(384 days)
Not Found
No
The summary describes a standard contact lens with UV blocking properties and an aspheric design, manufactured using a cast molding method. There is no mention of any computational or analytical functions that would suggest the use of AI or ML. The performance studies focus on visual acuity and safety, not on the performance of any AI/ML algorithm.
Yes
The device is indicated for the correction of refractive ametropia (myopia or hyperopia), which is a therapeutic purpose.
No
The device is a contact lens used for vision correction (refractive ametropia) and UV protection, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of a specific material (Otufilcon A) with a physical design (aspheric) and includes UV blocking properties. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Pure Plus UV Aspheric Contact Lens is a device that is placed on the eye to correct vision (refractive ametropia). It also provides UV protection.
- Intended Use: The intended use is for the correction of vision and protection from UV radiation, not for testing biological samples.
- Device Description: The description details the material, design, and properties of a contact lens, not a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on visual acuity correction and safety when worn on the eye, not on the accuracy of a diagnostic test.
Therefore, this device falls under the category of a medical device, specifically a contact lens, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated 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 practitioners may prescribe the contact lens for single use daily disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily disposable single use and should be discard after removal.
Product codes
LPL, MVN
Device Description
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a random copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% 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 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive.
The Pure Plus UV Aspheric (Otufilcon A) Silicone 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 wetting agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioners
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
A prospective, randomized, double-blind, parallel, active-controlled clinical study with 3 months treatment follow-up was completed in Taiwan, outside of the United States. The study screened 151 subjects, and 7 failed to be included. A total of 144 subjects were randomized and enrolled (73 in the test group, 71 in the control group). 5 subjects (3 test, 2 control) withdrew, and 139 subjects (70 test, 69 control) completed the study.
The primary efficacy endpoint was the effectiveness of corrected visual acuity at 3 months, defined as visual acuities of both eyes correctable to ≥ 1.0 with contact lens. The efficacy endpoints showed that the test group was non-inferior to the control group. Both lens types were effective in vision correction and did not cause unwanted diopter changes in spherical or cylindrical power or corneal astigmatism.
In safety endpoints, the incidence of adverse events was not higher than in the control group, and ocular conditions remained normal at the end of the study. No unpredictable side effects were observed.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2023
Yung Sheng Optical Co., Ltd. Wen-Han Chen RA Manager No. 8, Keya 2nd Road, Daya District Taichung City, 42881 Taiwan
Re: K223585
Trade/Device Name: Pure Plus UV Aspheric (Otufilcon A) Silicone 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: November 17, 2023 Received: November 17, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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/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 -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223585
Device Name
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use (Describe)
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated 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 practitioners may prescribe the contact lens for single use daily disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily disposable single use and should be discard after removal.
| 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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3
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.3514 | |
| Fax: | +886-4-25658387 | |
| Contact: | James Chang | |
| Date prepared: | November 30, 2022 | |
| Establishment Registration Number: | 3004021238 |
3. Identification of the Device
| Proprietary/Trade name: | Pure Plus UV Aspheric (Otufilcon A) Silicone
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) |
4. Identification of the Predicate Device
| Predicate Device
| Name: | Bausch + Lomb Ultra® (Samfilcon A) Contact Lens |
|---|---|
| Manufacturer: | Bausch & Lomb, Inc. |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear |
| MVN for Lens, Contact, (Disposable) | |
| 510(k) Number: | K131208 |
4
5. Intended Use and Indications for Use of the subject device
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-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 disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is daily disposable single use and should be discarded after removal.
6. Device Description
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a random copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% 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 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive.
The Pure Plus UV Aspheric (Otufilcon A) Silicone 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 wetting agent.
7. Characteristics of Substantial Equivalence
- Material and Process Comparison Table
5
| Subject Device | Predicate device | |
|---|---|---|
| Device Name | Pure Plus UV Aspheric (Otufilcon A) Silicone | |
| Soft (hydrophilic) Contact Lens for Daily Wear | Bausch + Lomb Ultra® | |
| (Samfilcon A) Contact Lens | ||
| Manufacturer | Yung Sheng Optical Co., Itd | Bausch & Lomb, Inc. |
| 510(k) Number | This submission | K131208 |
| FDA Category | Group V | Group V |
| Product Code | LPL and MVN | LPL and MVN |
| Intended Use | The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-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 disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is daily disposable single use and should be discarded after removal. | Bausch + Lomb Ultra® (Samfilcon A) Contact Lens are designed for the intended use to be worn, directly against the cornea and adjacent limb and sclera areas of the eyes to correct vision conditions. | |
| Material | ||
| USAN Name | Otufilcon A | Samfilcon A |
| Manufacturing | ||
| Method | Cast Molded | Cast Molded |
| Sterilization | Moist Heat (Steam) in Validated Autoclave | Moist Heat (Steam) in Validated |
| Autoclave | ||
| Packaging | Blister pack | Blister pack |
| Water Content | 44 % | 46 % |
| Tint | Reactive Blue 246 | Reactive Blue 246 |
| Packaging | ||
| solution | Sterile isotonic phosphate buffered saline | |
| containing wetting agents | Sterile borate buffered saline | |
| with poloxamine solution |
● Technological Characteristics Comparison Table
| Subject Device | Predicate device | |
|---|---|---|
| Device Name | Pure Plus UV Aspheric (Otufilcon A) Silicone | |
| Soft (hydrophilic) Contact Lens for Daily Wear | Bausch + Lomb Ultra® | |
| (Samfilcon A) Contact Lens | ||
| Base Curve | 7.50 ~ 9.00 mm | 7.80 ~ 9.50 mm |
| Diameter | 12.0 ~ 15.0 mm | 13.5 ~ 15.0 mm |
| Center Thickness | 0.04 ~ 0.14 mm | 0.05 ~ 0.50 mm |
| Refractive Index | $1.417 \pm 0.005$ nd | 1.411 nd |
| Oxygen | ||
| Permeability (Dk) | 120 x 10-11 | |
| (cm2/sec)(ml O2/ml x mmHg) | 114 x 10-11 | |
| (cm2/sec)(ml O2/ml x mmHg) | ||
| Light | ||
| Transmittance | 95 % | 97.3 % |
| UV-A |