(133 days)
PMA P940013, PMA P790020
No
The 510(k) summary describes a standard contact lens and does not mention any AI or ML components or functionalities.
No.
This device is intended to correct visual acuity, which is a functional correction rather than a therapeutic treatment for a disease or condition. While it protects against harmful UV radiation, its primary indication is vision correction.
No
Explanation: The device is a contact lens indicated for correcting visual acuity, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a physical contact lens made of a specific material (vasurfilcon A), 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 correction of visual acuity in living persons by being placed on the eye. This is a direct interaction with the patient's body for a therapeutic purpose (correcting vision).
- IVD Definition: IVDs are devices intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a contact lens, which is a medical device placed on the surface of the eye.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, the Precision UV™ (vasurfilcon A) Hydrophilic Contact Lens is a medical device, but it falls under the category of devices used in vivo (within the body) for therapeutic purposes, not in vitro for diagnostic purposes.
N/A
Intended Use / Indications for Use
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, comea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
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)
Wesley Jessen considers the study, data and referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6, evidence supporting the additional intended use and associated modified labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
PMA P940013, PMA P790020
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
6 1999 JAN
Attachment C
Summary of Safety and Effectiveness
A. General Information
- Name and Address of Applicant: 1.
Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018
Contact Person:
Joseph Foos Vice President Scientific Affairs (847) 294-3306 Phone: (847) 294-3853 Fax
-
- Name of the Device:
Proprietarv Name:
- Name of the Device:
Precision UVTM (vasurfilcon A)
-
- Identification of Predicate Device: Same as above
B. Indication for use:
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.
C. Description of device:
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.
1
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are currently marketed domestically and internationally by Wesley Jessen Corporation under PMA P940013. Previously, they were marketed by Pilkington Barnes Hind under Allergan Medical Optic's PMA P790020.
D. Substantial Equivalence/Safety & Effectiveness:
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material as under 510(k) premarket notification, K961299, and PMA P940013 for all properties (physical, optical, chemical, biocompatible, microbiological, and clinical). There were no changes to the lens material or design; however, the associated labeling and indications were changed.
E. Summary:
Wesley Jessen considers the study, data and referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6, evidence supporting the additional intended use and associated modified labeling.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 6 1999
Mr. Joseph Foos Vice President, Scientific Affairs Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018-5903
K982988 Re:
Trade Name: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted) (Labeling modifications) Regulatory Class: II Product Code: LPL Dated: November 20, 1998 Received: November 23, 1998
Dear Mr. Foos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
3
Page 2 - Mr. Joseph Foos
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment B
INDICATIONS STATEMENT
510(k) Number (if known): K982988
Device Name:
Precision UVTM clear and tinted (74% water) Daily Wear Soft Contact Lans
Indication for Use:
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eves that are myopic or hyperopic and may have 2,00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lanses help protect against transmission of harmful UV radiation to the comea and into the eve.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Conterence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The Counter
Kaver Warburton
(Division Sign-Off)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982988
000052