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.

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

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a soft contact lens (VISCO (olifilcon A) Soft Contact Lens). It explicitly states that clinical studies were NOT required for this submission. Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The basis for the substantial equivalence claim relies on physicochemical studies and the equivalence of the technical characteristics, formulation, manufacturing, and sterilization processes to previously cleared predicate devices.

Specifically, the document states:

"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 (K141348). Therefore, the clinical data is not required." (Page 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." (Page 9)

In summary, as this is a 510(k) submission for a contact lens cleared based on substantial equivalence to existing devices through non-clinical testing and manufacturing data, the detailed information about an AI/algorithm performance study (which would typically involve ground truth, expert adjudication, MRMC, etc.) is not applicable and not present in this document.

Therefore, I cannot provide the requested table and study details.

Summary

{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

{2}------------------------------------------------

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) 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

{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:

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) ToricSoft Contact LensVISCO (olifilcon A)Multifocal Soft ContactLens	BIOFINITY Toric(comfilcon A) Soft ContactLensBIOFINITY Multifocal(comfilcon A) Soft ContactLens	Visco (olifilcon A) softcontact lens
Manufacturer	Visco Vision Inc.	CooperVision Inc.	Visco Vision Inc.
Intended Use	Myopia, Hyperopia,Prysbyopia	The same	Myopia, Hyperopia
ReplacementSchedule	Daily wear (monthly) orDaily Disposable (Singleuse)	daily wear (monthly) orextended 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 ormultifocal	spheric
Classification	Class II,	The same	The same
Type	Group I (low water,nonionic)	The same	The same
Water Content	47 %	48 %	47%
OxygenPermeability(DK, 35°C )	150(Fatt method)	128(Fatt method)	150(Fatt method)
Base CurveRange	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 (0.08mm at -3.00D)	0.05 mm – 0.50 mm	Varies with power(0.08 mm at -3.00D)
Powers	-20.00D to +20.00Din 0.25 steps	The same	-20.00D to +20.00Din 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,-2.25DAxis from 10° to 180° (in10° increments)	-0.25D -5.00DAxis from 0° to 180°	NA
Refractive Index	1.410	1.40	1.410
LightTransmittance	94%	>97%	94%
Method ofManufacture	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	ToricThe VISCO (olifilcon A)Toric Soft Contact lensesare indicated as daily wearfor the correction ofametropia (myopia andhyperopia) withastigmatism in aphakic andnon-aphakic persons withnon-diseased eyes andwhose powers are from-20.00 to +20.00 dioptersand astigmatic correctionsare from -0.75 to -2.25diopters.	ToricBiofinity (comfilcon A)toric soft contact lenses areindicated for the correctionof ametropia (myopia orhyperopia withastigmatism) in aphakicand non-aphakic personswith non-diseased eyes inpowers from -20.00 to+20.00 diopters andastigmatic correctionsfrom -0.25 to -5.00diopters.	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 practitionersmay prescribe the lensfor either single-usedisposable wear, or forfrequent/plannedreplacement wear,with cleaning,disinfection, andscheduledreplacement. Whenprescribed for frequentreplacement, the lensmay be disinfectedusing 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 introductionof extended wear can befollowed as determined bythe prescribing eye carepractitioner.

{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.

Regulation Number and Section

§ 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.