(197 days)
Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D
Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.
Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).
This document describes the regulatory clearance of contact lenses, not a medical AI device requiring the kind of rigorous AI-specific validation outlined in your request. The provided text is a 510(k) clearance letter for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device through physicochemical, biocompatibility, and clinical performance in human subjects, rather than AI model performance metrics.
Therefore, many of the requested elements for an AI device's acceptance criteria and accompanying study (e.g., sample size for test set, data provenance for AI, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it does not relate to an AI device.
However, I can extract the relevant information from the provided document concerning the contact lens study and present it in a similar structured format, adapting where necessary.
Device: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Nature of Study: Clinical trial demonstrating substantial equivalence of a new contact lens product to an existing predicate device, focusing on safety and effectiveness for vision correction. This is not an AI device study.
1. Table of Acceptance Criteria (for Contact Lenses) and Reported Device Performance
Given this is a contact lens, the "acceptance criteria" are related to clinical efficacy (visual acuity) and safety (adverse events, slit lamp findings), and various physicochemical properties. The study aims to show non-inferiority or comparability to the predicate device rather than meeting specific numerical thresholds for many of the elements you'd expect in an AI performance table (e.g., sensitivity, specificity).
| Acceptance Criteria Category (for Contact Lenses) | Specific Metric / Criterion | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (Primary Endpoint) | Corrected contact lens visual acuity of 1.0 decimal (0.0 logMAR) or better at final visit | "no difference in control group and test group." "test and control groups are comparable in corrected contact lens visual acuity." |
| Clinical Safety (Secondary Endpoints) | Absence of serious and significant adverse device events (ADE) | "no serious and significant adverse device event occurred during the conduct of the study in both control and test group." |
| Slit Lamp Findings > Grade 2 | "No subject with adverse device effects accompanying Slit Lamp Findings > Grade 2 was reported in the control group and test group." | |
| Physicochemical Properties | Met established specifications and requirements (e.g., Refractive Index, Oxygen Permeability, Water content, Light Transmittance, Mechanical Property, Shelf Life, Solution Compatibility, Preservative Uptake and Release) | "The results demonstrated that the lens met all established specifications and requirements for physical, optical, and chemical properties." (Specific values for some properties are provided in the "Technological characteristics studies" table, indicating they were assessed against the predicate). |
| Biocompatibility | Exhibit no cytotoxicity, no ocular irritation, no skin sensitization, and no acute systemic toxicity. Product does not contain any toxic or harmful substances. | "All biocompatibility tests yielded passing results, confirming that the product does not contain any toxic or harmful substances that may pose a risk to biological systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Screened: 75 subjects
- Enrolled: 56 subjects (39 wore test lenses, 17 wore control lenses)
- Completed Study: 54 subjects (2 subjects in test group discontinued)
- Data Provenance: Prospective, randomized, double-blind, parallel, active-controlled clinical trial conducted in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not explicitly stated for establishing "ground truth," as this was a clinical trial involving patient outcomes and examinations. Clinical assessments were likely performed by eye care professionals involved in the study (e.g., ophthalmologists, optometrists), but a specific number or their detailed qualifications are not provided in the summary. The "ground truth" for contact lenses is physiological response, visual acuity, and safety outcomes from direct patient observation.
4. Adjudication Method for the Test Set
Not explicitly stated. Clinical trials typically have protocols for adverse event reporting and assessment, often by an independent safety committee or study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is specifically designed for evaluating diagnostic performance of imaging modalities or AI systems where multiple readers interpret cases. This document describes a clinical trial for a contact lens, comparing direct patient outcomes between a new lens and a predicate.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not Applicable. This is a physical medical device (contact lens), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this contact lens study was based on:
- Clinical Outcomes Data: Corrected visual acuity measurements.
- Safety Data: Adverse event reporting, assessment of slit lamp findings (direct observation of ocular health by clinicians).
- Physicochemical and Biocompatibility Test Results: Objective laboratory measurements demonstrating material properties and biological safety.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/machine learning study, so there is no training set in that context. The "training" for the device would be the manufacturing process and quality control.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. See point 8.
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
Pegavision Corporation
Estela Lin
Official Correspondent
2F-1, No. 5, Shing Yeh St., Guishan Dist
Taoyuan City, 33341
Taiwan
Re: K243868
Trade/Device Name: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (Hydrophilic) Contact Lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: November 25, 2024
Received: December 17, 2024
Dear Estela Lin:
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.
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K243868 - Estela Lin
Page 2
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).
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/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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K243868 - Estela Lin
Page 3
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-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
ELISSA WONG -S (Digitally signed by ELISSA WONG -S)
for Angelo Green
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243868
Device Name: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D
Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.
Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 6
K243868
510(k) SUMMARY
The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).
Submitter Information
| Company: | PEGAVISION CORPORATION |
|---|---|
| 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333, Taiwan | |
| Contact Person: | Estela Lin, Regulatory Affair Engineer Supervisor |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | EstelaLin@pegavision.com |
| Date Prepared: | June 6, 2025 |
Identification of Device
| Trade Name: | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses |
|---|---|
| Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | |
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
Classification
| Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, Product Code LPL |
|---|---|
| Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN | |
| FDA Classification: | Class II |
| Predicate Device: | K052560, Biofinity (Comfilcon A) Soft Contact Lens |
Description of Device
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
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Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).
Indications for use
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
- Sphere and Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D.
- Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.
- Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non‐diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The
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Page 8
lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Technological characteristics studies
The technological characteristics of the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses, as compared to the predicate devices, are summarized in the following table.
| Device Name/Subgroups | Subject Device | Predicate Device |
|---|---|---|
| PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Biofinity (Comfilcon A) Soft Contact Lens | |
| PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses | ||
| 510(k) Number | New Device | K052560 |
| USAN name | Toufilcon B | Comfilcon A |
| FDA Category (Group) | Group 5 | Group 5 |
| Intended use | Spherical and Aspherical, Toric, Multifocal | Spherical and Aspherical, Toric, Multifocal |
| Expected clinical performance | Eye for vision correction | Eye for vision correction |
| Indications | Daily wear | Daily wear |
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Page 9
| Device Name/Subgroups | Subject Device | Predicate Device |
|---|---|---|
| PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Biofinity (Comfilcon A) Soft Contact Lens | |
| PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses | ||
| Replacement schedule | Daily/Bi-weekly/Monthly | Monthly |
| Production Method | Cast-molding | Cast-molding |
| Sterilization Method | Moist Heat | Moist Heat |
| Lens color | Light blue | Light blue |
| UV-blocking | Class Ⅱ | NA |
| Water Content | 50%±2% | 48%±2% |
| Oxygen Permeability x10⁻¹¹ (cm²/s)﹝mlO₂/(ml × mmHg)﹞ | 91 | 128 |
| Light Transmittance | 95±5% | >97% |
| Powers | +6.00D ~ -12.25D | +20.00D ~ -20.00D |
| Cylinder Power | -0.25D ~ -3.50D | -0.25D ~ -10.00D |
| ADD Power | +0.25D ~ +3.00D | +0.50D ~ +3.00D |
| Refractive Index | 1.405 | 1.400 |
Summary of Clinical Study
A prospective, randomized, double-blind, parallel, active-controlled clinical trial with 3 months of treatment follow-up was conducted in Taiwan. The study screened 75 subjects, 10 subjects failed to be included and 9 subjects randomized but unsuccessful lens fitting. A total of 56 subjects were enrolled in this study (39 subjects wore the test lenses and 17 subjects wore control lenses "CooperVison Biofinity® (comfilcon A) Soft Contact Lens". A total 54 subjects completed the study, while 2 subjects in test group were discontinued from the study. The mean treatment compliance was high (98.81 % ~ 98.77 %) during the study period. Regarding the primary efficacy endpoint, the subjects with corrected contact lens visual acuity of 1.0 decimal (0.0 logMAR) or better at final visit shows no difference in control group and test group. The test and control groups are comparable in corrected contact lens visual acuity. In safety endpoints, there was no serious and significant adverse device event occurred during
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Page 10
the conduct of the study in both control and test group. No subject with adverse device effects accompanying Slit Lamp Findings > Grade 2 was reported in the control group and test group. Therefore, this clinical investigation supports the claim of substantial equivalence between the test product and control product with regard to clinical effectiveness and safety.
Non-clinical Study
All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses.
Non-Clinical testing performed includes:
● Physicochemical Properties
- Refractive Index (ISO 18369-4)
- Oxygen Permeability (ISO 18369-4)
- Water content (ISO 18369-4)
- Extractable (ISO 18369-4)
- Visible & UV Light Transmittance (ISO 18369-3)
- Mechanical Property (ASTM D1708-13)
- Solution Compatibility test (ISO 11981)
- Preservative Uptake and Release (ISO 11986)
- Shelf Life Test and Sterility Test (ISO 11987)
The results demonstrated that the lens met all established specifications and requirements for physical, optical, and chemical properties.
● Biocompatibility Test
The biocompatibility evaluation of this product was conducted in accordance with the ISO 10993 series and ISO 9394 standards for the biological evaluation of medical devices. The evaluation included relevant tests for both the contact lens materials and the packaging components:
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Page 11
Contact Lenses (Toufilcon B)
• Cytotoxicity Test (ISO 10993-5)
• Ocular Irritation Test (ISO 10993-10)
• Acute Systemic Toxicity Test (ISO 10993-11)
• Skin Sensitization Study (Maximization Test) (ISO 10993-10)
• 22-Day Ocular Irritation Study (ISO 9394)
PP blister and aluminum foil (identical to K232649)
• Cytotoxicity Test (ISO 10993-5)
• Ocular Irritation Test (ISO 10993-10)
• Acute Systemic Toxicity Test (ISO 10993-11)
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses use the same primary packaging materials as the K232649 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. The raw materials and formulation of the primary packaging materials (Aluminum Foil 4-Layer and PP blister) are identical. The safety of the these materials has been verified through biocompatibility testing performed for the referenced device (K232649) in accordance with the ISO 10993 series of standards; therefore, additional testing for primary packaging was not required.
The test results demonstrated that the contact lens exhibit no cytotoxicity, no ocular irritation, no skin sensitization, and no acute systemic toxicity. All biocompatibility tests yielded passing results, confirming that the product does not contain any toxic or harmful substances that may pose a risk to biological systems.
Substantial Equivalence Statement
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate device BIOFINITY (comfilcon A) Soft Contact Lens.
All of these lenses are categorized as Group V silicone hydrogel lenses and are manufactured using the same processes: cast molding and steam sterilization. Designed for vision correction, they are available in various optical designs, including spherical/aspherical, toric, and multifocal. The Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision Soft (Hydrophilic)
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Contact Lenses are considered substantially equivalent to the predicate device, CooperVision Biofinity® (comfilcon A) Soft Contact Lens.
Conclusion
A series of pre-clinical tests and clinical trial were performed to demonstrate the safety and effectiveness of the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.
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§ 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.