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.

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 non-diseased eyes and 6.00 diopters (D) or less of astigmatism.

The 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.

Device Description

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design.
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 persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism.
Precision 1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister 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 packaged into carton boxes available in different pack sizes.

AI/ML Overview

This document describes the 510(k) premarket notification for the Precision1 and Precision1 for Astigmatism soft contact lenses. The submission is for a modification to an already legally marketed predicate device (Precision1 for Astigmatism, K182902). The modification involves adding foil from an alternate supplier for primary packaging and extending the product expiration dating from 72 to 84 months.

The document states that the scope of the device modification did not require clinical testing to establish safety and effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (such as sample sizes, ground truth establishment, expert adjudication, or MRMC studies) is not present in this document. The device stability and process validation were completed to verify equivalence to the predicate device.

Here's the information that could be extracted from the document regarding acceptance criteria and the study, as much as applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device: Successful stability testing (to ensure product integrity over extended shelf life)	All acceptance criteria being met.
Equivalence to Predicate Device: Process validation (to ensure manufacturing consistency and sterilization efficacy)	All acceptance criteria being met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as part of a clinical study. The document refers to "stability testing" and "process validation," which are typically laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document states that clinical testing was not required for this submission. The "ground truth" for the non-clinical tests would be defined by pre-established scientific and engineering standards for stability and process validation, not by human expert consensus or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there was no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This submission is for a material and shelf-life extension change to an existing contact lens, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as this device is a contact lens, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical "stability testing" and "process validation," the ground truth would be established by scientific and engineering specifications and standards for contact lens materials, sterility, and performance over time. This is not medical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as there was no training set for an algorithm or AI.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set for an algorithm or AI.

Summary

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April 20, 2023

Alcon Laboratories, Inc. Dr. Andreas Friese Regulatory Project Director Industriering 1 Grosswallstadt, Bayern 63868 Germany

Re: K230785

Trade/Device Name: Precision1. Precision1 for Astigmatism Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 20, 2023 Received: March 22, 2023

Dear Dr. Andreas 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 (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.

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

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(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 (OS) 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 entitled, "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 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. 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

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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

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Indications for Use

Submission Number (if known)

K230785

Device Name

Precision1

Precision1 for Astigmatism

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.

The 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.

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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K230785			Prepared on: 2023-04-17
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	+18176155472
Applicant Contact	Mrs. Sherri Lakota
Applicant Contact Email	sherri.lakota@alcon.com
Correspondent Name	Alcon / CIBA Vision GmbH
Correspondent Address	Industriering 1 Grosswallstadt BY 63868 Germany
Correspondent Contact Telephone	+496022240514
Correspondent Contact	Dr. Andreas Friese
Correspondent Contact Email	andreas.friese@alcon.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Precision1, Precision1 for Astigmatism
Common Name	Soft (hydrophilic) contact lens
Classification Name	Soft (hydrophilic) contact lens
Regulation Number	886.5925
Product Code	LPL, MVN
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K182902	Precision1	LPL
Device Description Summary			21 CFR 807.92(a)(4)
Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design.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 persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism.

Precision 1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister 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

{4}------------------------------------------------

aluminum foil lidding. The blister packaged into carton boxes available in different pack sizes.

Intended Use/Indications for Use

The 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.

Indications for Use Comparison

The indications for use of the modified device remain the same as for the predicate device.

Technological Comparison

The 510(k) devices are a modification of the same predicate devices, i.e. Precision1 for Astigmatism (verofilcon A) soft contact lenses, which are legally commercialized devices in the US under 510(k) K182902.

The proposed device modification involves adding foil from alternate supplier for primary packaging of Precision 1 (verofilcon A) soft contact lens products and extending the product expiration dating from 72 to 84 months.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Successful stability testing as well as process validation were completed device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met.

The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 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.