(230 days)
Not Found
No
The description focuses on the material composition, manufacturing process, and optical properties of a contact lens. There is no mention of AI or ML technology being used in the device itself or its function.
No
The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia), which is a corrective function, not a therapeutic one.
No
The device is a contact lens indicated for optical correction of refractive ametropia (myopia and hyperopia), which is a treatment, not a diagnostic purpose.
No
The device description clearly details a physical contact lens made of hydrogel material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "optical correction of refractive ametropia (myopia and hyperopia)". This is a physical correction of vision, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used for vision correction. It does not describe a test kit, reagent, or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is clearly a medical device intended for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
Product codes
LPL, MVN
Device Description
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-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 Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive 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 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" 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.
The properties of the lenses are:
- Base Curve (mm): 7.85 to 10.0
- Chord Diameter (mm): 12.00 to 15.00
- Center Thickness (mm): Varies with power 0.080 mm at -3.00D 0.200 mm at +3.00D
- Power (D): +6.00 to -13.00
- Refractive Index (hydrated): 1.400 ±0.005
- Water Content (%): 58±2%
- Oxygen Permeability:(x10-11 (cm²/sec)(mlO₂/ml-mmHg)) 21±20%
- Visible Light Transmittance (%): 95±5%
- UV Transmittance (%): At 280~315 nm: Avg requirements.
- Biocompatibility tests: In Vitro Cytotoxicity, White Rabbit Ocular Irritation, Acute Systemic Toxicity. Tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 requirements.
- Performance tests: Humectant, Water Content, Transmittance, Refractive Index, Oxygen Permeability, Mechanical Properties of Materials, Extractables of Material Pigment, Extractables, pH Value, Osmolarity, Geometric Parameters, Specific Gravity. Tests were conducted in accordance with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13 requirements.
The safety and effectiveness of finished contact lenses manufactured from the etafilcon A 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.
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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 & Human Services logo. To the right of that is the FDA logo, which 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.
May 16, 2019
UNICON Optical CO., LTD Hsiao-Wei Shen, Coordinator No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, 30075 TW
Re: K182734
Trade/Device Name: Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 15, 2019 Received: April 17, 2019
Dear Hsiao-Wei Shen:
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.
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 (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.html; 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 mediation-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,
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182734
Device Name
Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Indications for Use (Describe)
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
| 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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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary
510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | May 14, 2019 |
| 5.3 | Submitter: | UNICON Optical CO., LTD |
| Address: | No 16, Gongye E. 9th Rd., Hsinchu Science Park, | |
| Baoshan Township, Hsinchu County 30075, | ||
| Taiwan (R.O.C.) | ||
| Phone: | +886-3-5775586 | |
| Fax: | +886-3-5777868 | |
| Contact: | HSIAO-WEI SHEN | |
| (ra@uniconvision.com.tw) |
5.4 Identification of the Device:
| Proprietary/Trade name: | Unicon Hydrogel (etafilcon A) Soft
(Hydrophilic) Daily Disposable Contact
Lens |
|------------------------------|--------------------------------------------------------------------------------------|
| Classification Product Code: | LPL, MVN |
| Regulation Number: | 886.5925 |
| Regulation Description: | Soft (hydrophilic) contact lens |
| Review Panel: | Ophthalmic |
| Device Class: | II |
ર્ રંડ Identification of the Predicate Device:
| Predicate Device Name: | Tangible Hydrogel with Tangible Polymer
(etafilcon A) ASPHERIC Soft
(Hydrophilic) Daily Disposable Contact
Lens |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Tangible Science LLC |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
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| Device Class: | II |
|---|---|
| 510(k) Number: | K172692 |
5.6 Intended Use/ Indications for Use of the Device
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
5.7 Device Description
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-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 Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive 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 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" 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
5
-6.50D to -13.00D in 0.50D per step.
The properties of the lenses are:
| ● | Base Curve (mm): | 7.85 to 10.0 |
|---|---|---|
| ● | Chord Diameter (mm): | 12.00 to 15.00 |
| ● | Center Thickness (mm): | Varies with power |
| 0.080 mm at -3.00D | ||
| 0.200 mm at +3.00D | ||
| ● | Power (D): | +6.00 to -13.00 |
| ● | Refractive Index (hydrated): | 1.400 ±0.005 |
| ● | Water Content (%): | 58±2% |
| ● | Oxygen Permeability: | |
| (x10-11 (cm²/sec)(mlO₂/ml-mmHg)) | 21±20% | |
| ● | Visible Light Transmittance (%): | 95±5% |
| ● | UV Transmittance (%): | At 280~315 nm: Avg requirements. |
Biocompatibilitv tests .
- In Vitro Cytotoxicity -
- -White Rabbit Ocular Irritation
- -Acute Systemic Toxicity
Tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 requirements.
. Performance tests
- Humectant -
- Water Content -
- Transmittance -
- Refractive Index -
- Oxygen Permeability -
- Mechanical Properties of Materials -
- Extractables of Material Pigment -
- Extractables -
- pH Value -
- Osmolarity -
- Geometric Parameters -
- Specific Gravity -
Tests were conducted in accordance with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13 requirements.
7
5.9 Clinical Testing
The safety and effectiveness of finished contact lenses manufactured from the etafilcon A have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.
5.10 Substantial Equivalence Determination
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens (K172692). Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Unicon Hydrogel (etafilcon A) Soft
(Hydrophilic) Daily Disposable
Contact Lens | Tangible Hydrogel with Tangible
Polymer (etafilcon A) ASPHERIC
Soft (Hydrophilic) Daily
Disposable Contact Lens | N/A |
| 510(k) No. | K182734 | K172692 | N/A |
| Intended Use | The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes | The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic | Same |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | who may have 1.00 D or less of
astigmatism. Eye care professionals
may prescribe the lenses for daily
disposable wear. Lenses shall be
discarded upon removal. | persons with non-diseased eyes
who may have 1.00 D or less of
astigmatism. Eye care professionals
may prescribe the lenses for daily
disposable wear. Lenses shall be
discarded upon removal. | |
| Type of use | Prescription Use | Prescription Use | Same |
| Single Use | Yes | Yes | Same |
| UV Blocking | Yes | Yes | Same |
| Production Method | Cast-Molded | Cast-Molded | Same |
| USAN Name | etafilcon A | etafilcon A | Same |
| Color additive | RB246
1,4-Bis[4-(2-methacryloxyethyl)ph
enylamino] anthraquinone
copolymers | [Phthalocyaninato(2-)]copper | Different but
RB246 is also
approved;
therefore it would
not affect the
equivalence |
| Base Curve | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm | Same |
| Chord Diameter | 12.0 mm to 15.00 mm | 12.0 mm to 15.00 mm | Same |
| Center Thickness | Varies with power
0.080 mm at -3.00D
0.200 mm at +3.00D | 0.01 mm to 0.20 mm | Different but the
specification meets
the requirement;
therefore it would
not affect the
equivalence |
| Water Content (%) | 58% | 58% | Same |
| Refractive Index
(hydrated) | 1.400 | 1.400 | Same |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Oxygen Permeability | $23.42 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$ | $29.96 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$ | Different but the
specification meets
the requirement;
therefore it would
not affect the
equivalence |
| Power Range | +4.50D ~ +6.00D in 0.50D per step
+4.00D ~ -6.00D in 0.25D per step
-6.50D ~ -13.00D in 0.50D per step | +6.00D to -10.00D (in 0.25D steps)
Cylinder: -0.75D to -2.50D (in 0.25D steps) Axis: 10° to 180° (in 10° steps) Add: +1.00D to +2.50D (in 0.50D steps) | Different but it
would not affect
the equivalence |
| Visible Light
Transmittance | 95±5% | >98% | Different but the
specification meets
the requirement;
therefore it would
not affect the
equivalence |
| UV transmittance | at 280~315 nm: Avg