(421 days)
Not Found
No
The 510(k) summary describes a standard soft contact lens with specific material properties and parameters for vision correction. There is no mention of AI, ML, image processing, or any computational analysis of patient data for diagnosis or treatment. The performance studies focus on clinical safety and visual acuity outcomes, not algorithmic performance.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are optical corrections rather than therapeutic treatments for a disease or condition.
No
Explanation: The device is a soft contact lens intended for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which is a treatment for existing conditions, not a diagnostic tool to identify or characterize medical conditions.
No
The device description clearly indicates that this is a physical contact lens made from a specific material with defined physical properties and manufacturing parameters. It is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "correction of refractive ametropia (myopia or hyperopia)" and "correction of refractive ametropia (myopia, hyperopia and astigmatism)" and "correction of refractive ametropia (myopia or hyperopia) and presbyopia". This describes a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and parameters of a contact lens designed to be worn on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVDs are typically used to test samples like blood, urine, or tissue to detect diseases, conditions, or infections. This contact lens is a medical device used to correct vision.
N/A
Intended Use / Indications for Use
The HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worm by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity.
The HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
Product codes
LPL, MVN
Device Description
The HOYA sorafilcon A material is made from a hydrophilic siloxane copolymer of N-vinyl pyrrolidone and is 48% water by weight when immersed in a sterile phosphate buffered saline packaging solution. A UV-absorbing monomer is used to block UV radiation. 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 HOYA sorafilcon A Contact Lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
- Refractive Index: 1.408
- Light Transmittance: >= 95%
- Water Content: 48%
- Specific Gravity: 1.123
- Surface Character: Hydrophilic
- Oxygen Permeability: 112 x 10-11 (cm²/sec)(cm³O₂)/(mL x mmHg) @ 35 °C (polarographic method).
The lenses will be manufactured with the following parameters:
- Diameter: 14.0 mm to 14.7 mm
- Center Thickness: 0.062 mm to 0.330 mm
- Base Curve: 8.40 mm to 9.20 mm
- Power Range: +5.00D to -12.00D
- Cylinder Power (Toric): -0.75D to -2.75D
- Cylinder Axis: 0° to 180° in 10° increments
- Add Power Range: +0.50D to +2.50D
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
HOYA conducted a three-month, double-masked (subject and investigator), bilateral, randomized, multicenter (9 centers) clinical trial was conducted in USA and UK with a total of 133 subjects enrolled. Eighty subjects completed the study as per protocol: 59 subjects wearing test lenses and 21 subjects wearing control lenses. No serious or significant ocular adverse events were reported.
The primary safety endpoint was HOYA sorafilcon A daily disposable contact lens was non-inferior to the control lens with respect to the percentage of eyes with ocular adverse events across all follow-up visits using a non-inferiority margin of 5%. No serious or significant ocular adverse events were reported. There were 20 reported adverse events in 17 subjects. Five of these were ocular adverse events in four subjects, all of which were classified as non-significant. Two of the ocular adverse events were considered lensrelated: bilateral redness. The low incidence of ocular adverse events ensured that both of the primary safety hypotheses were met.
The primary efficacy hypotheses related to visual acuity (VA). The proportion of eyes with VA with contact lenses and best sphere-correction corrected to 1.0 (0.0 logMAR, 20/20) or better was calculated at each visit. With VA calculated to the nearest line, the proportions ranged from 94% to 99% for the test lens and 94% to 100% for the control lens. Using this criterion, both lenses achieved the target threshold of 90% at each visit. With VA calculated to the nearest letter, these proportions ranged from 83% to 93% for the test lens and 83% to 91% for the control lens. It is notable, however, that with habitual lenses, the proportion was also below the target threshold of 90%: 77% of test eyes and 91% of control eyes. The mean spherecorrected VAs at follow-up (13 weeks) were 0.07 and -0.06 logMAR for the test and control lenses respectively. At each visit, the upper and lower limit values of the 95% confidence intervals were better than 0.0 logMAR (1.0 decimal, 20/20) and, therefore, a primary efficacy hypothesis was met.
The results of the study demonstrated that HOYA Illumina (sorafilcon A) Soft Contact Lens is safe and has effectiveness substantially equivalent to the predicate device, MyDay® (stenfilcon A) Soft Daily Disposable Contact Lens.
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.
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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 03, 2024
HOYA Lamphun Ltd. Timothy Ting Global QA/RA Director Northern Region Industrial Estate, 75/2 Moo 4, Tambol Banklang, Amphur Muang, Lamphun 51000 Thailand
Re: K223397
Trade/Device Name: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens.
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: December 2, 2023 Received: December 5, 2023
Dear Timothy Ting:
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.
1
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 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-reportingcombination-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-devices/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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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/deviceadvice-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.
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
3
Indications for Use
510(k) Number (if known) K223397
Device Name
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
Indications for Use (Describe)
The HOY A Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The HOY A Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worm by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity.
The HOY A Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
| 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) |
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Image /page/4/Picture/0 description: The image shows the word "HOYA" in blue font. A horizontal line extends from the left of the "H" to the right of the "O", bisecting the "O" in the middle. The font is sans-serif and the letters are evenly spaced.
Submission No.: K223397
510(k) Summary K223397
SUBMITTER INFORMATION
Date Prepared: November 10, 2022 Name: HOYA Lamphun Ltd. Address: Northern Region Industrial Estate, 75/2 Moo 4, Tambol Banklang, Amphur Muang, Lamphun 51000 Thailand. Contact Person: Timothy Ting Global Quality Assurance/Regulatory Affairs Director Phone Number: (66) 93-132-1699 Email: chongchai.ting@hoya.com
DEVICE INFORMATION
Trade Name: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
Brand Name: ILLUMINA 1 DAY Soft silicone hydrogel contact lens ILLUMINA 1 DAY Toric Soft silicone hydrogel contact lens ILLUMINA 1 DAY Multifocal Soft silicone hydrogel contact lens
Common Name: Soft contact lens, daily disposable wear. Device Classification: Class II (21 CFR 886.5925) Classification Name: Soft (hydrophilic) contact lens Product Code: LPL, MVN. Classification Panel: Ophthalmic.
PREDICATE DEVICES
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is substantially equivalent to the following predicate devices:
Primary predicate devices MyDay® (stenfilcon A) ASPHERE Soft Contact Lens, MyDay® (stenfilcon A) TORIC Soft Contact Lens, and MyDay® (stenfilcon A) MULTIFOCAL Soft Contact Lens. Cleared under K191763.
Secondary predicate devices
Bausch + Lomb® (samfilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb® (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism
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Image /page/5/Picture/0 description: The image shows the word "HOYA" in a sans-serif font. The letters are a bright blue color. The "O" in HOYA has a horizontal line going through it, which resembles a horizon line.
Bausch + Lomb® (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Cleared under K131208.
DEVICE DESCRIPTION
The HOY A sorafilcon A material is made from a hydrophilic siloxane copolymer of N-vinyl pyrrolidone and is 48% water by weight when immersed in a sterile phosphate buffered saline packaging solution. A UV-absorbing monomer is used to block UV radiation. 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 HOYA sorafilcon A Contact Lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
| Refractive Index | 1.408 |
|---|---|
| Light Transmittance | ≥ 95% |
| Water Content | 48% |
| Specific Gravity | 1.123 |
| Surface Character | Hydrophilic |
| Oxygen Permeability | 112 x 10-11 (cm²/sec)(cm³O₂)/(mL x mmHg) @ 35 °C |
| (polarographic method). |
The lenses will be manufactured with the following parameters:
| Diameter | 14.0 mm to 14.7 mm |
|---|---|
| Center Thickness | 0.062 mm to 0.330 mm |
| Base Curve | 8.40 mm to 9.20 mm |
| Power Range | +5.00D to -12.00D |
| Cylinder Power (Toric) | -0.75D to -2.75D |
| Cylinder Axis | 0 o to 180 o in 10 o increments |
| Add Power Range | +0.50D to +2.50D |
INDICATIONS FOR USE
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens
The HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens
The HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-
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Image /page/6/Picture/0 description: The image shows the word "HOYA" in a sans-serif font. The letters are a bright blue color. There is a horizontal line that extends from the left side of the "H" to the right side of the "A", passing through the center of the "O".
diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worn by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity.
HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
The HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with nondiseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
| Property | Primary Predicate Device | Secondary Predicate Device | Subject Device |
|---|---|---|---|
| MyDay® (stenfilcon A) Soft | |||
| Daily Disposable Contact | |||
| Lens Product Family | |||
| K191763 | Bausch + Lomb (samfilcon A) | ||
| Soft (hydrophilic) Contact | |||
| Lens Product Family | |||
| K131208 | HOYA Illumina | ||
| (sorafilcon A) Daily | |||
| Disposable Soft Contact | |||
| Lens Product Family | |||
| Intended Use | Daily wear and daily | ||
| disposable cornea soft | |||
| contact lens for myopia, | |||
| hyperopia, astigmatism, | |||
| presbyopia | Daily wear and daily | ||
| disposable cornea soft contact | |||
| lens for myopia, hyperopia, | |||
| astigmatism, presbyopia | Same as predicate devices | ||
| Functionality | The contact lenses act as a | ||
| refractive medium that | |||
| focus light rays from near | |||
| and distant objects on the | |||
| retina. | The contact lenses act as a | ||
| refractive medium that focus | |||
| light rays from near and distant | |||
| objects on the retina. | Same as predicate devices | ||
| Modality | Daily disposable wear | ||
| contact lens | Daily disposable wear contact | ||
| lens | Same as predicate devices | ||
| Manufacturing | |||
| Method | Cast Molded | Cast Molded | Same as predicate devices |
| Material Group | Silicone Hydrogel FDA | ||
| Group II (high water | |||
| content, nonionic polymer) | Silicone Hydrogel FDA Group | ||
| I (low water content, nonionic | |||
| polymer) | Silicone Hydrogel FDA | ||
| Group I (low water | |||
| content, nonionic polymer) | |||
| FDA Category | |||
| (Group) | content, nonionic polymer) | ||
| USAN Name | stenfilcon A | samfilcon A | sorafilcon A |
| Water Content | 54% | 46% | 48% |
| Oxygen | |||
| Permeability* | 80 | 114 | 112 |
| Refractive Index | 1.401 | 1.411 | 1.408 |
A side-by-side comparison of technological characteristics of the predicate devices and the new device:
7
| HOYA | HOYA Lamphun Ltd.
Traditional 510(k) Premarket Notification HOYA Illumina
(sorafilcon A) Daily Disposable
Soft Contact Lens | Submission Date:
02-December-2023 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Submission No.:
K223397 | | |
| Property | Primary Predicate Device
MyDay® (stenfilcon A) Soft
Daily Disposable Contact
Lens Product Family
K191763 | Secondary Predicate Device
Bausch + Lomb (samfilcon A)
Soft (hydrophilic) Contact
Lens Product Family
K131208 | Subject Device
HOYA Illumina
(sorafilcon A) Daily
Disposable Soft Contact
Lens Product Family |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Specific Gravity | 1.033 | 1.048 | 1.123 |
| Visibility Tint | Reactive Blue 246 | Reactive Blue 246 | No color pigment was
added |
| Sterilization
Method | Moist Heat | Autoclave | Same as predicate
devices |
Note: *Oxygen Permeability shown was determine by polarographic method:
x 10-11 [(cm2/sec)x(cm3O2)/ (ml x mmHg)] @ 35 ℃
SUMMARY OF NON-CLINICAL TESTING
Non-clinical studies for HOYA sorafilcon A Contact Lenses were conducted in accordance with FDA's Class II Daily Wear Contact Lenses - Premarket Notification [510(k)] Guidance Document issued date June 27, 1994 and 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. Each test was conducted based on the ANSI, ISO, and ASTM standard as indicated below:
- · Lens shape, edge thickness, inclusion and surface imperfection per ANSI Z80.20:2016 and ISO 18369-3:2017.
- · Lens parameters per ANSI Z80.20: 2016 and ISO 18369-3:2017.
- · Water content per ANSI Z80.20-2016 and ISO 18369-4:2017.
- · Refractive index per ANSI Z80.20-2016 and ISO 18369-4:2017.
- · Light transmittance per ANSI Z80.20-2016 and ISO 18369-4:2017.
- · UV radiation transmittance per ANSI Z80.20-2016 and ISO 18369-4:2017.
- Extractables per ANSI Z80.20-2016 and ISO 18369-4:2017. .
- · Contact angle per ANSI Z80.20-2016.
- · Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-02a.
- · Sterile blister packaging integrity per ASTM 1929-98.
All test results met the pre-established acceptance criteria which demonstrated the lenses are safe and effective.
SUMMARY OF BIOCOMPATIBILITY TESTING
Biocompatibility testing for HOY A sorafilcon A Contact Lenses was conducted on in accordance with the FDA's Class II Daily Wear Contact Lenses - Premarket Notification [510(k)] Guidance Document issued date June 27, 1994. ISO 10993-1:2018 Biological Evaluation of Medical Devices and 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies as listed below:
- · Cytotoxicity per ISO 10993-5: 2009
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- . Sensitization per ISO 10993-10: 2021
- 22 day contact lens wear study in rabbits per ISO 9394: 2012 .
- · Acute Ocular Irritation per ISO 10993-23:2021
- Systemic Toxicity per ISO 10993-11: 2017 .
- · Genotoxicity (bacterial reverse mutation and chromosomal aberration assays studies) per ISO 10993-3: 2014
- · Chemical characterization of lens materials per ISO 10993-18: 2020
The biological compatibility testing was conducted on the subject device phosphate buffered saline packaging solution as listed below:
- · Cytotoxicity per ISO 10993-5: 2009
- · Sensitization per ISO 10993-10: 2021
- · Acute Ocular Irritation per ISO 10993-23:2021
The biological compatibility testing was also conducted on the subject device final packaging materials as listed below:
- · Cytotoxicity per ISO 10993-5: 2009
- · Acute systemic toxicity per ISO 10993-11:2017
- · Acute Ocular Irritation per ISO 10993-23:2021
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens was demonstrated to be biocompatible with the mucosal membrane (cornea) and the device performs as expected and is equivalent to the predicates without creating additional risk to the user.
SUMMARY OF CLINICAL PERFORMANCE DATA
HOYA conducted a three-month, double-masked (subject and investigator), bilateral, randomized, multicenter (9 centers) clinical trial was conducted in USA and UK with a total of 133 subjects enrolled. Eighty subjects completed the study as per protocol: 59 subjects wearing test lenses and 21 subjects wearing control lenses. No serious or significant ocular adverse events were reported.
The primary safety endpoint was HOYA sorafilcon A daily disposable contact lens was non-inferior to the control lens with respect to the percentage of eyes with ocular adverse events across all follow-up visits using a non-inferiority margin of 5%. No serious or significant ocular adverse events were reported. There were 20 reported adverse events in 17 subjects. Five of these were ocular adverse events in four subjects, all of which were classified as non-significant. Two of the ocular adverse events were considered lensrelated: bilateral redness. The low incidence of ocular adverse events ensured that both of the primary safety hypotheses were met.
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Image /page/9/Picture/0 description: The image shows information about HOYA Lamphun Ltd. It mentions a Traditional 510(k) Premarket Notification for HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens. The submission date is 02-December-2023, and the submission number is K223397.
The primary efficacy hypotheses related to visual acuity (VA). The proportion of eyes with VA with contact lenses and best sphere-correction corrected to 1.0 (0.0 logMAR, 20/20) or better was calculated at each visit. With VA calculated to the nearest line, the proportions ranged from 94% to 99% for the test lens and 94% to 100% for the control lens. Using this criterion, both lenses achieved the target threshold of 90% at each visit. With VA calculated to the nearest letter, these proportions ranged from 83% to 93% for the test lens and 83% to 91% for the control lens. It is notable, however, that with habitual lenses, the proportion was also below the target threshold of 90%: 77% of test eyes and 91% of control eyes. The mean spherecorrected VAs at follow-up (13 weeks) were 0.07 and -0.06 logMAR for the test and control lenses respectively. At each visit, the upper and lower limit values of the 95% confidence intervals were better than 0.0 logMAR (1.0 decimal, 20/20) and, therefore, a primary efficacy hypothesis was met.
The results of the study demonstrated that HOYA Illumina (sorafilcon A) Soft Contact Lens is safe and has effectiveness substantially equivalent to the predicate device, MyDay® (stenfilcon A) Soft Daily Disposable Contact Lens.
SUBSTANTIAL EQUIVALENCE CONCLUSION
The cumulative results of the bench performance testing, in vitro and in vivo testing, biocompatibility testing, and clinical study sponsored by HOYA Lamphun Ltd. demonstrated that the safety, effectiveness, and performance of the subject device is substantially equivalent to the predicate devices.