(17 days)
Not Found
No
The 510(k) summary describes standard contact lenses and their material properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is indicated for the correction of ametropia, a refractive error, and does not treat or cure a disease.
No
Explanation: The device is a contact lens designed for the correction of ametropia, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical contact lens made of a specific material (stenfilcon A) and has physical properties and designs. It is a tangible medical 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.
- Device Function: The description clearly states that MyDay Contact Lenses are placed on the cornea and act as a refracting medium to focus light rays on the retina. Their purpose is to correct vision problems (ametropia, astigmatism, presbyopia).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely optical and mechanical.
Therefore, MyDay Contact Lenses fall under the category of medical devices, specifically ophthalmic devices, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have - 10.00 diopters of astigmatism or less.
Product codes
LPL, MVN
Device Description
MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.
The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.
When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
MyDay (stenfilcon A) contact lens parameters are:
• Chord Diameter: 13.0 mm to 15.5mm
• Base Curve: 8.4 ± 0.5 mm and 8.7 ± 0.5 mm
• Center Thickness: 0.08 mm to 0.218 mm (varies with power
• Powers: -20.00D to +20.00D
• Cylinder Powers: -0.25D to -10.00D
• Axis: 0° to 180° in 10° increments
• Add Power Range: +0.50 to +4.00
The physical/optical properties of the lens are:
- Specific Gravity: 1.033
- Refractive Index: 1.401
- Light Transmittance: 96%
- Surface Character: Hydrophilic
- Water Content: 54%
- Oxygen Permeability: 80x10-11 [(cm2/sec)x(ml O2)/(ml x mm Hg)]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
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 studies were performed to support substantial equivalence.
Performance testing was conducted in accordance with the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, May 12, 1994, amended June 28, 1994. All tests were performed per GLP regulation (21 CFR Part 58) or valid scientific protocols and according to ANSI, ISO, and/or ASTM standards.
Tests included:
- Contact angle per ANSI Z80.20-2016
- Light transmittance per ISO 18369-2:2017 and ISO 18369-3:2017
- Water content per ISO18369-2:2017 and ISO 18369-4:2017
- Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-18
- Refractive index per ISO 18369-2:2017 and ISO 16369-4:2017
- Total extractables per ANSI Z80.20-2016 and ISO 18369-4:2017
- Non-polymeric residuals in lens and packaging solution, solvents chosen per EN ISO 18369-4:2017
Biocompatibility testing:
An extractable residual analysis, in accordance with EN ISO 10993-18:2009, Annex C, was performed on both the current stenfilcon A and the modified stenfilcon A formulations. The residual concentration was maintained, establishing similarity in extractable residual levels.
Clinical testing:
Clinical performance data was not required as the test results were sufficient to characterize the subject device's physical/mechanical/optical characteristics compared to the predicate, and the results were found equivalent. The technical characteristics and manufacturing and sterilization processes of the subject lens are equivalent to the currently marketed stenfilcon A contact lens.
Key results: Results from performance testing demonstrate that the subject device is as safe, as effective, and performs as well as the predicate 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 29, 2019
CooperVision, Inc. Marie E. Dutton Senior Regulatory Affairs Specialist 5870 Stoneridge Drive. Suite 1 Pleasanton, CA 94588
Re: K190965
Trade/Device Name: MyDay (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 11, 2019 Received: April 12, 2019
Dear Ms. Dutton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
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
Indications for Use
510(k) Number (if known)
Device Name
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Indications for Use (Describe)
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have - 10.00 diopters of astigmatism or less.
| 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) |
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3
510(k) Summary
I. SUBMITTER:
CooperVision, Inc. 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588
Contact Person:
Marie Dutton Senior Regulatory Affairs Specialist CooperVision, Inc. 5870 Stoneridge Drive. Suite 1 Pleasanton, CA 94588 Phone: (925) 251-6645 (925) 251-6643 Fax: E-mail: MDutton@coopervision.com
Date Prepared:
April 11, 2019
II. DEVICE:
| Trade Name: | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable
Contact Lens |
|-----------------------|--------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lens |
| Classification Name: | Lens, Contact, (Disposable) [21 CFR 886.5925 (b) (1)] |
| Regulatory Class: | II |
| Product Code: | LPL, MVN |
| Classification Panel: | Ophthalmic |
III. PREDICATE DEVICE:
CooperVision's SUS (stenfilcon A) Soft (hydrophilic) Contact Lenses for Single Use Daily Wear, K131378
IV. DEVICE DESCRIPTION:
MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.
The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.
When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
4
MyDay (stenfilcon A) contact lens parameters are:
| • Chord Diameter: | 13.0 mm to 15.5mm |
|---|---|
| • Base Curve: | 8.4 ± 0.5 mm and 8.7 ± 0.5 mm |
| • Center Thickness: | 0.08 mm to 0.218 mm (varies with power |
| • Powers: | -20.00D to +20.00D |
| • Cylinder Powers: | -0.25D to -10.00D |
| • Axis: | 0° to 180° in 10° increments |
| • Add Power Range: | +0.50 to +4.00 |
The physical/optical properties of the lens are:
- Specific Gravity: 1.033 Refractive Index: 1.401 ● 96%
- Light Transmittance:
Surface Character:
- Hydrophilic
- Water Content: 54%
- Oxygen Permeability: 80x10-11 [(cm2/sec)x(ml O2)/(ml x mm Hg)]
V. INDICATIONS FOR USE:
●
●
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The technological characteristics of the subject device and the predicate device are compared in the table below.
| Technology/Material Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Product Name | CooperVision | |
| SUS (stenfilcon A) | CooperVision | |
| MyDay (stenfilcon A) | ||
| Material USAN Name | stenfilcon A | Same |
| 510(k) Number | K131378 | TBD – Current Submission |
| FDA Category (Group) | Silicone Hydrogel | Same |
| Manufacturing Method | Molded | Same |
| Sterilization | Moist Heat | Same |
| Packaging Materials | Injection molded | |
| polypropylene blisters | ||
| covered by aluminum foil | ||
| laminate; blister strips are | ||
| packed into printed cartons | Same | |
| Packaging Solution | Phosphate Buffered Saline | |
| Solution with Tween | Same | |
| Visibility Tint | Reactive Blue #246 (RB246) | Same |
| UV Blocker | Norbloc | Same |
VII. PERFORMANCE DATA
Results from non-clinical studies were provided in support of the substantial equivalence determination.
Performance testing:
In accordance with the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, May 12, 1994 amended June 28, 1994, the following battery of testing was performed. All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols. Each test was conducted according to the ANSI, ISO, and/or ASTM standard indicated:
- Contact angle per ANSI Z80.20-2016 ●
- Light transmittance per ISO 18369-2:2017 and ISO 18369-3:2017 ●
- Water content per ISO18369-2:2017 and ISO 18369-4:2017
- Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-18 ●
- Refractive index per ISO 18369-2:2017 and ISO 16369-4:2017
- Total extractables per ANSI Z80.20-2016 and ISO 18369-4:2017 ●
- Non-polymeric residuals in lens and packaging solution, solvents chosen o per EN ISO 18369-4:2017
6
Biocompatibility testing:
An extractable residual analysis, in accordance with EN ISO 10993-18:2009, Annex C. was performed on both the current stenfilcon A and the modified stenfilcon A formulations. Based on the comparison of the extractable residual profiles, the residual concentration is maintained. Therefore, the similarity in the extractable residual levels is established, and additional biocompatibility testing was not required to complete the substantial equivalent determination.
Clinical testing:
Test results provided in this 510(k) are sufficient to adequately characterize the subject device in terms of its physical/mechanical/optical characteristics when compared to the predicate. The results are equivalent, determining that additional clinical performance data was not required to complete the substantial equivalent determination. Additionally, the technical characteristics and manufacturing and sterilization processes of the subject lens are equivalent to stenfilcon A contact lens currently marketed by Cooper Vision; therefore, it was confirmed that no clinical data is required.
VIII. CONCLUSIONS:
Conclusive evidence was provided to demonstrate that the subject device lens material is equivalent to the currently marketed predicate device lens material through the statistical analysis of the physical/mechanical/optical properties of the lens. Based on the performance testing and the fact that the subject device has the same manufacturing process as the marketed predicate device lens, clinical performance data was not required to be submitted in this 510(k). The performance testing demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device.