(48 days)
No
The device description and intended use are for a standard contact lens with no mention of AI/ML capabilities or functions.
No.
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, which are refractive errors, not diseases or conditions that require therapeutic treatment.
No
The device is a contact lens intended for the correction of refractive ametropia, not for diagnosing medical conditions.
No
The device is a physical contact lens made of Polymacon material, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Largan U38 contact lens is a medical device intended to be worn on the eye to correct vision problems (refractive ametropia, astigmatism, and presbyopia). It directly interacts with the eye for therapeutic purposes (vision correction).
- Lack of Specimen Analysis: The description and intended use do not mention the analysis of any biological specimens from the patient.
Therefore, the device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) 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 +0.75 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.
Product codes
LPL, MVN
Device Description
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatis.am and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. It is supplied in a sterile package with buffered saline solution.
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
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear.
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)
Nonclinical Tests Performed:
- 1.9.1 Oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation to break, toughness, sterility, and shelf-life tests were performed. The physical, optical, chemical and sterility properties of the lens are within established specifications for the lenses.
- 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
- Polymacon material Cytotoxicity, ocular irritation, systemic toxicity
- Packaging materials Cytotoxicity, ocular irritation, systemic toxicity
Clinical Studies:
The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824). Therefore, no clinical data is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 13, 2018
Largan Medical Co., Ltd Amy Tien RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, 40850 Taiwan
Re: K182674
Trade/Device Name: Largan U38 (polymacon) Daily Wear 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: September 20, 2018 Received: September 26, 2018
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 eyaluate 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
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
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Indications for Use
510(k) Number (if known) K182674
Device Name
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) 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 +0.75 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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K182674 510(k) Summary
Preparation Date: Sep 20, 2018
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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens |
|---|---|
| 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 | CFR 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL/MVN |
1.4 Legally Marketed Equivalent Device:
1.4.1 Lens material, lens design, and intended use:
| Predicate Device Name | Frequency 38 and Silver 07 |
|---|---|
| (polymacon)Soft | |
| (hydrophilic) Contact Lens | |
| Manufacturer | CooperVision, Inc. |
| 510(k) Number | K042824 |
| Product Code | LPL |
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1.5 Device Description
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatisam and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. It is supplied in a sterile package with buffered saline solution.
1.6 Indication for Use:
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with nondiseased 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eves and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 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.
5
1.7 Technological characteristic
Largan U38(Polymacon) 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:0.100 mm for -3.00 D
- Power: +3.00 to -10.00 D
Largan U38(Polymacon) 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:0.100 mm for -3.00 D
- Power: +3.00 to -10.00 D ●
- Cylinder: -0.25D to -5.00 D .
- Axis: 10° to 180° (in 10° increments)
Largan U38(Polymacon) 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:0.100 mm for -3.00 D
- . Power: +3.00 to -10.00 D
- Additional Powers: +0.75D to +3.50D .
6
1.8 Comparison table:
The characteristic comparison to predicate device is summarized in the following table.
| Item | Subject Device | Predicate (K042824) |
|---|---|---|
| Product Name | Largan U38(Polymacon) Daily | |
| Wear Soft (hydrophilic) Contact | ||
| Lens | Frequency 38 and Silver 07 | |
| (polymacon) Soft (hydrophilic) | ||
| Contact Lens | ||
| Manufacturer | Largan Medical Inc. | CooperVision Manufacturing, Ltd. |
| Intended Use | Myopia, Hyperopia, | |
| astigmatism, Presbyopia | The same | |
| Lens Design | Aspherical, toric, or | |
| multifocal | The same | |
| Replacement | Daily Wear | The same |
| Chemical | Polymacon | The same |
| Classification | Group I (Nonionic, Low | |
| water) | The same | |
| Water Content | 38 % (97% | |
| Blue handling tint | Reactive Blue 247 | C.I. Reactive Blue #4 |
| Method of | ||
| Manufacture | Cast Molded | Cast Molded |
1.9 Nonclinical Tests Performed
- 1.9.1 Oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation to break, toughness, sterility, and shelf-life tests were performed. The physical, optical, chemical and sterility properties of the lens are within established specifications for the lenses.
7
- · ISO18369-2 Ophthalmic optics Contact lenses Part 2: Tolerances
- · ISO18369-3 Ophthalmic optics Contact lenses Part 3: Measurement Methods
- · ISO18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
- · ISO11987 Ophthalmic optics -- Contact lenses-Determination of shelf-life
- · ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- · ISO17665-2 sterilization Of Health Care Products Moist Heat Part 2: Guidance on the Application of ISO 17665-1.
- 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
- ●Polymacon material Cytotoxicity, ocular irritation, systemic toxicity
- · Packaging materials Cytotoxicity, ocular irritation, systemic toxicity
1.10 Clinical Studies
The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824). Therefore, no clinical data is required.
1.11 Conclusion
Comparison to the predicate devices for chemical composition, physical and optical properties. it shows that " Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens " is as safe, as effective and performs as well as the predicate devices.