(44 days)
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft 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 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.
The 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.
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.
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.
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The 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.
DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 approximately 1.50 diopters of astigmatism.
The 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.
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable:
Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1
Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric
Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal
The lens material of Focus DAILIES, DAILIES AquaComfort Plus and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products 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. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.
DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products 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 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 (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses 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 (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.
This document is a 510(k) premarket notification for contact lenses, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include extensive de novo clinical studies with acceptance criteria for a novel AI device as would be seen for a new technology or an AI/ML diagnostic.
Therefore, the information required to answer the questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an AI device is not present in this document.
Instead, this submission focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use: The modified contact lenses have the same intended use as the predicate devices.
- Similar Technological Characteristics: The materials, manufacturing methods, lens designs, sterilization, and basic performance specifications (refractive index, light transmittance, oxygen permeability, elastic modulus) are either identical or very similar to the predicate devices.
- Non-clinical Performance Testing: Biocompatibility and stability testing were performed to show that the minor modifications (primarily to the primary packaging foil lidding supplier) do not negatively impact safety or performance.
- No Clinical Testing Required: Due to the high similarity and successful non-clinical testing, clinical testing was deemed unnecessary to establish substantial equivalence.
In summary, this document is for a medical device (contact lenses) and not an AI/ML-based device. Hence, the detailed criteria for AI device validation (like acceptance criteria for AI performance, MRMC studies, ground truth establishment, etc.) are entirely irrelevant and absent from this submission.
If this question was intended for an AI/ML-based medical device, the provided document does not contain the necessary information.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 27, 2018
Alcon Laboratories, Inc. Andreas Friese Regulatory Project Director, GRA Alcon Vision Care Alcon / CIBA Vision GmbH Industriering 1 Grosswallstadt, DE 63868 Bavaria
Re: K180669
Trade/Device Name: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 8, 2018 Received: March 14, 2018
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. Iisting 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Scott E. Steffen -S 2018.04.27 14:38:07 -04'00'
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}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |||
|---|---|---|---|
| Food and Drug Administration | |||
| Form Approved: OMB No. 0910-0120 | |||
| Indications for Use | Expiration Date: 06/30/2020 | ||
| See PRA Statement below. | |||
| 510(k) Number (if known) | K180669 | ||
| Device Name | 1 (of 4): Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | ||
| Indications for Use (Describe) | Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes. | ||
| Focus DAILIES Progressives (nelfilcon A) One-Day soft 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 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. | |||
| The 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K180669 |
|---|---|
| -------------------------- | --------- |
Device Name
2 (of 4): DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
Indications for Use (Describe)
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.
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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-67-10
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name 3 (of 4): FreshLook One-Day
Indications for Use (Describe)
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
{5}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K180669 |
| Device Name | 4 (of 4): DAILIES Total1, DAILIES Total1 Multifocal |
| Indications for Use (Describe) | DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism. |
| DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 approximately 1.50 diopters of astigmatism. | |
| The 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. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
{6}------------------------------------------------
K180669 510(k) SUMMARY
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
Submitter of 510(k) I.
| Company: | Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA |
|---|---|
| Primary Contact Person: | Dr. Andreas FrieseRegulatory Project Director, GRA Alcon Vision Care |
| Phone: | +49 6022-240-514 |
| Fax: | +49 6022-240-512 |
| Email: | andreas.friese@alcon.com |
| Back up Contact Person: | Sherri Lakota,Head, GRA Alcon Vision Care |
| Phone: | 817-615-5472 |
| Fax: | 817-551-4630 |
| Email: | sherri.lakota@alcon.com |
| Date Prepared: | March 8, 2018 |
II. Devices Subject to this 510(k)
| Trade Names: | DAILIES AquaComfort Plus soft contact lenses:DAILIES AquaComfort Plus, DAILIES AquaComfort PlusToric, DAILIES AquaComfort Plus Multifocal |
|---|---|
| Focus DAILIES soft contact lenses:Focus DAILIES, Focus DAILIES Toric, Focus DAILIESProgressives | |
| DAILIES Total1 soft contact lenses:DAILIES Total1, DAILIES Total1 Multifocal | |
| FreshLook One-Day soft contact lenses:FreshLook One-Day | |
| Common Name:Classification Name: | Soft Contact LensesSoft (Hydrophilic) Contact Lens |
{7}------------------------------------------------
| Device Classification: | Class II [21 CFR 886.5925] |
|---|---|
| Product Code: | LPL, MVN |
III. Predicate Device
The 510(k) devices are modifications of the same predicate devices, i.e. the currently legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILIES Total1 products).
IV. Device Description
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable:
Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal
The lens material of Focus DAILIES, DAILIES AquaComfort Plus and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products 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. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.
DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses
{8}------------------------------------------------
contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products 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 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 (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses 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 (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.
V. Indications for Use
The 510(k) devices are a modification of the same predicate devices. The Indications for Use remain the same, as follows:
DAILIES AquaComfort Plus:
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.
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.
{9}------------------------------------------------
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.
Focus DAILIES:
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft 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 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.
The 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.
FreshLook One-Day:
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The 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.
DAILIES Total1:
DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 approximately 1.50 diopters of astigmatism .
The 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.
{10}------------------------------------------------
VI. Comparison of Technological Characteristics with the Predicate Device
The following matrix (Table 1) summarizes the characteristics of the modified devices as compared to the predicate devices:
| Element ofComparison | Predicate Devices | Modified Devices |
|---|---|---|
| Administrative / Regulatory Information | ||
| 510(k) Number | K172066 (DAILIESAquaComfort Plus)K153643 (Focus DAILIES)K050213 (FreshLook One-Day)K113168 (DAILIESTotal1) | To be assigned |
| Product Name | DAILIES AquaComfortPlus, DAILIESAquaComfort Plus Toric,DAILIES AquaComfortPlus MultifocalFocus DAILIES, FocusDAILIES Toric, FocusDAILIES ProgressivesFreshLook One-DayDAILIES Total1, DAILIESTotal1 Multifocal | Same |
| DeviceClassificationInformation | Class II, Daily Wear Soft(Hydrophilic) Contact Lenses,21 CFR 886.5925 (b) (1) | Same |
| Indications For Use Information | ||
| Intended Use | One-day contact lenses for theoptical correction of vision.Single use, daily disposablewear. | Same |
| Element ofComparison | Predicate Devices | Modified Devices |
| Technology Information | ||
| Lens Material | nelfilcon A (FocusDAILIES, DAILIESAquaComfort Plus andFreshLook One-Day)delefilcon A (DAILIESTotal1) | Same |
| Water Content | 69% (Focus DAILIES,DAILIES AquaComfortPlus and FreshLook One-Day)33% (DAILIES Total1) | Same |
| Visibility Tint | Focus DAILIES, DAILIESAquaComfort Plus andDAILIES Total1: Lightblue (copper phthalo-cyanine blue)FreshLook One-Day: Notint | Same |
| ManufacturingMethod | Lightstream Technology: Fullmold cast | Same |
| Lens Designs | Spherical, toric, multifocal(Focus DAILIES andDAILIES AquaComfortPlus)Spherical (FreshLook One-Day)Spherical, multifocal(DAILIES Total1) | Same |
| Sterilization | Steam sterilization, validatedautoclave | Same |
| PrimaryPackagingSystem inGeneral | Foil blister pack containersystem: Polypropylene blistershell sealed with a polyestercoated aluminum foil lidding | Same |
| Element ofComparison | Predicate Devices | Modified Devices |
| PrimaryPackagingBlister Shell | Injection-moldedpolypropylene blister shellmade from Flint HillsResources P4C5N-046polypropylene or Formosa4142T polypropylene | Same |
| PrimaryPackaging FoilLidding | Multi-layer laminatestructure polyester-coatedaluminum foil liddingsupplied by HuhtamakiCurrent 2017 grade assupplied by Huhtamaki | Multi-layer laminatestructure polyester-coatedaluminum foil liddingsupplied by HuhtamakiModified 2018 grades assupplied by Huhtamaki |
| Package Storage/ Saline Solution | Nelfilcon A products:Phosphate-acetate bufferedsaline with up to 0.05%Poloxamer 108.Additionally contains PEGand HPMC (for DAILIESAquaComfort Plus)Delefilcon A products:Phosphate buffered salinesolution withapproximately 0.3% ofpolymeric wetting agentsconsisting of copolymers ofpolyamidoamine and poly(acrylamide-acrylic acid) | Same |
| Element ofComparison | Predicate Devices | Modified Devices |
| Performance Specifications including any Testing | ||
| RefractiveIndex | Nelfilcon A products: 1.38Delefilcon A products: 1.42 | Same |
| LightTransmittance | Nelfilcon A products:92%T ( 88%T forFreshLook One-Day)Delefilcon A products:93%T | Same |
| OxygenPermeability(Dk) | Nelfilcon A products: 26Delefilcon A products: 140 | Same |
| Elastic Modulus | Nelfilcon A products: 0.9MPaDelefilcon A products: 0.7MPa | Same |
| Biocompatibility | Biocompatible as confirmed byappropriate biocompatibilitytesting | Same |
| Shelf-life | Up to 60 months asconfirmed by shelf-lifestability testing (FocusDAILIES and DAILIESAquaComfort Plus)Up to 48 months asconfirmed by shelf-lifestability testing (FreshLookOne-Day DAILIES Totall) | Same |
Table 1: Substantial Equivalence Comparison
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Table 1: Substantial Equivalence Comparison
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Table 1: Substantial Equivalence Comparison
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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.
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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 and applicable ISO standards for contact lenses. The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
Test results from a series of in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing, confirm that the minor device modification does not negatively impact the safety of the devices and that the modified devices are non-toxic and biocompatible.
All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.
Stability Testing
Successful stability testing supports the labeled expiration date for the modified devices.
Clinical Testing
Based on the great similarity of the modified devices to the predicate devices and successful results from nonclinical testing, clinical testing was not required to establish substantial equivalence.
VIII. Conclusions
The cumulative results of all performance testing demonstrate the safety, efficacy and performance of the modified devices and, thus, substantial equivalence to the predicate devices.
§ 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.