(108 days)
Not Found
No
The document describes a standard contact lens and its clinical performance, with no mention of AI or ML in its design, function, or intended use.
No.
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and astigmatism, which are conditions addressed by corrective devices, not therapeutic ones.
No
This device is a contact lens intended for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, not for diagnosing medical conditions.
No
The device 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 Si-Hy Silicone Hydrogel Soft Contact Lenses are a medical device intended to be worn directly on the eye to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia). They are a therapeutic device, not a diagnostic test.
- Intended Use: The intended use clearly states the correction of refractive ametropia and presbyopia. It does not mention any diagnostic purpose.
- Device Description: The description focuses on the material, composition, and physical characteristics of the contact lens. It does not describe any components or processes related to analyzing biological samples.
- Clinical Study: The clinical study evaluates the safety and effectiveness of the lens in terms of visual acuity, adverse reactions, and slit lamp findings, which are relevant to the performance of a contact lens as a vision correction device, not a diagnostic test.
Therefore, the Si-Hy Silicone Hydrogel Soft Contact Lenses fall under the category of a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-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 Si-Hy Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in 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
LPL, MVN
Device Description
The Si-Hy (olifilcon B) 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 53% olifilcon B and 47% 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 about 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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Visco Vision Inc. % Ms. Jennifer Ting, Manager Jens Medical Consulting Ltd. 6F. No. 39, Ln 224, Jixian Rd. Luzhou Dist. 247 New Taipei City Taiwan R.O.C
Re: K160344
Trade/Device Name: Si-Hy (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens; Si-Hy (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses; Si-Hy (olifilcon B) 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: April 20, 2016 Received: April 22, 2016
Dear Ms. 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 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
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(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 Alexander
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160344
Device Name
Si-Hy (olifilcon B) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-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 Si-Hy Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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005_510(k) Summary
Preparation Date: May 6, 2016
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:
| Company | Jens Medical Consulting Ltd. |
|---|---|
| Name | Jennifer TING |
| Phone No | 886-2-82823192 |
| Fax No | 886-2-82867686 |
| e-mail: | jen.medical@msa.hinet.net |
5.3 Device Identification:
| Proprietary Name | Si-Hy (olifilcon B) Silicone Hydrogel Soft (Hydrophilic) 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:
Indication
Vistakon (narafilcon A), K073485, Product Code: MVN
Johnson & Johnson Vision Care Inc.
Material
Visco (olifilcon A) soft contact lens, K141348, Product Code: LPL/MVN Visco Vision Inc.
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5.5 Device Description
The Si-Hy (olifilcon B) 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 53% olifilcon B and 47% 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 about 2.2% ( 85% |
| Blue handling tint | Reactive Blue19 | Reactive Blue19 | Reactive Blue Dye #4 |
| Method of Manufacture | Molded | Molded | Molded |
5.9 Nonclinical Tests Performed
- 5.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical,
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optical and chemical properties of the lens are within established specifications for the lenses.
- 5.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
5.10 Clinical Studies
A three-month clinical study was conducted to demonstrate the safety and efffectiveness of the Si-Hy (olifilcon B) silicone hydrogel soft contact lens by comparison with Vistakon (narafilcon A) Contact Lens when worn on a daily wear basis. At least 50 evaluable subjects were participated. Parameters measured include visual acuities, adverse reactions, symptom, problem and complaints, slit lamp findings, as well as lens wearing time. It was found that the mean VA for both lenses was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better. No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups.
The clinical study provided data to establish substantial equivalence with the predicate, control lens, Vistakon (narafilcon A) soft contact lens, JOHNSON & JOHNSON VISION CARE INC. (K073485), with respect to the safety and effectiveness.
5.11 Conclusion
Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Si-Hy silicone hydrogel soft contact lens" is as safe, as effective and performs as well as the predicate device.