(27 days)
Not Found
No
The document describes standard contact lenses and their materials, packaging, and intended use. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, which means it corrects vision rather than treating a disease or condition.
No
This device, a contact lens, is intended for the "optical correction of refractive ametropia (myopia and hyperopia)," which is a treatment or correction of vision, not a diagnostic purpose.
No
The device description clearly states it is a soft contact lens made of a specific material (nelfilcon A) and is supplied as a physical product in sterile packaging. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that these are "soft contact lenses, intended for the optical correction of refractive error." They are worn on the eye to improve vision.
- Intended Use: The intended use is for "optical correction of refractive ametropia (myopia and hyperopia)" and "optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia." This is a physical correction of vision, not a diagnostic test performed on a biological sample.
The document describes a medical device used for vision correction, not a diagnostic test.
N/A
Intended Use / Indications for Use
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear 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 AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily 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 AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia) and/or presbyopia in not-aphakic persons with non-diseased eves 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.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and ultra-high molecular weight PVA and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: Successful stability testing including biocompatibility testing, i.e. cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods, was completed for the modified device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met.
Clinical Testing: The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
September 22, 2020
Alcon Laboratories, Inc. Dr. Andreas Friese Regulatory Project Director Industriering 1 Grosswallstadt, Bavaria 63868 Germany
Re: K202448
Trade/Device Name: DAILIES AquaComfort Plus / DAILIES AquaComfort Plus FreshTech / DAILIES AquaComfort Plus Toric / DAILIES AquaComfort Plus Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 24, 2020 Received: August 26, 2020
Dear Dr. Andreas Friese:
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.
1
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 (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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202448
Device Name
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
Indications for Use (Describe)
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear 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 AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily 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 AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia) and/or presbyopia in not-aphakic persons with non-diseased eves 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.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary 8
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter Information
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-----------------|----------------------------------------------------------------------------------|
| Contact Person: | Dr. Andreas Friese, Regulatory Project Director |
| Phone: | +49 6022-240-514 |
| Fax: | +49 6022-240-512 |
| Email: | andreas.friese@alcon.com |
| Date Prepared: | August 20, 2020 |
Devices Subject to this 510(k) II.
| Trade Names: | DAILIES AquaComfort Plus,
DAILIES AquaComfort Plus FreshTech,
DAILIES AquaComfort Plus Toric,
DAILIES AquaComfort Plus Multifocal |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lenses |
| Classification Name: | Soft (Hydrophilic) Contact Lenses |
| Device Classification: | Class II [21 CFR 886.5925] |
| Product Code: | LPL, MVN |
III. Predicate Device
The 510(k) devices are a modification of the same predicate devices, i.e. DAILIES AquaComfort Plus family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearance: K181454.
4
IV. Device Description
DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and ultra-high molecular weight PVA and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
Indications for Use V.
The 510(k) devices are a modification of the same predicate devices. The Indications for Use remain the same:
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear 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 AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily 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.
5
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia 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.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
VI. Comparison of Technological Characteristics with the Predicate Device
The proposed device modification involves a labeling change in terms of an extension of the expiration dating for DAILIES AquaComfort Plus soft contact lenses.
The following matrix (Table 1) summarizes the characteristics of the modified devices as compared to the predicate devices.
| Element of
| Comparison | Predicate Device(s) | Modified Device(s) |
|---|---|---|
| Administrative / Regulatory Information | ||
| 510(k) Number | K181454 | To be assigned |
| Product Name(s) | DAILIES AquaComfort Plus, | |
| DAILIES AquaComfort Plus FreshTech, DAILIES | ||
| AquaComfort Plus Toric, DAILIES AquaComfort Plus | ||
| Multifocal | Same | |
| Device | ||
| Classification | ||
| Information | Class II, Soft (Hydrophilic) | |
| Contact Lenses, 21 CFR | ||
| 886.5925 | Same | |
| Indications For Use Information | ||
| Intended Use | One-day contact lenses for the | |
| optical correction of refractive | ||
| error. Single use, daily | ||
| disposable wear. | Same | |
| Technology Information | ||
| Lens Material | nelfilcon A | Same |
| Material | ||
| Classification | FDA Group II (>50% H2O, | |
| nonionic) | Same | |
| Element of | ||
| Comparison | Predicate Device(s) | Modified Device(s) |
| Water Content | 69% | Same |
| Visibility Tint | Light blue | Same |
| Manufacturing | ||
| Method | Lightstream Technology: | |
| Full mold cast | Same | |
| Lens Designs | Spherical, aspherical, toric, | |
| multifocal | Same | |
| Sterilization | Steam sterilization, validated | |
| autoclave | Same | |
| Primary | ||
| Packaging System | Foil blister pack: | |
| polypropylene blister shell | ||
| sealed with a polyester coated | ||
| aluminum foil lidding | Same | |
| Primary | ||
| Packaging Blister | ||
| Shell | Injection-molded poly- | |
| propylene (PP) blister shell | Same | |
| Primary | ||
| Packaging Foil | ||
| Lidding | Multi-layer laminate structure | |
| polyester-coated aluminum | ||
| foil lidding supplied by: | ||
| Constantia-Pirk Folien Huhtamaki | Same | |
| Package Storage / | ||
| Saline Solution | Phosphate-acetate buffered | |
| saline (with PEG and HPMC | ||
| additives for DAILIES Aqua- | ||
| Comfort Plus products) and up | ||
| to 0.05% Poloxamer 108 | Same | |
| Performance Specifications including any Testing | ||
| Refractive Index | 1.38 | Same |
| Light | ||
| Transmittance | $\ge$ 92%T | Same |
| Oxygen | ||
| Permeability (Dk) | 26 | Same |
| Elastic Modulus | 0.9 MPa | Same |
| Biocompatibility | Biocompatible as confirmed | |
| by biocompatibility testing | Same | |
| Shelf-life | 60 months as confirmed by | |
| shelf-life stability testing | 84 months as confirmed by | |
| shelf-life stability testing |
Table 1: Substantial Equivalence Comparison
6
Table 1: Substantial Equivalence Comparison
7
In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.
VII. Performance Data
Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses. The following performance data are provided in support of the substantial equivalence determination:
Non-clinical Testing
Successful stability testing including biocompatibility testing, i.e. cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods, was completed for the modified device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met.
Clinical Testing
The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.
VIII. Conclusions
The cumulative results of performance testing demonstrate the safety, efficacy and performance of the modified device(s) and, thus, substantial equivalence to the predicate device(s).
DAILIES AquaComfort Plus (nelfilcon A) soft contact lenses with extended shelf-life are substantially equivalent to the predicate lenses of material properties, biocompatibility, clinical performance, and indications for use.
Any differences which may exist between the modified and the predicate device do not adversely affect the established performance characteristics and safety and effectiveness profile.