(54 days)
Not Found
No
The 510(k) summary describes a standard soft contact lens made from a specific material. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device description focuses on the material composition, physical properties, and manufacturing process of the lens itself.
No.
The device is indicated for the correction of refractive error (myopia or hyperopia) and astigmatism, which are not considered diseases that require a therapeutic effect. It is also used for cosmetic purposes (eye color alteration).
No
This device is a therapeutic device (contact lens) used for the correction of refractive errors, not for diagnosing a condition.
No
The device description clearly states it is a physical contact lens made from a copolymer 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Desio contact lenses are designed to be worn on the eye for the correction of refractive errors (myopia, hyperopia, astigmatism) and for cosmetic purposes (altering eye color). They are a medical device that interacts directly with the body, but they do not perform any diagnostic testing on biological samples.
- Intended Use: The intended use clearly states correction of refractive error and cosmetic enhancement, not diagnosis of any condition.
- Device Description: The description focuses on the material composition, physical properties, and manufacturing process of the contact lenses. There is no mention of any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on toxicology, shelf life, and physicochemical/mechanical properties, which are relevant to the safety and effectiveness of a contact lens worn on the eye, not to the accuracy of a diagnostic test.
Therefore, the Desio contact lenses fall under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 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.
Product codes
LPL, MVN
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. 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 1.50 D → ±5° | |
| Surface Appearance | Lenses should be clear with no surface defect | |
| Oxygen Permeability | ||
| (x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg)) | 21.50 | ±20% |
| Light Transmission - Clear | ||
| (@ 380-780nm) | >98% | ±5% |
| Light Transmission - Tinted | ||
| (@ 380-780nm) | >96% (at region corresponding to | |
| pupil); Opaque or 0-10% (at | ||
| region corresponding to iris) | ±5% | |
| Ultraviolet Radiation | ||
| Transmittance |
§ 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/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.
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
Indications for Use (Describe)
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.
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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Page 1 of 1
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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 Uhrova
Legal Representative |
|-----------------|--------------------------------------------------------------------------------|
| Phone number: | +39 0331 1629910 |
| Consultant: | Bret Andre
EyeReg Consulting, Inc
6119 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) |
|-------------------------|------------------------------------------------------------------------------------------|
| Common
Name: | Contact Lens, Daily Wear |
| Classification
Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory
Class: | Class II |
| Product Code: | LPL; MVN |
4
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
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:
| 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 |
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.
5
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. 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 1.50 D → ±5° | |
| Surface Appearance | Lenses should be clear with no surface defect | |
| Oxygen Permeability | ||
| (x 10-11(cm²/sec)(mlO2)/(ml | ||
| x mmHg)) | 21.50 | ±20% |
| Light Transmission - Clear | ||
| (@ 380-780nm) | >98% | ±5% |
| Light Transmission - Tinted | ||
| (@ 380-780nm) | >96% (at region corresponding to | |
| pupil); Opaque or 0-10% (at | ||
| region corresponding to iris) | ±5% | |
| Ultraviolet Radiation | ||
| Transmittance | 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 Permeability | ||
| x 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
8
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.