DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 9, 2017 Alcon Laboratories, Inc. % Andreas Friese Principal Regulatory Specialist, Alcon GRA Vision Care Alcon / CIBA Vision GmbH Industriering 1, Grosswallstadt, DE 63868 Bayern Re: K172066 Trade/Device Name: DAILIES® AquaComfort Plus®, 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: June 29, 2017 Received: July 7, 2017 Dear 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. 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. 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. {1}------------------------------------------------ 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. 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 {2}------------------------------------------------ #### 510(k) Summary This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92. #### Submitter Information I. | Company: | Alcon Laboratories, Inc.<br>6201 South Freeway<br>Fort Worth, TX 76134-2099, USA | |-----------------|----------------------------------------------------------------------------------| | Contact Person: | Dr. Andreas Friese,<br>Principal Regulatory Specialist | | Phone: | +49 6022-240-514 | | Fax: | +49 6022-240-512 | | Email: | andreas.friese@alcon.com | | Date Prepared: | June 29, 2017 | ### II. Devices Subject to this 510(k) | Trade Names: | DAILIES® AquaComfort Plus® family soft contact lenses: | | |------------------------|-----------------------------------------------------------------------------------------------------------|--| | | DAILIES® AquaComfort Plus®,<br>DAILIES® AquaComfort Plus® Toric,<br>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: K161391, cleared November 30, 2016. {3}------------------------------------------------ # IV. Device Description DAILIES® AquaComfort Plus® are a family of soft contact lenses intended for the optical correction of refractive error. DAILIES® AquaComfort Plus® lenses are available in spherical, toric and multifocal designs. The DAILIES® AquaComfort Plus® lens material is nelfilcon A, a high water, nonionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The lens material is considered a Group II contact lens material per 1994 FDA 510(k) guidance document for daily wear contact lenses. The lens material further contains non-functionalized PVA (high- and/or 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® (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. {4}------------------------------------------------ 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 adding an alternate foil lidding material (i.e. 'Oracle 6B' lidding) from an existing approved supplier (i.e. Oracle Packaging) for use in the primary packaging (i.e. foil-blister pack container system) of DAILIES® AquaComfort Plus® family soft contact lenses. The following matrix (Table 1) summarizes the characteristics of the modified device as compared to the predicate device. | Element of<br>Comparison | Predicate Device | Modified Device | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Administrative / Regulatory Information | | | | 510(k) Number | K161391 | To be assigned | | Product Name(s) | DAILIES AquaComfort Plus,<br>DAILIES AquaComfort Plus<br>Toric,<br>DAILIES AquaComfort Plus<br>Multifocal | Same | | Device<br>Classification<br>Information | Class II, Soft (Hydrophilic)<br>Contact Lenses, 21 CFR<br>886.5925 | Same | | Indications For Use Information | | | | Intended Use | One-day contact lenses for the<br>optical correction of refractive<br>error. Single use, daily<br>disposable wear. | Same | | Technology Information | | | | Lens Material | nelfilcon A | Same | | Material<br>Classification | FDA Group 2 (>50% H2O,<br>nonionic) | Same | | Element of<br>Comparison | Predicate Device | Modified Device | | Water Content | 69% | Same | | Visibility Tint | Light blue | Same | | Manufacturing<br>Method | Lightstream Technology:<br>Full mold cast | Same | | Lens Designs | Spherical, toric, multifocal | Same | | Sterilization | Steam sterilization, validated<br>autoclave | Same | | Primary<br>Packaging System | Foil blister pack<br>(polypropylene blister shell<br>sealed with a polyester coated<br>aluminum foil lidding) | Same | | Primary<br>Packaging Blister<br>Shell | Injection-molded poly-<br>propylene (PP) blister shell<br>made from Flint Hills<br>Resources P4C5N-046 PP or<br>Formosa 4142T PP | Same | | Primary<br>Packaging Foil<br>Lidding | Multi-layer laminate structure<br>polyester-coated aluminum<br>foil lidding supplied by: | Multi-layer laminate structure<br>polyester-coated aluminum<br>foil lidding supplied by: | | | Constantia-Hueck Folien | Constantia-Hueck Folien | | | Huhtamaki | Huhtamaki | | | | Oracle Packaging | | Package Storage /<br>Saline Solution | Phosphate-acetate buffered<br>saline with PEG and HPMC<br>and up to 0.05% Poloxamer<br>108. | Same | | Performance Specifications including any Testing | | | | Refractive Index | 1.38 | Same | | Light<br>Transmittance | 92%T | Same | | Oxygen Per-<br>meability (Dk) | 26 | Same | | Elastic Modulus | 0.9 MPa | Same | | Biocompatibility | Biocompatible as confirmed<br>by biocompatibility testing | Same | | Element of<br>Comparison | Predicate Device | Modified Device | | Shelf-life | 60 months as confirmed by<br>shelf-life stability testing | Same | Table 1: Substantial Equivalence Comparison {5}------------------------------------------------ Table 1: Substantial Equivalence Comparison {6}------------------------------------------------ Table 1: Substantial Equivalence Comparison 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 and 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. #### 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 all performance testing demonstrate the safety, efficacy and performance of the modified device and, thus, substantial equivalence to the predicate device. DAILIES® AquaComfort Plus® (nelfilcon A) soft contact lenses in modified primary packaging including the alternate foil lidding material 'Oracle 6B' are substantially equivalent to the predicate lenses in terms 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. {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. 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