(60 days)
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, Methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and Methacrylic acid (MAA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used 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 lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.
The provided text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.
Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.
However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K133735) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Name | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
| Intended Use | Correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters; for astigmatism ≤ 2.00 diopters not interfering with visual acuity. Prescribed for daily disposable or daily wear in a Frequent Replacement Program. Disinfection with chemical or hydrogen peroxide systems. | Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes; for astigmatism ≤ 2.00 diopters not interfering with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program. Disinfection with chemical or hydrogen peroxide systems. |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 55 % | 55 % |
| Powers | -0.00 ~ -12.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A Transmittance | < 50 % | < 50 % |
| UV-B Transmittance | < 5 % | < 5 % |
| Refractive Index | 1.409 (± 0.005 nd) | 1.409 (± 0.005 nd) |
| Base Curve | 8.60 (± 0.20 mm) | 7.85 ~ 10.00 (± 0.20 mm) |
| Diameter | 14.20 (± 0.20 mm) | 12.00 ~ 15.00 (± 0.20 mm) |
| Tint | C.I. Reactive Blue #4 for handling purpose | C.I. Reactive Blue #4 for handling purpose |
| Packaging Solution | Phosphate buffered saline solution | Phosphate buffered saline solution containing sodium hyaluronate and trehalose. |
| Toxicity (Acute Systemic Injection) | Non-toxic (implied by predicate) | Meets requirements, non-toxic |
| Toxicity (White Rabbit Ocular Irritation) | No ocular irritation (implied) | No ocular irritation |
| Toxicity (Cytotoxicity) | Meets ISO 10993-5 (implied) | Meets ISO 10993-5 |
| Extractables (Leachability) | Demonstrated safety (implied) | Performed, equivalent to predicate |
| Finished Lens Parameters | Matches predicate (implied) | Performed, equivalent to predicate |
| Water Content | 55% (explicitly stated) | Performed, equivalent to predicate |
| Shelf-life | Demonstrated stability (implied) | Performed, equivalent to predicate |
| Mechanical Properties Comparative Testing | Matches predicate (implied) | Performed, equivalent to predicate |
| Physical Compatibility with Contact Lens Care Solution and Packaging Solution | Demonstrated compatibility (implied) | Performed, equivalent to predicate |
Note: For properties like "Powers", "Base Curve", and "Diameter", the subject device offers a broader range, which is typically acceptable if the safety and performance for the new range are demonstrated, often through bridging data or established manufacturing controls, and the material and fundamental design remain equivalent.
The packaging solution for the subject device is more specific but still within the expected range of saline solutions for contact lenses.
2. Sample size used for the test set and the data provenance
The document states: "A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens." However, it does not specify the exact sample sizes for each non-clinical test (e.g., number of lenses, animals tested).
- Data Provenance: The tests were conducted by Yung Sheng Optical Co., Ltd. (Taiwan). The nature of the tests (e.g., in-vitro, animal studies) means they are primarily lab-based and not derived from human patient data in the clinical trial sense. The status is "preclinical testing".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this premarket notification for a contact lens. The "ground truth" for contact lens performance is established through standardized non-clinical (bench) testing, material characterization, and established clinical performance of the material. Expert consensus, in the diagnostic sense, is not typically used here. The assessment is based on physical and chemical measurements against industry standards and comparisons to a legally marketed predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers assessing medical imaging or other diagnostic outputs to establish ground truth or resolve discrepancies. This document describes non-clinical testing of a physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are specific to evaluating diagnostic systems, particularly those involving AI assistance with human interpretation. This document pertains to a contact lens and its physical/chemical properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question relates to AI/ML software performance. The device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by:
- Standardized Test Methods: Adherence to established standards (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994).
- Material Specifications: Chemical and physical properties of the Methafilcon A material and the finished lens parameters (e.g., water content, light transmittance, refractive index).
- Predicate Device Equivalence: The primary "ground truth" or benchmark is the performance and safety profile of the legally marketed predicate device (K133735), which has already been deemed safe and effective.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Yung Sheng Optical Co., Ltd. Mr. Wen-Han Chen RA Supervisor 3f-1, No. 6, Jhongke Road, Daya District Taichung City, TW 42881
Re: K151586
Trade/Device Name: Eye Secret 55 UV Aspheric (methafilcon 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: June 9, 2015 Received: June 11, 2015
Dear Mr. Chen:
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.
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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 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and Part 809), 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,
Kesia Y. Alexander -A
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)
Device Name
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disintected using a chemical or hydrogen peroxide disinfecting systems.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
- Traditional 510(k) 1. Type of Submission:
| 2. | Submitter: | Yung Sheng Optical Co., Ltd. |
|---|---|---|
| Address: | 3F-1, No.6, Jhongke Road, Daya District, TaichungCity 42881 Taiwan | |
| Manufacturingfacility: | No.8, Keya 2nd Road, Daya District, Taichung City42881, Taiwan | |
| Phone: | (04) 25658384 #156 、 191 | |
| Fax: | (04) 25658387 | |
| Contact: | Wen-Han Chen / Che-Yu Shen | |
| Date prepared: | May 29, 2015 | |
| Establishment Registration Number: | 3004021238 |
3. Identification of the Device
| Proprietary/Tradename: | Eye Secret 55 UV Aspheric (Methafilcon A)Soft (hydrophilic) Contact Lens | |
|---|---|---|
| Common Name: | Contact Lens | |
| Classification Name: | Lenses, Soft Contact, Daily Wear | |
| Device Classification: | II | |
| Regulation Number: | 886.5925 | |
| Panel: | Ophthalmic | |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear | |
| MVN for Lens, Contact, (Disposable) |
4. Identification of the Predicate Device
| Predicate Device Name: | Eye Secret 55 UV Aspheric (Methafilcon A) Soft(hydrophilic) Contact Lens |
|---|---|
| Manufacturer: | Yung Sheng Optical Co., Ltd. |
| 510(k) Number or Clearance Information: | K133735 |
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Yung Sheng Optical Co., Ltd. 510(k) notification
5. Intended Use and Indications for Use of the subject device
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
6. Device Description
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, Methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and Methacrylic acid (MAA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used 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 lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.
7. Summary of Clinical Study
Methafilcon A lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA "Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K133735)" submitted by Yung Sheng Optical Co., Ltd. is an example.
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Yung Sheng Optical Co., Ltd. 510(k) notification
Clinical study for the subject device is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate device.
8. Non-Clinical Testing
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. The results of all testing demonstrated that the safety and effectiveness of the subject device are equivalent to the predicate device, Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K133735). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994:
- · Toxicity
-
- Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
-
- White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
-
- Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.
-
- Extractables (Leachability)
- Finished Lens Parameters .
- · Light Transmittance
- Refractive Index .
- . Water Content
- . Shelf-life
- Mechanical Properties Comparative Testing .
- . Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution
The results of the non-clinical testing demonstrated that the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device.
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Yung Sheng Optical Co., Ltd. 510(k) notification
9. Substantial Equivalence Determination
The information presented in this submission establishes the substantial equivalence of the subject device "Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens" to the predicate device. The following table summarized the substantial equivalence comparison information.
| Subject Device | K133735 | |
|---|---|---|
| Device Name | Eye Secret 55 UV Aspheric(Methafilcon A) Soft (hydrophilic)Contact Lens | Eye Secret 55 UV Aspheric(Methafilcon A) Soft (hydrophilic)Contact Lens |
| Intended Use | The Eye Secret 55 UV Aspheric(Methafilcon A) Soft (hydrophilic)Contact Lens is indicated for thecorrection of refractive ametropia(myopia) in aphakic andnot-aphakic persons withnon-diseased eyes. The lenses maybe worn by person who exhibitastigmatism of 2.00 diopters or lessthat does not interfere with visualacuity. The Eye Secret 55 UVAspheric (Methafilcon A) Soft(hydrophilic) Contact Lens helpsprotect against transmission ofharmful UV radiation to the corneaand into the eye. The eye careprofessionals may prescribe thelens for single use daily disposableor daily wear in a FrequentReplacement Program. Asprescribed for plannedreplacement, the lens should bedisinfected using a chemical orhydrogen peroxide disinfectingsystems. | The Eye Secret 55 UV Aspheric(Methafilcon A) Soft (Hydrophilic)Contact lenses are indicated for thecorrection of ametropia (myopia) inaphakic and non-aphakic persons withnon-diseased eyes in powers from 0.00to -12.00 diopters. The lenses may beworn by persons who exhibitastigmatism of 2.00 diopters or lessthat does not interfere with visualacuity. Eye Care professionals mayprescribe the lens for daily disposableor daily wear in a FrequentReplacement Program. As prescribedfor planned replacement, the lensshould be disinfected using a chemicalor hydrogen peroxide disinfectingsystems. |
| Material | Methafilcon A | Methafilcon A |
| ManufacturingMethod | Cast Molded | Cast Molded |
| Water Content | 55 % | 55 % |
| Subject Device | K133735 | |
| Device Name | Eye Secret 55 UV Aspheric(Methafilcon A) Soft (hydrophilic)Contact Lens | Eye Secret 55 UV Aspheric(Methafilcon A) Soft (hydrophilic)Contact Lens |
| Powers | -0.50 D ~ -20.00 D | -0.00 ~ -12.00 D |
| LightTransmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A | < 50 % | < 50 % |
| UV-B | < 5 % | < 5 % |
| RefractiveIndex | 1.409 (± 0.005 nd) | 1.409 (± 0.005 nd) |
| Base Curve | 7.85 ~ 10.00 (± 0.20 mm) | 8.60 (± 0.20 mm) |
| Diameter | 12.00 ~ 15.00 (± 0.20 mm) | 14.20 (± 0.20 mm) |
| Tint | C.I. Reactive Blue #4 for handling purpose | C.I. Reactive Blue #4 for handling purpose |
| Packagingsolution | Phosphate buffered saline solution containing sodium hyaluronate and trehalose. | Phosphate buffered saline solution. |
{7}------------------------------------------------
Yung Sheng Optical Co., Ltd. 510(k) notification
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
10. Conclusion
After analyzing the bench tests and safety testing data, it can be concluded that the Eye Secret 55 UV Aspheric (Methafilcon 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.