(507 days)
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Not Found
No
The summary describes standard contact lenses and does not mention any AI or ML components or functionalities.
No.
The device is a contact lens intended to correct vision (myopia, hyperopia, astigmatism) in non-diseased eyes, which is a refractive correction and not a therapeutic function.
No
The device description indicates that these are contact lenses for vision correction, not for identifying or diagnosing conditions.
No
The device description clearly states "Contact Lenses," which are physical hardware devices. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these are contact lenses worn on the eyes for vision correction. They do not involve the analysis of biological samples like blood, urine, or tissue.
- The description focuses on the physical properties and intended use for vision correction. There is no mention of analyzing biological markers or diagnosing a condition through the examination of a specimen.
Therefore, the Envoy and Envoy Toric Contact Lenses are medical devices, but they do not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters.
Product codes
86 LPL
Device Description
Trade Name: Envoy and Envoy Toric (epsifilcon A) Contact Lenses (clear and visibility tint with a molded back surface and a lathe cut front surface)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eyes
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1997
Mr. Bernard F. Hallatt Manager, Quality Assurance and Regulatory Affairs CooperVision, Inc. 711 North Road Scottsville, NY 14546
Re: K963013
Trade Name: Envoy and Envoy Toric (epsifilcon A) Contact Lenses (clear and visibility tint with a molded back surface and a lathe cut front surface) Regulatory Class: II Product Code: 86 LPL Dated: October 7, 1997 Received: October 8, 1997
Dear Mr. Hallatt:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) 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 devices 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.
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Page 2 - Mr. Bernard F. Hallatt
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
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Image /page/2/Picture/0 description: The image shows the CooperVision logo. The logo is black and white and features the company name in a stylized font. The word "CooperVision" is written in a bold, sans-serif font, with a distinctive swirl design inside a square to the right of the name.
711 North Road Scottsville, Now York 14546 (716) 385-6810 Fax (716) 869-5668
Indications for Use Statement
510(k) Number: K963013
Device Name: Enovy Envoy Toric
Indications for Use:
The Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
Daniel W. C. Brown Ph.D.