(29 days)
Not Found
No
The document describes a contact lens and its intended use, manufacturing, and testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for the optical correction of refractive ametropia; it is not described as treating or curing an underlying condition.
No
Explanation: The device is a soft contact lens intended for optical correction of refractive ametropia (myopia and hyperopia), which is a treatment for a condition rather than a diagnostic tool.
No
The device description explicitly states that the device is a physical contact lens made of verofilcon A, supplied sterile in blister packs. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "optical correction of refractive ametropia (myopia and hyperopia)". This describes a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details a physical device (contact lenses) used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions.
Contact lenses are considered medical devices, but they fall under a different regulatory category than IVDs.
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.
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.
Product codes
LPL, MVN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-diseased eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribed by the eye care professional
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)
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.
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
(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
Image /page/1/Picture/6 description: The image shows the letters 'FDA' in a large, light blue font. The letters are partially transparent, and they appear to be overlaid on a white background. To the left of the letters, there is some text that is partially visible.
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
2
Indications for Use
Submission Number (if known)
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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3
| K230785 | 510(k) Summary | 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
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.
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)(5)
21 CFR 807.92(a)(6)