(59 days)
No
The document describes a contact lens and its material properties, intended use, and clinical study results. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is indicated for the optical correction of refractive ametropia and presbyopia, which are vision impairments, not for treating a disease or condition in a therapeutic manner.
No
Explanation: The device is a contact lens indicated for the optical correction of refractive ametropia (myopia and hyperopia), not for diagnosis. Its purpose is to correct vision, not to identify or determine the presence of a disease or condition.
No
The device is a physical contact lens made from a specific material (lehfilcon A) with defined physical properties and designs. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are soft contact lenses for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia). This is a direct interaction with the eye for vision correction.
- Device Description: The description details the material, properties, and parameters of the contact lenses themselves.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.
Contact lenses are considered medical devices, but they fall under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
TOTAL30™ (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.
TOTAL30™ Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and byperopia) in phakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded with a new pair each month, or more often, if recommended by the eye care professional.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The subject device, TOTAL30™ (lehfilcon A) soft contact lenses, are made from a surface treated, silicone containing hydrogel lens material that is approximately 55% water and 45% lehfilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edgeto-edge color to make it easier to see when handling. The lenses contain two benzotriazole monomers to block UVA and UVB radiation and, additionally, reduce transmittance in the range from 380 nm to 450 nm.
Lehfilcon A represents a Group 5B silicone hydrogel contact lens material ("enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows:
| Group Suffix | Hydrogel Material | Description |
|---|---|---|
| 5B | High water subgroup | A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8 |
Lehfilcon A lens designs include spherical, asphere, toric, multifocal toric contact lenses in the following parameter ranges:
- . Diameter Range: 13.0 to 15.0 mm
- Base Curve Range: 8.0 to 9.2 mm .
- . Power Range: -20.00 D to +20.00 D
- Center Thickness: varies with design and power .
(Example: 0.08 mm for -3.00 D spherical) - Cylinder Power (Toric) -0.25 D to -10.00 D .
- ADD Power (Multifocal) LO, MED, HI .
Lenses have the following properties:
- . 1.40 (hydrated) Refractive index:
- . Water content: 55% by weight in normal saline
- . Surface water content: ≥ 90%
- Oxygen permeability: 123 x 10 -11 .
[(cm2/sec)(ml O2 /ml.mmHg)] measured at 35 °C (normalized Dk-Polarographic method) - Light transmittance: . >85%
- . UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 315 to 380 nm for the entire power range.
Lehfilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents. The compatibility and package integrity of the blister pack packaging system have been demonstrated and successfully used for other Alcon marketed contact lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).
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
eye care professional
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
Product safety was assessed based on adverse events, device deficiencies and biomicroscopy findings.
Eight (8) study sites in the US enrolled a total of 119 subjects of whom 118 were randomized and exposed to study lenses in this prospective, randomized, stratified (by corneal curvature radius), controlled, double-masked, parallel group study. Of the 118 subjects (236 eyes) enrolled into the study, 78 subjects were dispensed Phoenix (lehfilcon A) test lenses and 40 subjects were dispensed Biofinity control lenses (2:1 ratio). Through the course of the study, 3 subjects discontinued early (2 subjects from the control group withdrew and 1 subject, from the test group, moved due to COVID-19). Lenses were worn in a daily wear modality and were replaced monthly. The primary effectiveness endpoint was Snellen VA at distance. The demographic characteristics for all enrolled subjects were similar between the lehfilcon A and comfilcon A groups. Overall, the maiority of subjects were female (74.6%), predominantly White, and most were not of Hispanic or Latino ethnicity. The overall mean age of the subjects was 33.9 years.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A three-month clinical study, conducted according to the May 1994 FDA 510(k) contact lens guidance document for a new contact lens material and ISO 11980:2012, Ophthalmic optics -Contact lenses and contact lens care products - Guidance for clinical investigations, assessed the safety and performance of lehfilcon A soft contact lenses for daily wear as compared to a predicate control lens (2:1 ratio test to control).
Eight (8) study sites in the US enrolled a total of 119 subjects of whom 118 were randomized and exposed to study lenses in this prospective, randomized, stratified (by corneal curvature radius), controlled, double-masked, parallel group study. Of the 118 subjects (236 eyes) enrolled into the study, 78 subjects were dispensed Phoenix (lehfilcon A) test lenses and 40 subjects were dispensed Biofinity control lenses (2:1 ratio). Through the course of the study, 3 subjects discontinued early (2 subjects from the control group withdrew and 1 subject, from the test group, moved due to COVID-19). Lenses were worn in a daily wear modality and were replaced monthly. The primary effectiveness endpoint was Snellen VA at distance.
The study results showed similar clinical performance between the test lehfilcon A contact lenses and control comfilcon A contact lenses in the clinically relevant areas of vision, comfort, fit, handling and health when worn on a daily wear basis.
The clinical study demonstrated the substantial equivalence of the subject device with the predicate, control lens.
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.
K151918, K100349, K131378, K182782, K113168, K180669
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.
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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 USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2021
Alcon Laboratories Inc. Alicia Plesnarski, RAC Director, Global Regulatory Affairs 6201 South Freeway Fort Worth, TX 76131-2099
Re: K210436 Trade/Device Name: TOTAL30TM brand soft contact lenses: TOTAL30TM TOTAL30TM Asphere, TOTAL30TM for Astigmatism, TOTAL30TM Multifocal. TOTAL30™ Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 11, 2021 Received: February 12, 2021
Dear Alicia Plesnarski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou. 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
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210436
Device Name
TOTAL30™ soft contact lenses: TOTAL30, TOTAL30 Asphere, TOTAL30 for Astigmatism, TOTAL30 Multifocal, TOTAL30 Multifocal Toric
Indications for Use (Describe)
TOTAL30™ (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.
TOTAL30™ Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30™ Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and byperopia) in phakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded with a new pair each month, or more often, if recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-------------------------|----------------------------------------------------------------------------------|
| Primary Contact Person: | Alicia M. Plesnarski, RAC |
| Phone: | 678 415-3924 |
| Fax: | N/A |
| Email: | alicia.plesnarski@alcon.com |
| Back up Contact Person: | Sherri Lakota |
| Phone: | 817 615-5472 |
| Fax: | 817 302-4574 |
| Email: | sherri.lakota@alcon.com |
| Date Prepared: | April 12, 2021 |
II. Devices Subject to this 510(k)
| Trade name: | TOTAL30TM brand soft contact lenses
TOTAL30TM,
TOTAL30TM Asphere,
TOTAL30TM for Astigmatism,
TOTAL30TM Multifocal,
TOTAL30TM Multifocal Toric |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | (lehfilcon A) contact lens |
| Classification name: | Soft (hydrophilic) Contact Lens |
| Device classification: | 21 CFR 886.5925 (b) (1) |
| Product code: | LPL; MVN |
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III. Predicate Device
The predicate device is the CooperVision® Biofinity® (comfilcon A) soft contact lens. Comfilcon A represents a Group 5C silicone hydrogel contact lens material ('enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows:
| Group Suffix | Hydrogel Material | Description |
|---|---|---|
| 5C | Low water subgroup | A subgroup of Group 5 which contains less than |
| 50 % water and no ionic monomer or oligomer | ||
| at pH 6 to pH 8 |
The predicate device has US FDA Premarket Notification 510(k) clearance for daily wear (K052560, December 6, 2005).
IV. Device Description
The subject device, TOTAL30™ (lehfilcon A) soft contact lenses, are made from a surface treated, silicone containing hydrogel lens material that is approximately 55% water and 45% lehfilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edgeto-edge color to make it easier to see when handling. The lenses contain two benzotriazole monomers to block UVA and UVB radiation and, additionally, reduce transmittance in the range from 380 nm to 450 nm.
Lehfilcon A represents a Group 5B silicone hydrogel contact lens material ("enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows:
| Group Suffix | Hydrogel Material | Description |
|---|---|---|
| 5B | High water subgroup | A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8 |
5
Lehfilcon A lens designs include spherical, asphere, toric, multifocal toric contact lenses in the following parameter ranges:
- . Diameter Range: 13.0 to 15.0 mm
- Base Curve Range: 8.0 to 9.2 mm .
- . Power Range: -20.00 D to +20.00 D
- Center Thickness: varies with design and power .
(Example: 0.08 mm for -3.00 D spherical)
- Cylinder Power (Toric) -0.25 D to -10.00 D .
- ADD Power (Multifocal) LO, MED, HI .
Lenses have the following properties:
- . 1.40 (hydrated) Refractive index:
- . Water content: 55% by weight in normal saline
- . Surface water content: ≥ 90%
- Oxygen permeability: 123 x 10 -11 .
[(cm2/sec)(ml O2 /ml.mmHg)] measured at 35 °C (normalized Dk-Polarographic method)
- Light transmittance: . >85%
- . UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 315 to 380 nm for the entire power range.
Lehfilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents. The compatibility and package integrity of the blister pack packaging system have been demonstrated and successfully used for other Alcon marketed contact lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).
6
V. Indications for Use
TOTAL30 (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30 Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
TOTAL30 for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes with up to 6.00 diopters (D) of astigmatism.
TOTAL30 Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
TOTAL30 Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be prescribed for daily wear with removal for cleaning and disinfection (chemical not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
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VI. Comparison to Technological Characteristics with the Predicate Device
Table 1 provides a side-by-side comparison of the device as compared to the predicate device in terms of intended use and technological information.
| | Predicate Device
(CooperVision) | Subject Device
(Alcon) |
|--------------------------------------------------|------------------------------------------------------------|-------------------------------------------|
| Trade Name
(brand) | Biofinity | TOTAL30 |
| Submission
Number | 510(k) K052560 | 510(k) K210436 |
| Device
Classification Name | Daily Wear Soft Contact Lens
21 CFR 886.5925 (b)(1) | Same |
| Intended Use | Vision correction | Same |
| Wearing Modality | Daily wear | Same |
| Replacement
Schedule | Monthly | Same |
| Material
Classification
(ISO 18369-1:2017) | Group 5C, low water silicone
hydrogel | Group 5B, high water silicone
hydrogel |
| Lens Material | Comfilcon A | Lehfilcon A |
| Surface Treatment | No | Yes |
| Visibility Tint | Light blue | Light blue-green |
| UV/UV vis
absorbing
monomers | No | Yes* |
| Manufacturing
Method | Cast molded | Cast molded
(DSM FLEX) |
| Lens Designs | Spherical, asphere, toric,
multifocal, multifocal toric | Same |
| Parameter Ranges: | | |
Table 1. Substantial Equivalence Comparison
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| Table 1. Substantial Equivalence Comparison | |
|---|---|
| --------------------------------------------- | -- |
| | Predicate Device
(CooperVision) | Subject Device
(Alcon) |
|------------------------------------|---------------------------------------------|---------------------------------------------------|
| Power: | +20.00 to -20.00 D | Same |
| Base Curve: | 8.0 to 9.5 mm | 8.0 to 9.2 mm |
| Diameter: | 13.0 to 15.0 mm | Same |
| Cylinder Power
(toric): | -0.25 to -10.00 D | Same |
| Add Power
(multifocal): | +0.50 to +3.00D | LO, MED, HI |
| Water Content | 48% | 55% |
| Surface Water
Content | -- | ≥ 90%** |
| Refractive Index | 1.40 | 1.40 |
| Oxygen
Permeability | 128***
(coulometric method) | 123***
(polarographic method) |
| Sterilization | Steam sterilization,
validated autoclave | Same |
| Packaging | Cartons containing
sealed blister packs | Same |
| Package Storage
Saline Solution | Isotonic saline | Phosphate buffered saline (PBS)
with additives |
*UV absorbers are commonly found in numerous US legally commercialized contact lenses (examples K151918; K100349; K131378; K182782)
** High surface water content property similar to other US legally commercialized contact lenses with a surface treatment (example K113168)
***units 10 -11 (cm2/sec)(ml O2 /ml x mm Hg)
Lehfilcon A soft contact lenses are equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use.
Any differences which may exist between the subject device (lehfilcon A soft contact lenses) and the predicate device or other silicone hydrogel soft contact lenses for daily wear do not adversely affect the safety and effectiveness of the subject device.
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VII. Performance Data
A series of nonclinical tests and a clinical study were performed to demonstrate the substantial equivalence of lehfilcon A contact lenses to the predicate device. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and ISO standards, as applicable. In addition, nonclinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).
Biocompatibility Testing
As listed below, a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation, sensitization, systemic toxicity and genotoxicity testing, confirms that lehfilcon A contact lenses are non-toxic and biocompatible.
- . Cytotoxicity Studies (lens, lens extracts, and package saline)
- Ocular Irritation / toxicity (Ocular) in Rabbits .
- o Lens wear study in rabbits per ISO 9394 (lens)
- Primary ocular irritation studies per ISO 19993-10 (lens extracts and package o saline)
- Sensitization Studies (lens extracts and package saline) .
- Acute Systemic Toxicity Study in Mice (lens extracts) .
- . Genotoxicity Studies (lens extracts and package saline)
The primary packaging materials used for lehfilcon A lenses are the same as those used for other Alcon contact lenses with FDA 510(k) clearance (K113168, K180669); therefore, existing biocompatibility data for the packaging materials applies.
Biocompatibility testing was conducted in accordance with the US Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies regulation (21 CFR Part 58) and relevant FDA guidance and ISO 10993 series of biocompatibility standards.
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Physical-Chemical Testing
The following nonclinical bench testing, conducted using GxP conditions, and, where applicable, ISO 18369-2, -3, -4 standards, established the physico-chemical properties of lehfilcon A contact lenses:
- · Refractive Index
- · Oxygen Permeability
- · Ion Permeability
- · Mechanical Properties
- · Wetting Contact Angle
- Transmittance Properties .
- Percent Water Content .
- Residuals and Extractables .
- Lens Parameters .
- Package Saline Properties (pH and osmolality) .
Solution Compatibility Testing
Lehfilcon A contact lenses are for daily wear use with daily removal for cleaning and disinfection and one-month replacement. Therefore, the compatibility of lehfilcon A contact lenses with commonly available cleaning and disinfection solutions (peroxide and MPDS), and preserved or unpreserved commercial contact lens saline and rewetting drops 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.
Lehfilcon A contact lenses were also analyzed for uptake and release of preservatives found in various 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 lehfilcon A contact lenses for Polyguad (PQ), Aldox, Polyhexamethylene biguanide (PHMB) and alexidine were comparable to the control lenses tested.
Sterilization and Stability Testing
Lehfilcon A contact lenses in buffered saline solution are provided sterile in sealed blister packs. Results of an ongoing stability study demonstrate that package lenses remain sterile and stable for the labeled expiration date.
The results of all non-clinical testing demonstrate:
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- The lens material, lens extracts and package saline of the device are non-toxic, non-irritating ● and non-sensitizing.
- Lens physical and material properties of the device are consistent with industry-marketed . lenses and equivalent to the predicate lens.
- Like the predicate device is compatible with commonly available contact lens . cleaning and disinfecting solutions, saline solutions and rewetting drops.
- Successful stability testing supports the labeled expiration date for the device. .
Clinical Performance Testing
A three-month clinical study, conducted according to the May 1994 FDA 510(k) contact lens guidance document for a new contact lens material and ISO 11980:2012, Ophthalmic optics -Contact lenses and contact lens care products - Guidance for clinical investigations, assessed the safety and performance of lehfilcon A soft contact lenses for daily wear as compared to a predicate control lens (2:1 ratio test to control). Product safety was assessed based on adverse events, device deficiencies and biomicroscopy findings.
Eight (8) study sites in the US enrolled a total of 119 subjects of whom 118 were randomized and exposed to study lenses in this prospective, randomized, stratified (by corneal curvature radius), controlled, double-masked, parallel group study. Of the 118 subjects (236 eyes) enrolled into the study, 78 subjects were dispensed Phoenix (lehfilcon A) test lenses and 40 subjects were dispensed Biofinity control lenses (2:1 ratio). Through the course of the study, 3 subjects discontinued early (2 subjects from the control group withdrew and 1 subject, from the test group, moved due to COVID-19). Lenses were worn in a daily wear modality and were replaced monthly. The primary effectiveness endpoint was Snellen VA at distance. The demographic characteristics for all enrolled subjects were similar between the lehfilcon A and comfilcon A groups. Overall, the maiority of subjects were female (74.6%), predominantly White, and most were not of Hispanic or Latino ethnicity. The overall mean age of the subjects was 33.9 years.
Additional endpoints include manifest refraction, keratometry, lens fit, surface characteristics and subjective ratings of vision, comfort and handling.
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The study results showed similar clinical performance between the test lehfilcon A contact lenses and control comfilcon A contact lenses in the clinically relevant areas of vision, comfort, fit, handling and health when worn on a daily wear basis.
The clinical study demonstrated the substantial equivalence of the subject device with the predicate, control lens.
Risk and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of silicone hydrogel contact lenses on a daily wear basis. The benefits to the patient are the same as those for other silicone hydrogel contact lenses.
VIII. Conclusions
Lehfilcon A soft contact lenses are substantially equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use. Nonclinical and clinical data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Any differences which may exist between the subject device (lehfilcon A soft contact lenses) and the predicate device or other daily wear silicone hydrogel soft contact lenses do not adversely affect the safety and effectiveness of the subject device.