(102 days)
Not Found
No
The summary describes a standard contact lens with UV protection and tinting, manufactured using a cast molding method. There is no mention of any computational analysis, image processing, or AI/ML terms. The performance studies are preclinical and based on equivalence to a predicate device, not on algorithmic performance.
No
The device is indicated for the correction of ametropia (myopia) and astigmatism to improve visual acuity, which serves a corrective and non-therapeutic purpose.
No
The device is a contact lens indicated for the correction of ametropia (myopia) and minor astigmatism, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical contact lens made of specific materials and manufactured using a cast molding method. It is a tangible hardware device.
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) in aphakic and non-aphakic persons with non-diseased eyes. 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.
- No mention of in vitro testing: The text does not describe any process involving testing samples (like blood, urine, tissue) outside of the body to diagnose a condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for 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.
Product codes
LPL, MVN
Device Description
The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced 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 280~315 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care professionals
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 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 Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens are equivalent to the SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:
- 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
- Oxygen Permeability
- pH and Osmolality Test
- Shelf-life
- Mechanical Comparative Testing
In addition to biocompatible tests, shelf-life, physical compatibility test of contact lens care solution, mechanical comparative testing and the comparative tests of the performance tests mentioned above are provided. The results of the non-clinical testing demonstrate that the Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is substantially equivalent to the predicate devices.
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
MAR 2 1 2014
510(k) Summary
| 1 | Type of Submission: | Traditional |
|---|---|---|
| 2 | Orginal Submission | |
| Date: | 2013/11/29 | |
| 3 | Submitter: | Yung Sheng Optical Co., Ltd. |
| Address: | 3F-1, No.6, Jhongke Road, Daya District, Taichung City | |
| 42881 Taiwan | ||
| Manufacturer Address | No.8, Keya 2nd Road, Daya District, Taichung City 42881, | |
| Taiwan | ||
| Phone: | +886-4-25658384 #156 | |
| Fax: | +886-4-25658387 | |
| Contact: | Wen-Han Chen | |
| Establishment Registration Number: | N/A |
4 Identification of the Device:
| Proprietary/Trade name: | Eye Secret 55 UV Aspheric (methafilcon A) Soft |
|---|---|
| (hydrophilic) Contact Lens | |
| Common Name: | Contact Lens |
| Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) |
| Device Classification: | II |
| Regulation Number: | 886.5925 |
| Panel: | Ophthalmic |
| Product Code: | LPL |
| Subsequent Product Code: | MVN |
5 Identification of the Predicate Device:
| Predicate Device Name: | SAUFLON 55 UV (methafilcon A) Soft |
|---|---|
| (Hydrophilic) Visibility Tinted Contact | |
| Lens for Daily Wear | |
| Manufacturer: | Sauflon Pharmaceuticals Ltd. |
| 510(k) Number: | K013649 |
1
Intended Use and Indications for Use of the subject device. 6
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for 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.
7 Device Description
The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced 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 280~315 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.
8 Summary of Clinical Study
Methafilcon A lenses have been used widely. Its safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by the lenses cleared by FDA.
SAUFLON 55 UV (Methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear. K013649 submitted by Sauflon Pharmaceuticals Ltd.
Clinical study for Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact Lens is not required for the premarket notification as the USAN name and process are the same as above mentioned predicated device.
2
9 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 Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens are equivalent to the SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:
- . 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 .
- Oxygen Permeability .
- pH and Osmolality Test .
- . Shelf-life
- Mechanical Comparative Testing
In addition to biocompatible tests, shelf-life, physical compatibility test of contact lens care solution, mechanical comparative testing and the comparative tests of the performance tests mentioned above are provided.
The results of the non-clinical testing demonstrate that the Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is substantially equivalent to the predicate devices.
10 Substantial Equivalence Determination
The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens submitted in
3
this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which is the subject of K013649. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | ||
|---|---|---|
| Regulatory Number | Eye Secret 55 UV Aspheric | |
| (methafilcon A) Soft (hydrophilic) | ||
| contact lens | Predicate Device (K013649) | |
| SAUFLON 55 UV (methafilcon A) | ||
| Soft (Hydrophilic) Visibility Tinted | ||
| Contact Lens for Daily Wear | ||
| Classification | 886.5925 | 886.5925 |
| Intended Use | II | |
| The Eye Secret 55 UV Aspheric | ||
| (Methafilcon A) Soft (Hydrophilic) | ||
| Contact lenses are indicated for the | ||
| correction of ametropia (myopia) in | ||
| aphakic and non-aphakic persons | ||
| with non-diseased eyes in powers | ||
| from 0.00 to -12.00 diopters. The | ||
| lenses may be worn by persons who | ||
| exhibit astigmatism of 2.00 diopters | ||
| or less that does not interfere with | ||
| visual acuity. | ||
| Eye Care professionals may | ||
| prescribe the lens for 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. | II | |
| The Sauflon 55 UV soft | ||
| (hydrophilic) contact lens is | ||
| indicated for daily wear for the | ||
| correction of the refractive | ||
| ametropia (myopia and hyperopia) | ||
| and astigmatism in aphakic and | ||
| not-aphakic persons with | ||
| non-diseased eyes that may exhibit | ||
| astigmatism up to 2.00 Dioptres that | ||
| does not interfere with visual | ||
| acuity. Eyecare Practitioners may | ||
| prescribe the lens for daily wear in a | ||
| Frequent Replacement Program. | ||
| The lenses may be disinfected using | ||
| chemical or hydrogen peroxide | ||
| disinfection systems. | ||
| Prescription Use | Yes | Yes |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing | ||
| Method | Cast Molded | Cast Molded |
| Water Content | 55% | 55% |
| Dk | 22.0 x 10-11 (cm²/sec) (mlO₂/ml x | |
| mmHg) | 22.0 x 10-11 (cm²/sec) (mlO₂/ml x | |
| mmHg) | ||
| Powers | 0 ~ -12.00 D | ± 20.00D |
| Light Transmittance | 95% ± 5% | 94.61% |
| UV-A | 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: December 23, 2013 Received: December 27, 2013 |
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.
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.
6
Page 2 - Mr. Wen-Han Chen
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 -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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133735
Device Name
1
he Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses
Indications for Use (Describe)
The Eye Secret SS UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be wom by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Eve Care professionals may prescribe the lens for 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
. . . . . . . . . . . . . . . . . . . . . . . . ' FOR FDA USE ONLY ... :
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Leonid Livshitz -S 2014.02.19 10:14:43 -05'00'
FORM FDA 3881 (1/14)
8
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