(30 days)
Not Found
No
The summary describes a physical contact lens and its material properties, manufacturing process, and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is indicated for the correction of ametropia, which is a refractive error and not a disease or pathology that is treated. While the irregular cornea indication could suggest a therapeutic aspect, its primary purpose is still visual correction rather than treating the underlying corneal condition.
No
Explanation: The device, contact lenses, is indicated for correction of ametropia and astigmatism, not for diagnosing these conditions. The document describes its use as a vision correction aid, not a tool for identifying or determining a medical condition.
No
The device is a physical contact lens made from efrofilcon A, not a software program. The description details the material composition, physical properties, and manufacturing process of the lens.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Flexlens contact lenses are designed to be worn on the eye to correct vision problems (ametropia, astigmatism, presbyopia) and manage irregular corneal conditions. They are a therapeutic and corrective device, not a diagnostic one that analyzes biological samples.
- Intended Use: The intended use clearly states the correction of vision and management of corneal conditions, not the diagnosis of disease through analysis of biological samples.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself, not on any components or processes for analyzing biological specimens.
- Performance Studies: The performance studies described are bench testing, toxicology, and shelf life testing related to the safety and performance of the contact lens as a physical device worn on the eye. There are no studies related to the analysis of biological samples.
Therefore, the Flexlens contact lenses described are medical devices, but they fall under the category of corrective or therapeutic devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal, multifocal toric and irregular cornea configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
Bench Testing-manufacturing verification testing was conducted to demonstrate our firm's ability to manufacture the finished lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.
- In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses are not cytotoxic.
- Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11. The extracts from finished lenses produced no evidence of systemic toxicity.
- Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23. The extracts from finished lenses produced no evidence of ocular irritation.
The following non-clinical testing was performed previously or by the lens material manufacturer for finished contact lenses manufactured from efrofilcon A contact lens blanks:
Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.
- Skin Sensitization Study (Maximization Test): The skin sensitization study was conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
- 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in accordance with ISO 9394 on the finished lenses, and the finished contact lenses produced no ocular irritation.
Performance Testing-The following bench tests were completed: refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses and the predicate device.
Preservative Uptake and Release-efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses were analyzed for uptake and release of preservatives found in lens care products. Testing was conducted according to ISO 11986:2017, Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release. Uptake and release profiles of efrofilcon A contact lenses for the preservatives tested demonstrate sub-detection limit amounts of release at each time point evaluated.
Solution Compatibility-The physical compatibility of efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed following the methodology described in ISO 11981:2017, Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses.
Shelf Life-Testing was performed to evaluate the stability, sterility, and package integrity of the lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.
Clinical Studies: Not necessary for this application.
Conclusion: Results from testing demonstrated no relevant differences from the predicate devices and support the substantial equivalence claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
August 14, 2024
X-Cel Specialty Contacts, A Walman Optical Company Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068
Re: K242059
Trade/Device Name: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 28, 2024 Received: July 15, 2024
Dear Mr. Andre:
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
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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
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). 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
3
Indications for Use
510(k) Number (if known) K242059
Device Name
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
Indications for Use (Describe)
The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
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.
4
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."
5
SPECIAL 510 (k) SUMMARY
This special 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K242059 | |
|---|---|---|
| I. | SUBMITTER | |
| Date Prepared: | June 20, 2024 | |
| Name: | X-CEL SPECIALTY CONTACTS, A Walman | |
| Optical Company | ||
| Address: | 2775 Premiere Pkwy Ste 600 | |
| DULUTH, GA 30097 | ||
| United States | ||
| Contact Person: | Hue Tang | |
| Director of Quality Assurance | ||
| Phone number: | (770) 709-3324 | |
| Consultant/ | ||
| Correspondent: | ANDRE VISION AND DEVICE RESEARCH | |
| Bret Andre | ||
| 6119 Canter Lane | ||
| WEST LINN, OR 97068 | ||
| United States | ||
| Phone number | (503) 372-5226 | |
| II. | DEVICE | |
| Trade Name: | Flexlens Silicone Hydrogel Daily Wear Soft | |
| (Hydrophilic) Contact Lens (efrofilcon A) | ||
| Common Name: | Soft, daily wear contact lens | |
| Classification Name: | Soft (hydrophilic) contact lens. | |
| (21 CFR 886.5925) | ||
| Regulatory Class: | Class II | |
| Product Code: | LPL |
6
III. PREDICATE DEVICE
The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is substantially equivalent to the following predicate devices:
- "Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" Manufactured by X-CEL SPECIALTY CONTACTS 510(k) Number: K100443
- "IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" ● Manufactured by Art Optical Contact Lens, Inc. 510(k) number: K230824
DEVICE DESCRIPTION IV.
The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The physical properties of the device are as follows:
| Flexlens Silicone Hydrogel Daily Wear Soft Contact Lenses | |
|---|---|
| Refractive Index (wet) | 1.3770 |
| Visible light transmission (%) @ 380-780nm | 94.4% |
| Specific Gravity (wet) | 1.049 |
| Water Content | 74±2% |
| Oxygen Permeability | |
| (Dk) ISO/FATT Method | $56 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg} @ 35°C$ |
7
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal, multifocal toric and irregular cornea configurations with the following features and properties.:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 8.0mm to 9.5mm | $\pm$ 0.20mm |
| Center Thickness | 0.01mm to 0.50mm | When $\leq$ 0.10 mm $\rightarrow$ $\pm$ 0.010 mm + 10% |
| When > 0.10 mm $\rightarrow$ $\pm$ 0.015 mm + 5% | ||
| Diameter | 12.00mm to 16.00mm | $\pm$ 0.20mm |
| Spherical Power | -20.00 D to +20.00 D | |
| (in .25D steps) | When 0.00 4.00 D $\rightarrow$ $\pm$ 1.00 D | |
| Cylindrical Power (Multifocal Toric) | -0.25 D to -4.00 D | When 0.00 97% |
| Specific Gravity (wet) | 1.049 | 1.048 |
| Water Content | 74±2% | 74±2% |
| Oxygen Permeability | ||
| (Dk) ISO/FATT Method | $56.0 x 10^{-11}$ (cm²/sec) (ml O₂/ml x | |
| mm Hg @ 35 °C) | $59.8 x 10^{-11}$ (cm²/sec) (ml O₂/ml x | |
| mm Hg @ 35°C) | $56.0 x 10^{-11}$ (cm²/sec) (ml O₂/ml x | |
| mm Hg @ 35°C) |
10
| Indications for Use | |
|---|---|
| Flexlens Silicone | |
| Hydrogel Daily Wear | |
| Soft Contact Lens | |
| (Subject Device) | The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are |
| indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non- | |
| diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less | |
| where the astigmatism does not interfere with visual acuity. | |
| The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are | |
| indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non- | |
| diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. | |
| The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are | |
| indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non- | |
| diseased eyes and/or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring | |
| add power of up to ±4.00 diopters. | |
| The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear | |
| are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with | |
| non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring | |
| add power of up to +4.00 diopters. | |
| The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily | |
| wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons | |
| and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of | |
| irregular corneal conditions such as keratoconus and post graft fitting. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, | |
| disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may | |
| be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection | |
| systems. | |
| Flexlens Silicone | |
| Hydrogel Daily Wear | |
| Soft Contact Lens | |
| (Predicate Device: | |
| K100443) | Same as the subject device |
| IntelliWave³ Silicone | |
| Hydrogel Daily Wear | |
| Soft Contact Lenses | |
| (Predicate Device: | |
| K230824) | The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for |
| the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. | |
| The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the | |
| astigmatism does not interfere with visual acuity. | |
| The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the | |
| correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes | |
| and/or possesses refractive astigmatism not exceeding 12 diopters. | |
| The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated | |
| for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased | |
| eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power | |
| of up to +4.00 diopters. | |
| The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are | |
| indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non- | |
| diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add | |
| power of up to +4.00 diopters. | |
| The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are | |
| indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may | |
| be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular | |
| corneal conditions such as keratoconus and post graft fitting. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection | |
| and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned | |
| and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems. |
11
VII. PERFORMANCE DATA
~ Non-Clinical Studies ~
The following non-clinical testing was performed on Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A):
Bench Testing-manufacturing verification testing was conducted to demonstrate our firm's ability to manufacture the finished lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.
- In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ● ISO 10993-5 with results indicating that the finished lenses are not cytotoxic.
- Systemic Toxicity: The finished lenses meet the requirements of the systemic ● injection test in accordance with ISO 10993-11. The extracts from finished lenses produced no evidence of systemic toxicity.
- . Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23. The extracts from finished lenses produced no evidence of ocular irritation.
The following non-clinical testing was performed previously or by the lens material manufacturer for finished contact lenses manufactured from efrofilcon A contact lens blanks:
Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.
- Skin Sensitization Study (Maximization Test): The skin sensitization study was . conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
- 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in . accordance with ISO 9394 on the finished lenses, and the finished contact lenses produced no ocular irritation.
The biocompatibility of the primary packaging and packaging solution have been previously addressed by reference to 510(k) K100443 and there are no changes to these components as compared to the predicate.
Performance Testing-The following bench tests were completed: refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material
12
properties between the efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses and the predicate device.
Preservative Uptake and Release-efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses were analyzed for uptake and release of preservatives found in lens care products. Testing was conducted according to ISO 11986:2017, Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release. Uptake and release profiles of efrofilcon A contact lenses for the preservatives tested demonstrate sub-detection limit amounts of release at each time point evaluated.
Solution Compatibility-The physical compatibility of efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed following the methodology described in ISO 11981:2017, Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses.
Shelf Life-Testing was performed to evaluate the stability, sterility, and package integrity of the lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.
- ~ Clinical Studies ~
Clinical testing was not necessary for this application.
~ Conclusions Drawn from Testing ~
Results from testing presented in this premarket notification for the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) demonstrate no relevant differences from the predicate devices and support the substantial equivalence claim.
13
VIII. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) for daily wear are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indications.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft contact lenses.