(60 days)
The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as aspherical lenses manufactured by cast-molding method. The material is a high water content (59 % wt/wt) material. The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) 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-yl)-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 50% in the UVA range of 316 to 380 nm.
The provided text is related to a 510(k) premarket notification for a soft contact lens and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI device, human readers, or the establishment of ground truth in the context of medical imaging or diagnostic aid. Therefore, I cannot extract the information requested as it is not present in the document.
Specifically, the document states:
- "No clinical test data was used to support the decision of substantial equivalence." (Page 6, Section 5.9 Clinical Testing)
- The studies conducted were non-clinical safety and performance studies for the contact lens, such as sterilization validation, shelf-life, biocompatibility, and material performance (e.g., water content, oxygen permeability). These are physical and chemical tests, not studies related to diagnostic accuracy or AI performance.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance in the context of an AI device and diagnostic accuracy.
- Sample size for a test set or its provenance for an AI device.
- Number of experts or their qualifications for establishing ground truth for an AI device.
- Adjudication method for an AI test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI assistance.
- Standalone performance of an algorithm (as there is no AI algorithm described).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
- Sample size for a training set for an AI device.
- How ground truth for a training set was established for an AI device.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
September 17, 2019
UNICON Optical CO., LTD Hsiao-Wei Shen Coordinator No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, TW 30075
Re: K191929
Trade/Device Name: UNICON Hydrogel (Hioxifilcon A) 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: July 16, 2019 Received: July 19, 2019
Dear Mr. 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.
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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 devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-devicesafety/medical-device-reporting-mdr-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/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-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, Ph.D. 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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Indications for Use
510(k) Number (if known)
K191929
Device Name
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Section 5 - 510(k) Summary
510(k) SUMMARY
- 5.1 Type of Submission: Traditional
- 5.2 Date of Summary: 07/16/2019
- 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 (Hioxifilcon A) Soft(Hydrophilic) Contact Lens |
|---|---|
| Classification Product Code: | LPL, MVN |
| Regulation Number: | 886.5925 |
| Regulation Description: | Soft (hydrophilic) contact lens |
| Review Panel: | Ophthalmic |
| Device Class: | II |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | Clalen 58 (hioxifilcon A) Soft (hydrophilic)Contact Lens for Daily Wear |
|---|---|
| Applicant: | Interojo, Inc. |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
| Device Class: | II |
| 510(k) Number: | K153766 |
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5.6 Indications for Use / Intended Use of the Device
The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
5.7 Description of the Device
Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as aspherical lenses manufactured by cast-molding method. The material is a high water content (59 % wt/wt) material. The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) 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-yl)-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 50% in the UVA range of 316 to 380 nm.
The properties of the lens are:
- . Chord Diameter: 13.0~15.0 mm
- Base Curve: ● 8.0 ~ 10.0 mm
- Power: +6.00~-12.00D
- (+4.50D ~ +6.00D in 0.50D per step;
- +4.00D ~ -6.00D in 0.25D per step;
- (+4.50D ~ +6.00D in 0.50D per step;
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Traditional 510(k) Section 5 - 510(k) Summary
| -6.50D ~ -12.00D in 0.50D per step) | ||
|---|---|---|
| Center Thickness: | 0.080 ~ 0.250 mm (varies with power) | |
| ● | Refractive Index: | 1.404 (hydrated) |
| ● | Water Content: | 59% |
| ● | Oxygen Permeability: | 25 × 10-11(cm²/sec)(ml O2/mLmmHg) |
| ● | Spectral Transmittance: | 95% ± 5% |
| ● | UV Transmittance | at 280~315 nm: Avg<5% |
| at 316~380 nm: Avg<50% | ||
5.8 Non-clinical Testing
A series of non-clinical safety and performance studies were conducted on the subject device. The following tests and studies were according to the FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. All the test results met the requirements of products specification.
-
. Sterilization validation and Shelf life
Test results demonstrated that subject device complies with ISO 11737-1, ISO 11737-2. ISO 11138-3. ISO 17665-1. ASTM F2338. USP <71>. ISO 11987. ISO 18369-1, ISO 18369-2, ISO 18369-3, and ISO 18369-4 requirements. -
. Biocompatibility
Test results demonstrated that subject device complies with ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-2, and ANSI/AAMI/ISO 10993-12 requirements. -
Performance ●
- Water Content -
- Transmittance -
- Refractive Index -
- Oxygen Permeability -
- Mechanical Properties of Materials -
- Extractables -
- pH Value -
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Traditional 510(k) Section 5 - 510(k) Summary
- Osmolarity -
- Geometric Parameters -
- Specific Gravity -
- Lens Compatibility with Multi-Purpose Solution -
Test results demonstrated that subject device complies with ISO 18369-2, ANSI Z80.20, ISO 18369-3, ISO 18369-4, ASTM D882, and ASTM D1708 requirements.
5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing.
5.10 Substantial Equivalence Determination
The UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main materials, and safety and performance claims to the cleared device, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens For Daily Wear (K153766). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | |
|---|---|---|---|
| Manufacturer | UNICON Optical Co., LTD. | Interojo, Inc. | |
| Trade Name | UNICON Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | Clalen 58 (hioxifilcon A) Soft(hydrophilic) Contact Lens for DailyWear | Substantial EquivalenceDiscussion |
| 510(k) No. | (to be assigned) | K153766 | |
| Indications ForUse | The Unicon Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens isindicated for the correction ofametropia (myopia and | The Clalen 58 (hioxifilcon A)Spherical Soft Contact Lenses fordaily wear are indicated for thecorrection of refractive error inaphakic and not aphakic persons | EquivalentThe main indication is thesame, and the fewdifferent wordings do notaffect the equivalence. |
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Traditional 510(k) Section 5 - 510(k) Summary
| hyperopia) in aphakic andnon-aphakic persons withnon-diseased eyes and 6.00diopters (D) or less ofastigmatism.Eye Care Professionals mayprescribe the lenses either forsingle-use disposable wear orfrequent/planned replacementwear with cleaning,disinfection and scheduledreplacement. Whenprescribed for dailydisposable wear, the lens is tobe discarded after eachremoval. When prescribed forfrequent/planned replacementwear, the lens may be cleanedand disinfected using achemical disinfection systemonly. | with non-diseased eyes with myopiaor hyperopia. The lens may be wornby persons who exhibit refractiveastigmatism of 0.75 diopters or lesswhere the astigmatism does notinterfere with visual acuity. The lensis available clear or tinted forvisibility and handling.Daily wear replacement schedulesmay vary from patient to patient andshould be decided by eyecarepractitioners in consultation withtheir patients.Frequent/Planned ReplacementWear:Eyecare practitioners may prescribeany of the above lenses forfrequent/planned replacement wear,with cleaning disinfection andscheduled replacement. Whenprescribed for frequent/plannedreplacement wear, the lens may bedisinfected using a chemicaldisinfecting system.Disposable Wear:Eyecare practitioners may prescribeany of the above lenses for singleuse daily disposable wear. WhenPrescribed for daily disposable wearthe lens is to be discarded after eachremoval. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Traditional 510(k) Section 5 - 510(k) Summary
| Item | Subject device | Predicate device | Substantial EquivalenceDiscussion |
|---|---|---|---|
| Manufacturer | UNICON Optical Co., LTD. | Interojo, Inc. | |
| Trade Name | UNICON Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | Clalen 58 (hioxifilcon A) Soft(hydrophilic) Contact Lens ForDaily Wear | |
| 510(k) No. | (to be assigned) | K153766 | |
| Type of Use | Prescription Use | Prescription Use | Same |
| UV blocking | Yes | Yes | Same |
| ProductionMethod | Cast-molded | Fully molded | Same |
| USAN Name | Hioxifilcon A | Hioxifilcon A | Same |
| Water Content | 59 ± 2% | 59 ± 2% | Same |
| OxygenPermeability | $25 \times 10^{-11} (cm^2/sec)(ml O_2/mLmmHg)$ | $20.76 \times 10^{-11} (cm^2/sec) (mlO_2/ml x mm Hg)$ | EquivalentNot significantly different and meets therequirement; therefore it would not affect theequivalence. |
| RefractiveIndex | 1.404 (hydrated) | 1.403 (hydrated) | EquivalentNot significantly different and meets therequirement; therefore it would not affect theequivalence. |
5.11 Similarity and Difference
The UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is compared with Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. The subject device has same intended use and technology/mechanism of action, and similar safety and performance as the predicate device. No specifications are significantly
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different between these two devices.
Furthermore, the subject device has undergone other safety and performance tests, and the results complied with the testing guidance. Therefore, any differences between the subject device and the predicate device are insignificant and do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, design and performance claims.
5.12 Conclusion
After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is substantially equivalent to 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.