(266 days)
Not Found
No
The 510(k) summary describes a standard soft contact lens with specific material properties and indications for use. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The performance studies focus on physiochemical properties and equivalence to a predicate device.
No
The device corrects vision (ametropia, astigmatism, presbyopia) rather than treating a disease or therapeutic condition.
No
The device is a contact lens used for vision correction, not for diagnosing medical conditions.
No
The device is a physical contact lens made of a silicon 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 VISCO (olifilcon A) Toric/Multifocal Soft Contact Lenses are medical devices intended to be worn on the surface of the eye to correct vision problems (ametropia, astigmatism, presbyopia). They do not analyze samples from the body to provide diagnostic information.
- Intended Use: The intended use clearly states the correction of vision, not the diagnosis of any disease or condition.
- Device Description: The description focuses on the physical properties and materials of the contact lens itself.
- Performance Studies: The performance studies mentioned are related to the physical, optical, chemical, and biocompatibility properties of the lens, not diagnostic accuracy.
Therefore, the VISCO (olifilcon A) Toric/Multifocal Soft Contact Lenses fall under the category of medical devices, specifically contact lenses, and not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The VISCO (olifilcon A) toric/multifocal soft contact lenses are manufactured in toric or multifocal configurations with UV blocker. The lens material, olifilcon A, is a silicon hydrogel with water content 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. The lens is supplied in a sterile state, packaged in a buffered saline solution containing Sodium Hyaluronate and Sodium Alginate
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
Eye care practitioners
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)
Nonclinical Tests Performed: Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses. Toxicology studies show that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
Clinical Studies: The technical characteristic, formulation, manufacturing, and sterilization processes of the subject device are equivalent to the VISCO (olifilcon A) soft contact lens currently available (K 141348). Therefore, the clinical data is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
Visco Vision Inc. % Ms. Jennifer Ting Manager Jens Medical Consulting Ltd. 6F. No. 39. Jixian Rd. Luzhou Dist. New Taipei City, TW 247
Re: K160245
Trade/Device Name: VISCO (olifilcon A) Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 12, 2016 Received: September 14, 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 (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
1
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.
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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Indications for Use
510(k) Number (if known) K160245
Device Name VISCO (olifilcon A) Soft Contact Lens
Indications for Use (Describe)
The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (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 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent the lens may be disinfected using a chemical disinfection system only.
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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3
510(K) SUMMARY
Preparation Date: Sep. 12, 2016
Establishment Information: 1.1
| Name | Visco Vision Inc. |
|---|---|
| Address | No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan |
| Contact | Evan Huang |
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
1.2 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 |
Device Identification: 1.3
| Proprietary Name | VISCO (olifilcon A) 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 |
Legally Marketed Equivalent Device: 1.4
| Predicate Device Name | Biofinity (comfilcon A), K052560, CooperVision Inc. | |
|---|---|---|
| VISCO (olifilcon A), K141348, Visco Vision Inc. | ||
| Product Code | LPL, MVN |
1.5 Device Description
The VISCO (olifilcon A) toric/multifocal soft contact lenses are manufactured in toric or multifocal configurations with UV blocker. The lens material, olifilcon A, is a silicon hydrogel with water content 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing
4
monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. The lens is supplied in a sterile state, packaged in a buffered saline solution containing Sodium Hyaluronate and Sodium Alginate
1.6 Indication for Use:
The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
1.7 Technological characteristics
The optical lens design specification:
| ● | Power Range | 20.00D to +20.00D |
|---|---|---|
| ● | Add Power (Multifocal) | Low (+0.75D ~ +1.25D) |
| Mid (+1.50D ~ +2.00D) | ||
| High (+2.25D ~ +2.75D) | ||
| ● | Cylinder Power (Toric) | -0.75D, -1.25D, -1.75D, -2.25D |
| Axis from 10° to 180° (in 10° increments) | ||
| ● | Diameter | 13.0 mm to 15.0 mm |
| ● | Center Thickness | 0.08mm @ -3.00D (Varies with Power) |
| ● | Base Curve | 8.0 mm to 9.2 mm |
The physical properties of the lenses are:
| • Refractive index: | 1.410 (hydrated) |
|---|---|
| --------------------- | ------------------ |
- Light transmittance: > 94%
5
- Water content: 47% by weight in normal saline 150 x 10-11 Oxygen permeability ●
- (cm²/sec)(ml O2/ml.mmHg) measured at 35°C
(intrinsic Dk-Colormetric method)
1.8 Comparison table:
The characteristic comparison to predicate device is summarized in the following table.
| Similarities | |||
|---|---|---|---|
| Item | Device | Predicate | |
| (K052560) | predicate | ||
| (K141348) | |||
| Product Name | VISCO (olifilcon A) Toric | ||
| Soft Contact Lens | |||
| VISCO (olifilcon A) | |||
| Multifocal Soft Contact | |||
| Lens | BIOFINITY Toric | ||
| (comfilcon A) Soft Contact | |||
| Lens | |||
| BIOFINITY Multifocal | |||
| (comfilcon A) Soft Contact | |||
| Lens | Visco (olifilcon A) soft | ||
| contact lens | |||
| Manufacturer | Visco Vision Inc. | CooperVision Inc. | Visco Vision Inc. |
| Intended Use | Myopia, Hyperopia, | ||
| Prysbyopia | The same | Myopia, Hyperopia | |
| Replacement | |||
| Schedule | Daily wear (monthly) or | ||
| Daily Disposable (Single | |||
| use) | daily wear (monthly) or | ||
| extended wear | Daily wear (monthly) | ||
| or Daily Disposable | |||
| (Single use) | |||
| USAN Name | olifilcon A | comfilcon A | olifilcon A |
| Material | Silicone Hydrogel | Silicone Hydrogel | Silicone Hydrogel |
| Lens Design | toric or multifocal | Spheric, aspheric, toric or | |
| multifocal | spheric | ||
| Classification | Class II, | The same | The same |
| Type | Group I (low water, | ||
| nonionic) | The same | The same | |
| Water Content | 47 % | 48 % | 47% |
| Oxygen | |||
| Permeability | |||
| (DK, 35°C ) | 150 | ||
| (Fatt method) | 128 | ||
| (Fatt method) | 150 | ||
| (Fatt method) | |||
| Base Curve | |||
| Range | 8.0~9.2 | 8.0~9.5 | 8.0~9.2 |
| Diameter (mm) | 13.0~15.0 | 13.5~15.0 | 13.0~15.0 |
| Center Thickness | Varies with power (0.08 | ||
| mm at -3.00D) | 0.05 mm – 0.50 mm | Varies with power | |
| (0.08 mm at -3.00D) | |||
| Powers | -20.00D to +20.00D | ||
| in 0.25 steps | The same | -20.00D to +20.00D | |
| in 0.25 steps | |||
| Add Power | |||
| (Multifocal) | Low (+0.75D ~ +1.25D) | ||
| Mid (+1.50D ~ +2.00D) | |||
| High (+2.25D ~ +2.75D) | +0.50D to +3.00D | NA | |
| Cylinder Power | |||
| (Toric) | -0.75D, -1.25D, -1.75D, | ||
| -2.25D | |||
| Axis from 10° to 180° (in | |||
| 10° increments) | -0.25D -5.00D | ||
| Axis from 0° to 180° | NA | ||
| Refractive Index | 1.410 | 1.40 | 1.410 |
| Light | |||
| Transmittance | 94% | >97% | 94% |
| Method of | |||
| Manufacture | Cast-Molded | The same | The same |
| Surface Treatment | No | No | No |
| Sterilization | steam | The same | The same |
| Packaging | Blister pack | The same | The same |
| Blue handling tint | Yes, reactive Blue19 | Yes, Phthalocyanine Blue | Yes, reactive Blue19 |
| Indication for Use | Toric | ||
| The VISCO (olifilcon A) | |||
| Toric 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. | Toric | ||
| Biofinity (comfilcon A) | |||
| toric soft contact lenses are | |||
| indicated for the correction | |||
| of ametropia (myopia or | |||
| hyperopia with | |||
| astigmatism) in aphakic | |||
| and non-aphakic persons | |||
| with non-diseased eyes in | |||
| powers from -20.00 to | |||
| +20.00 diopters and | |||
| astigmatic corrections | |||
| from -0.25 to -5.00 | |||
| diopters. | NA | ||
| Multifocal | Multifocal | ||
| The VISCO (olifilcon A) | Biofinity (comfilcon A) | ||
| Multifocal Soft Contact | multifocal lenses are | ||
| lenses are indicated as | indicated for the correction | ||
| daily wear for the | of refractive ametropia | ||
| correction of ametropia | (myopia and hyperopia) | ||
| (myopia and hyperopia) | and emmetropia with | ||
| and emmetropia with | presbyopia in aphakic and | ||
| presbyopia in aphakic and | non-aphakic persons with | ||
| non-aphakic persons with | non-diseased eyes in | ||
| non-diseased eyes and | powers from -20.00 to | ||
| whose powers are from | +20.00 diopters and with | ||
| -20.00 to +20.00 diopters | add powers from +0.50 to | ||
| with add powers from | +3.00 diopters. The lenses | ||
| +0.75 to +2.75 diopters. | may be worn by persons | ||
| The lenses may be worn | who exhibit astigmatism of | ||
| by persons who exhibit | 2.00 diopters or less that | ||
| astigmatism of 1.00 | does not interfere with | ||
| diopters or less where the | visual acuity. | ||
| astigmatism does not | |||
| interfere with visual acuity. | |||
| Eye care practitioners may | Eye care practitioners may | Eye care practitioners | |
| may prescribe the lens | |||
| for either single-use | |||
| disposable wear, or for | |||
| frequent/planned | |||
| replacement wear, | |||
| with cleaning, | |||
| disinfection, and | |||
| scheduled | |||
| replacement. When | |||
| prescribed for frequent | |||
| replacement, the lens | |||
| may be disinfected | |||
| using a chemical | |||
| prescribe the lens for either | prescribe the lens for | ||
| single-use daily disposable | frequent replacement wear, | ||
| wear, or for | with cleaning, disinfecting | ||
| frequent/planned | and scheduled | ||
| replacement wear, with | replacements. | ||
| cleaning, disinfection, and | |||
| scheduled replacement. | |||
| When prescribed for | |||
| frequent replacement, the | |||
| lens may be disinfected | |||
| using a chemical | |||
| disinfection system only. | disinfection system only. | ||
| disinfection system | |||
| only.The VISCO Soft | |||
| (Hydrophilic) Contact | |||
| Lenses help protect | |||
| against transmission of | |||
| harmful UV radiation | |||
| to the cornea and into | |||
| the eye. | |||
| NA | Spherical and Aspherical | Spherical | |
| Biofinity (comfilcon A) | The VISCO Soft | ||
| sphere and Asphere soft | (Hydrophilic) Contact | ||
| contact lenses are indicated | Lenses is indicated for | ||
| for the correction of | daily wear for the | ||
| ametropia (myopia and | correction of refractive | ||
| hyperopia) in aphakic and | ametropia (myopia and | ||
| non-aphakic persons with | hyperopia) in phakic | ||
| non-diseased eyes in | or aphakic persons | ||
| powers from -20.00 to | with non-diseased eyes | ||
| +20.00 diopters. The | who exhibit refractive | ||
| lenses may be worn by | astigmatism of 2.00D | ||
| persons who exhibit | or less where the | ||
| astigmatism of 2.00 | astigmatism does not | ||
| diopters or less that does | interfere with visual | ||
| not interfere with visual | acuity. | ||
| acuity. | |||
| NA | The Biofinity (comfilcon | ||
| A) soft (hydrophilic) | |||
| contact lenses have been | |||
| approved for extended | |||
| wear for up to 6 nights/7 | |||
| days of continuous wear. It | |||
| is recommended that the | |||
| contact lens wearer first be | |||
| evaluated on a daily wear | |||
| schedule. If successful, | |||
| then a gradual introduction | |||
| of extended wear can be | |||
| followed as determined by | |||
| the prescribing eye care | |||
| practitioner. |
6
7
8
9
1.9 Nonclinical Tests Performed
Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses. Toxicology studies show that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
1.10 Clinical Studies
The technical characteristic, formulation, manufacturing, and sterilization processes of the subject device are equivalent to the VISCO (olifilcon A) soft contact lens currently available (K 141348). Therefore, the clinical data is not required.
1.11 Conclusion
The established safety profile of the device is equivalent to the predicate device, Biofinity (comfilcon A) soft contact lens (K052560), VISCO (olifilcon A) soft contact lens (K141348) in terms of optical property, physical, chemical and pre-clinical toxicology. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.