(51 days)
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.
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.
The provided document is a 510(k) premarket notification for a contact lens, and as such, it does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria and studies for an "AI device" is not applicable.
The document focuses on demonstrating the substantial equivalence of the "Clearcolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens" to a legally marketed predicate device (clearlab (hioxifilcon A) 1-day soft (hydrophilic) contact lens, clear and visibility tinted for spherical, single use daily wear contact lens, cleared under K080632).
The "acceptance criteria" presented in the document are primarily the characteristic specifications of the contact lens. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed to show the equivalence of the subject device to the predicate device, not the performance of an AI algorithm.
Below is a breakdown of the requested information, adapted to the context of this contact lens submission:
1. A table of acceptance criteria and the reported device performance
The document lists various characteristics of the subject device (Clearcolor 1-Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens) and states they are identical to the predicate device (clearlab (hioxifilcon A) 1-day). Therefore, the "acceptance criteria" are implied to be these specifications, and the "reported device performance" is that the subject device meets these specifications, as evidenced by non-clinical testing and comparison to the predicate.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|
| Device Classification | Class II, 21 CFR 886.5925 (b) (1), CODE-LPL, MNV SOFT (HYDROPHILIC) CONTACT LENS |
| Intended Use | Vision Correction |
| Wearing Schedule | Daily Wear |
| Replacement Schedule | Single Use (daily disposable) |
| Method of Manufacture | Spun cast molding |
| USAN Name | Hioxifilcon A |
| FDA Contact Lens Group Number | Group 2 - Low Water (>50% H2O) Nonionic Hydrogel Polymer |
| Lens Design | Spherical |
| Power Range (Diopters) | -10.0 D to +6.0 D |
| Base Curve Range | 8.0 mm to 9.4 mm |
| Diameter Range | 12.8 to 15.0 mm |
| Center Thickness (varies with power) | 0.08 mm to 0.266 mm |
| Water Content | 58% |
| Oxygen Permeability (Dk) | 25.38 x 10-11 (cm2/sec) (O2/mL x mm Hg), revised Fatt Method |
| Refractive Index | 1.40 |
| Light Transmission | Greater than > 95% |
| Sterilization | Steam Sterilization, validated autoclave |
| Packaging | Buffered Saline |
| Package Storage Saline | Buffered Saline |
| Biocompatibility (ISO 10993) | Non-Toxic |
| Toxicology Testing | Favorable results (Cytotoxicity, Ocular Irritation, Systemic Toxicity) |
| Leachable Testing | Favorable results |
| Physical & Chemical Testing | Favorable results |
| Stability Testing | Favorable results |
"Study that proves the device meets the acceptance criteria":
The document explicitly states: "Toxicology, physical, chemical and stability testing confirm the subject device [...] is safe and effective." It also mentions specific tests conducted as recommended by the US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, 12 May 1984:
- Toxicology Testing:
- Cytotoxicity testing using the Argose Overlay method
- ISO Ocular Irritation Study
- USP & ISO Systemic Toxicity in Mice
- Leachable Testing
- Physical & Chemical Testing
- Stability Testing
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document for the non-clinical tests. The tests are mentioned generally (e.g., "Cytotoxicity testing"), without details on the number of samples or the experimental setup. Data provenance for such lab-based material testing is typically internal to the manufacturer and not specified in the 510(k) summary beyond the type of test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes non-clinical testing of a physical product (contact lens materials and characteristics), not an AI algorithm requiring expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
5. 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
This is not applicable. This document is for a contact lens, not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a contact lens, not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is typically established by physical and chemical standards, validated protocols (e.g., ISO standards, USP standards), and material properties, rather than expert consensus on medical images or pathology. For example, water content is a direct measurement, and biocompatibility is assessed against established toxicological benchmarks.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" involved in this submission.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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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.
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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) 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
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
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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 CtSuwanee, 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 |
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| Common Nameof Device: | Soft (Hydrophilic) Contact Lens, Daily Wear |
|---|---|
| Trade Name /ProprietaryName: | 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 DeviceInformation | 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 pursuantK080632. |
Facilities Used to Manufacture Device
| Name | Address & Phone Number | FDA RegistrationNumber |
|---|---|---|
| Clearlab SG Pte, Ltd. | 139 Joo Seng Road #01-01Singapore, 368362+65 6749 1090 | 9614154 |
| MIGWANG CONTACTLENS CO, LTD | Namcheon-ro, Namcheon-myeon, Gyeongsan-si,Gyeongsangbuk-do, Korea.+82-53-819-8072 | 9710495 |
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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.
| Indicationsfor Use | The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated fordaily wear single use only for the optical correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens isintended to be worn once and then discarded at the end of each wearingperiod on a daily basis. The patient should be instructed to start the nextwearing period with a new lens. The lens is available clear or tinted andmay be used to enhance or alter the apparent color of the eye. |
|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 (hioxifilconA) Daily Disposable Soft(hydrophilic) Contact Lensand Aryancolor 1-Day(hioxifilcon A) DailyDisposable Soft (hydrophilic)Contact Lens | clear 1-day |
| SubmissionNumber | K192129 | K080632 |
| DeviceClassificationUnder 21 CFR886.5925 | II | II |
| Intended Use | Vision Correction | Vision Correction |
| Wearing Schedule | Daily Wear | Daily Wear |
| ReplacementSchedule | Single Use(daily disposable) | Single Use(daily disposable) |
| Method ofManufacture | Spun cast molding | Spun cast molding |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| FDA Contact LensGroup Number | Group 2 - Low Water (>50%H2O) Nonionic HydrogelPolymer | Group 2 - Low Water (>50%H2O) Nonionic HydrogelPolymer |
| 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
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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 withPower) | 0.08 mm to 0.266 mm | 0.08 mm to 0.266 mm |
| Water Content | 58% | 58% |
| OxygenPermeability (Dk) | 25.38 x 10-11 (cm2/sec) (O2/mLx mm Hg), revised Fatt Method | 25.38 x 10-11 (cm2/sec) (O2/mL xmm Hg), revised Fatt Method |
| Refractive Index | 1.40 | 1.40 |
| Light Transmission | Greater than > 95% | Greater than > 95% |
| Sterilization | Steam Sterilization, validatedautoclave | Steam Sterilization, validatedautoclave |
| Packaging | Buffered Saline | Buffered Saline |
| Package StorageSaline | 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}------------------------------------------------
| ClinicalTesting | The technological characteristics, formulation, manufacturing,sterilization processes are the same as predicate device-1 clearedunder K080632. Therefore, no clinical data is required. | |
|---|---|---|
| SubstantialEquivalence | The subject device, clearcolor 1-day, (hioxifilcon A) soft(hydrophilic) daily wear single use cosmetically tinted contact lens issubstantially equivalent to the predicate devices. Favorable resultsfrom chemical, physical, stability, and toxicology tests substantiatethe contact lenses are within established finished productspecifications, remain stable, and are non-toxic and biocompatiblewith the ocular environment. | |
| Conclusions | Toxicology, physical, chemical and stability testing confirm thesubject device (Clearcolor 1- Day (hioxifilcon A) Daily DisposableSoft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilconA) Daily Disposable Soft (hydrophilic) Contact Lens) is safe andeffective. The results of the side by side comparison show the subjectdevice and predicate devices have the same intended use and aresubstantially equivalent. Being similar with respect to indications foruse, materials, physical construction and safety & effectiveness topredicate devices, this meets the requirements per section 510(k) ofthe act regarding substantial equivalence and does not raise differentquestions of safety and effectiveness than the predicate devicesidentified in this document. This submission is for a daily wearcontact lens, Class II subject to Special Controls. The Special Controlis the FDA Daily Wear Contact Lens Guidance Document, May 1994to which this submission is applied. All testing listed in this 510(k)submission is in accordance with that document. |
§ 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.