(74 days)
No
The document describes a standard contact lens with different designs and color additives. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
A therapeutic device is typically used to treat or prevent a disease, or to restore, correct, or modify physiological function. This device is indicated for the correction of refractive ametropia (myopia and hyperopia) and astigmatism, which are refractive errors, not diseases. It also enhances or alters the apparent color of the eye. While it corrects visual acuity, it does not treat a disease.
No
The device is a soft contact lens intended for the correction of refractive ametropia and to enhance or alter eye color. It is not described as being used to diagnose any medical condition.
No
The device description clearly identifies the device as a physical contact lens made of specific materials and containing color additives. It does not describe any software component.
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 refractive errors (myopia, hyperopia, astigmatism) and to enhance or alter the apparent color of the eye. This is a direct interaction with the eye for vision correction and cosmetic purposes.
- Device Description: The device is a contact lens, a physical object placed on the surface of the eye.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that definition.
N/A
Intended Use / Indications for Use
The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft 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 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia 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.
The lens may also be indicated to enhance or alter the apparent color of the eye. 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 Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (
§ 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
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April 19, 2018
Visco Vision, Inc. Jennifer Ting RA Manager Jens Medical Consulting Ltd. 6F, No. 39, Jixian Rd., Luzhou Dist. New Taipei City, TW 247
Re: K180322
Trade/Device Name: Si-Hy (olifilcon B) color 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: January 20, 2018 Received: February 21, 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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
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
2
Indications for Use
510(k) Number (if known) K180322
Device Name
Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft 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 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia 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.
The lens may also be indicated to enhance or alter the apparent color of the eye. 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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510(k) Summary
Preparation Date: April 11, 2018
1.1 Establishment Information:
| Name | Visco Vision Inc. |
|---|---|
| Address | No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan |
| Contact | Ted TT Huang |
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
1.2 Contact Person:
| Name | Evan Huang |
|---|---|
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
| e-mail: | evan.huang@viscovision.com.tw |
1.3 Device Identification:
| Proprietary Name | Si-Hy (olifilcon B) Color Silicone Hydrogel Soft Contact
Lens |
|---------------------|------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Soft (hydrophilic) contact lens. (21 CFR 886.5925) |
| Product Codes | LPL, MVN |
| Classification | II |
1.4 Legally Marketed Equivalent Device:
Intended use
| Predicate Device Name | Saview-Color Aqua 42 UV (hefilcon A)
soft (hydrophilic) contact lens |
|-----------------------|-------------------------------------------------------------------------|
| Manufacturer | St. Shine Optical Co., Ltd. |
| 510(k) Number | K162317 |
| Product Codes | LPL, MVN |
| Lens material | |
| Predicate Device Name | Si-Hy (olifilcon B) silicone hydrogel soft contact len |
| Manufacturer | Visco Vision Inc. |
| 510(k) Number | K160344 |
| Product Codes | LPL, MVN |
1.5 Device Description
The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses
4
are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (