(205 days)
No
The document describes a standard contact lens with UV blocking, made from a specific polymer. There is no mention of any computational or analytical functions that would typically involve AI/ML. The performance studies are clinical trials evaluating the physical and optical properties of the lens, not the performance of an algorithm.
No
The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia), which is a corrective function, not a therapeutic one.
No.
This device is a contact lens intended for optical correction of refractive ametropia, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of a hydrophilic polymer, not software.
Based on the provided information, 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 Function: The Deseyne contact lens is a medical device worn on the eye for the optical correction of refractive errors (myopia and hyperopia). It physically interacts with the eye to improve vision.
- Lack of Sample Testing: The description does not mention the device being used to test any biological samples. Its function is purely optical correction.
Therefore, the Deseyne contact lens falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 1.00D or less of astigmatism.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or a.phakic persons with non- diseased eyes that may have 4.00D or less of astigmatism.
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking are manufactured in spherical or toric configurations. The lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2v1)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocvanine) to make the lens more visible for handling.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 3-month multi-arm (2). randomized, un-masked, active control study was conducted on the test material, the Deseyne (vifilcon C) daily disposable soft (hydrophilic) contact lens in comparison to a daily disposable control soft (hydrophilic) contact lens. The study was conducted at five (5) clinical sites, all in the United States.
The objective of this clinical study was to provide clinical performance data comparing the test lens (Deseyne [vifilcon C] daily disposable soft contact lens) to a control lens (1-Day Acuvue® Moist® [etafilcon A] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens wear exposure).
Study participation was 90 days in duration and consisted of 81 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects selected were healthy male or female between the ages of 18-40, and exhibited myopia between -1.00 diopter (D) and -6.00 D and astigmatism no greater than 1.00 D that did not interfere with visual acuity (VA).
There were 2 primary effectiveness endpoints for the study:
-
- Change from baseline to each post-baseline visit in distance logMAR VA by eve.
-
- Number and percentage of subjects, where there was no more than a -5logMAR letters read loss from baseline (change from baseline in number of letters read ≥ -5logMAR).
The Primary Effectiveness Endpoints were met in accordance with the parameters outlined in the protocol.
Secondary effectiveness endpoints were symptoms/complaints and subjective assessments; lens wettability, centration, and movement; and lens deposits and a visual function satisfaction survey.
Primary safety evaluation was addressed by the proportion of eves with any slit lamp findings. Secondary safety endpoints included adverse reactions (serious and incidental) and adverse device effects, including conjunctival hyperemia, keratometry, slit lamp biomicroscopy, lens discontinuation rates at any follow-up visit, and use of unpreserved lubricant eyedrops or artificial tears during the study.
At no time during the study was there any loss of vision of 2 or more lines of vision. There were three adverse reactions attributed to the use of the control lenses, none to the test lens, All subjects completed the study with VA within one line of initial visual acuity.
There were a total of 3 discontinuations out of 81 subjects who were enrolled in the protocol. 78 subjects completed the clinical trial. Of the 3 discontinuations during tthe study one subject preferred habitual lenses, one-subject for poor lens movement and centration at the fitting visit, and one subject for voluntary withdrawal at the screening visit. Each of these discontinuations were from the Control Group. There were no discontinuations associated with findings related to safety or for visual acuity.
There were 4 reports of excessive use of lens lubrication that were attributed to prior sensitivities or dry eve: all with the test lens, none with the control lens. Nevertheless, there were no associated findings with slit lamp biomicrosopy, or notations of red-eve. Low levels of hyperemia resolved and all subjects with these findings completed the protocol successfully.
The Primary Safety Endpoints were met in accordance with the definitions of the protocol.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that 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.
October 25, 2024
Bruno Vision Care, LLC % Christina Kuhn Special Counsel Covington & Burling LLP 850 10th St NW Washington, DC 20001
Re: K240918
Trade/Device Name: Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 24, 2024 Received: September 25, 2024
Dear Christina Kuhn:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/postmarketingsafety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
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
3
Indications for Use
Submission Number (if known)
K240918
Device Name
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia:
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism
Indications for Use (Describe)
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 1.00D or less of astigmatism.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 4.00D or less of astigmatism
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
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
| 510(k) Number: | K240918 |
|---|---|
| Date Prepared: | October 21, 2024 |
| Submitter: | Bruno Vision Care, LLC |
| 2255 Glades Road. Suite 324A | |
| Boca Raton, FL 33431 | |
| (646) 239-2024 | |
| Contact Person | Mr. Eddie Catalfamo, CEO |
| e.catalfamo@brunovisioncare.com | |
| Correspondent: | Christina Kuhn |
| Covington and Burling | |
| 850 10th St. NW | |
| Washington, DC 20001 | |
| (202) 662-5653 | |
| ckuhn@cov.com | |
| Device: | |
| Trade/Proprietary Name: | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact |
| Lens with UV Blocking for Myopia and Hyperopia; | |
| Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact | |
| Lens with UV Blocking for Astigmatism | |
| Common Name: | |
| Classification Name: | |
| Device Classification: | |
| Regulatory Class: | |
| Product Code: | |
| Panel: | Soft, daily wear contact lens |
| Soft (Hydrophilic) Contact Lens | |
| 21 CFR 886.5925 | |
| Class II | |
| LPL, MVN | |
| Ophthalmic | |
| Predicate Device: | K051900 Vistakon (etafilcon A) soft (Hydrophilic) Contact Lens |
| Clear and Tinted | |
| Product Code: LPL | |
| Reference Device: | K090806 Safi-Gel (methafilcon A) Daily Disposable Soft |
| (Hydrophilic) Contact Lens | |
| Product Code: LPL |
Description of Device:
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking are manufactured in spherical or toric configurations. The lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using
5
azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2v1)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocvanine) to make the lens more visible for handling.
Indications for Use:
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes that may have 1.00D or less of astigmatism.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or a.phakic persons with non- diseased eyes that may have 4.00D or less of astigmatism.
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
Material Properties:
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking for Myopia and Hyperopia has the following optical characteristics:
| Powers: | From -20.00D to +20.00D |
|---|---|
| Cylinder: | none |
| Axis: | none |
| Base Curve: | 8.60 |
| Diameter: | 14.10 |
| Center Thickness: | 0.05 |
| Optic Zone: | 10.00 |
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking for Astigmatism has the following optical characteristics:
| Powers: | From -20.00D to +20.00D |
|---|---|
| Cylinder: | From -1.00D to -3.50D |
| Axis: | From 5° to 180° with 5° step |
| Base Curve: | 8.50 |
| Diameter: | 14.40 |
| Center Thickness: | 0.08 |
| Optic Zone: | 8.00 |
The tolerances for the above optical characteristics are as follows:
| Powers: | 0.00 D ~ ± 10 D, ± 0.25 D |
|---|---|
| ± 10.12 D ~ ± 20 D, ± 0.50 D | |
| Base Curve: | ± 0.20 mm Diameter: ± 0.20 mm |
6
| Center Thickness: | $\pm$ 0.010 mm + 10% |
|---|---|
| Surface Appearance: | No Surface Defect, No Edge Defect, No Bubble |
The physical properties of the lenses are:
| Refractive Index: | 1.403 |
|---|---|
| Light Transmittance: | >90% |
| UV Transmittance: | τUVB 50% water |
50% water | Group IV
50% water |
| Indication | Daily Disposable | Daily Wear | Daily Disposable |
| Surface
Character | lonic | lonic | lonic |
| USAN Name | vifilcon C | etafilcon A | methafilcon A |
| Water Content | 60% | 58% | 55% |
| Refractive Index | 1.403 | 1.40 | 1.41 |
| Oxygen
Permeability | 27.5 X 10-11
Dk-Fatt Method (cm2/
sec)*
(ml O2/ mlmmHg) | 28.0 x
10-11
Dk-Fatt Method
(cm2/sec) (ml O2/
ml*mmHg) | 18.9 X 10-11
Coulometric@35
degree C |
| Wetting Agent | Hyaluronic Acid (HA)
and TSP co- polymer | | Hyaluronic Acid (HA) |
7
| Characteristics | Subject Device:
Deseyne (vifilcon C)
Soft (hydrophilic)
Contact Lens | Predicate Device:
Vistakon (etafilcon A)
Soft (hydrophilic)
Contact Lens (clear
and tinted (visibility
tint) with UV Blocker
for Daily Wear | Reference Device:
Safi-gel Daily
Disposable
(methafilcon A) Soft
(hydrophilic) Contact
Lens |
|----------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Light
Transmittance | >90% | Minimum
85% | 90.3% |
| Base Curve | 8.5mm | 7.85mm to 10.0mm | 8.40mm-9.3mm |
| Diameter | 14.10mm to 14.4mm | 12.0mm to 15.0mm | 14.0mm to 15.0mm |
| Center Thickness | 0.05mm to
0.08mm | 0.06mm to
1.00mm | 0.06mm to
0.40mm |
| Powers | -20.00D to
+20.00D | -20.00D to
+20.00D | -20.00D to
+12.00D |
| UV
Transmittance | UVB: