(282 days)
No
The summary describes standard contact lenses and their material properties and performance testing, with no mention of AI or ML.
No.
The contact lenses are indicated for the correction of ametropia (myopia and hyperopia) and presbyopia, which are refractive errors, not diseases or injuries requiring therapeutic intervention.
No
The device is a contact lens intended for correcting refractive errors (ametropia, presbyopia, astigmatism) and protecting against UV radiation. It is a therapy device, not one used for identifying or diagnosing a condition.
No
The device described is a physical contact lens, not a software-only medical device. The description details the material composition, manufacturing method, and physical properties of the lenses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the contact lenses are for the "correction of ametropia (myopia and hyperopia)" and "correction of refractive ametropia (myopia and hyperopia) and presbyopia". This describes a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details the material composition and physical properties of the contact lenses, consistent with a medical device for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described focus on material properties, biocompatibility, microbiology, and leachability, which are relevant for the safety and effectiveness of a contact lens as a medical device, but not for the performance of a diagnostic test. Key metrics for IVDs like sensitivity, specificity, PPV, and NPV are not applicable and not mentioned.
In summary, the Aquamax and NaturalVue contact lenses described are medical devices intended for vision correction, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
- Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement
(Replacement Recommended Every 2 Weeks):
Spherical and Aspheric
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
- NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric
NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
NaturalVue (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
Product codes
LPL, MVN
Device Description
The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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 Study:
All non-clinical tests were conducted in accordance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses.
The non-clinical performance tests have been performed to demonstrate the safety and effectiveness of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Aquamax Disposable Soft (Hydrophilic) Contact Lenses (K120028) and OSPREY spherical multifocal and multifocal toric soft daily wear contact lenses (K013445) and ACUVUE (Etafilcon A) spherical, toric, and multifocal soft (hydrophilic) daily wear contact lenses (K962804).
Material Properties Testing: Tested for Production Method, USAN Name, Material Classification, Water Content (%), Refractive Index, Oxygen Permeability, Percent Transmittance.
Biocompatibility: Standard cytotoxicity, maximization, and ocular irritation tests were carried out. Negative responses were recorded for all tests. Validity of blister packaging demonstrated by passing standard extraction tests.
Microbiology: Steam sterilization process validated to deliver a minimum SAL of 10-6. Shelf-life stability supports sterility through expiration date.
Bacteriostatic Validation: Steam sterilizer tested for effectiveness by measuring and demonstrating temperature uniformity. Tested microorganisms were killed. Lenses remained sterilized with no microbial growth for 5 years under accelerated conditions. Seal of lens packages remained tight for 5 years under accelerated conditions.
Leachability: Studies conducted to determine leachable materials from finished lenses. Results show no leachable monomers and additive residues at reported detection levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120228 Pegavision Corporation, Aquamax (Etafilcon A) disposable soft (hydrophilic) contact lenses, K013445 Florida Optical Engineering, OSPREY spherical and Multifocal Toric soft daily wear contact lenses, K962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal, and Toric Multifocal soft (hydrophilic) daily wear contact lenses
Reference Device(s)
ACUVUE (Etafilcon A) Contact lens, clear and visibility tint with UV blocker, K962804, ACUVUE (Etafilcon A) contact lens, clear and visibility tint with UV blocker, K991134
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the hair and neck of each figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2014
Pegavision Corporation Mr. Tony Hsu, President 2F-1 No. 5, Shing Yeh St. Shan Ding Vil Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan
Re: 510(k) Number: K140025
Trade/Device Name: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lenses (daily wear) Regulatory Class: Class II Product Code: LPL, MVN Dated: September 15, 2014 Received: September 16, 2014
Dear Mr. Hsu:
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
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Page 2 – Mr. Tony Hsu
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/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,
Image /page/1/Picture/8 description: The image shows the text "Deborah L. Falls -S" in a simple, sans-serif font. The text is arranged horizontally, with the name "Deborah L. Falls" appearing prominently, followed by "-S". The text is black against a white background.
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) K140025
Device Name
Aquamax and NaturalVue (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
- Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement
(Replacement Recommended Every 2 Weeks):
Spherical and Aspheric
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
3
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric
NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
NaturalVue (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are
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indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/1 description: The image contains the text "K140025" at the top. Below that is the logo for PEGA VISION. Underneath the logo is the text "Brighten Your View."
510k Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE: | September 15, 2014 |
|---|---|
| Pegavision Corporation | |
| Tony Hsu, President | |
| 2521 Beechwood Drive | |
| 2F-1 No. 5, Shing Yeh St. Shan Ding Vil Kwei Shan | |
| Hsiang, Taoyuan Hsien 333, Taiwan | |
| 886-3-329-8808 (phone) | |
| 886-3-329-8897 (fax) | |
| tonyhsu@pegavision.com (email) | |
| OFFICIAL | |
| CORRESPONDENT | |
| FOR THIS | |
| SUBMISSION: | Penny Northcutt, RAC, FRAPS, CQA |
| 174 Watercolor Way, Suite 103-403 | |
| Santa Rosa Beach, FL 32459 | |
| 678-428-6978 (phone) | |
| 678-513-0937 (fax) | |
| pennynorthcutt@theregsolutions.com (email) | |
| TRADE NAME: | Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent |
| Replacement | |
| Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) | |
| Contact Lenses | |
| NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) | |
| Contact Lenses | |
| COMMON NAME: | Soft (hydrophilic) Contact Lenses (daily wear) |
| DEVICE | |
| CLASSIFICATION and | |
| Product Code: | Class II |
| Lenses, Soft Contact, Daily Wear, per 21 CFR 886.5925, | |
| Product Code: LPL | |
| Class II | |
| Lens, Contact, (Disposable), per CFR 886.5925, | |
| Product Code: MVN | |
| PREDICATE | |
| DEVICE NAME: | K120228 Pegavision Corporation, Aquamax (Etafilcon A) disposable |
| soft (hydrophilic) contact lenses | |
| K013445 Florida Optical Engineering, OSPREY spherical | |
| and Multifocal Toric soft daily wear contact lenses |
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Image /page/6/Picture/1 description: The image shows the logo for Pegavision, a company that specializes in vision-related products. The logo features the company name in a stylized font, with the tagline "Brighten Your View" underneath. The image also includes the number K140025, which may be a product or reference number.
K962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal, and Toric Multifocal soft (hydrophilic) daily wear contact lenses
SUBSTANTIAL EQUIVALENCE:
It is Pegavision Corporation's conviction that the data submitted in this 510(k) provides evidence of substantial equivalence for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses with the same established safety profile and effectiveness of the predicate devices K120028 Aquamax (Etafilcon A) Disposable and Bi-weekly Soft (Hydrophilic) Contact Lenses for spheric lenses for myopia and hyperopia, K013445 Florida Optical Engineering OSPREY spherical multifocal and multifocal toric soft daily wear contact lenses, and K962804 Vistakon, Johnson & Johnson Vision Products ACUVUE (Etafilcon A) spherical, toric, and multifocal soft (hydrophilic) daily wear contact lenses.
DESCRIPTION OF THE DEVICE:
The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
INTENDED USE/INDICATIONS FOR USE:
1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric
Aquamax (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Traditional 510(k) Pegavision Corporation
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Multifocal
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses mav be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses mav be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks):
Spherical and Aspheric
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased
Traditional 510(k) Pegavision Corporation
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Image /page/8/Picture/1 description: The image shows the logo for Pegavision, with the text "PEGA" in blue and "VISION" in gray. Below the logo is the text "Brighten Your View" in a smaller font size. At the top right corner of the image, the text "K140025" is visible.
eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric
NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
Toric
NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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.
Multifocal
NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
TECNOLOGICAL CHARACTERISTICS:
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Image /page/9/Picture/1 description: The image shows the logo for Pegavision, with the tagline "Brighten Your View" underneath. The logo is in blue and gray. The image also contains the text "K140025" in the upper right corner.
Historical Clinical Use
Etafilcon A lenses have been used widely. Their safety and effectiveness have been well established and documented for more than eighteen years. Their safety and effectiveness can be further exemplified by three lenses, as well as many others as discussed in the 510(k), cleared by FDA:
· ACUVUE (Etafilcon A) Contact lens, clear and visibility tint with UV blocker, K962804 submitted by Vistakon USA
• ACUVUE (Etafilcon A) contact lens, clear and visibility tint with UV blocker, K991134 submitted by Vistakon USA
· Aquamax (Etafilcon A) Disposable Soft (Hydrophilic) Contact Lenses, K120028 submitted by Pegavision Corporation, Taiwan
Aquamax (Etaflicon A) Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K120028 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned ACUVUE predicate (and reference) devices.
Non-Clinical Study
All non-clinical tests were conducted in accordance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses.
The non-clinical performance tests have been performed to demonstrate the safety and effectiveness of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Aquamax Disposable Soft (Hydrophilic) Contact Lenses (K120028) and OSPREY spherical multifocal and multifocal toric soft daily wear contact lenses (K013445) and ACUVUE (Etafilcon A) spherical, toric, and multifocal soft (hydrophilic) daily wear contact lenses (K962804). The evidence of substantial equivalence to the predicate lenses is described below.
a) Material Properties Testing
The material properties of Aquamax and NaturalVue (Etafilcon A) Soft (Hydrophilic) Contact Lenses were tested as illustrated in the following table:
| Proposed Device | K120028 Predicate | K013445 Predicate | K962804 Predicate | |
|---|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Lathe-Cut | Cast-Molded |
| USAN Name | Etafilcon A | Etafilcon A | Hioxifilcon B | Etafilcon A |
| Material Classification | Group 4 high water ionic | Group 4 high water ionic | Group 1 low water non-ionic | Group 4 high water ionic |
| Water Content (%) | 58% | 58% | 48% | 58% |
| Refractive Index | 1.4023 | 1.4023 | 1.425 | 1.4000 |
| Oxygen Permeability | ||||
| (edge corrected) @ 35°C | $19.73 \times 10^{-11}$ | |||
| (cm²/sec)(ml O₂/ml-mmHg) | $19.73 \times 10^{-11}$ | |||
| (cm²/sec)(ml O₂/ml-mmHg) | $15 \times 10^{-11}$ | |||
| (cm²/sec)(ml O₂/ml-mmHg) | $21.4 \times 10^{-11}$ | |||
| (cm²/sec)(ml O₂/ml-mmHg) | ||||
| Percent Transmittance | ||||
| % T at 593nm | > 95% | > 95% | >95% | > 85% |
| % T at 380-315nm |