(28 days)
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses with refractive power, are indicated for the optical correction of refractive ametropia (myopia, hyperopia ) in not-aphakic persons with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES® Colors Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES® Colors Progressives (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses (with or without corrective power) also act to enhance or alter the apparent color of the eye.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses are to be prescribed for single-use daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The subject device, DAILIES Colors contact lenses, are a modification of the currently commercialized FreshLook® One-Day (nelfilcon A) color contact lenses. DAILIES Colors are soft contact lenses intended for the optical correction of refractive error, and the enhancement or alteration of the apparent color of the eye. Geometries include spherical, toric, and multifocal lens designs.
DAILIES Colors lenses are composed of nelfilcon A, which is a non-ionic, hydrophilic lens material, that consists of approximately 69% water and 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are pad printed with intermittent ink layers containing a combination of the following color additives, approved for use in color contact lenses: chromium oxide, iron oxides, [phthalocyaninato (2- )] copper, phthalocyanine green, and titanium dioxide.
Lens designs for DAILIES Colors (nelfilcon A) lenses include spherical, toric, and multifocal lenses in the following parameter range:
• 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 (0.100 mm for -3.00D spherical)
Lenses have the following properties:
• Refractive index: 1.38 (hydrated)
• Water content: 69% by weight in normal saline
• Oxygen permeability 26 barrer units at 35 °C (Fatt corrected)
• % Light transmittance > 88% (average over 380-780 nm)
Lenses are provided in sterile packages of foil-sealed blister-packs containing buffered saline.
The provided text is a 510(k) summary for new contact lenses. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a test set, ground truth, and expert evaluation in the way a diagnostic AI device would.
Therefore, the information required to answer the prompt directly, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for diverse test sets, establishment of ground truth by multiple experts, and comparative effectiveness studies, is not present in this document.
This document states that the scope of the device modification did not necessitate clinical testing and instead relies on non-clinical testing (biocompatibility and process validation) to verify equivalence to the predicate device.
However, I can extract what is provided regarding the "acceptance criteria" and "device performance" within the context of this 510(k) summary:
- Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is substantial equivalence to the predicate device, FreshLook® One-Day (nelfilcon A) color contact lenses (K050213, K180398, K180669). This is demonstrated by showing that the modified device (DAILIES® Colors) has:
- The same material properties (Nelfilcon A, 69% water content, 26 barrer oxygen permeability, 1.38 refractive index, >88% light transmittance).
- The same manufacturing method (Lightstream Technology: Full mold cast, integrated print step).
- The same sterilization method (Steam sterilization).
- The same packaging (Blister pack) and storage solution.
- The same intended use and indications for use.
- Successful biocompatibility testing and process validation (implicitly meeting established safety standards for contact lenses, which are the acceptance criteria for these tests).
- Clinical performance similar to the predicate device (implied by not requiring new clinical testing due to the nature of the modification).
Since the document explicitly states that clinical testing was not necessitated due to the nature of the modification (an altered print pattern), the concepts of a test set, expert-established ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.
Here's how I can address the prompts based only on the provided text, noting where information is absent:
Acceptance Criteria and Device Performance for DAILIES® Colors Contact Lenses
Given that this 510(k) summary is for a medical device (contact lenses) and not a diagnostic AI/algorithm, the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Material Properties: Must be equivalent to predicate (Nelfilcon A, 69% water, 26 barrer O2 permeability, 1.38 refractive index, >88% light transmittance). | Equivalent. • Nelfilcon A: Same • Water Content: 69%, by weight • Oxygen Permeability: 26 barrer units @ 35 °C • Refractive Index: 1.38 (hydrated) • % Light Transmittance: > 88% (average over 380-780 nm) |
| Manufacturing Method: Must be equivalent to predicate (Lightstream Technology: full mold cast, integrated print step). | Equivalent. • Manufacturing Method: Lightstream Technology: Full mold cast, integrated print step • Print Technology: In-mold pad print technology |
| Sterilization: Must be equivalent to predicate (Steam sterilization). | Equivalent. • Sterilization: Steam sterilization in validated autoclave |
| Biocompatibility: Must be confirmed through appropriate testing. | Successful. • Biocompatibility: Biocompatible as confirmed by appropriate biocompatibility testing (stated as being "Successful biocompatibility testing") |
| Process Validation: Must verify equivalence to the predicate device. | Successful. • Process Validation: Successfully completed for the modified device to verify equivalence to the predicate device. Results met the acceptance criteria accordingly. |
| Indications for Use: Must be substantially equivalent. | Equivalent. • Indications for Use: Same as predicate. (Corrected refractive ametropia, presbyopia, and enhance/alter eye color for single-use daily disposable wear). |
| Safety and Efficacy: Must be demonstrated. | Demonstrated. • "The cumulative results of all performance testing demonstrate the safety, efficacy, and performance of the modified device and thus, the substantial equivalence to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of diagnostic performance testing. The "testing" referred to is biocompatibility and manufacturing process validation. Sample sizes for these types of engineering/chemistry tests are typically determined by relevant ISO standards or internal quality protocols, and are not detailed in this summary.
- Data Provenance: Not applicable in the context of diagnostic performance testing. The tests are non-clinical (biocompatibility, process validation) and are implicitly performed by/for the manufacturer (Alcon Laboratories, Inc., Fort Worth, TX).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission does not involve diagnostic ground truth establishment by experts for image interpretation or similar tasks. Biocompatibility testing follows established lab protocols and standards, and process validation is an engineering/manufacturing assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a "test set" in the diagnostic sense is mentioned or implied.
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 not a study of AI assistance for human readers. The document explicitly states: "The scope of the device modification did not necessitate clinical testing, in order to establish safety or efficacy."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not a submission for an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, "ground truth" relates to material specifications (chemical composition, physical properties), manufacturing process parameters, and standard biocompatibility assay results. These are established through validated laboratory tests and engineering specifications, not expert consensus on clinical cases or pathology.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 6, 2019
Alcon Laboratories, Inc. Heather Smith Regulatory Affairs Specialist 6201 South Freeway Fort Worth, TX 76134-2099
Re: K190045
Trade/Device Name: DAILIES® Colors, DAILIES® Colors Toric, DAILIES® Colors Progressives Alternate family trade name: FreshLook® One-Day color contact lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 3, 2019 Received: January 9, 2019
Dear Heather Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190045
Device Name
DAILIES® Colors; DAILIES® Colors Toric; DAILIES® Colors Progressives Alternate family trade name: FreshLook® One-Day color contact lenses
Indications for Use (Describe)
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses with refractive power, are indicated for the optical correction of refractive ametropia (myopia, hyperopia ) in not-aphakic persons with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES® Colors Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES® Colors Progressives (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses (with or without corrective power) also act to enhance or alter the apparent color of the eye.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses are to be prescribed for single-use daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA |
|---|---|
| Primary Contact Person: | Heather Smith |
| Phone: | (678) 415-6884 |
| Fax: | n/a |
| Email: | Heather.Smith@alcon.com |
| Back up Contact Person: | Martina Heim |
| Phone: | (678) 415 3565 |
| Fax: | n/a |
| Email: | Martina.Heim@alcon.com |
| Date Prepared: | 03 January 2019 |
II. Devices Subject to this 510(k)
| Trade Names: | DAILIES® Colors |
|---|---|
| DAILIES® Colors Progressives | |
| DAILIES® Colors Toric | |
| Alternate family trade name: FreshLook® One-Day colorcontact lenses | |
| Common Name: | Soft Contact Lens |
| Classification Name: | Soft (Hydrophilic) Contact Lens [for daily wear] |
| Device Classification: | Class II [21 CFR 886.5925 (b)(1)] |
| Product Code: | LPL, MVN |
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III. Predicate Device
The predicate lens FreshLook® One-Day (nelfilcon A) colors contact lenses received FDA clearance under Premarket Notification 510(k) K050213, with recent updates cleared under K180398 and K180669.
Device Description IV.
The subject device, DAILIES Colors contact lenses, are a modification of the currently commercialized FreshLook® One-Day (nelfilcon A) color contact lenses. DAILIES Colors are soft contact lenses intended for the optical correction of refractive error, and the enhancement or alteration of the apparent color of the eye. Geometries include spherical, toric, and multifocal lens designs.
DAILIES Colors lenses are composed of nelfilcon A, which is a non-ionic, hydrophilic lens material, that consists of approximately 69% water and 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are pad printed with intermittent ink layers containing a combination of the following color additives, approved for use in color contact lenses: chromium oxide, iron oxides, [phthalocyaninato (2- )] copper, phthalocyanine green, and titanium dioxide.
Lens designs for DAILIES Colors (nelfilcon A) lenses include spherical, toric, and multifocal lenses in the following parameter range:
| • 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(0.100 mm for -3.00D spherical) |
Lenses have the following properties:
| • Refractive index: | 1.38 (hydrated) |
|---|---|
| • Water content: | 69% by weight in normal saline |
| • Oxygen permeability | 26 barrer units at 35 °C (Fatt corrected) |
| • % Light transmittance | > 88% (average over 380-780 nm) |
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Lenses are provided in sterile packages of foil-sealed blister-packs containing buffered saline.
V. Indications for Use
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses, with refractive power, are indicated for the optical correction of refractive ametropia (myopia and hyperopia ) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES® Colors Toric (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with nondiseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES® Colors Progressives (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia), in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses (with or without corrective power) also act to enhance or alter the apparent color of the eye.
DAILIES® Colors (nelfilcon A) One-Day Contact Lenses are to be prescribed for single-use daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
VI. Comparison to Technological Characteristics with the Predicate Device
The design modification for DAILIES Colors involves addition of a modified print pattern, with a larger, more pronounced outer diameter and a less pronounced inner print pattern, utilizing the same, currently approved color additives as applied in FreshLook One-Day color contact lenses.
The following table summarizes the characteristics of the modified device as compared to the commercially available predicate device.
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| Predicate Device | Modified Device | |
|---|---|---|
| Trade Name (brand) | FreshLook® One-Day | Additional (alternate) trade name:DAILIES® Colors |
| 510(k) | K050213 | K190045 |
| Device ClassificationInformation | Class II [21 CFR 886.5925 (b)(1)] | Same |
| Intended Use | With refractive power:Vision correctionWith or without refractive power:Enhancement or alteration of theapparent color of the eye | Same |
| Wearing schedule | Daily wear | Same |
| Replacement schedule | Daily disposable | Same |
| Material Classification | Group 2(>50% H2O, nonionic polymer),according to ISO 18369-1: 2017 | Same |
| Lens Material | Nelfilcon A | Same |
| Power Range | -20.00D to +20.00D | Same |
| Print technology | In-mold pad print technology | Same |
| Color Additives | Chromium Oxide, Iron oxides,[phthalocyaninato (2- )] copper,phthalocyanine green, TitaniumDioxide | Same |
| Water Content | 69%, by weight | Same |
| Light Transmittance | > 88%T | Same |
| Refractive Index | 1.38 | Same |
| Oxygen Permeability | 26 barrer units @ 35 °C | Same |
| Manufacturing Method | Lightstream Technology:Full mold cast, integrated print step | Same |
| Sterilization | Steam sterilization in validatedautoclave | Same |
| Biocompatibility | Biocompatible as confirmed byappropriate biocompatibility testing | Same |
| Packaging | Blister pack | Same |
| Package Storage SalineSolution | Phosphate-acetate buffered salinesolution with up to 0.05%Poloxamer 108 | Same |
Table 1: Substantial Equivalence Comparison
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In accordance with the criteria for claims of substantial equivalence in the FDA Guidance document Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the information provided herein supports the claim of substantial equivalence to the lens with an existing USAN name and the same manufacturing process.
VII. Performance Data
Performance testing was conducted in consideration of the May 1994 FDA Guidelines entitled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses. The modified device underwent a successful process validation to verify equivalence to the predicate device. Results met the acceptance criteria accordingly.
Non-clinical testing
Successful biocompatibility testing as well as process validation were completed for the modified device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met.
Stability testing for the predicate device continues to support the labeled expiration date.
Clinical testing
The scope of the device modification did not necessitate clinical testing, in order to establish safety or efficacy.
Substantial Equivalence
DAILIES® Colors, DAILIES® Colors Toric, and DAILIES® Colors Progressives (nelfilcon A) one-day contact lenses are substantially equivalent to the predicate lenses and similar to other daily wear contact lenses, in terms of water content (69% water, by weight) and ionic characteristics (FDA Group II (>50% H2O, non-ionic polymer)).
VIII. Conclusions
The cumulative results of all performance testing demonstrate the safety, efficacy, and performance of the modified device and thus, the substantial equivalence to the predicate device.
DAILIES Colors (nelfilcon A) one day contact lenses, with a modified print pattern, are substantially equivalent to the predicate lens in terms of material properties, biocompatibility, clinical performance, and indications for use.
§ 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.