(71 days)
No
The document describes standard contact lenses and their material properties, with no mention of AI or ML technology.
No.
The device is indicated for the correction of ametropia (myopia and hyperopia), which is a refractive error, not a disease or condition that requires therapeutic treatment. While it "helps protect against transmission of harmful UV radiation," its primary function isn't therapeutic.
No
The device is a contact lens intended for correcting refractive errors (ametropia) and presbyopia, not for diagnosing medical conditions. Its function is to provide visual correction, not to identify or characterize diseases.
No
The device description clearly states it is a physical contact lens made of etafilcon A, a co-polymer, and includes details about its material properties, manufacturing method, and physical characteristics. It is 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 correction of vision (ametropia, astigmatism, presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and composition of a contact lens designed to be worn on the eye. It does not describe a device used to examine specimens from the human body.
- Performance Studies: The studies mentioned are non-clinical tests related to material properties, biocompatibility, and microbiology, which are relevant to the safety and performance of a contact lens worn on the eye. They are not diagnostic performance studies.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
NaturalVue (etafilcon A) Sphere 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.
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.
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 eves 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.
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.
Product codes
LPL, MVN
Device Description
The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, 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 316-380mm. 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, cornea
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K140025 Pegavision Corporation, NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Reference Device(s)
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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
Visioneering Technologies, Inc. c/o Ms. Penny Northcutt, RAC, FRAPS, CQA Regulatory Consultant and Official Correspondent 174 Watercolor Way Suite 103-403 Santa Rosa Beach, Florida 32459
Re: K150385
Trade/Device Name: Naturalvue (etafilcon A) Daily Disposable Soft (hydrophilic) Contact Lenses NaturalVue (etafilcon A) SPHERE and ASPHERE NaturalVue (etafilcon A) Toric NaturalVue (etafilcon A) Multifocal NaturalVue (etafilcon A) Multifocal Toric
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 9, 2015 Received: March 10, 2015
Dear Ms. Northcutt:
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.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (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 Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150385
Device Name
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
Spherical and Aspheric
NaturalVue (etafilcon A) Sphere 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 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 Spherical
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 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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
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 | February 13, 2015 |
|---|---|
| APPLICANT | Visioneering Technologies, Inc. |
| Stephen Snowdy, CEO | |
| 4555 Mansell Road | |
| Suite 300 | |
| Alpharetta, GA 30022 | |
| 770-521-4358 (office phone) | |
| 404-863-8892 (cell phone) | |
| ssnowdy@vtivision.com (email) | |
| OFFICIAL | |
| CORRESPONDENT | Penny Northcutt, RAC, FRAPS, CQA |
| 174 Watercolor Way, Suite 103-403 | |
| Santa Rosa Beach, FL 32459 | |
| 678-428-6978 (phone) | |
| 866-630-4082 (fax) | |
| pennynorthcutt@theregsolutions.com (email) | |
| TRADE NAME | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) |
| Contact Lenses | |
| COMMON NAME | Soft (hydrophilic) Contact Lenses (daily wear) |
| Soft (hydrophilic) Contact Lenses (disposable) | |
| 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 21 CFR 886.5925, Product | |
| Code: MVN | |
| PREDICATE | |
| DEVICE | K140025 Pegavision Corporation, NaturalVue (etafilcon A) |
| Daily Disposable Soft (Hydrophilic) Contact Lenses |
SUBSTANTIAL EQUIVALENCE:
It is Visioneering Technologies, Inc.'s conviction that the data submitted in this 510(k) provides evidence of substantial equivalence for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses with the same established safety profile and effectiveness of the predicate device K140025 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses.
5
DESCRIPTION OF THE DEVICE:
The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, 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 316-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
INTENDED USE/INDICATIONS FOR USE:
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 eves 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.
6
TECNOLOGICAL CHARACTERISTICS:
Historical Clinical Use
etafilcon A lenses have been used widely. Their safety and effectiveness have been well established and documented. Their safety and effectiveness can be further exemplified by the following 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
- NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, . K140025 submitted by Pegavision Corporation, Taiwan
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K140025 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned predicate (and reference) devices.
Non-Clinical Study
All 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 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to the predicate NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K140025). The evidence of substantial equivalence to the predicate lenses is described below.
a) Material Properties Testing
The material properties of NaturalVue (etafilcon A) Soft (Hydrophilic) Contact Lenses were tested as illustrated in the following table.
| Proposed Device | K140025 Predicate | |
|---|---|---|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | etafilcon A | etafilcon A |
| Material Classification | Group 4 high water ionic | Group 4 high water ionic |
| Water Content (%) | 58% | 58% |
| Refractive Index | 1.4023 | 1.4023 |
| Oxygen Permeability | ||
| (edge corrected) @ 35°C | 19.3 x 10-11 | |
| (cm²/sec)(ml O2/ml-mmHg) | 19.3 x 10-11 | |
| (cm²/sec)(ml O2/ml-mmHg) | ||
| Percent Transmittance | ||
| % T at 593nm | > 95% | > 95% |
| % T at 380-315nm |