(96 days)
Not Found
No
The 510(k) summary describes a standard contact lens with no mention of AI or ML technology in its intended use, device description, or performance studies.
No.
The device is indicated for correction of vision (ametropia) in persons with non-diseased eyes, not for treating a disease or therapeutic purpose.
No
This device is a contact lens used for corrective ametropia (myopia and hyperopia) and astigmatism, which is a treatment for vision impairment rather than a diagnostic tool.
No
The device description clearly states it is a physical contact lens made of silicone hydrogel material, 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 OxyAqua contact lenses are physical devices worn on the eye to correct vision problems (ametropia, astigmatism, presbyopia). They do not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly states the lenses are for "corrective ametropia," "correction of ametropia with astigmatism," and "correction of ametropia and emmetropia with presbyopia." These are all related to vision correction, not diagnosis.
- Device Description: The description focuses on the material composition, physical characteristics, and UV blocking properties of the lens, not on any diagnostic testing components.
- Clinical Study: The clinical study evaluated the safety and effectiveness of the lenses for vision correction and wear, not for diagnostic accuracy.
Therefore, the OxyAqua contact lens is a medical device, but it falls under the category of a corrective optical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft (hydrophilic) contact lenses are daily wear single use soft contact lens indicated for the corrective ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft (hydrophilic) Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft (hydrophilic) Contact lenses are indicated as daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 42% olifilcon D and 58 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (
§ 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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April 3, 2018
Visco Vision, Inc. % Jennifer Ting Manager Jens Medical Consulting, Ltd. 6F, No. 39 Jixian Rd., Luzhou Dist. New Taipei City, TW 247
Re: K173958
Trade/Device Name: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 24, 2017 Received: February 5, 2018
Dear Jennifer Ting:
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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
Denise L. Hampton -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
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Indications for Use
510(k) Number (if known) K173958
Device Name
OxyAqua (olifilcon D) Silicone Hydrogel Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft (hydrophilic) contact lenses are daily wear single use soft contact lens indicated for the corrective ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft (hydrophilic) Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft (hydrophilic) Contact lenses are indicated as daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
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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K173958 510 (k) Summary
Preparation Date: March 20, 2018
5.1 Establishment Information:
Name | Visco Vision Inc. |
---|---|
Address | No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan |
Contact | Ted TT Huang |
Phone No. | 886-3-3490202 |
Fax No. | 886-3-3596868 |
5.2 Contact Person:
Name | Evan Huang |
---|---|
Phone No | 886-3-3490202 |
Fax No | 886-3-3596868 |
e-mail: | evan.huang@viscovision.com.tw |
5.3 Device Identification:
Proprietary Name | OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens |
---|---|
Common Name | Soft (hydrophilic) Contact Lenses |
Classification Name | Lenses, Soft Contact, Daily Wear, |
(21 CFR 886.5925, Product Code LPL) | |
Lenses, Soft Contact, Daily Wear (Disposable), | |
(21 CFR 886.5925, Product Code MVN) |
Classification II
5.4 Legally Marketed Equivalent Device:
Predicate Device Name | Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens |
---|---|
Manufacturer | Visco Vision Inc. |
510(k) Number | K160344 |
Product Code | MVN |
5.5 Device Description
The OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 42% olifilcon D and 58 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV
4
absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (