(25 days)
K233856 (P1)
No
The document describes soft contact lenses and their manufacturing process, with no mention of AI or ML technology.
No
The devices are indicated for optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which is a vision correction, not a therapeutic treatment.
No.
The device (contact lens) is intended for optical correction of refractive ametropia, not for diagnosing a condition.
No
The device description clearly states that the devices are "soft contact lenses," which are physical hardware components. The summary describes their material, packaging, and sterilization, all related to a physical product, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that these are soft contact lenses intended for "on-eye use" for "optical correction of refractive ametropia." They are physical devices worn on the eye to improve vision.
- Lack of Biological Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device's function is purely optical correction.
Therefore, these contact lenses fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision1 for Astigmatism (verofilcon 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 and 6.00 diopters (D) or less of astigmatism.
Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Dailies Total1 (delefilcon 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.
Dailies Total1 Multifocal (delefilcon 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 (D) of astigmatism that does not interfere with visual acuity.
Dailies Total1 for Astigmatism (delefilcon 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 6.00 diopters (D) of astigmatism.
Dailies Total 1 Multifocal Toric (delefilcon 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.
Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes
LPL, MVN
Device Description
Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only.
Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.
Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design.
Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.
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
Eye care professional / 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 bench testing of the devices manufactured via the proposed modified extraction and coating processes for lens optical, dimensional and surface properties as well as extractables and residuals demonstrated that the lenses meet established finished product specifications and are therefore substantially equivalent to the predicate devices, i.e. Precision 1 and DAILIES Total1 contactured via the current established manufacturing processes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K233856 (P1)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.
January 13, 2025
Alcon Laboratories, Inc. Dr. Andreas Friese Regulatory Project Director 6201 South Freeway Fort Worth, TX 76134-2099
Re: K243909
Trade/Device Name: Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 18, 2024 Received: December 19, 2024
Dear Dr. Friese:
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 CFR 830.300(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 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Precision1: Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
Indications for Use (Describe)
Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision1 for Astigmatism (verofilcon 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 and 6.00 diopters (D) or less of astigmatism.
Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Dailies Total1 (delefilcon 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.
Dailies Total1 Multifocal (delefilcon 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 (D) of astigmatism that does not interfere with visual acuity.
Dailies Total1 for Astigmatism (delefilcon A) 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.
Dailies Total 1 Multifocal Toric (delefilcon 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.
Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
4
| 510(k) #: | K243909 | 510(k) Summary | Prepared on: 2024-12-18 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Alcon Laboratories, Inc. | |
| Applicant Address | 6201 South Freeway Fort Worth TX 76134-2099 United States | |
| Applicant Contact Telephone | +496022240514 | |
| Applicant Contact | Dr. Andreas Friese | |
| Applicant Contact Email | andreas.friese@alcon.com |
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | Precision1; | |
| Precision1 for Astigmatism; | ||
| Dailies Total1; | ||
| Dailies Total1 for Astigmatism; | ||
| Dailies Total1 Multifocal; | ||
| Dailies Total1 Multifocal Toric | ||
| Common Name | Soft (hydrophilic) contact lens | |
| Classification Name | ailies Total1: LPL (Class 2) - Lenses, Soft Contact, Daily Wear; MVN | |
| (class2) lens, contact, (disposable) | ||
| Regulation Number | 886.5925 | |
| Product Code(s) | Precision1 and Dailies Total1: LPL (Class 2) - Lenses, Soft Contact, Daily |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| ------------------------------------ | -- | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K233856 (P1) and | Precision1 / Dailies Total1 | LPL; MVN |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only.
Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.
Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design.
Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
5
Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision 1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Precision 1 lenses are to be prescribed for single use, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Dailies Total (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Dailes Total Multifocal (delefilcon 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 aproximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Dailies Total 1 for Astigmatism (delefilcon 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 6.00 diopters (D) of astigmatism.
Dailies Total 1 Multifocal Toric (delefilcon 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.
Dailies Total 1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Indications for Use Comparison
There are no device modifications related to the proposed change is a manufacturing change for modification of extraction and coating processes within the manufacturing processes of Precision 1 and Dailies Total 1 contact lenses.
Technological Comparison
21 CFR 807.92(a)(6)
The 510(k) devices are modifications of the same predicate devices, i.e. Precision A) family soft contact lenses, which are legally commercialized devices in the US under 510(k) K233856, and Dailes Total 1 (delefilcon A) family soft contact lenses, which are legally commercialized devices in the US under 510(k) K232921.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
There are no device modifications related to the proposed change is a manufacturing change for modification of extraction and coating processes within the manufacturing processes of Precision1 and Dailes Total1 contact lenses. Therefore, the change did not require clinical testing to establish safety and effectiveness of the modified devices. Non-clinical bench testing of the devices manufactured via the proposed modified extraction and coating processes for lens optical, dimensional and surface properties as well as extractables and residuals demonstrated that the lenses meet established finished product specifications and are therefore substantially equivalent to the predicate devices, i.e. Precision 1 and DAILIES Total1 contactured via the current established manufacturing processes.