(256 days)
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246.
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.
This document is a 510(k) Premarket Notification for a soft contact lens, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI models, such as detailed clinical study designs for AI performance, expert adjudication, MRMC studies, and separate training/test sets for AI, is not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to demonstrate the safety and effectiveness of the contact lens itself, primarily through physiochemical and toxicology studies, and by demonstrating substantial equivalence to legally marketed predicate devices.
Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" through the lens of contact lens regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a single formal "acceptance criteria" table in the way one might see for an AI model. Instead, acceptance is demonstrated by meeting established specifications for physical, optical, and chemical properties, and by demonstrating biocompatibility. The performance is compared against predicate devices and relevant ISO standards.
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Eye Secret 59 UV Aspheric) |
|---|---|---|
| Material/Process | Substantially equivalent to predicate devices (Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens (K061948) & Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses (K162223)) in material (Omafilcon A), manufacturing, sterilization, and packaging. | Same material (Omafilcon A), Cast Molded, Moist Heat (Steam) Sterilization, Blister pack packaging. |
| Intended Use | Substantially equivalent to predicate devices. | Similar indications: correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes; astigmatism ≤ 2.00 D. |
| Water Content | Within established specifications; comparable to predicates ($60 \pm 2%$ for predicate 1, $59 \pm 2%$ for predicate 2). | $59 \pm 2 %$ |
| Oxygen Permeability (Dk) | Within established specifications; comparable to predicates ($21.00 \pm 20 %$ for predicate 1, $25.68 \pm 20 %$ for predicate 2). | $25 \pm 20 %$ |
| Light Transmittance | Within established specifications; comparable to predicates ($>90%$ for predicate 1, $98%$ for predicate 2). | $95 \pm 5 %$ |
| UV-A Transmittance | < 50% (This is a specific claim for UV blocking) | < 50 % |
| UV-B Transmittance | < 5% (This is a specific claim for UV blocking) | < 5 % |
| Refractive Index | Within established specifications; comparable to predicates ($1.400 \pm 0.005 \text{ nd}$ for predicate 1, $1.4002 \pm 0.005 \text{ nd}$ for predicate 2). | $1.390 \pm 0.005 \text{ nd}$ |
| Biocompatibility | Non-toxic and biocompatible with ocular environment (demonstrated via ISO 10993 series tests). | Passed Cytotoxicity, Ocular Irritation, Acute Systemic Toxicity, Skin Sensitization tests for lens, packaging solution, and packaging materials. |
| Physical/Optical Properties | Within established specifications (references ISO 18369-4:2017, ISO 18369-3:2017, and FDA Guidance Document for Daily Wear Contact Lenses, 1994). | "The physical, optical and chemical properties of the lens are within established specifications." |
| Mechanical Properties | Tested and within specifications. | Tested and within specifications. |
| Shelf-life | Verified and within specifications. | Verified and within specifications. |
| Physical Compatibility with Packaging Solution | Verified and within specifications. | Verified and within specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing and a substantial equivalence argument, not a clinical trial with human subjects for device performance. Therefore:
- Sample size: The document does not specify exact sample sizes for each type of non-clinical test (e.g., how many lenses were tested for Dk, how many samples for cytotoxicity). It broadly refers to "a series of preclinical testing."
- Data Provenance: The document is a regulatory submission from "Yung Sheng Optical Co., Ltd" in Taichung City, Taiwan. The testing itself would have been performed in laboratories (likely in Taiwan) according to international standards (ISO) and FDA guidance. This is retrospective in the sense that the data was collected prior to the submission for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this submission relates to a physical medical device (contact lens) and relies on objective, measurable physiochemical and biological properties, not human interpretation of medical images or data requiring expert consensus for "ground truth." The "ground truth" for these tests comes from established scientific methods, physical measurements, and biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. Adjudication methods are relevant for subjective assessments, typically in clinical readings or interpretations, which are not part of this device's non-clinical testing.
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
This is not applicable. This is a contact lens, not an AI-powered diagnostic or assistive device. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation comes from:
- Objective material and physical property measurements: e.g., water content, Dk, light transmittance, refractive index.
- Standardized biological assays: e.g., ISO 10993 series for biocompatibility (cytotoxicity, irritation, systemic toxicity, sensitization).
- Comparison to established specifications and predicate device characteristics.
There is no "expert consensus" or "pathology" in the context of typical AI model ground truth for this type of device.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI model for this device. The manufacturer relies on knowledge gained from prior research, development, and testing of materials (Omafilcon A) and manufacturing processes, along with the performance of predicate devices.
9. How the ground truth for the training set was established
This is not applicable as there is no AI training set. The "ground truth" for the overall understanding of contact lens materials and design is established through decades of ophthalmic research, material science, clinical trials of similar devices, and regulatory standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
September 2, 2022
Yung Sheng Optical Co., Ltd Wen-Han Chen RA Manager No. 8, Keya 2nd Road, Daya District Taichung City, 428 Taiwan
Re: K213983
Trade/Device Name: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens 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 26, 2022 Received: July 26, 2022
Dear Wen-Han 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. 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 (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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-devicereporting-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/medicaldevices/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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-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.
J. 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213983
Device Name
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use (Describe)
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
510(k) Summary
-
- Type of Submission: Traditional 510(k)
| 2. Submitter: | Yung Sheng Optical Co., Ltd. |
|---|---|
| Address: | No.8, Keya 2nd Rd., Daya District, Taichung City |
| 42881, Taiwan | |
| Phone: | +886-4-25658384 Ext.3509 |
| Fax: | +886-4-25658387 |
| Contact: | Wen-Han Chen |
| Date prepared: | November 24, 2021 |
| Establishment Registration Number: | 3004021238 |
3. Identification of the Device
| Proprietary/Trade name: | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear |
|---|---|
| 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) |
| 510(k) Number: | K213983 |
4. ldentification of the Predicate Device
| Predicate Device Name: | Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens |
|---|---|
| Manufacturer: | CooperVision Inc. |
| Product Code: | LPL for Lenses, Soft Contact, Daily WearMVN for Lens, Contact, (Disposable) |
| 510(k) Number: | K061948 |
| Predicate Device Name: | Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses |
| Manufacturer: | Supervision Optimax Sdn Bhd |
| Product Code: | LPL for Lenses, Soft Contact, Daily WearMVN for Lens, Contact, (Disposable) |
| 510(k) Number: | K162223 |
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5. Intended Use and Indications for Use of the subject device
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
6. Device Description
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246.
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.
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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
7. Characteristics of Substantial Equivalence
| Material and Process comparison table | |||
|---|---|---|---|
| Subject Device | Predicate device | Predicate device | |
| Device Name | Eye Secret 59 UV Aspheric(Omafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear | Proclear (omafilcon A) DailyDisposable/Daily Wear SoftContact Lens | Aveo (omafilcon A) 1-DayAspheric Soft (Hydrophilic)Contact Lenses |
| Manufacturer | Yung Sheng Optical Co., ltd | CooperVision, Inc. | Supervision Optimax Sdn Bhd |
| 510(k) Number | This submission | K061948 | K162223 |
| FDA Category | Group IINon-ionicHigh water content | Group IINon-ionicHigh water content | Group IINon-ionicHigh water content |
| Product Code | LPL and MVN | LPL and MVN | LPL and MVN |
| Intended Use | The Eye Secret 59 UV Aspheric(Omafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear isindicated for daily wear for thecorrection of refractiveametropia (myopia orhyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may beworn by person who exhibitastigmatism of 2.00 diopters orless that does not interferewith visual acuity. | Proclear (omafilcon A) DailyDisposable/Daily Wear SoftContact Lens are indicatedfor daily wear for thecorrection of visual acuity innot aphakic persons withnon-diseased eyes that aremyopic or hyperopic andexhibit astigmatism of 2.00Dor less that does notinterfere with visual acuity. | Aveo (omafilcon A)1-DayAspheric Soft (Hydrophilic)Contact Lenses are indicatedfor daily wear for thecorrection of visual acuity innot aphakic persons withnon-diseased eyes that aremyopic orhyperopic andexhibit astigmatism of 1.00Dor less that does not interferewith visual acuity. Thecontact lenses are intendedfor daily wear, single use andare to be discarded at theend of the day. |
| MaterialUSAN Name | Omafilcon A | Omafilcon A | Omafilcon A |
| ManufacturingMethod | Cast Molded | Cast Molded | Cast Molded |
| Sterilization | Moist Heat (Steam) in ValidatedAutoclave | Moist Heat (Steam) inValidated Autoclave | Moist Heat (Steam) inValidated Autoclave |
| Packaging | Blister pack | Blister pack | Blister pack |
| Water Content | $59 \pm 2$ % | $60 \pm 2$ % | $59 \pm 2$ % |
| Tint | Reactive Blue 246 | Vat Blue 6 | Reactive Blue 246 |
| Packagingsolution | Phosphate buffered salinesolution containing 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethylphosphate-n-butylmethacrylate copolymerwetting agent | Not Stated | Phosphate Buffered Saline |
- Material and Process Comparison Table
● Technological Characteristics Comparison Table
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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
| Subject Device | Predicate device | Predicate device | |
|---|---|---|---|
| Device Name | Eye Secret 59 UV Aspheric(Omafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear | Proclear (omafilcon A) DailyDisposable/Daily Wear SoftContact Lens | Aveo (omafilcon A) 1-DayAspheric Soft (Hydrophilic)Contact Lenses |
| Base Curve | 7.50 ~ 9.00 ± 0.20 mm | 8.00 ~ 9.50 ± 0.20 mm | 8.40 ~ 8.80 ± 0.20 mm |
| Diameter | 12.0 ~ 15.0 ± 0.20 mm | 13.0 ~ 15.5 ± 0.20 mm | 14.0 ~ 14.4 ± 0.20 mm |
| Center Thickness | 0.030 ~ 0.200 mm | 0.035 ~ 0.960 mm | Not Stated |
| Refractive Index | 1.390 ± 0.005 nd | 1.400 ± 0.005 nd | 1.4002 ± 0.005 nd |
| OxygenPermeability (Dk)x 10-11 (cm²/sec) (mlO2/ml x mmHg) | 25 ± 20% | 21.00 ± 20 % | 25.68 ± 20 % |
| LightTransmittance | 95 ± 5 % | > 90% | 98 % |
| UV-A | < 50 % | Not Stated | Not Stated |
| UV-B | < 5 % | Not Stated | Not Stated |
| Powers | -20.00 ~ +20.00 D | -20.00 ~ +20.00 D | -10.00 ~ +6.00 D |
8. Non-Clinical Testing
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear.
-
Physiochemical Studies
The physiochemical studies were conducted according to ISO 18369-4:2017 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2017 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses. The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994: -
Finished Lens Parameters
-
Refractive Index
-
Light Transmittance
-
Water Content
-
Extractables (Leachability)
-
Oxygen Permeability
-
. Mechanical Properties Testing
-
1 Physical Compatibility Test with Packaging Solution
-
1 Shelf-life
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- Toxicology Studies Toxicology studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.
| Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens forDaily Wear |
|---|
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |
| ● Skin Sensitization Test (ISO 10993-10) |
| Packaging Solution |
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |
| PP blister and aluminum foil (which is identical to that cleared underK132854) |
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |
The results of the non-clinical testing, including physiochemical studies and toxicology studies, demonstrated that Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear which met all the specifications is substantially equivalent to the safety and effectiveness of both predicate devices.
9. Summary of Clinical Study
The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate devices. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
10. Conclusion
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate devices, Proclear (Omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens (K061948) and Aveo (Omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses (K162223)
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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
in term of optical property, physiochemical and pre-clinical toxicology. They are produced from the same material (Omafilcon A), have the same functional and scientific technology, lens characteristics as well as the intended uses are identical. It is concluded that the lenses are as safe, as effective and perform as well as the both predicate devices.
§ 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.