(212 days)
No
The 510(k) summary describes a physical contact lens and its material properties and manufacturing process. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is indicated for the correction of refractive ametropia (myopia), which is a medical condition. This correction serves a therapeutic purpose.
No
The device is a contact lens indicated for the correction of refractive ametropia (myopia) and is not used to diagnose a medical condition.
No
The device is a physical contact lens made of polymacon, not software. The description details the material composition, manufacturing process, and physical properties of the lens.
Based on the provided text, 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 TREVUES contact lenses are a medical device intended for the correction of refractive errors (myopia) and for cosmetic purposes (altering eye color). They are worn on the surface of the eye and do not involve testing samples taken from the body.
- Intended Use: The intended use clearly states correction of refractive ametropia and enhancing/altering eye color, not diagnostic testing.
- Device Description: The description focuses on the material, manufacturing process, and physical properties of the contact lens itself.
- Performance Studies: The performance studies described are related to the safety and physical properties of the lens, not diagnostic accuracy or performance in detecting a condition.
Therefore, the TREVUES contact lens is a medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 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 eye care professionals may prescribe the lens for single use daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be dising a chemical or hydrogen peroxide disinfecting system.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
- Iron Oxide
- C.I. Reactive Blue No.4
- Reactive Black 5
- Titanium Dioxide
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments 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 clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm).
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:
- Chord Diameter: 11.00 mm to 15.00 mm
- Center Thickness: 0.05 mm to 0.15 mm
- Base Curve: 7.00 mm to 10.0 mm
- Back Vertex Power (F'v) (in 0.25D steps): -0.50 D to -12.00D
- Surface Appearance: Lenses should be clear with no surface defect
- Oxygen Permeability: 11.12 x 10-11(cm²/sec)(mlO2)/(ml x mmHg)
- Light Transmission - Tinted (@ 380-780nm): 95%
- 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.
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August 5, 2022
DK Medivision Co., Ltd. % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
Re: K220045
Trade/Device Name: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 28, 2022 Received: July 1, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K220045
Device Name
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Indications for Use (Describe)
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 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 eve,
The eye care professionals may prescribe the lens for single use daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be dising a chemical or hydrogen peroxide disinfecting system.
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
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: K220045
I. SUBMITTER
| Date Prepared: | June 25th, 2022 |
|---|---|
| Name: | |
| Address: | DK Medivision Co., Ltd. |
| 23 Busong 1-gil, jiksan-eup, | |
| Seobuk-gu Cheonan-si, Chungcheongnam-do, | |
| KOREA | |
| Contact Person: | Henry Hong |
| Q.A manager | |
| Phone number: | (82)415810100 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted Color) |
|---|---|
| Common Name: | Contact Lens, Daily Wear |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory Class: | Class II |
| Product Code: | LPL; MVN |
Purpose of 510(k) Submission:
~ New Device ~
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III. PREDICATE DEVICE
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the following predicate device(s):
- "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens" By YUNG SHENG OPTICAL 510(k) number; K132854 Primary Predicate
- "ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses (Tinted/Color)" By JOOWON INNOVATION CO., LTD. 510(k) number: K161098 Reference Predicate
IV. DEVICE DESCRIPTION
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Iron Oxide | 21 CFR § 73.3125 |
| C.I. Reactive Blue No.4 | 21 CFR § 73.3121 |
| Reactive Black 5 | 21 CFR § 73.3127 |
| Titanium Dioxide | 21 CFR § 73.3126 |
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments 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 clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm).
5
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are
manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | ||
| (in 0.25D steps) | -0.50 D to -12.00D | When 0.00 |