(222 days)
Not Found
No
The device description and performance studies focus on the material properties, physical characteristics, and biocompatibility of the contact lenses. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No
The device corrects refractive ametropia (myopia and hyperopia), which is a condition but not a disease or injury that requires therapy.
No
This device is a soft contact lens indicated for correcting refractive ametropia (myopia and hyperopia) and for cosmetic purposes (altering eye color), not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of polymacon, a hydrophilic polymer, and includes physical characteristics and materials. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive ametropia (myopia and hyperopia) and to enhance or alter the apparent color of the eyes. This is a therapeutic and cosmetic purpose, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens designed to be worn on the eye. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to diagnose a disease or condition.
- Anatomical Site: The device is applied to the eye, which is the target of the therapy/cosmetic effect, not a source of a diagnostic specimen.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Dream Color I, II, and III (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eyes. Eyecare practitioners may prescribe 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
Product codes
LPL
Device Description
Dream soft contact lenses are hemispherical shape with molded spherical base curves and lathe-cut front surfaces. Its' sectional configuration has symmetrical shape. Back-cover surface except optic zone and edge side is colored with various colors.
The lenses are made of hydrophilic polymer of 2-Hydroxyethyl methacrylate(HEMA) and cross-linked with ethylene glycol dimethacrylate(EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Iron Oxides, C.I. Pigment Green 7, (Phthalocyaninato(2-)) Copper and Reactive Black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only amount of color additive need to accomplish the intended coloring effect.
In hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming colored optical surface. The hydrophilic properties of the lens require that it is maintained in a fully hydrated state in a solution compatible with the eye. If the lens dry out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:
Refractive Index: 1.428 (hydrated)
Light Transmission: greater than 90%
Water Content: 38 % +/- 2%
Oxygen Permeability: 9.77 * 10-11 (cm²/sec)(ml O2/ml * mm Hg at 35°C) (revised Fatt method)
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
Eyecare 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
All results met current Biocompatibility requirements per ISO 10993-1 consensus standards. Studies conducted include:
- BAR-01 Biocompatibility Assessment Report (Cytotoxicity, Sensitization, Irritation) for Dream Color I & II
- VRC-02 Validation Report of Cleaning Process for Soft Contact Lens
- BS-2009-KoTIMeD-010001 Dream Color I Maximization test for Delayed hypersensitivity
- MD 2007-035 Dream Color I, Dream Color II -Shape and Appearance Torsion Test Diameter Curvature Radius Apex Flexibility Extractable Substances Cell Growth Inhibition test Agarose Overlay Test Ocular Irritation Test Sterility Test - Direct Innoculation
- MD 2008-033 Dream Color I - Gold, Gray Water content Extractables
- MD 2011-033 Extractables
- BS-2009-KoTIMeD-010002 Dream Color II - (Aqua, Blue) Maximization test for Delayed hypersensitivity
- MD 2007-036 Dream Color II - (Aqua, Blue) Shape and Appearance Torsion Test Diameter Curvature Radius Apex Flexibility Extractable Substances Cell Growth Inhibition test Agarose Overlay Test Ocular Irritation Test Sterility Test - Direct Innoculation
- MD 2008-034 Dream Color II - (Aqua, Blue) Water content Extractables
- VRS-01 Validation Report: Sterilization
- VRP-02 Validation Report: Packaging Process
- MD 2007-037 Dream Color II - Physicochemical Test Report
- TRC-01 30 Cycle Cleaning Validation
Key Metrics
Not Found
Predicate Device(s)
K051477 Migwang Comfort 38
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
12343
JUN 1 7 2013
510(k) SUMMARY (As required by 21 CFR 807)
TRADE NAME
CLASSIFICATION
SUBMITTED BY
Dream Color
Class II (21 CFR 807.92)
Albert Rego, Ph.D.
DATE SUBMITTED
November 4, 2012
K051477 Migwang
DreamCon Co., Ltd. 469-1 Sanmak-dong, Yangson-si Gyeongsangnam-do Korea
Telephone Number: 949-770-8710
CONTACT
PREDICATE DEVICE
DEVICE DESCRIPTION
Comfort 38 Decision Date: 03-10-2006 Dream soft contact lenses are hemispherical shape with molded
spherical base curves and lathe-cut front surfaces. Its' sectional configuration has symmetrical shape. Back-cover surface except optic zone and edge side is colored with various colors.
The lenses are made of hydrophilic polymer of 2-Hydroxyethyl methacrylate(HEMA) and cross-linked with ethylene glycol dimethacrylate(EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Iron Oxides, C.I. Pigment Green 7, (Phthalocyaninato(2-)) Copper and Reactive Black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only amount of color additive need to accomplish the intended coloring effect.
in hydrated state. the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming colored optical surface. The hydrophilic properties of the lens require that it is maintained in a fully hydrated state in a solution compatible with the eye. If the lens dry out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.
1
The hydrophilic characteristics allow aqueous to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:
| Refractive Index | 1.428 (hydrated) |
|---|---|
| Light Transmission | greater than 90% |
| Water Content | 38 % + 2% |
| Oxygen Permeability | 9.77 * 10-11 (cm²/sec)(ml O2/ml * mm Hg |
| 35°C) (revised Fatt method) |
INDICATIONS FOR USE
The Dream Color I, II, and III (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eyes.
Eyecare practitioners may prescribe 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
TESTING (All results met current Biocompatibility requirements per ISO 10993-1 consensus standards)
BAR-01 Biocompatibility Assessment Report Cytotoxicity - Dream Color I & II Sensitization - Dream Color I & II Irritation - Dream Color I & II VRC-02 Validation Report of Cleaning Process for Soft Contact Lens
BS-2009-KoTIMeD-010001 Dream Color I Maximization test for Delayed hypersensitivity
MD 2007-035 Dream Color I, Dream Color II -Shape and Appearance Torsion Test Diameter Curvature Radius Apex Flexibility Extractable Substances Cell Growth Inhibition test Agarose Overlay Test Ocular Irritation Test Sterility Test - Direct Innoculation
MD 2008-033 · Dream Color I - Gold, Gray Water content Extractables
2
MD 2011-033 Extractables
BS-2009-KoTIMeD-010002 Dream Color II - (Aqua, Blue) Maximization test for Delayed hypersensitivity
MD 2007-036 Dream Color II - (Aqua, Blue) Shape and Appearance Torsion Test Diameter Curvature Radius Apex Flexibility Extractable Substances Cell Growth Inhibition test Agarose Overlay Test Ocular Irritation Test Sterility Test - Direct Innoculation
MD 2008-034 Dream Color II - (Aqua, Blue) Water content Extractables
VRS-01 Validation Report: Sterilization
VRP-02 Validation Report: Packaging Process
MD 2007-037 Dream Color II - Physicochemical Test Report
TRC-01 30 Cycle Cleaning Validation
SUMMARY OF SUBSTANTIAL EQUIVALENCE Comparison to Predicate Device(s):
This device is substantially equivalent to the predicate devices in its intended use and technological characteristics, manufacturing process specified in following table;
| Substantial Equivalency | Soft (hydrophilic) contact lens | |
|---|---|---|
| Manufacture | MiGwang Contact Lens Co., Ltd. | Dreamcon Co., Ltd. |
| Article name | Migwang Comfort 38 | Dream Color |
| Material | ||
| USAN name | Polymacon | Polymacon |
| Type | Spherical, Toric | Spherical |
| FDA Classification | Lenses, Soft Contact, Daily Wear | |
| (Class II) | Lenses, Soft Contact, | |
| Daily Wear (Class II) | ||
| Water Content | $38\pm2%$ | $38\pm2%$ |
| Light Transmittance | >90% | >90% |
| Index of Refraction | 1.43 | 1.428 |
| Oxygen permeability | $9.77 * 10^{-11} (cm^2/sec)(ml O_2/ml * mm Hg @ 35°C)$ | $9.77 * 10^{-11} (cm^2/sec)(ml O_2/ml * mm Hg @ 35°C)$ |
| Manufacturing Method | Lathe-cut | |
| (semi molded) | Lathe-cut | |
| (semi molded) | ||
| Sterilization | Steam Validated Autoclave | Steam Validated |
| Autoclave | ||
| Packaging | Blister Pack & vial | Blister Pack & vial |
| Visibility tint | Titanium Dioxide; | |
| 21CFR 73.3126 | Titanium | |
| Dioxide(White); | ||
| 21CFR 73.3126 | ||
| Visibility tint | Iron Oxides; | |
| 21CFR 73.3125 | Iron Oxides(Red); | |
| 21CFR 73.3125 | ||
| Visibility tint | C.I Pigment Green 7; | |
| 21CFR 73.3124 | C.I Pigment Green 7; | |
| 21CFR 73.3124 | ||
| Visibility tint | (Phthalocyaninato(2-)) Copper; | |
| 21CFR 74.3045 | (Phthalocyaninato(2-)) Copper; | |
| 21CFR 74.3045 | ||
| Visibility tint | C.I. Reactive Black 5 | |
| 21CFR 73.3121 | Reactive Black 5 | |
| 21CFR 73.3121 | ||
| Tint Process | Entrapment | Entrapment |
| Indication | Soft Contact Lenses for daily | |
| wear are indicated for the | ||
| correction of visual in aphakic and | ||
| non-aphakic persons with non- | ||
| diseased eyes with myopia or | ||
| hyperopia and/or possesses | ||
| refractive astigmatism not | ||
| exceeding 5.00 diopter, and/or | ||
| are presbyopia. | ||
| NOTE: Refractive astigmatism | ||
| and presbyopia N/A for spherical | ||
| lenses. | Soft Contact Lens for | |
| daily wear are indicated | ||
| for the correction of | ||
| refractive ametropia | ||
| (myopia and | ||
| hyperopia). | ||
| Powers | +25.00 ~ -25.00 Diopter | +25.00 ~ -25.00 Diopter |
| Total diameter | 12.8 ~ 14.8 | 13.5 ~ 14.5 |
| Geometrical center | ||
| thickness | 0.03 ~ 0.30 | 0.03 ~ 0.50 |
| Curvature | 8.0 ~ 9.5 | 8.3 ~ 9.0 |
| Optic zone | 6.0 ~ 12.5 | 6.0 ~ 12.5 |
| Radial edge thickness | 0.03 ~ 0.12 | 0.03 ~ 0.05 |
| Color | brown, gray, aqua, blue, violet, | |
| green | brown, gray, aqua, blue | |
| Toxicity(Safety) | Non-Toxic | Non-Toxic |
| Tensile Strength (MPa) | 0.427 | 0.425 |
3
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
June 17, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Dreamcon Co. Ltd. % Albert Rego, Ph.D. 27001 La Paz Road, Ste. 312 Mission Viejo. CA 92691
Re: K123431
Trade Name: Dream Color I, II, and III (polymacon) Soft (hydrophilic) Contact Lenses Regulatory Class: II Product Code: LPL Dated: June 1, 2013 Received: June 11, 2013
Dear Dr. Rego:
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:-GDRH-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 (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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia YAlexander -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
6
Indications for Use
510(k) Number (if known): K123431
Device Name: Dream Color I, II, and III (polymacon) Soft (hydrophilic) Contact Lenses
Indications for Use:
The Dream Color I, II, and III (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eves. Eyecare practitioners may prescribe 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
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joseph C. Hutter: SSS A
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K123431
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