(244 days)
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.
This document describes a 510(k) premarket notification for contact lenses. No studies are presented that describe acceptance criteria and device performance in the context of AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to a predicate device, which for contact lenses primarily relies on physicochemical and biocompatibility testing rather than clinical performance studies when the technological characteristics are comparable.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study results in the context of device performance as you describe (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth establishment for AI/ML models) because this information is not present in the provided text.
The closest information provided related to "acceptance criteria" and "device performance" in this document is:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the new device and predicate devices. While not a strict "acceptance criteria" table with numerical thresholds for performance, it implicitly shows that the Largan DB (Ocufilcon D) Daily Wear Soft Contact Lenses meet the implied performance standards by being identical or highly similar to the legally marketed predicate devices across key technical and material characteristics.
| Item | Device (Largan DB Ocufilcon D) | Predicate (Largan 55 UV Ocufilcon D) |
|---|---|---|
| Manufacturer | Largan Medical Co. Ltd. | The same |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | The same |
| Indication for use | Correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes; correction of ametropia with astigmatism; correction of ametropia and emmetropia with presbyopia. Can be single-use disposable or frequent/planned replacement. Color version enhances/alters eye color. | The same |
| Lens Design | Aspherical, toric, or multifocal | The same |
| Replacement Schedule | Daily Wear | The same |
| Chemical composition | Ocufilcon D | The same |
| Classification | Group IV (Ionic, High water) | The same |
| Water Content | 55 % | The same |
| Oxygen Permeability (DK, 35°C) | 19.6 (Fatt method) | The same |
| Base Curve Range(mm) | 8.0~9.0 | The same |
| Diameter (mm) | 13.0~15.0 | The same |
| Center Thickness | Varies with power (e.g., 0.084 mm for -3.00D for spherical & astigmatism, 0.130 mm for -3.00D for presbyopia) | The same |
| Powers | -10.00D to +3.00D (Cylinder -0.25D ~ -5.00 D with Axis 10° to 180° for astigmatism; Add Powers +0.25D ~ +3.50D for presbyopia) | The same |
| Refractive Index | 1.405 | The same |
| Light Transmittance | 90% | The same |
| Color additives | Device: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment, Yellow 15Predicate K181232: Reactive Blue 246Predicate K182523: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment | Predicate K181232: Reactive Blue 246Predicate K182523: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment |
| Method of Manufacture | Cast Molded | The same |
| Packaging saline | Saline solution with sodium hyaluronate and poloxamer kolliphor P407 | The same |
Note: The color additives vary slightly between the new device and the predicate K181232, but are similar to K182523. This difference is addressed through nonclinical testing below.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission is for contact lenses, and no clinical test set for AI/ML performance is mentioned. The primary studies referenced are physicochemical and biocompatibility tests.
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)
Not applicable, as no clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable, as no AI or diagnostic imaging component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/ML algorithm. The "ground truth" for contact lenses is established by meeting specified physical, chemical, and biological safety standards.
8. The sample size for the training set
Not applicable, as no AI/ML training set is mentioned.
9. How the ground truth for the training set was established
Not applicable.
Studies that prove the device meets acceptance criteria:
The document states:
- Nonclinical Tests Performed:
- Physiochemical studies were conducted according to ISO 18369-4 second edition 2017-08, Ophthalmic optics -Contact lenses (Ophthalmic). The report states: "The physical, optical and chemical properties of the lens are within established specification for the lenses."
- Biocompatibility studies (cytotoxicity, acute ocular irritation, and acute systemic injection toxicity) of the subject lenses and primary package were conducted according to ISO 10993 series biocompatibility standard. The report states: "all of them are nontoxic and biocompatible." Specific standards referenced include:
- ISO 10993 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. (2009)
- ISO 10993 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. (2010)
- ISO 10993 Biological evaluation of medical devices- Part 11: Tests for Systemic toxicity. (2006)
- ISO 10993 Biological evaluation of medical devices- Part 12: Sample preparation and reference materials. (2012)
- Clinical Studies: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232) and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) current marketed by Largan Medical Co., Ltd, therefore no clinical data is required." This indicates that the equivalence to predicate devices, supported by nonclinical testing, is deemed sufficient to establish safety and effectiveness, meaning no new clinical trials were performed or required.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 1, 2021
Largan Medical Co., Ltd. Amy Tien RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, 40850 Taiwan
Re: K202129
Trade/Device Name: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 25, 2021 Received: February 26, 2021
Dear Amy Tien:
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 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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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.
for Angelo Green 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
510(k) Number (if known) K202129
Device Name
Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
Indications for Use (Describe)
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Preparation Date: March 22, 2021
1.1 Establishment Information:
| Name | Largan Medical Co. Ltd. |
|---|---|
| Owner | Adam Lin |
| Title | CEO |
| Address | 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist.,Taichung, 40850, Taiwan |
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| info@larganmed.com.tw |
1.2 Contact Person:
| Phone No. | 886-4-3600-0203 |
|---|---|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Amy Tien |
| amytien@larganmed.com.tw |
1.3 Device Identification:
| Proprietary Name | Largan DB (Ocufilcon D) Daily Wear Soft(hydrophilic) Contact Lens; Largan DB Color(Ocufilcon D) Daily Wear Soft (hydrophilic) ContactLens; Largan DB (Ocufilcon D) Daily Wear Soft(hydrophilic) Contact Lens for Astigmatism; LarganDB Color (Ocufilcon D) Daily Wear Soft(hydrophilic) Contact Lens for Astigmatism; LarganDB (Ocufilcon D) Daily Wear Soft Contact Lens forPresbyopia; Largan DB Color (Ocufilcon D) DailyWear Soft (hydrophilic) Contact Lens for Presbyopia |
|---|---|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear,(21 CFR 886.5925, Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(21 CFR 886.5925, Product Code MVN) |
| Classification | II |
| Regulation Number | CRF 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL;MVN |
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1.4 Legally Marketed Equivalent Device:
| Predicate Device Name | Largan 55 UV (Ocufilcon D) Daily Wear Soft(hydrophilic) Contact Lens; Largan 55 UV (OcufilconD) Daily Wear Soft (hydrophilic) Contact Lens forAstigmatism; Largan 55 UV (Ocufilcon D) Daily Wear |
|---|---|
| Soft (hydrophilic) Contact Lens for Presbyopia/ | |
| Largan 55 UV Color(Ocufilcon D) Daily Wear Soft | |
| (hydrophilic) Contact Lens; Largan 55 UV | |
| Color(Ocufilcon D) Daily Wear Soft (hydrophilic) | |
| Contact Lens for Astigmatism; Largan 55 UV | |
| Color(Ocufilcon D) Daily Wear Soft (hydrophilic) | |
| Contact Lens for Presbyopia | |
| Manufacturer | Largan Medical Co. Ltd. |
| 510(k) Number | K181232/ |
| K182523 | |
| Product Code | LPL; MVN |
1.5 Device Description
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.
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1.6 Indication for Use:
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.
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- 1.7 Technological characteristic
Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens characteristics:
- Diameter Range: 13.0 to 15.0 mm ●
- Base Curve:8.0 to 9.0 mm .
- Center Thickness:0.084 mm for -3.00D (varies with power) ●
- Power: +3.00 to -10.00 D ●
Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism
characteristics:
- Diameter Range: 13.0 to 15.0 mm ●
- Base Curve:8.0 to 9.0 mm ●
- Center Thickness:0.084 mm for -3.00D (varies with power) .
- Power: +3.00 to -10.00 D ●
- . Cylinder: -0.25D ~ -5.00 D
- Axis: 10° to 180° (in 10°increments) .
Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
characteristics:
- Diameter Range: 13.0 to 15.0 mm ●
- Base Curve:8.0 to 9.0 mm .
- Center Thickness:0.130 mm for -3.00D (varies with power) .
- Power : +3.00 to -10.00 D
- Additional Powers: +0.25D ~ +3.50D ●
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1.8 Comparison table:
The characteristic comparison to predicate devices is summarized in the following table.
| Similarities and differences | |||
|---|---|---|---|
| Item | Device | Predicate (K181232) | Predicate (K182523) |
| Product Name | Largan DB (Ocufilcon D) DailyWear Soft (hydrophilic) ContactLens | Largan 55 UV (OcufilconD) Daily Wear Soft(hydrophilic) Contact Lens | Largan 55 UV Color(Ocufilcon D) Daily WearSoft (hydrophilic) Contact Lens |
| Manufacturer | Largan Medical Co. Ltd. | The same | The same |
| Intended Use | Myopia, Hyperopia,astigmatism, Presbyopia | The same | The same |
| Indication for use | The Largan DB (Ocufilcon D)Daily Wear Soft (hydrophilic)Contact Lens/ Largan DB Color(Ocufilcon D) Daily Wear Soft(hydrophilic) Contact Lens is adaily wear soft contact lensindicated for the correction ofrefractive ametropia (myopia andhyperopia) in phakic or non-aphakicpersons with non-diseased eyes whoexhibit refractive astigmatism of1.00D or less where the astigmatismdoes not interfere with visual acuity. | The same | The same |
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The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color(Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and nonaphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add
powers from +0.25 to +3.50
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| diopters. The lenses may be worn bypersons who exhibit astigmatism of1.00 diopters or less where theastigmatism does not interfere withvisual acuity. | |
|---|---|
| Eye care practitioners may prescribethe lens for either single-usedisposable wear, or forfrequent/planned replacement wear,with cleaning, disinfection, andscheduled replacement. Whenprescribed for single-use disposablewear, the lens is to be discardedafter each removal, therefore nocleaning or disinfecting is required.When prescribed for frequentreplacement, the lens may bedisinfected using a chemicaldisinfection system only. Whenprescribed for frequent replacement,it is recommended that the lenses bediscarded and replaced with a newlens not more than every 1 month.However, the Eye Care Professionalis encouraged to determine anappropriate replacement schedulebased upon response of the patient. |
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| The Largan DB Color (OcufilconD) Daily Wear Soft (hydrophilic)Contact Lens is also intended toenhance or alter the apparent colorof the eye. | |||
|---|---|---|---|
| Lens Design | Aspherical, toric, ormultifocal | The same | The same |
| Replacement Schedule | Daily Wear | The same | The same |
| Chemical composition | Ocufilcon D | The same | The same |
| Classification | Group IV (Ionic, High water) | The same | The same |
| Water Content | 55 % | The same | The same |
| Oxygen Permeability(DK, 35°C ) | 19.6(Fatt method) | The same | The same |
| Base Curve Range(mm) | 8.0~9.0 | The same | The same |
| Diameter (mm) | 13.0~15.0 | The same | The same |
| Center Thickness | Varies with power | The same | The same |
| Powers | -10.00D to +3.00D | The same | The same |
| Refractive Index | 1.405 | The same | The same |
| Light Transmittance | 90% | The same | The same |
| Color additives | ● Phthalocyanine green● Carbazole violet● [Phthalocyaninato(2-)]copper● Titanium dioxide● Iron oxides● Chromium-cobaltaluminumoxide● Mica-based pearlscent pigment● Yellow 15 | ● Reactive Blue 246 | ● Phthalocyanine green● Carbazole violet● [Phthalocyaninato(2-)]copper● Titanium dioxide● Iron oxides● Chromium-cobaltaluminumoxide● Mica-based pearlscentpigment |
| Method ofManufacture | Cast Molded | The same | The same |
| Packaging saline | Saline solution with sodiumhyaluronate and poloxamerkolliphor P407 | The same | The same |
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1.9 Nonclinical Tests Performed
- 1.9.1 Physiochemical studies were conducted according to ISO 18369-4 second edition 2017-08, Ophthalmic optics -Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specification for the lenses.
- 1.9.2 Biocompatibility studies including cytotoxicity, acute ocular irritation, and acute systemic injection toxicity studies of subject lenses and primary package (polypropylene blister and aluminum foil) were conducted according to ISO 10993 series biocompatibility standard to assess the biological safety of the medical device and all of them are nontoxic and biocompatible. Biocompatibility tests following referenced standards as below:
- ISO 10993 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. (2009) 1.
-
- ISO 10993 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. (2010)
- ISO 10993 Biological evaluation of medical devices- Part 11: Tests for Systemic toxicity. (2006) 3.
-
- ISO 10993 Biological evaluation of medical devices- Part 12: Sample preparation and reference materials. (2012)
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1.10 Clinical Studies
The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232) and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) current marketed by Largan Medical Co., Ltd, therefore no clinical data is required.
1.11 Conclusion
Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens" demonstrates substantial equivalence as the predicate device.
§ 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.