(195 days)
Not Found
No
The document describes standard contact lenses and their materials, with no mention of AI or ML technology.
No.
The contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia), which is a physiological correction rather than a therapeutic treatment for disease or injury.
No
Explanation: The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, acting as a corrective lens rather than performing any diagnostic function.
No
The device description clearly states that the device is a soft contact lens made of a specific material (nelfilcon A) and is a physical product intended for optical correction. It is 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The text clearly describes the DAILIES® contact lenses as devices for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia). They are worn on the surface of the eye to improve vision.
- Lack of Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any specimens from the human body. Its function is purely optical correction.
Therefore, the intended use and description of the DAILIES® contact lenses do not align with the definition of an In Vitro Diagnostic device.
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 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.
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.
All 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 a single use.
Product codes
LPL, MVN
Device Description
Focus® DAILIES® family and DAILIES® AquaComfort Plus® family are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs.
The DAILIES® lens material is nelfilcon A, a high water, non-ionic 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® 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 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 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.
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)
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.
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 modifications do 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.
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 features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Alcon Laboratories, Inc. % Dr. Andreas Friese Principal Regulatory Specialist, GRA Alcon Vision Care Alcon / CIBA Vision GmbH INDUSTRIERING 1 Grosswallstadt, DE 63868 Bayern
Re: K161391
Trade/Device Name: Dailies® AquaComfort Plus® Dailies® AquaComfort Plus® Toric,
Focus Dailies® AquaComfort Plus® Multifocal, Focus Dailies®, Focus Dailies Toric, Focus Dailies Progressives Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 24, 2016 Received: October 27, 2016
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.
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 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/ResourcesforYou/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 yours,
Kesia Alexander
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161391
Device Name
DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal; Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives
Indications for Use (Describe)
indication one (Doombo) 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 (myopia or hyperopia) and/or presbyopia in not-aphakic persons with nondiseased 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.
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) 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.
All 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 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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3
510(k) SUMMARY
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of 510(k) K161391
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-------------------------|----------------------------------------------------------------------------------|
| Primary Contact Person: | Dr. Andreas Friese,
Principal Regulatory Specialist |
| Phone: | +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 |
| Phone: | 817-615-5472 |
| Fax: | 817-551-4630 |
| Email: | sherri.lakota@alcon.com |
| Date Prepared: | May 12, 2016 |
II. Devices Subject to this 510(k)
| Trade Names: | DAILIES® AquaComfort Plus® family soft contact lenses:
DAILIES® AquaComfort Plus®, DAILIES® AquaComfort
Plus® Toric, DAILIES® AquaComfort Plus® Multifocal
Focus® DAILIES® family soft contact lenses:
Focus® DAILIES®, Focus® DAILIES® Toric, Focus®
DAILIES® Progressives |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lenses |
| Classification Name: | Soft (Hydrophilic) Contact Lenses |
| Device Classification: | Class II [21 CFR 886.5925] |
| Product Code: | LPL, MVN |
4
III. Predicate Device
The 510(k) devices are a modification of the same predicate devices, i.e. DAILIES® AquaComfort Plus® family (nelfilcon A) and Focus® DAILIES® family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K153642 and K153643, respectively, both cleared January 20, 2016.
Device Description IV.
Focus® DAILIES® family and DAILIES® AquaComfort Plus® family are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs.
The DAILIES® 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 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® 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 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 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.
5
V. Indications for Use
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.
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.
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.
All 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 a single use.
6
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 of
Comparison | Predicate Devices
Focus DAILIES® family and
DAILIES® AquaComfort Plus®
family soft contact lenses | Modified Devices
Focus DAILIES® family and
DAILIES® AquaComfort Plus®
family soft contact lenses |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Administrative / Regulatory Information | | |
| 510(k) number | K153642 (DAILIES AquaComfort
Plus family), K153643 (Focus
DAILIES family) | K161391 |
| Product name | DAILIES AquaComfort Plus,
DAILIES AquaComfort Plus Toric,
DAILIES AquaComfort Plus
Multifocal, Focus DAILIES, Focus
DAILIES Toric, Focus DAILIES
Progressives | 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 2 (>50% H2O, nonionic) | Same |
| Water Content | 69% | Same |
| Visibility Tint | Light blue | Same |
| Manufacturing
Method | Lightstream Technology:
Full mold cast | Same |
| Lens Designs | Spherical, toric, multifocal | Same |
| Sterilization | Steam sterilization, validated
autoclave | Same |
Table 1: Substantial Equivalence Comparison
7
Predicate Devices | Modified Devices | |
---|---|---|
Element of | ||
Comparison | Focus DAILIES® family and | |
DAILIES® AquaComfort Plus® | ||
family soft contact lenses | Focus DAILIES® family and | |
DAILIES® AquaComfort Plus® | ||
family soft contact lenses | ||
Primary | ||
Packaging | ||
System | Foil blister pack (polypropylene | |
blister shell sealed with a polyester | ||
coated aluminum foil lidding.) | Same | |
Primary | ||
Packaging | ||
Blister Shell | Injection-molded polypropylene | |
blister shell made from Flint Hills | ||
Resources P4C5N-046 polypropylene | Injection-molded polypropylene | |
blister shell made from Flint | ||
Hills Resources P4C5N-046 or | ||
Formosa 4142T polypropylene | ||
Primary | ||
Packaging Foil | ||
Lidding | Multi-layer laminate structure | |
polyester-coated aluminum foil | ||
lidding supplied by: | ||
• Constantia-Hueck Folien or | ||
• Huhtamaki (for Focus DAILIES | ||
family) | ||
• Constantia-Hueck Folien (for | ||
DAILIES AquaComfort Plus | ||
family) | Multi-layer laminate structure | |
polyester-coated aluminum foil | ||
lidding supplied by: | ||
• Constantia-Hueck Folien or | ||
• Huhtamaki (for Focus | ||
DAILIES family and for | ||
DAILIES AquaComfort Plus | ||
family) | ||
Package Storage | ||
/ Saline Solution | Phosphate-acetate buffered saline | |
with up to 0.05% Poloxamer 108. | ||
Additionally contains PEG and | ||
HPMC (for DAILIES AquaComfort | ||
Plus family) | Same | |
Performance Specifications including any Testing | ||
Refractive | ||
Index | 1.38 | Same |
Light | ||
Transmittance | ≥ 92%T | Same |
Oxygen Per- | ||
meability (Dk) | 26 | Same |
Elastic Modulus | 0.9 MPa | Same |
Biocompatibility | Biocompatible as confirmed by | |
appropriate biocompatibility testing | Same | |
Shelf-life | 60 months as confirmed by shelf-life | |
stability testing | Same |
8
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 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 modifications do 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.