(116 days)
No
The summary describes a physical contact lens made of a specific material with defined parameters and properties. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia, which are optical corrections, not therapeutics.
No
Explanation: The device is described as soft contact lenses intended for the optical correction of refractive ametropia (myopia, hyperopia, presbyopia, and astigmatism). Its purpose is to correct vision, not to diagnose a condition. The performance studies focus on safety and effectiveness of vision correction, not on diagnostic accuracy.
No
The device description clearly states the device is a physical contact lens made from a silicone containing hydrogel material.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these are soft contact lenses intended for the optical correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia). They are worn on the surface of the eye to improve vision.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples from the body or to diagnose any condition. Its function is purely optical correction.
Therefore, the information provided indicates that this device is a medical device for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Alcon (serafilcon 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 astignatism that does not interfere with visual acuity.
Alcon for Astigmatism (serafileon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism.
Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic 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.
Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia) 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 disposal, or cleaning and heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded with a new pair each week, 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 is made from a silicone containing hydrogel lens material that is approximately 55% water and 45% serafilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edge-to-edge color to make it easier to see when handling. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm.
Serafilcon 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: 5B, Hydrogel Material: High water subgroup, Description: A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8
Serafilcon A lens designs include spherical, toric, multifocal toric 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) Range: -0.25 D to -10.00 D
- Cylinder Axis (toric) Range: 001 to 180°
- ADD Power (multifocal) Range: LO, MED, HI
Lenses have the following properties:
- Refractive index: 1.40 (hydrated)
- Water content : 55% by weight in normal saline
- Oxygen permeability: 119 x 10 -11 [(cm2 /sec)(ml O2 /mlommHg)] 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 316 to 380 nm for the entire power range.
Serafilcon 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 variable information such as 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
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed for daily wear, recommended by the 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of nonclinical tests and a clinical study were performed to demonstrate the substantial equivalence of serafilcon 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:
A series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation/toxicity, sensitization, systemic and genotoxicity testing, confirm that serafilcon A contact lenses are non-toxic and biocompatible.
- Cytotoxicity Studies (lens, lens extracts and package saline)
- Ocular Irritation / Toxicity (Ocular) in Rabbits:
- Lens wear study in rabbits per ISO 9394 (lens)
- Primary ocular irritation studies per ISO 10993-10 (lens extracts and package 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 serafilcon A lenses are the same as those used for other Alcon contact lenses with FDA 510(k) clearance (K113168, K180398, K180669, K210436), 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 ISO 10993 series of biocompatibility standards.
Physical-Chemical Testing:
The following nonclinical bench testing, conducted using GxP conditions, and, where applicable ISO 18369-2. -3. -4 standards, established the physicochemical properties of serafilcon A contact lenses:
- Refractive Index
- Oxygen Permeability
- Ion Permeability
- Transmittance Properties
- Percent Water Content
- Residuals and Extractables
- Mechanical Properties
- Wetting Contact Angle
- Lens Parameters
- Package Saline Properties (pH and osmolality)
Solution Compatibility Testing:
Serafilcon A contact lenses are for daily wear use with daily removal for cleaning and disinfection and one-week replacement. Therefore, the compatibility of serafilcon A contact lenses with commonly available cleaning and disinfection solutions (3% hydrogen peroxide and MPDS), and preserved or unpreserved commercial contact lens saline and rewetting drops, was confirmed following the methodology described in ISO 11981, Ophthalmic optics - Contact lenses and contact lens care products – Determination of physical compatibility of contact lens care products with contact lenses.
Serafilcon 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, Ophthalmic optics -Contact lenses and contact lens care products – Determination of preservative uptake and release. Uptake and release profiles of serafilcon A contact lenses for Polyquad (PQ), Aldox, Polyhexamethylene biguanide (PHMB) and Alexidine were comparable to the control lenses tested.
Sterilization and Stability Testing:
Serafilcon A contact lenses in 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.
Summary of Nonclinical Testing Results:
- 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) daily wear contact lens guidance document for a new contact lens material and ISO 11980, Ophthalmic optics-Contact lenses and contact lens care products – Guidance for clinical investigations, assessed the safety and performance of serafilcon 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 one hundred and twenty (120) subjects in this prospective, randomized, stratified (by corneal curvature radius), controlled, double-masked, parallel group study. One subject was a screen failure. Of the 120 subjects (240 eyes) enrolled into the study, 119 subjects were randomized, exposed to the study lenses and 110 subjects completed the study. The study evaluated 78 serafilcon A (test) subjects and 41 comfilcon A (control) subjects. Contact lenses were worn bilaterally in a daily wear modality for approximately 3 months each. The test lenses were replaced weekly and the control lenses were replaced monthly. The primary effectiveness endpoint was study lens visual acuity at distance. The demographic characteristics for all enrolled subjects were similar between the serafilcon A groups. The majority of the subjects in both groups were female (76.5%), predominantly White, and most were not of Hispanic or Latino ethnicity. The overall mean age of the subjects was 32.4 years.
Additional assessments and endpoints included refraction, keratometry, lens fit, surface characteristics and subjective ratings of vision, comfort and handling.
Key results:
The study results showed similar clinical performance between the test and control 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, K210436, K113168, K180398, K180669, K210436
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 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 28, 2021
Alcon Laboratories, Inc Alicia Plesnarski Director, Global Regulatory Affairs Alcon Laboratories, Inc 6201 South Freeway, Fort Worth, TX 76134-2099
Re: K212806
Trade/Device Name: Alcon™, Alcon™ for Astigmatism, Alcon™ Multifocal, Alcon™ Multifocal Toric (serafilcon A) soft contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 19, 2021 Received: November 22, 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 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
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 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 titled, "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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212806
Device Name
Alcon, Alcon for Astigmatism, Alcon Multifocal, Alcon Multifocal Toric (serafilcon A) soft contact lenses
Indications for Use (Describe)
Alcon (serafilcon 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 astignatism that does not interfere with visual acuity.
Alcon for Astigmatism (serafileon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism.
Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic 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.
Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia) 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 disposal, or cleaning and heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded with a new pair each week, or more often, if recommended by the eye care professional.
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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510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
Submitter of the 510(k) I.
| 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: | December 22, 2021 |
II. Devices Subject to this 510(k)
Trade name (brand):
| AlconTM | |
|---|---|
| AlconTM for Astigmatism | |
| AlconTM Multifocal | |
| AlconTM Multifocal Toric | |
| Common name: | (serafilcon A) soft contact lens |
| Classification name: | Soft (hydrophilic) Contact Lens |
4
Serafilcon A Soft Contact lenses 510(k) K212806
Device classification: 21 CFR 886.5925 (b) (1) Product code: LPL; MVN
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 is made from a silicone containing hydrogel lens material that is approximately 55% water and 45% serafilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edge-to-edge color to make it easier to see when handling. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm.
Serafilcon 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:
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Image /page/5/Picture/0 description: The image shows the word "Alcon" in blue font. The font is sans-serif and appears to be bolded. The word is centered in the image and takes up most of the space. The background is white.
| 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 |
Serafilcon A lens designs include spherical, toric, multifocal toric lenses in the following parameter ranges:
- Diameter Range: ● 13.0 to 15.0 mm
- Base Curve Range: 8.0 to 9.2 mm ●
- -20.00 D to +20.00 D ● Power Range:
- Center Thickness: varies with design and power
- (Example: 0.08 mm for -3.00 D spherical)
- Cylinder Power (toric) Range: -0.25 D to -10.00 D ●
- Cylinder Axis (toric) Range: 001 to 180° ●
- ADD Power (multifocal) Range: LO, MED, HI .
Lenses have the following properties:
- Refractive index: 1.40 (hydrated) ●
- Water content : 55% by weight in normal saline
- Oxygen permeability: 119 x 10 -11 .
[(cm2 /sec)(ml O2 /mlommHg)] 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 316 to 380 nm for the entire power range.
Serafilcon 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
6
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 variable information such as 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).
V. Indications for Use
Alcon™ (serafilcon 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.
Alcon™ for Astigmatism (serafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) or less of astigmatism.
Alcon™ Multifocal (serafilcon 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 have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Alcon™ Multifocal Toric (serafilcon 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 disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each week, or more often, if recommended by the eye care professional.
7
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 | Alcon |
| Submission
Number | 510(k) K052560 | 510(k) K212806 |
| 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 | One month | One week |
| Material
Classification
ISO 18369-1:2017 | Group 5C, low water silicone
hydrogel | Group 5B, high water silicone
hydrogel |
| Lens Material | Comfilcon A | Serafilcon A |
| Visibility Tint | Light blue | Light blue-green |
| UV/UV vis
absorbing
monomers | No | Yes* |
| Manufacturing
Method | Cast molded | Cast molded
(DSMFLEX) |
| Lens Designs | Spherical, asphere, toric,
multifocal, multifocal toric | Spherical, toric, multifocal,
multifocal toric |
Table 1. Substantial Equivalence Comparison
8
| Table 1. Substantial Equivalence Comparison | ||||
|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------- | -- |
| | Predicate Device
(Coopervision) | Subject Device
(Alcon) |
|------------------------------------|---------------------------------------------|---------------------------------------------------|
| Power Range | +20.00 to -20.00 D | Same |
| Base Curve Range | 8.0 to 9.5 mm | 8.0 to 9.2 mm |
| Diameter Range | 13.5 to 15.0 mm | 13.0 to 15.0 mm |
| Cylinder Power
(toric): | -0.25 to -10.00 D | Same |
| ADD Power
(multifocal) | +0.50 to +3.00 D | LO, MED, HI |
| Water Content | 48% | 55% |
| Refractive Index | 1.4 | Same |
| Oxygen
Permeability | 128**
(Coulometric method) | 119
(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; K210436) **units 10 -11 (cm2/sec)(ml O2 /ml x mm Hg)
Serafilcon 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 (serafilcon 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.
9
VII. Performance Data
A series of nonclinical tests and a clinical study were performed to demonstrate the substantial equivalence of serafilcon 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/toxicity, sensitization, systemic and genotoxicity testing, confirm that serafilcon 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 10993-10 (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 serafilcon A lenses are the same as those used for other Alcon contact lenses with FDA 510(k) clearance (K113168, K180398, K180669, K210436), 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 ISO 10993 series of biocompatibility standards.
Physical-Chemical Testing
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The following nonclinical bench testing, conducted using GxP conditions, and, where applicable ISO 18369-2. -3. -4 standards, established the physicochemical properties of serafilcon A contact lenses:
- Refractive Index
- · Oxygen Permeability
- · Ion Permeability
- . Transmittance Properties
- Percent Water Content ●
- Residuals and Extractables
- Mechanical Properties
- Wetting Contact Angle
- Lens Parameters ●
- Package Saline Properties (pH and osmolality) ●
Solution Compatibility Testing
Serafilcon A contact lenses are for daily wear use with daily removal for cleaning and disinfection and one-week replacement. Therefore, the compatibility of serafilcon A contact lenses with commonly available cleaning and disinfection solutions (3% hydrogen peroxide and MPDS), and preserved or unpreserved commercial contact lens saline and rewetting drops, was confirmed following the methodology described in ISO 11981, Ophthalmic optics - Contact lenses and contact lens care products – Determination of physical compatibility of contact lens care products with contact lenses.
Serafilcon 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, Ophthalmic optics -Contact lenses and contact lens care products – Determination of preservative uptake and release. Uptake and release profiles of serafilcon A contact lenses for Polyquad (PQ), Aldox, Polyhexamethylene biguanide (PHMB) and Alexidine were comparable to the control lenses tested.
Sterilization and Stability Testing
Serafilcon A contact lenses in 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) daily wear contact lens guidance document for a new contact lens material and ISO 11980, Ophthalmic optics-Contact lenses and contact lens care products – Guidance for clinical investigations, assessed the safety and performance of serafilcon 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 one hundred and twenty (120) subjects in this prospective, randomized, stratified (by corneal curvature radius), controlled, double-masked, parallel group study. One subject was a screen failure. Of the 120 subjects (240 eyes) enrolled into the study, 119 subjects were randomized, exposed to the study lenses and 110 subjects completed the study. The study evaluated 78 serafilcon A (test) subjects and 41 comfilcon A (control) subjects. Contact lenses were worn bilaterally in a daily wear modality for approximately 3 months each. The test lenses were replaced weekly and the control lenses were replaced monthly. The primary effectiveness endpoint was study lens visual acuity at distance. The demographic characteristics for all enrolled subjects were similar between the serafilcon A groups. The majority of the subjects in both groups were female (76.5%), predominantly White, and most were not of Hispanic or Latino ethnicity. The overall mean age of the subjects was 32.4 years.
Additional assessments and endpoints included 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 and control 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
Serafilcon 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 demonstrate 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 (serafilcon 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.