(51 days)
Not Found
No
The document describes a standard contact lens and its physical properties, with no mention of AI or ML technology.
No.
The contact lens is indicated for the correction of refractive ametropia (myopia and hyperopia) and astigmatism, which are visual corrections rather than therapeutic treatments for a disease or condition. The device description also highlights its use for vision correction.
No
Explanation: The device is a contact lens designed for correcting refractive errors (myopia, hyperopia, astigmatism, presbyopia) and not for diagnosing medical conditions. It is a therapeutic/corrective device.
No
The device description clearly states it is a physical contact lens made from HEMA containing UV blocker, ocufilcon D, and water. It is a tangible medical device, not software.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Largan 55 UV contact lens is a medical device intended to be worn on the eye to correct vision problems (refractive ametropia, astigmatism, presbyopia). It does not analyze any biological samples from the body.
- Intended Use: The intended use clearly states its purpose is for vision correction in living individuals, not for analyzing biological specimens.
- Device Description: The description focuses on the physical properties and composition of the lens itself, not on any components or processes for analyzing biological samples.
Therefore, the Largan 55 UV contact lens falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Largan 55 UV (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 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 55 UV (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 55 UV (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.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% ocufilcon D and 55% water. The lens is tinted with "Reactive Blue 246" to make a light blue color for handling visibility purpose. A Benzophenone UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. 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
phakic or non-aphakic persons
Intended User / Care Setting
Eye care practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Performed
- Physiochemical studies were conducted according to ISO 18369 First edition 1.9.1 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical 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.
Clinical Studies
The technical characteristics and formulation of the subject device are equivalent to Biomedics 55 Daily Wear Contact Lens (K091339) current marketed by CooperVision Inc., 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
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: a stylized human figure on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size than the rest of the text. The human figure is also in blue and appears to be a representation of health and well-being. The logo is commonly used to represent the FDA and its role in regulating food and drugs in the United States.
June 29, 2018
Largan Medical Co. Ltd. % Jennifer Ting Project Manager Jens Medical Consulting Ltd. 6F, No. 39, Ln 224, Jixian Rd., Luzhou Dist. 247 New Taipei City, Taiwan R.O.C.
Re: K181232
Trade/Device Name: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (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: May 7, 2018 Received: May 9, 2018
Dear Jennifer Ting:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: 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.
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
1
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181232
Device Name
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for astigamtism Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for presbyopia
Indications for Use (Describe)
The Largan 55 UV (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 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 55 UV (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 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 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated 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 +0.25 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.
| 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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K181232
510(k) Summary
Preparation Date: June 23, 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:
| Contact Name | Amy Tien |
|---|---|
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| amytien@larganmed.com.tw |
1.3 Device Identification:
| Proprietary Name | Largan 55 UV (ocufilcon D) 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:
| Predicate Device Name | Biomedics 55 (ocufilcon D) Soft (hydrophilic) Contact Lens |
|---|---|
| Manufacturer | CooperVision, Inc. |
| 510(k) Number | K091339 |
| Product Code | LPL/MVN |
1.5 Device Description
The Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% ocufilcon D and 55% water. The lens is tinted with "Reactive Blue 246" to make a light blue color for handling visibility purpose. A Benzophenone UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. It is supplied in a sterile package with buffered saline solution.
4
1.6 Indication for Use:
The Largan 55 UV (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 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 55 UV (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 55 UV (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.
1.7 Technological characteristic
Largan 55 UV (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 55 UV (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 55 UV (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:
| Similarities and differences | ||
|---|---|---|
| Item | Device | Predicate (K091339) |
| Product Name | Largan 55 UV daily wear soft | |
| contact lens | Biomedics Daily Wear Soft | |
| Contact Lens | ||
| Manufacturer | Largan Medical Co. Ltd | Cooper Vision., Inc. |
| Intended Use | Myopia, Hyperopia, | |
| astigmatism, Presbyopia | myopia, hyperopia, | |
| astigmatism, Presbyopia | ||
| Lens Design | aspherical, toric, or multifocal | Spherical, aspherical, toric, |
| multifocal | ||
| Replacement Schedule | Daily Wear | The same |
| Chemical composition | Ocufilcon D | The same |
| Classification | Group IV (ionic, High water) | The same |
| Water Content | 55 % | 55% |
| Oxygen Permeability | ||
| (DK, 35°C ) | 19.6 | |
| (Fatt method) | 19.6 | |
| Base Curve Range | ||
| (mm) | 8.0~9.0 | 6.50 to 10.8 |
| Diameter (mm) | 13.0~15.0 | 12.8 to 18.0 |
| Center Thickness | Varies with design and power | |
| (0.084 mm at -3.00D) | 0.025-0.40 mm (Varies with | |
| power) | ||
| Powers | -10.00D to +3.00D | -20.00 to +20.00D |
| Add Powers | +0.25E to +3.50D | +0.25D to +3.00D |
| Cylinder Power | -0.25D to -5.00D | -0.25D to -10.00D |
| Axis | 1° to 180° | 1° to 180° |
| Refractive Index | 1.405 | 1.41 |
| Light Transmittance | 90% | >95% |
| Blue handling tint | Reactive Blue 246 | Entrapment Dye |
The characteristic comparison to predicate device is summarized in the following table.
1.9 Nonclinical Tests Performed
- Physiochemical studies were conducted according to ISO 18369 First edition 1.9.1 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical 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.
1.10 Clinical Studies
The technical characteristics and formulation of the subject device are equivalent to Biomedics 55 Daily Wear Contact Lens (K091339) current marketed by CooperVision Inc., 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 55 UV daily wear soft (hydrophilic) contact lens" is as safe, as effective and performs as well as the predicate device.