(94 days)
Not Found
No
The device description and performance studies focus on the material properties, manufacturing process, and physical characteristics of a contact lens. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the correction of ametropia (myopia and hyperopia) in aphakic persons, which is a therapeutic purpose.
No
Explanation: The device is a contact lens used for the correction of ametropia, which is a treatment rather than a diagnostic function. It corrects vision, it does not diagnose a condition.
No
The device description clearly details a physical contact lens made of specific materials (HEMA, MAA, etc.) and manufactured using a case-molding method. It also describes physical properties like water content, mechanical properties, and UV blocking capabilities, all of which are hardware characteristics.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of ametropia (myopia and hyperopia) in aphakic persons. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used for vision correction.
- Performance Studies: The performance studies focus on the physical and biological properties of the lens (sterilization, shelf life, biocompatibility, mechanical properties, etc.) and its ability to block UV radiation. These are relevant to the safety and effectiveness of a contact lens for vision correction, not for diagnosing a condition.
- No mention of in vitro testing: The text does not describe any testing performed on samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
IVD devices are used to perform tests on samples from the human body to diagnose, monitor, or screen for diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The UNICON (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes
LPL, MVN
Device Description
UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.
With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and into the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of non-clinical studies were completed on this product. The tests and studies were performed in UNICON QC lab and subcontracted test services which were according to the FDA guidance (Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, February 27, 1997) and related recognized consensus standards. All the test results were met the requirements of products specification.
The following tests were conducted on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear'':
- . Sterilization Test
- o Shelf Life Test
- Biocompatibility
- -Cytotoxicity
- Irritation -
- -Acute Systemic toxicity
- Water Content
- . Mechanical Properties of Materials
- . Refractive Index
- Oxygen Permeability
- Transmittance
- Extractables Test
- . Specific Gravity
The Sterilization Method used on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear" is moist heat sterilization and the study for sterilization is based on the EN/ISO 17665 : 2006 Sterilization of health care product-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The overkill method is used as validation method for sterilization and the results demonstrates achievement of the required sterility assurance limit (SAL) of 10 °.
The safety and effectiveness of etafilcon A lenses have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three overlapping heads suggesting a sense of community and interconnectedness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Unicon Optical Co., Ltd. % Mr. Michael Lee President No. 45, Mingsheng Rd., Danshui District New Taipei, 251 TW
Re: K141917
Trade/Device Name: Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 8, 2014 Received: July 15, 2014
Dear Mr. Lee.
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 or any Federal statutes and regulations administered by other Federal agencies.
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -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) K141917
Device Name
Unicon (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear
Indications for Use (Describe)
The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into 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) |
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3
UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Preparation Date: | 7th July, 2014 |
| 5.3 | Submitter: | UNICON Optical Co., LTD. |
| Address: | No 16, Gongye E. 9th Rd., Hsinchu Science Park, | |
| Baoshan Township, Hsinchu County 30075, | ||
| Taiwan | ||
| Phone: | +886-3-5775586 | |
| Fax: | +886-3-5777868 | |
| Contact: | Robert |
5.4 Identification of the Device:
| Proprietary/Trade name: | UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear |
|---|---|
| Common Name: | Soft (hydrophilic) contact lenses for daily wear |
| Classification Name: | LENS, CONTACT, (DISPOSABLE) |
| Device Classification: | II |
| Regulation Number: | 886.5925 |
| Panel: | Ophthalmic |
| Product Code: | MVN ; LPL |
5.5 Identification of the Predicate Device:
| Predicate Device
Name: | VISTAKON (Etafilcon A) Soft (hydrophilic)
Contact Lens (spherical), Clear and Visibility
Tinted with UV Blocker for Daily Disposable
Wear |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | VISTAKON |
| Product Code: | MVN ; LPL |
| 510(k) Number: | K051900 |
4
5.6 Intended Use and Indications for Use of the subject device.
The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less astigmatism. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear are indicated for single-use disposable wear and are to be discarded after each removal. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
5.7 Device Description
UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.
With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic)
5
Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.
5.8 Non-clinical Testing
A series of non-clinical studies were completed on this product. The tests and studies were performed in UNICON QC lab and subcontracted test services which were according to the FDA guidance (Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, February 27, 1997) and related recognized consensus standards. All the test results were met the requirements of products specification.
The following tests were conducted on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear'':
- . Sterilization Test
- o Shelf Life Test
- Biocompatibility
- -Cytotoxicity
- Irritation -
- -Acute Systemic toxicity
- Water Content
- . Mechanical Properties of Materials
- . Refractive Index
- Oxygen Permeability
- Transmittance
- Extractables Test
6
- . Specific Gravity
The Sterilization Method used on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear" is moist heat sterilization and the study for sterilization is based on the EN/ISO 17665 : 2006 Sterilization of health care product-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The overkill method is used as validation method for sterilization and the results demonstrates achievement of the required sterility assurance limit (SAL) of 10 °.
5.9 Clinical Testing
The safety and effectiveness of etafilcon A lenses have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.
5.10 EMC and Electrical safety
The devices do not require EMC/Electrical Safety evaluation.
5.11 Substantial Equivalence Determination
The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the cleared VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear which is the subject of K051900. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
7
UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear
| Proposed Device | Predicate Device | |
|---|---|---|
| Device name | UNICON (Etafilcon A) Soft | |
| (Hydrophilic) Contact Lens | ||
| with UV Blocker for Daily | ||
| Wear | VISTAKON (Etafilcon A) Soft | |
| (hydrophilic) Contact Lens | ||
| (spherical), Clear and Visibility | ||
| Tinted with UV Blocker for | ||
| Daily Disposable Wear | ||
| Regulatory | ||
| Number | 886.5925 | 886.5925 |
| Classification | II | II |
| Intended Use | The UNICON (Etafilcon A) | |
| Soft (Hydrophilic) Contact Lens | ||
| with UV Blocker for Daily | ||
| Wear is indicated for daily wear | ||
| for the correction of ametropia | ||
| (myopia and hyperopia) in | ||
| aphakic or non-aphakic persons | ||
| with non-diseased eyes who | ||
| may have 1.00D or less | ||
| astigmatism. The UNICON | ||
| (Etafilcon A) Soft (Hydrophilic) | ||
| Contact Lens with UV Blocker | ||
| for Daily Wear are indicated for | ||
| single-use disposable wear and | ||
| are to be discarded after each | ||
| removal. The UNICON | ||
| (Etafilcon A) Soft (Hydrophilic) | ||
| Contact Lens with UV Blocker | ||
| for Daily Wear helps protect | ||
| against transmission of harmful | ||
| UV radiation to the cornea and | ||
| into the eye. | The VISTAKON (Etafilcon A) | |
| Soft (hydrophilic) Contact Lens | ||
| (spherical), Clear and Visibility | ||
| Tinted with UV Blocker for Daily | ||
| Disposable Wear for the | ||
| correction of refractive ametropia | ||
| (myopia and hyperopia) in | ||
| aphakic or not-aphakic persons | ||
| with not diseased eyes who may | ||
| have 1.00D or less of | ||
| astigmatism. | ||
| VISTAKON (Etafilcon A) Soft | ||
| (hydrophilic) Contact Lens, Clear | ||
| and Visibility Tinted with UV | ||
| Blocker for Daily Disposable | ||
| Wear help protect against | ||
| transmission of harmful UV | ||
| radiation to the cornea and into | ||
| the eye. | ||
| The VISTAKON (Etafilcon A) | ||
| Soft (hydrophilic) Contact Lens, | ||
| Clear and Visibility Tinted with | ||
| UV Blocker for Daily Disposable | ||
| Wear is to be prescribed for Daily | ||
| Disposable Wear and is to be | ||
| discarded after each removal. | ||
| Prescription Use | Yes | Yes |
| Single Use | Yes | Yes |
8
| Material | Etafilcon A | Etafilcon A |
|---|---|---|
| Base Curve | 7.85mm to 10.0mm | 7.85mm to 10.0mm |
| Diameter | 12.0mm to 15.0mm | 12.0mm to 15.0mm |
| Water Content | 58% | 58% |
| UV | ||
| transmittance | ||
| @280~315 nm | ||
| @316~380 nm | Avg |