(58 days)
Not Found
No
The summary describes contact lenses and their physical properties and performance testing, with no mention of AI or ML.
Yes.
The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia, which are conditions that impair vision and therefore benefit from treatment with these lenses.
No
Explanation: The device, DAILIES TOTAL 1 soft contact lenses, is indicated for the optical correction of refractive ametropia and presbyopia. It acts as a refracting medium to focus light rays on the retina. It does not diagnose any condition; instead, it corrects vision.
No
The device is a physical contact lens made of silicone hydrogel, not software. The description details material properties, dimensions, and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these contact lenses are for the "optical correction of refractive ametropia (myopia and hyperopia)" and "optical correction of presbyopia". This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the lens and how it functions as a "refracting medium to focus light rays on the retina." This aligns with a corrective device.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a person's health status based on in vitro testing.
- Performance Studies: The performance studies focus on material properties, dimensional and optical properties, biocompatibility, and shelf-life stability, which are relevant to the safety and effectiveness of a corrective contact lens. There are no studies related to diagnostic accuracy or performance.
In vitro diagnostics are devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. Contact lenses, as described here, are placed on the eye to correct vision, which is a different category of medical device.
N/A
Intended Use / Indications for Use
DAILIES TOTAL 1® (delefilcon A) 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® Toric (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.
DAILIES TOTAL 1® 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 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.
The 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
DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs. The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina. It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when handling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Performance testing for the modified DAILIES TOTAL 1 % (delefilcon A) soft contact lenses followed the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lench testing was conducted using GxP conditions, and, where applicable ISO 18369-2, -3, -4 standards. Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device. Results of an ongoing shelf-life stability study demonstrate that packaged lenses remain sterile and stable for the labeled expiration date.
Nonclinical biocompatibility testing was conducted in accordance with the GLP requlation (21 CFR Part 58) and relevant parts of the ISO 10993 series. Specifically, the following testing was completed, all with passing results:
- Cytotoxicity Studies (lens, lens extracts, and package saline) per ISO 10993-5
- Ocular Irritation / Toxicity (Ocular) in Rabbits
- Ocular biocompatibility of soft contact lenses, 22-day Evaluation per ISO 9394
- Ocular biocompatibility of package saline, 22-Day Evaluation per ISO 9394
- Primary ocular irritation studies per ISO 19993-10 (lens extracts and package saline)
- Sensitization Studies (lens extracts and package saline) per ISO 10993-10
- Acute Systemic Toxicity Study in Mice (lens extracts) per ISO 10993-11
- Genotoxicity Studies (lens extracts and package saline) per ISO 10993-12
Additional biocompatibility testing was conducted to support minor changes of the primary packaging foil lidding material. Biocompatibility testing for the blister shells was previously submitted for the predicate device.
- Cytotoxicity Studies (foil lidding, foil lidding extracts) per ISO 10993-5
- Ocular Irritation / Toxicity (Ocular) in Rabbits
- Primary ocular irritation studies per ISO 19993-10 (foil lidding extracts)
The scope of the device modification did not require clinical testing to establish safety and effectiveness of the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process is supported by nonclinical testing.
Non-clinical data demonstrates that the subject device is as effective, and performs as well as or better than the legally marketed, predicate device. Modified DALIES TOTAL1® (delefilcon A) soft contact lenses are substantially equivalent to the predicate device lenses, and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use.
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.
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.
November 16, 2023
Alcon Laboratories, Inc. Martina Heim Director. Global Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099
Re: K232921
Trade/Device Name: DAILIES TOTAL1®; DAILIES TOTAL1® Toric; 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: September 19, 2023 Received: September 19, 2023
Dear Martina Heim:
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.
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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
DAILIES TOTAL 18: DAILIES TOTAL 1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL 1® Multifocal Toric
Indications for Use (Describe)
DAILIES TOTAL 1® (delefilcon A) 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® Toric (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.
DAILIES TOTAL 1® 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 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.
The 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)
Dver-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Sumn
Prepared on: 2023-11-08
| 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 | (678) 415-3565 | |
| Applicant Contact | Dr. Martina Heim | |
| Applicant Contact Email | martina.heim@alcon.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | DAILIES TOTAL1®; | |
| DAILIES TOTAL1® Toric; | ||
| DAILIES TOTAL1® Multifocal; | ||
| DAILIES TOTAL 1® Multifocal Toric | ||
| Common Name | Soft (hydrophilic) contact lens | |
| Classification Name | Lenses, Soft Contact, Daily Wear | |
| Regulation Number | 886.5925 | |
| Product Code | LPL |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K113168 | DAILIES TOTAL1; DALIES TOTAL1 FOR ASTIGMATISM; DAILIJ | LPL |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs. | |
| The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. |
handling. When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when
Intended Use/Indications for Use
DAILIES TOTAL 1® (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to aproximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1® Toric (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.
DALIES TOTAL 1® 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 approximately 1.50 diopters (D) of astigmatism that does not interfere with visual
21 CFR 807.92(a)(5)
5
acuity.
DALIES TOTAL 1º 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 persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be 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
The indications for use of the subject device remain the same as for the predicate device.
Technological Comparison
The predicate and subject DAILIES TOTAL 1® (delefilcon A) soft contact lenses have the same lens material properties:
- Refractive Index (hydrated): 1.42
- · Light Transmittance: ≥ 93% (@ 610 nm, -1.00 D)
- Oxygen Permeability: 140 barrer
• Water Content: 33% by weight in normal saline
The modified lenses are tinted using Reactive Blue 247.
The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range:
- Diameter: 13.0 to 15.0 mm
- Base Curve: 8.0 to 9.2 mm
- Power Range: +20.0 D to -20.0 D
- · Center Thickness: 0.070 mm to 0.340 mm (varies with power)
- Cylinder Power: Up to 5.00 D
- · Cylinder Axis: 1° to 180°
- · ADD power: Up to 5.00 D
Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing for the modified DAILIES TOTAL 1 % (delefilcon A) soft contact lenses followed the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lench testing was conducted using GxP conditions, and, where applicable ISO 18369-2, -3, -4 standards. Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device. Results of an ongoing shelf-life stability study demonstrate that packaged lenses remain sterile and stable for the labeled expiration date.
Nonclinical biocompatibility testing was conducted in accordance with the GLP requlation (21 CFR Part 58) and relevant parts of the ISO 10993 series. Specifically, the following testing was completed, all with passing results:
- · Cytotoxicity Studies (lens, lens extracts, and package saline) per ISO 10993-5
- Ocular Irritation / Toxicity (Ocular) in Rabbits
- Ocular biocompatibility of soft contact lenses, 22-day Evaluation per ISO 9394
- Ocular biocompatibility of package saline, 22-Day Evaluation per ISO 9394
- Primary ocular irritation studies per ISO 19993-10 (lens extracts and package saline)
- Sensitization Studies (lens extracts and package saline) per ISO 10993-10
- Acute Systemic Toxicity Study in Mice (lens extracts) per ISO 10993-11
- · Genotoxicity Studies (lens extracts and package saline) per ISO 10993-12
Additional biocompatibility testing was conducted to support minor changes of the primary packaging foil lidding material. Biocompatibility testing for the blister shells was previously submitted for the predicate device.
- · Cytotoxicity Studies (foil lidding, foil lidding extracts) per ISO 10993-5
- Ocular Irritation / Toxicity (Ocular) in Rabbits
- Primary ocular irritation studies per ISO 19993-10 (foil lidding extracts)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
The scope of the device modification did not require clinical testing to establish safety and effectiveness of the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process is supported by nonclinical testing.
Non-clinical data demonstrates that the subject device is as effective, and performs as well as or better than the legally marketed, predicate device. Modified DALIES TOTAL1® (delefilcon A) soft contact lenses are substantially equivalent to the predicate device lenses, and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use.