(51 days)
Not Found
No
The 510(k) summary describes a standard daily disposable contact lens for vision correction and cosmetic purposes. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is indicated for the optical correction of refractive ametropia and to enhance or alter the apparent color of the eye. It does not treat a disease or improve a health condition.
No
Explanation: The device is a contact lens intended for optical correction of refractive ametropia and to enhance or alter eye color, not for diagnosing diseases or conditions.
No
The device description clearly states it is a physical contact lens made of hioxifilcon A and various colorants, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the optical correction of refractive ametropia (myopia and hyperopia) and to enhance or alter the apparent color of the eye. This is a therapeutic and cosmetic purpose, not a diagnostic one.
- Device Description: The device is a contact lens made of a specific material with added colorants. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on toxicology, leachables, physical/chemical properties, and stability. These are relevant to the safety and performance of a medical device worn on the eye, but not to diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids, tissues, or other biological samples, which is a core characteristic of IVDs.
In summary, the device is a contact lens intended for vision correction and cosmetic purposes, not for diagnosing any condition.
N/A
Intended Use / Indications for Use
The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The subject device, Clearcolor 1- Day (hioxifilcon A) Daily Disposable Device Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Description Daily Disposable Soft (hydrophilic) Contact Lens is a Soft Hydrophilic Daily Disposable Color Soft Contact Lens. The subject device is made of a nonionic lens material, hioxifilcon A, which is a random co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and glycerol methacrylate (HEMA/GMA) cross-linked with ethylene glycol dimethacrylate. The copolymer consists of 42% hioxifilcon A and 58% water by weight when immersed in normal buffered saline solution. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN). The subject device is a cosmetically tinted contact lens and contains a pigmented area that will mask or enhance the color of the natural iris. The cosmetically tinted lenses contain one or more of the following US FDA approved colorants for contact lenses: D&C Yellow, No. 10, D&C Green, D&C Red No. 17, Phthalocyanine-2-Copper, Carbazole Violet, Titanium dioxides, reactive Black 5, C.I. Vat Orange 1, C.I. Vat yellow 3, C.I. Pigment Green, C.I. Vat Orange 5, C.I. Vat Brown 1, C.I. Vat Green 1, Pigment Blue 36, and Iron Oxides. These colorants will be used to make 1-tone, 2-tone and 3-tone color patterns on contact lenses. The cosmetically tinted lens is available in variety of opaque colors including: Gray, Brown, Tan Brown, Black, Green, and Blue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted as recommended by the US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, 12 May 1984
- Toxicology Testing 1.
- a. Cytotoxicity testing using the Argose Overlay method
- b. ISO Ocular Irritation Study
- c. USP & ISO Systemic Toxicity in Mice
- ii. Leachable Testing
- iii. Physical & Chemical Testing
- iv. Stability Testing
The technological characteristics, formulation, manufacturing, sterilization processes are the same as predicate device-1 cleared under K080632. Therefore, no clinical data is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
September 27, 2019
Clearlab SG Pte Ltd. Dr. John Christopher Phelan Head of Research & Development 4200 Jenkins Ct. Suwanee, GA 30024
Re: K192129
Trade/Device Name: Clear Color 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 27, 2019 Received: August 30, 2019
Dear Dr. Phelan:
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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192129
Device Name
Clearcolor 1- Day (hioxifilcon A) 1-Day, Daily Disposable Soft (hydrophilic) Contact Lens Aryancolor1- Day (hioxifilcon A) 1-Day, Daily Disposable Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
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
K192129
Summary of Safety and Effectiveness
Special 510(k) Submission
SUBMITTER INFORMATION
Date Prepared: | 26 September, 2019 |
---|---|
Submitter Name: | Dr. John Christopher Phelan |
Address: | Clearlab US, Inc. |
4200 Jenkins Ct | |
Suwanee, GA 30024 |
Phone: | (770) 271-0211 or 1-888-777-7147 |
---|---|
Fax | 1-888-773-2904 or 770-271-0225 |
jphelan@clearlab.com | |
Establishment Registration Number | 200709186M |
4
| Common Name
of Device: | Soft (Hydrophilic) Contact Lens, Daily Wear |
---|---|
Trade Name / | |
Proprietary | |
Name: | Clearcolor 1- Day (hioxifilcon A) Daily Disposable Soft |
(hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) | |
Daily Disposable Soft (hydrophilic) Contact Lens | |
Classification: | Classification Class II, 21 CFR 886.5925 (b) (1), CODE-LPL, |
MNV SOFT (HYDROPHILIC) CONTACT LENS | |
Predicate Device | |
Information | The predicate devices are: (1) clearlab (hioxifilcon A) 1-day soft |
(hydrophilic) contact lens, clear and visibility tinted for spherical, | |
single use daily wear contact lens, previously cleared pursuant | |
K080632. |
Facilities Used to Manufacture Device
| Name | Address & Phone Number | FDA Registration
Number |
|---------------------------------|-----------------------------------------------------------------------------------------------|----------------------------|
| Clearlab SG Pte, Ltd. | 139 Joo Seng Road #01-01
Singapore, 368362
+65 6749 1090 | 9614154 |
| MIGWANG CONTACT
LENS CO, LTD | Namcheon-ro, Namcheon-
myeon, Gyeongsan-si,
Gyeongsangbuk-do, Korea.
+82-53-819-8072 | 9710495 |
5
The subject device, Clearcolor 1- Day (hioxifilcon A) Daily Disposable Device Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Description Daily Disposable Soft (hydrophilic) Contact Lens is a Soft Hydrophilic Daily Disposable Color Soft Contact Lens. The subject device is made of a nonionic lens material, hioxifilcon A, which is a random co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and glycerol methacrylate (HEMA/GMA) cross-linked with ethylene glycol dimethacrylate. The copolymer consists of 42% hioxifilcon A and 58% water by weight when immersed in normal buffered saline solution. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN). The subject device is a cosmetically tinted contact lens and contains a pigmented area that will mask or enhance the color of the natural iris. The cosmetically tinted lenses contain one or more of the following US FDA approved colorants for contact lenses: D&C Yellow, No. 10, D&C Green, D&C Red No. 17, Phthalocyanine-2-Copper, Carbazole Violet, Titanium dioxides, reactive Black 5, C.I. Vat Orange 1, C.I. Vat yellow 3, C.I. Pigment Green, C.I. Vat Orange 5, C.I. Vat Brown 1, C.I. Vat Green 1, Pigment Blue 36, and Iron Oxides. These colorants will be used to make 1-tone, 2-tone and 3-tone color patterns on contact lenses. The cosmetically tinted lens is available in variety of opaque colors including: Gray, Brown, Tan Brown, Black, Green, and Blue.
| Indications
for Use | The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for
daily wear single use only for the optical correction of refractive
ametropia (myopia and hyperopia) in phakic or aphakic person with non-
diseased eyes who may have 1.00 D or less of astigmatism. The lens is
intended to be worn once and then discarded at the end of each wearing
period on a daily basis. The patient should be instructed to start the next
wearing period with a new lens. The lens is available clear or tinted and
may be used to enhance or alter the apparent color of the eye. |
------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
---|
6
Comparison of Subject Device to Predicate Devices
Side by side comparisons of the label claim characteristics of the Technological predicate device are identical to that of the legally marketed device Characteristics cleared under K080632. A side by side comparison of to the subject device with predicate devices is shown in the table below.
Matrix illustrating the equivalencies of subject device clearcolor 1-day contact lens and Predicate Device-1 (clear 1-day)
Subject Device | Predicate Device- | |
---|---|---|
Trade Name | Clearcolor 1- Day (hioxifilcon | |
A) Daily Disposable Soft | ||
(hydrophilic) Contact Lens | ||
and Aryancolor 1-Day | ||
(hioxifilcon A) Daily | ||
Disposable Soft (hydrophilic) | ||
Contact Lens | clear 1-day | |
Submission | ||
Number | K192129 | K080632 |
Device | ||
Classification | ||
Under 21 CFR | ||
886.5925 | II | II |
Intended Use | Vision Correction | Vision Correction |
Wearing Schedule | Daily Wear | Daily Wear |
Replacement | ||
Schedule | Single Use | |
(daily disposable) | Single Use | |
(daily disposable) | ||
Method of | ||
Manufacture | Spun cast molding | Spun cast molding |
USAN Name | Hioxifilcon A | Hioxifilcon A |
FDA Contact Lens | ||
Group Number | Group 2 - Low Water (>50% | |
H2O) Nonionic Hydrogel | ||
Polymer | Group 2 - Low Water (>50% | |
H2O) Nonionic Hydrogel | ||
Polymer | ||
USAN name | hioxifilcon A | hioxifilcon A |
Lens Design | Spherical | Spherical |
Power Range | ||
(Diopters) | -10.0 D to +6.0 D | -10.0 D to +6.0 D |
Continued on next page
Page 4 of 6
7
Continued, Matrix illustrating the equivalencies of Subject device (Clearcolor 1- Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens)and Predicate Device-1 (clear 1-day)
Base Curve Range | 8.0 mm to 9.4 mm | 8.0 mm to 9.4 mm |
---|---|---|
Diameter Range | 12.8 to 15.0 mm | 12.8 to 15.0 mm |
Center Thickness | ||
(varies with | ||
Power) | 0.08 mm to 0.266 mm | 0.08 mm to 0.266 mm |
Water Content | 58% | 58% |
Oxygen | ||
Permeability (Dk) | 25.38 x 10-11 (cm2/sec) (O2/mL | |
x mm Hg), revised Fatt Method | 25.38 x 10-11 (cm2/sec) (O2/mL x | |
mm Hg), revised Fatt Method | ||
Refractive Index | 1.40 | 1.40 |
Light Transmission | Greater than > 95% | Greater than > 95% |
Sterilization | Steam Sterilization, validated | |
autoclave | Steam Sterilization, validated | |
autoclave | ||
Packaging | Buffered Saline | Buffered Saline |
Package Storage | ||
Saline | Buffered Saline | Buffered Saline |
Biocompatibility | ||
(ISO 10993) | Non-Toxic | Non-Toxic |
Summary of Non-clinical Testing
The following tests were conducted as recommended by the US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, 12 May 1984
- Toxicology Testing 1.
- a. Cytotoxicity testing using the Argose Overlay method
- b. ISO Ocular Irritation Study
- c. USP & ISO Systemic Toxicity in Mice
- ii. Leachable Testing
- iii. Physical & Chemical Testing
- iv. Stability Testing
- V.
8
| Clinical
Testing | The technological characteristics, formulation, manufacturing,
sterilization processes are the same as predicate device-1 cleared
under K080632. Therefore, no clinical data is required. | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Substantial
Equivalence | The subject device, clearcolor 1-day, (hioxifilcon A) soft
(hydrophilic) daily wear single use cosmetically tinted contact lens is
substantially equivalent to the predicate devices. Favorable results
from chemical, physical, stability, and toxicology tests substantiate
the contact lenses are within established finished product
specifications, remain stable, and are non-toxic and biocompatible
with the ocular environment. | |
| Conclusions | Toxicology, physical, chemical and stability testing confirm the
subject device (Clearcolor 1- Day (hioxifilcon A) Daily Disposable
Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon
A) Daily Disposable Soft (hydrophilic) Contact Lens) is safe and
effective. The results of the side by side comparison show the subject
device and predicate devices have the same intended use and are
substantially equivalent. Being similar with respect to indications for
use, materials, physical construction and safety & effectiveness to
predicate devices, this meets the requirements per section 510(k) of
the act regarding substantial equivalence and does not raise different
questions of safety and effectiveness than the predicate devices
identified in this document. This submission is for a daily wear
contact lens, Class II subject to Special Controls. The Special Control
is the FDA Daily Wear Contact Lens Guidance Document, May 1994
to which this submission is applied. All testing listed in this 510(k)
submission is in accordance with that document. | |