the predicate device (K140025) and applied to the current device due to substantial equivalence, so the specifics of their sample sizes are not in this document.
Data Provenance: The document refers to the predicate device (K140025), which was submitted by Pegavision Corporation, Taiwan. The current device is from Visioneering Technologies, Inc., and the non-clinical tests were performed to demonstrate equivalence. It's a non-clinical, retrospective comparison to previously established data and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device, and no "ground truth" established by experts for a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication is described for this type of device and study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. This is not an AI/ML device, and thus, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device or an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML. For the non-clinical tests, "ground truth" would be the established scientific and regulatory standards for contact lens material properties, biocompatibility, sterility, and leachability. For example:
- Material Properties: Direct measurements using laboratory techniques.
- Biocompatibility: Standardized in vitro and in vivo (animal, if applicable, though not specified here) tests.
- Microbiology: Validation of sterilization processes and sterility testing.
- Leachability: Analytical chemistry techniques.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is described.
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(282 days)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric: Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal: Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric: Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. - Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks):
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric: Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal: Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric: Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. - NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric: NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal: NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric: NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
This document is a 510(k) premarket notification for three types of soft contact lenses: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices based on material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. There are no explicit quantitative acceptance criteria stated beyond "complying with the requirement of FDA Group 4" for sterilization. Differences in oxygen permeability and percent transmittance are evaluated against the predicate devices.
| Criteria/Property | Acceptance Criteria (Implied by Predicate) | Proposed Device (Aquamax/NaturalVue Etafilcon A) Reported Performance |
|---|---|---|
| Material Properties | ||
| Production Method | Cast-Molded (for K120028 & K962804 predicates) | Cast-Molded |
| USAN Name | Etafilcon A (for K120028 & K962804 predicates) | Etafilcon A |
| Material Classification | Group 4 high water ionic (for K120028 & K962804 predicates) | Group 4 high water ionic |
| Water Content (%) | 58% (for K120028 & K962804 predicates) | 58% |
| Refractive Index | 1.4023 (for K120028 predicate) | 1.4023 |
| Oxygen Permeability (Dk) @ 35°C | Approx. $19.73 \times 10^{-11}$ (K120028) to $21.4 \times 10^{-11}$ (K962804) | $19.73 \times 10^{-11}$ (cm²/sec)(ml O₂/ml-mmHg) |
| Percent Transmittance % T at 593nm | > 95% (for K120028 & K013445 predicates), > 85% (for K962804 predicate) | > 95% |
| % T at 380-315nm (UVA) | < 30% (for K120028 & K962804 predicates) | < 30% |
| % T at 315-280nm (UVB) | < 5% (for K120028 & K962804 predicates) | < 5% |
| Biocompatibility | Negative responses for cytotoxicity, maximization, and ocular irritation | Negative responses recorded for all tests |
| Microbiology (Sterilization) | Minimum SAL of 10-6 (FDA Group 4 requirement) | Validated to deliver a minimum SAL of 10-6 |
| Bacteriostatic Validation | Effective killing of microorganisms, sterility maintained (5 years) | Steam sterilizer effective, no microbial growth for 5 years |
| Leachability | No leachable monomers and additive residues at detection levels | No leachable monomers and additive residues at detection levels |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical study with a specific sample size. The evaluation relies heavily on non-clinical tests comparing the device's properties to legally marketed predicate devices.
- Data Provenance: The document explicitly states that "Aquamax (Etaflicon A) Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K120028 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned ACUVUE predicate (and reference) devices." This indicates a reliance on the historical performance and existing regulatory clearances of similar devices.
- Non-Clinical Tests: These tests would involve laboratory samples of the contact lenses. The specific number of contact lenses or batches tested for each non-clinical criterion (e.g., water content, Dk, transmittance, biocompatibility) is not provided. The provenance of these laboratory samples (e.g., country of manufacture) is implicitly Taiwan, where Pegavision Corporation is located. These would be retrospective in the sense that they are conducted on manufactured devices for regulatory submission, rather than a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no "test set" in the context of clinical data requiring expert review for ground truth. The evaluation is based on non-clinical laboratory testing and equivalence to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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 information is not applicable. This submission is for a medical device (contact lenses), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a contact lens and not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Laboratory measurements/standards: For material properties (water content, Dk, transmittance, refractive index), biocompatibility (standard cytotoxicity, maximization, ocular irritation tests), microbiology (sterilization SAL), bacteriostatic validation, and leachability. These are objective, quantifiable measurements against established scientific and regulatory standards.
- Demonstrated equivalence to predicate devices: The "ground truth" for the overall safety and effectiveness is largely based on the fact that the proposed devices are substantially equivalent to previously cleared devices (K120028, K013445, K962804) which have established safety and effectiveness profiles through prior regulatory review and historical clinical use.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
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(76 days)
The MIERU (etafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The MIERU (etafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D or less.
The MIERU (etafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1 - trimethylol propane trimethacrylate glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.3121. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the MIERU Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for MIERU averages > 99% in the UVB range of 280nm - 315nm and 83% in the UVA range of 316 - 380nm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out. it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are: Refractive Index 1.4050 (wet), Light Transmission (clear) greater than 95%, Light Transmission (tinted) greater than 91%, Water Content 58 %, Specific Gravity 1.017 (hydrated), Oxygen Permeability 19.9 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
Here's a breakdown of the acceptance criteria and study information for the MIERU (etafilcon A) Daily Wear Contact Lens, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
This 510(k) submission doesn't explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, the study focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. The acceptance criteria are implicitly met if the new device's properties are comparable to or within acceptable ranges of the predicate devices.
Here's a table summarizing the key technological characteristics considered for equivalence:
| Pre-Clinical Equivalency / Device | ClearLab800 (etafilcon A) (New Device) | Frequency 58 (etafilcon A) (Predicate) | AcuVue 2 (etafilcon A) (Predicate) | Igel 55 UV (methafilcon A) (Predicate) | Reported Device Performance (ClearLab800) |
|---|---|---|---|---|---|
| Intended Use | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Matches intended use of predicates |
| Functionality | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Matches functionality of predicates |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Matches indications of predicates |
| Production Method | Cast-molded | Cast-molded | Cast-molded | Cast-molded | Cast-molded |
| FDA Group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | etafilcon A | etafilcon A | etafilcon A | methafilcon A | etafilcon A |
| Water Uptake (%) | 58.0% | 58.0% | 58.0% | 55.0% | 58.0% |
| Oxygen Permeability | 19.9 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 20.2 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.9 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.6 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.9 x 10^-11 (cm²/sec) |
| Specific Gravity | 1.017 | 1.054 | 1.021 | 1.062 | 1.017 |
| UV Blocking (UVB) | Averages > 99% | Not explicitly stated in table | Not explicitly stated in table | Not explicitly stated in table | > 99% |
| UV Blocking (UVA) | 83% | Not explicitly stated in table | Not explicitly stated in table | Not explicitly stated in table | 83% |
Summary of Non-Clinical Performance Data (Used to demonstrate equivalence):
The device underwent the following non-clinical tests as recommended by the Premarket Notification 510(k) guidance document for Daily Wear Contact Lenses, revised May 1994:
- Toxicology testing:
- Cytotoxicity
- USP Ocular Irritation
- USP Systemic Injection
- Leachability / Residual monomer Studies
- Physicochemical property testing
The conclusion drawn from these studies was that the MIERU Soft Contact Lens is substantially equivalent to the predicate devices and does not raise different questions of safety and effectiveness.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials. The data presented for the new device (ClearLab800 etafilcon A) are physical and chemical properties derived from laboratory testing of the device itself.
- Data Provenance: The data refers to the characteristics of the device (ClearLab800 (etafilcon A)) itself, rather than test data from patients. The origin of the raw materials for manufacturing is not specified, nor is there a mention of specific countries for testing. This is a non-clinical submission, not a clinical trial. The data is prospective in the sense that these properties were measured on the newly developed device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). This submission relies on non-clinical data (physical and chemical properties, toxicology) to demonstrate substantial equivalence to predicate devices, not on expert-adjudicated clinical outcomes for a "ground truth." The "ground truth" here is the established safety and effectiveness of the predicate devices based on their own prior approvals and the standardized methods used for material characterization and toxicology.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. As there's no clinical test set requiring expert adjudication for a diagnosis or outcome, no adjudication method was used.
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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 not an AI/CAD device. It is a contact lens. Therefore, no MRMC study was performed, and this question is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "device performance" in this context refers to the inherent physical and chemical properties of the contact lens itself, measured directly in a laboratory setting, independent of human interaction or a human-in-the-loop scenario. The non-clinical tests (toxicology, leachability, physicochemical properties) are standalone assessments of the device's characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this submission is indirectly established by the legally marketed predicate devices and the objective measurements of the new device's physical, chemical, and biological properties through standardized laboratory testing (e.g., water content, oxygen permeability, specific gravity, toxicology tests). The concept of "ground truth" derived from expert consensus or pathology, as typically used in AI/CAD imaging, does not apply here. The benchmark is the established safety and performance profile of the predicate devices.
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The sample size for the training set:
- Not applicable (N/A). This is a submission for a medical device (contact lens), not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable (N/A). As stated above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in that context.
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