(30 days)
Not Found
No
The summary describes a physical contact lens with specific material properties and designs. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The contact lenses are indicated for the "optical correction of refractive ametropia," which is a refractive (optical) correction and not a therapeutic treatment for a disease or condition.
No
Explanation: The device, DAILIES® AquaComfort Plus® contact lenses, is indicated for "optical correction of refractive ametropia," meaning it corrects vision. It is not used to diagnose a medical condition or disease.
No
The device description clearly describes a physical contact lens made of polymer and water, supplied in sterile blister packs. This is a hardware device, not software.
Based on the provided information, 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. They are used to diagnose, monitor, or screen for medical conditions.
- Device Function: The description clearly states that these are contact lenses intended for the "optical correction of refractive ametropia (myopia and hyperopia)" and/or presbyopia. They are worn on the surface of the eye to improve vision.
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing any biological samples from the patient. Its function is purely optical correction.
Therefore, the DAILIES® AquaComfort Plus® contact lenses, in their various forms described, fall under the category of medical devices used for vision correction, not in vitro diagnostics.
N/A
Intended Use / Indications for 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, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes with 6.0 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 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® (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 single use.
Product codes
LPL, MVN
Device Description
The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). For VISINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.
Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Power Range: -20.00 D to +20.00 D
Center Thickness varies with design and power (0.10 mm for -3.00 D spherical)
Lenses have the following properties:
Refractive index: 1.38
Light transmittance: 92% (@ 610 nm)
Water content: 69% by weight
Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method)
Lenses are supplied sterile in sealed blister packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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:
A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Alcon Laboratories, Inc. Dr. Andreas Friese Principal Regulatory Specialist 6201 South Freeway Fort Worth, TX 76134-2099
Re: K153642
Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Soft (hydrophilic) Contact Lens for Daily Wear
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens. Regulatory Class: Class II Product Code: LPL/MVN Dated: December 18, 2015 Received: December 21, 2015
Dear Dr. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (21CFR 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 yours,
Kesia Y. Alexander -A
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
Indications for Use
510(k) Number (if known)
Device Name
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 (nelfileon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and asigmatism) in not-aphakic persons with non-diseased eyes with 6.0 diopters (D) or less of astigmatism.
DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) Ore-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 nondiseased 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.
DAILIES® (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 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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3
510(k) Summary
1. Submitter Information:
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX USA 76134-2099 | |
|-------------------------|---------------------------------------------------------------------------------|---------------------------------------------|
| Primary Contact Person: | Dr. Andreas Friese | Principal Regulatory Specialist |
| Telephone: | +49 6022 240 514 | |
| Fax: | +49 6022 240 512 | |
| Email: | andreas.friese@alcon.com | |
| Back up Contact Person: | Sherri Lakota | Head Global Regulatory Affairs, Vision Care |
| Telephone: | 817-615-5472 | |
| Fax: | 817-551-4630 | |
| Email: | sherri.lakota@alcon.com | |
| Date Prepared: | 12 October 2015 | |
2. Device Name
| Common Name: | Soft Contact Lens |
|---|---|
| Trade/Proprietary Name: | DAILIES® AquaComfort Plus® |
| DAILIES® AquaComfort Plus® Toric | |
| DAILIES® AquaComfort Plus® Multifocal | |
| Classification Name: | Daily Wear Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II [21 CFR 886.5925 (b) (1)] |
3. Predicate Device:
DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) contact lenses (cleared under K123994) have been identified as predicate device.
4. Description of Device:
The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to
4
the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.
Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
| Power Range: | -20.00 D to +20.00 D |
|---|---|
| Center Thickness | varies with design and power |
| (0.10 mm for -3.00 D spherical) |
Lenses have the following properties:
| Refractive index: | 1.38 |
|---|---|
| Light transmittance: | 92% (@ 610 nm) |
| Water content: | 69% by weight |
| Oxygen permeability | 26 barrer measured at 35°C |
| (single point Dk-Polarographic method) |
Lenses are supplied sterile in sealed blister packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).
5. Indications for 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.
5
DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day 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 with 6.0 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 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® (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 single use.
6. Description of Safety and Substantial Equivalence:
The modification involves using the same print technology already established for the Focus® DAILIES® family of (nelfilcon A) soft contact lenses as well as for the DAILIES® AquaComfort Plus® family of (nelfilcon A) soft contact lenses. The following matrix summarizes the characteristics of the modified device as compared to the predicate device.
| Modified Device | Predicate Device | |
|---|---|---|
| DAILIES® AquaComfort | ||
| Plus® Family (nelfilcon A) | DAILIES® AquaComfort Plus® | |
| Family (nelfilcon A) | ||
| 510(k) number: | TBD | K123994 |
| Intended Use: | Daily Wear, | |
| Daily Disposable | Daily Wear, | |
| Daily Disposable | ||
| Material | FDA Group 2 | FDA Group 2 |
| Classification: | (>50% H2O, nonionic polymer) | (>50% H2O, nonionic polymer) |
| Lens Material: | nelfilcon A | nelfilcon A |
| Water Content: | 69% | 69% |
| Power Range: | +20.00 to -20.00 D | +20.00 to -20.00 D |
Table 1: Substantial Equivalence Comparison
6
| Visibility Tint: | With or without copper
phthalocyanine | With or without copper
phthalocyanine |
|----------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Manufacturing
Method: | Lightstream® Technology:
Full mold cast,
integrated print step | Lightstream® Technology:
Full mold cast,
integrated print step |
| Lens Designs: | Spherical, toric, multifocal | Spherical, toric, multifocal |
| Sterilization: | Steam sterilization,
validated autoclave | Steam sterilization,
validated autoclave |
| Packaging: | Blister pack | Blister pack |
| Package
Storage Saline
Solution: | Phosphate-acetate buffered
saline with up to 0.5%
Poloxamer 108. Contains PEG
and HPMC. | Phosphate-acetate buffered saline
with up to 0.5% Poloxamer 108.
Contains PEG and HPMC. |
Non-clinical Testing:
A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the 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.
Substantial Equivalence:
DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are substantially equivalent to the predicate lenses and similar to other daily wear soft contact lenses in terms of water content (69% water) and ionic characteristics (FDA Group II: high water, nonionic), and indications for use.
Any differences which may exist between the DAILIES® AquaComfort Plus , DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses and other Group II soft hydrophilic contact lenses do not adversely affect the safety and effectiveness of the device.