(57 days)
K07277, K083216
Not Found
No
The 510(k) summary describes standard contact lenses and their material properties. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No
Explanation: This device is for optical correction of refractive ametropia and presbyopia, which are refractive errors, not diseases. It does not treat a therapeutic condition.
No
The device is a contact lens used for the optical correction of refractive ametropia. Its intended use is to correct vision, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical contact lens made of polymer and water, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the optical correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the contact lenses, which are designed to alter the way light enters the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) or to provide information about a person's health status or disease.
- Anatomical Site: While the device interacts with the eye, its purpose is to correct vision, not to diagnose a condition of the eye itself.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
DAILIES® AquaComfort Plus® (neifilcon 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 6.00 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 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 a single use.
Product codes
LPL, MVN
Device Description
The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® 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: -20.00D to +20.00D
Center Thickness: varies with design and power (0.10 mm for -3.00D 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 CIBA Vision 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). Shelf-life studies are ongoing to further confirm the labeled expiration date.
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
Not Found
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 series of non-clinical testing was performed to verify equivalence of the device to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).
The results of all non-clinical testing demonstrate:
- · Physicochemical characteristics of the device are substantially equivalent to the predicate lens.
- . The lens material and extracts of the device are substantially equivalent to the predicate device and are non toxic and non-irritating.
Successful stability testing supports the labeled expiration date.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K07277, K083216
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Shared Passion for Healthy Vision and Better Life
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
11-Feb-2013, v01 Page 1 of 4
Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence
510(k) Summary: K123994
1. Submitter Information:
| Company: | CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 |
|-----------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martina Heim, PhD, RAC
Senior Regulatory Specialist, Global Regulatory Affairs
martina.heim@cibavision.com |
| Telephone: | 678-415-3565 |
| FAX: | 678-415-3454 |
| Date Prepared: | 11 Feb 2013 |
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® (nelfilcon A) contact lenses (cleared under K07277) and FOCUS® DAILIES® (nelfilcon A) lenses with print marks (cleared under K083216) have been identified as predicate devices for this Premarket Notification.
4. Description of Device:
The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially
acetalized with N-formylmethyl acrylamide). For VISITINT® 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: | -20.00D to +20.00D |
|---|---|
| Center Thickness: | varies with design and power |
| (0.10 mm for -3.00D spherical) |
1
Image /page/1/Picture/0 description: The image shows the CIBA VISION logo. The logo is black and white and features the company name in bold letters. Below the company name is the tagline "Shared Passion for Healthy Vision and Better Life."
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
11-Feb-2013. v01 Page 2 of 4
Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence
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 CIBA Vision 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). Shelf-life studies are ongoing to further confirm the labeled expiration date.
5. Indications for Use:
.
DAILIES® AquaComfort Plus® (neifilcon 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 6.00 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 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 a single use.
2
Image /page/2/Picture/0 description: The image shows the CIBA VISION logo. The logo is in black and white and features the words "CIBA VISION" in a bold, sans-serif font. The "O" in "VISION" is replaced by an eye symbol. Below the logo is the tagline "Shared Passion for Healthy Vision and Better Life" in a smaller font.
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097
Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence
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 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 devices:
Table 1. Substantial Equivalence Comparison
| Modified Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| DAILIES® | |||
| AquaComfort Plus® | |||
| Family | DAILIES® | ||
| AquaComfort Plus® | |||
| Family | FOCUS® DAILIES® | ||
| Family | |||
| 510(k) number | K123994 | K072777 | K083216 |
| Intended Use | Daily Wear, | ||
| Daily Disposable | Daily Wear. | ||
| Daily Disposable | Daily Wear. | ||
| Daily Disposable | |||
| Material | |||
| Classification: | FDA Group 2 | ||
| (> 50% H2O, nonionic | |||
| polymer) | FDA Group 2 | ||
| (> 50% H2O, nonionic | |||
| polymer) | FDA Group 2 | ||
| (> 50% H2O, nonionic | |||
| polymer) | |||
| Lens Material: | nelfilcon A | nelfilcon A | nelfilcon A |
| Water | |||
| Content: | 69% | 69% | 69% |
| Power Range: | +20.00 to -20.00D | +20.00 to -20.00D | +20.00 to -20.00D |
| Visibility Tint: | With or without copper | ||
| phthalocyanine | 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 | Lightstream® | ||
| Technology: | |||
| Full mold cast, | |||
| integrated print step | |||
| Lens Designs: | Spherical, toric, | ||
| multifocal | Spherical, toric, | ||
| multifocal | Spherical, toric, | ||
| multifocal | |||
| Sterilization: | Steam sterilization, | ||
| validated autoclave | Steam sterilization, | ||
| validated autoclave | Steam sterilization, | ||
| validated autoclave | |||
| Packaging: | Blister pack | Blister pack | Blister pack |
| Package | |||
| Storage saline | |||
| solution | Phosphate-acetate | ||
| buffered saline with up | |||
| to 0.05% Poloxamer |
Contains PEG and
HPMC. | Phosphate-acetate
buffered saline with up
to 0.05% Poloxamer
108.
Contains PEG and
HPMC. | Phosphate-acetate
buffered saline with up
to 0.02% Poloxamer
108. |
3
Image /page/3/Picture/0 description: The image shows the CIBA VISION logo. The logo consists of the word "CIBA" in large, bold letters, followed by a stylized eye symbol and the word "VISION." The tagline "Shared Passion for Healthy Vision and Better Life" is printed in smaller font below the main logo.
Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence
Non-clinical Testing:
A series of non-clinical testing was performed to verify equivalence of the device to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).
The results of all non-clinical testing demonstrate:
- · Physicochemical characteristics of the device are substantially equivalent to the predicate lens.
- . The lens material and extracts of the device are substantially equivalent to the predicate device and are non toxic and non-irritating.
Successful stability testing supports the labeled expiration date.
Clinical Testing:
The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.
Substantial Equivalence:
The 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.
4
Image /page/4/Picture/0 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 symbol that resembles a human figure embracing a bird or eagle, which is a common symbol associated with health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
February 21, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ciba Vision Corporation % Martina Heim, Ph.D., RAC Senior Regulatory Specialist 11460 Johns Creek Parkway Duluth, GA 30097
Re: K123994
Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Regulation Number: 21 CFR 886.5925 (nelfilcon A)
Regulation Name: Soft (hydrophilic) contact lens
Regulatory Class: Class II Product Code: LPL. MVN Dated: December 21, 2012 Received: December 26, 2012
Dear Dr. Heim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
5
Please be advised that FDA's issuance of a substantial equivalencé determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Kesia YAlexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K123994
Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric,
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 notaphakic 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 notaphakic 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.
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Y. 2013.02.20
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123994