(57 days)
Not Found
No
The summary describes a contact lens and its material properties, intended use, and performance testing. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is indicated for correcting ametropia (myopia and hyperopia) and astigmatism, which are refractive errors, not diseases or conditions that require therapeutic intervention.
No
The device is a contact lens designed for the correction of ametropia and astigmatism, which are refractive errors, not for diagnosing medical conditions. Its function is to provide vision correction, not to identify or detect diseases.
No
The device description clearly states it is a physical contact lens made from silicone hydrogel material, 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 the device is a contact lens for the correction of ametropia (myopia, hyperopia, astigmatism, presbyopia). This is a therapeutic and vision correction purpose, not a diagnostic one.
- Device Description: The description details the material and physical properties of a contact lens. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "specimen."
- Anatomical Site: The anatomical site is the cornea, which is where a contact lens sits for vision correction. IVDs typically interact with biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the safety and physical properties of the contact lens (toxicology, shelf life, material properties). They do not involve evaluating the device's ability to diagnose a condition.
In summary, the Lucens 41 contact lens is a medical device intended for vision correction, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and nonaphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal design is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal-toric design is indicated for daily wear for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.
Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement, or for singleuse disposable wear.
When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Product codes
LPL, MVN
Device Description
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is for daily wear and is fully molded in the sphere, toric, multifocal-toric design configurations. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from senofilcon C, which contains silicone hydrogel material and other hydrophilic monomers. The lens consists of 59.0% senofilcon C and 41.0% water by weight when immersed in saline solution. The senofilcon C name has been adopted by the United States Adopted Names Council (USAN).
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens contains Reactive Blue 246 (21 CFR Part 73.3106) for visibility and handling. The Lucens 41 (senofileon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315nm - 380mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea / eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens. The results support the claim that the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is substantially equivalent to the currently marketed predicate devices.
Toxicology:
- In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the packaging solution, and extracts from the finished lenses and packaging materials are not cytotoxic.
- Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and do not produce acute systemic toxicity.
- Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23. The packaging solution and extracts from finished lenses and packaging materials produced no ocular irritation.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.
Performance Testing - Bench:
The following bench tests were completed: refractive index, water content. Dk. % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens and the predicate device.
Clinical Testing:
Clinical performance testing for the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is not required for this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
October 8, 2024
Lucens Technology Co., Ltd C/o Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068
Re: K242391
Trade/Device Name: Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 8, 2024 Received: August 12, 2024
Dear Bret Andre:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (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/cdrb/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 titled "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.
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
510(k) Number (if known) K242391
Device Name
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere:
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
Toric:
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and nonaphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal design is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
Multifocal-Toric:
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal-toric design is indicated for daily wear for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.
Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement, or for singleuse disposable wear.
When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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5
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K242391
I. SUBMITTER
- September 9, 2024 Date Prepared:
| Name: | LUCENS TECHNOLOGY Co., Ltd |
|---|---|
| Address: | 8F.-1, No. 31, Xintai Rd., |
| Zhubei City, Hsinchu County, | |
| Taiwan (R.O.C.). |
| Contact Person: | Kari Huang |
|---|---|
| Section Manager | |
| Phone number: | +886-3-450-1986 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens |
|---|---|
| Common | |
| Name: | Contact Lens, Daily Wear |
| Classification | |
| Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory | |
| Class: | Class II |
| Product Codes: | LPL; MVN |
Purpose of 510(k) Submission: ~ New Device ~
6
III. PREDICATE DEVICE
The Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the following predicate device:
- I "ACUVUE (senofilcon C) Soft Contact Lens" By Johnson & Johnson Vision Care, Inc. 510(k) number; K160212 Primary Predicate
IV. DEVICE DESCRIPTION
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is for daily wear and is fully molded in the sphere, toric, multifocal-toric design configurations. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from senofilcon C, which contains silicone hydrogel material and other hydrophilic monomers. The lens consists of 59.0% senofilcon C and 41.0% water by weight when immersed in saline solution. The senofilcon C name has been adopted by the United States Adopted Names Council (USAN).
The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens contains Reactive Blue 246 (21 CFR Part 73.3106) for visibility and handling. The Lucens 41 (senofileon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315nm - 380mm). The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.050 mm to 0.580 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 8.0 mm to 9.8 mm | ±0.20 mm |
| Back Vertex Power (F'v) | -20.00 D to +20.00 D | |
| (in 0.25 D steps) | When 0.00 1.50 D→± 5° | |
| Multifocal Power | +0.25 D to +4.00 D | |
| (in 0.25 D steps) | ±0.25D | |
| Oxygen Permeability | ||
| ( x 10-11 (cm2•ml | ||
| O2)/(sec•ml•mmHg)) | 103 | ±20% |
| Visible Light Transmittance | >89% | ±5% |
| Ultraviolet radiation Transmittance |