The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The Desio (hioxifileon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

Device Description

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from hioxifilcon D, which is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA), and cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the pad-printing manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >67% in the UVA range (316nm - 380nm).

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, based on the provided text:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Tolerance*)	Reported Device Performance
Chord Diameter	±0.20 mm	Not explicitly reported as a single value, but range 12.80 mm to 15.00 mm
Center Thickness	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%	Not explicitly reported as a single value, but range 0.05 mm to 0.210 mm
Base Curve	±0.20 mm	Not explicitly reported as a single value, but range 7.85 mm to 10.0 mm
Back Vertex Power (F'v)	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D → ±0.50 D	Not explicitly reported as a single value, but range +20.00D to -20.00D
Cylinder Power (F'c) (for Toric)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤ 4.00 D → ±0.37 D	Not explicitly reported as a single value, but range -0.25D to -4.00D
Cylinder Axis (for Toric)	When 0.00 < F'c ≤ 1.50 D → ±8°When F'c > 1.50 D → ±5°	Not explicitly reported as a single value, but range 10° to 180°
Surface Appearance	Lenses should be clear with no surface defect	Not explicitly reported, but implied by compliance with acceptance criteria.
Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg))	±20% (relative to a specific value)	21.50
Light Transmission - Clear (@ 380-780nm)	±5% (relative to a specific value)	>98%
Light Transmission - Tinted (@ 380-780nm)	±5% (relative to a specific value)	>96% (at pupil); Opaque or 0-10% (at iris)
Ultraviolet Radiation Transmittance	TUVB (280 to 315 nm) < 0.05TVTUVA (316 to 380 nm) < 0.50TV (This appears to be a typo in the original, likely meaning % transmittance)	<5% TUVB <33% TUVA (Blocks >95% UVB and >67% UVA)
Water Content	±2%	54%
Refractive Index (hydrated)	±0.005	1.400

*Note: The "Tolerance" column is directly from the provided text and represents the acceptance criteria for each parameter. The "Reported Device Performance" column directly states the device's measured or designed values for these parameters. The document implies that the device performance meets these tolerances without explicitly stating "passed" for each one.

Study Details

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing including toxicology, shelf-life, and physicochemical & mechanical properties. However, it does not specify explicit sample sizes for these tests beyond general statements like "A series of preclinical testing was performed."
- Data Provenance: The toxicology tests were conducted "in accordance with the GLP regulation." The overall testing was conducted in laboratories, with the data determined to be scientifically valid under 21 CFR 860.7. No specific country of origin for the test data is mentioned, but the submitter is Qualimed SRL in Italy. The tests are considered retrospective as they are performed on the manufactured product to demonstrate its properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding experts establishing ground truth for the non-clinical tests. These tests typically rely on standardized laboratory procedures and measurements rather than expert human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as the reported tests are objective measurements for physical and chemical properties and toxicology, not requiring adjudication of human interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a contact lens.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a contact lens, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
  - Cytotoxicity: Measured by ISO 10993-5.
  - Systemic Toxicity: Measured by ISO 10993-11.
  - Acute Ocular Irritation: Measured by ISO 10993-10.
  - Physicochemical & Mechanical Properties: Measured to assess refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals against established material standards (implied, as they support substantial equivalence).
The sample size for the training set:
- Not applicable. This document describes the testing for a physical medical device (contact lenses) and does not involve AI or machine learning algorithms that require training sets.
How the ground truth for the training set was established:
- Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 13, 2018

Qualimed SRL % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

Re: K181050

Trade/Device Name: Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 16, 2018 Received: April 20, 2018

Dear Bret Andre:

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 device-related 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 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,

J Angelo Green -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181050

Device Name

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

Indications for Use (Describe)

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

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 OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K181050

I. SUBMITTER

April 16, 2018 Date Prepared:
Qualimed SRL Name: Address: Corso Sempione 176 Busto Arsizio Varese, Italy 21052

Contact Person:	Ms. Tereza UhrovaLegal Representative
Phone number:	+39 0331 1629910
Consultant:	Bret AndreEyeReg Consulting, Inc6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses(Clear and Tinted)
CommonName:	Contact Lens, Daily Wear
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Code:	LPL; MVN

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Purpose of 510(k) Submission:

~ New Device ~

III. PREDICATE DEVICE

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lens is substantially equivalent to the following predicate device:

. "Extreme H2O 54% (hioxifilcon D) Soft Contact Lens" Hydrogel Vision Corporation 510(k) number: K051430 Primary Predicate

IV. DEVICE DESCRIPTION

Color Additive	Listing
Titanium Dioxide	21 CFR § 73.3126
Phthalocyanine Green	21 CFR § 73.3124
Carbazole Violet	21 CFR § 73.3107
Reactive Blue 19	21 CFR § 73.3127
C.I. Reactive black 5	21 CFR § 73.3127

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The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations. The material properties and available parameters of the finished lenses are as follows:

Parameter	Range	Tolerance*
Chord Diameter	12.80 mm to 15.00 mm	±0.20 mm
Center Thickness	0.05 mm to 0.210 mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	7.85 mm to 10.0 mm	±0.20 mm
Back Vertex Power (F'v)	+20.00D to -20.00D(in 0.25D steps)	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D → ±0.50 D
Cylinder Power (F'c)	-0.25D to -4.00D(in 0.25D steps)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤ 4.00 D → ±0.37 D
Cylinder Axis	10° to 180°(in 10° steps)	When 0.00 < F'c ≤ 1.50 D → ±8°When F'c > 1.50 D → ±5°
Surface Appearance		Lenses should be clear with no surface defect
Oxygen Permeability(x 10-11(cm²/sec)(mlO2)/(mlx mmHg))	21.50	±20%
Light Transmission - Clear(@ 380-780nm)	>98%	±5%
Light Transmission - Tinted(@ 380-780nm)	>96% (at region corresponding topupil); Opaque or 0-10% (atregion corresponding to iris)	±5%
Ultraviolet RadiationTransmittance	<5% TUVB<33% TUVA	TUVB (280 to 315 nm) < 0.05TVTUVA (316 to 380 nm) < 0.50TV
Water Content	54%	±2%
Refractive Index	1.400 (hydrated)	±0.005

ANSI Z80.20, Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements And Physicochemical Properties (2010)

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V. INDICATIONS FOR USE

The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The Desio (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are substantially equivalent to Extreme H2O 54% (hioxifilcon D) Soft Contact Lenses (cleared under K051430) in terms of the following:

트 USAN contact lens material (hioxifilcon D)
트 Intended use - daily wear contact lenses
트 Indications for use
I Cast molded production method

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The following matrix illustrates the production method, lens function and material characteristics of the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, as well as the predicate device.

	Qualimed SRLDesio(Subject Device)	Hydrogel Vision Corp.Extreme H2O 54% (Predicate)
Indications for Use	Indicated for daily wear for the correctionof refractive error in aphakic and notaphakic persons with non-diseased eyeswith myopia or hyperopia.	Indicated for daily wear for the correctionof refractive error in aphakic and notaphakic persons with non-diseased eyeswith myopia or hyperopia.
Functionality	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina
FDA Classification	Soft (hydrophilic) Contact Lens (21 CFR886.5925)	Soft (hydrophilic) Contact Lens (21 CFR886.5925)
FDA Group	FDA Group 2(>50% H2O, non-ionic polymer)	FDA Group 2(>50% H2O, non-ionic polymer)
Production Method	Fully molded	Fully molded
USAN name	hioxifilcon D	hioxifilcon D
Water Content (%)	54±2%	54±2%
Oxygen Permeabilityx 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @35°C)) (revised Fatt method)	21.50	21
Refractive Index(hydrated)	1.40	1.41
UV Blocker	Yes	No
Pad-Printed Tinting	Yes	No

Substantial Equivalence Matrix

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Testing

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the Desio (hioxifilcon D) finished contact lenses. The results support the claim that the Desio (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.

Toxicology:

All non-clinical toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the test article is non-toxic.
· Systemic Toxicity: The lens material meets the requirements of the systemic injection test in accordance with ISO 10993-11 and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation.

Shelf Life:

The data presented supports substantial equivalence of the Desio (hioxifilcon D) finished contact lenses to the already marketed predicate devices.

Physicochemical & Mechanical Properties:

The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Desio (hioxifilcon D) contact lenses and the predicate devices.

Clinical Testing

Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from hioxifilcon D materials has been demonstrated previously.

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VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Desio (hioxiffileon D) Daily Wear Soft (hydrophilic) Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.

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.