(109 days)
No
The document describes contact lenses and their physical properties and intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The product is indicated for "optical correction of refractive ametropia" and "presbyopia", which means it corrects vision, it does not treat or cure any disease.
No
The device is a soft contact lens intended for optical correction of refractive ametropia and presbyopia, not for diagnosing conditions.
No
The device description clearly states that the device is a physical contact lens made from delefilcon A, a silicone hydrogel material. It describes physical properties like water content, oxygen permeability, and dimensions. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are soft contact lenses for the optical correction of refractive ametropia and presbyopia. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the contact lenses, not on any components or processes used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for the diagnosis of a disease or condition based on in vitro testing.
The device is a medical device, specifically a contact lens, used for vision correction.
N/A
Intended Use / Indications for Use
DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1 for ASTIGMATISM (delefilcon A) soft contact leases are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to 6.00 diopters (D) of astigmatism.
DAILIES TOTAL 1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be used 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.
Product codes
LPL, MVN
Device Description
The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).
Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.
Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric 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 (0.09 mm for -3.00D spherical)
Lenses have the following properties: - Refractive index: 1.42 (hydrated)
- Water content: 33% by weight in normal saline
- Oxygen permeability: 140 barrer units measured at 35 °C (intrinsic Dk - Coulometric method)
- % Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm)
- UVA (315-380 nm):
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 18, 2019
Alcon Laboratories, Inc. Martina Heim Global Project Regulatory Director, Global Regulatory Affairs, Vision Care 6201 South Freeway Fort Worth, TX 76134
Re: K182782
Trade/Device Name: DAILIES TOTAL1 Soft Contact Lenses: DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 17, 2018 Received: December 21, 2018
Dear Martina Heim:
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 (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.html; 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 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 yours,
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)
Device Name DAILIES TOTAL 1 soft contact lenses: DAILIES TOTAL 1, DAILIES TOTAL 1 Asphere, DAILIES TOTAL 1 for ASTIGMATISM, DAILES TOTAL 1 Multifocal, DAILIES TOTAL 1 Multifocal Toric
Indications for Use (Describe)
DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1 for ASTIGMATISM (delefilcon A) soft contact leases are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to 6.00 diopters (D) of astigmatism.
DAILIES TOTAL 1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be used 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.
Submitter of the 510(k) I.
| Company: | Alcon Laboratories, Inc. | ||
|---|---|---|---|
| 6201 South Freeway | |||
| Fort Worth, TX 76134-2099, USA | |||
| Primary Contact Person: | Martina Heim, Ph.D., RAC | ||
| Phone: | (678) 415-3565 | ||
| Fax: | n/a | ||
| Email: | Martina.Heim@alcon.com | ||
| Back up Contact Person: | Sherri Lakota | ||
| Phone: | (817) 615-5472 | ||
| Fax: | 817-302-4574 | ||
| Email: | Sherri.Lakota@alcon.com | ||
| Date Prepared: | 17 December 2018 |
II. Devices Subject to this 510(k)
| Trade Names: | DAILIES TOTAL1® soft contact lenses:
DAILIES TOTAL1®, DAILIES TOTAL1® Asphere,
DAILIES TOTAL1® for ASTIGMATISM, DAILIES
TOTAL1® Multifocal, DAILIES TOTAL1® Multifocal
Toric
Alternate family trade name: DAILIES TOTAL1® PRO |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft contact lens |
| Classification Name: | Soft (hydrophilic) contact lens [for daily wear] |
| Device Classification: | 21 CFR 886.5925 (b) (1) |
| Product Code: | LPL, MVN |
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III. Predicate Device
The subject device is a modification of the currently commercialized DAILIES TOTAL 10 (delefilcon A) soft contact lens. The predicate DAILIES TOTAL1 soft contact lenses have received FDA clearance per Premarket Notification 510(k) K113168, with recent updates cleared under K180398 and K180669.
IV. Device Description
The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).
Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.
Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric lenses in the following parameter range:
- 13.0 to 15.0 mm . Diameter Range:
| • Base Curve Range: | 8.0 to 9.2 mm |
|---|---|
| • Power Range: | -20.00D to +20.00D |
| • Center Thickness: | varies with design and power |
- (0.09 mm for -3.00D spherical)
Lenses have the following properties:
| • Refractive index: | 1.42 (hydrated) |
|---|---|
| • Water content: | 33% by weight in normal saline |
| • Oxygen permeability | 140 barrer units |
| measured at 35 °C (intrinsic Dk - Coulometric method) |
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- % Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm) . UVA (315-380 nm):