(185 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI or ML technology. The device description and intended use focus on a physical process for contact lens modification.
No
The device is used to modify the surface of contact lenses, not to treat a medical condition or disease in a patient.
No
The device is used to modify the surface of contact lenses, which is a treatment or maintenance function, not a diagnostic one.
No
The device description is not found, but the intended use describes a "System" for "in-office only re-hydrophilization" of contact lenses, which strongly implies a physical process involving hardware, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "re-hydrophilize" rigid gas permeable contact lenses. This is a process performed on a medical device (the contact lens) outside of the human body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Nova-New Lens Re-hydrophilization System is a device used to modify the surface properties of a contact lens, which is a medical device itself. It does not analyze biological samples from a patient.
N/A
Intended Use / Indications for Use
The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only re-hydrophilization of NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear. The Nova-New Lens Re-hydrophilization System permits a practitioner to modify the surface of the contact lens.
Product codes
86 HQD
Device Description
Not Found
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
Professional In-Office Use / In-office
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a circular logo with the words "U.S. Department of Health & Human Services" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is drawn with thick, black lines and has a simple, abstract design.
Food and Drug Administration 9200 Corporato Boulevard Rockville MD 20850
AUG 1 5 1996
Dr. Alan J. Touch NovaVision, Inc. 2700-200 Gateway Centre Blvd. Morrisville, NC 27560
Re: K960584
Trade Name: NOVA-NEW Reconditioning System for Professional In-Office Use with NOVAWET, PERCEPTION and VANGUARD Daily Wear (rosilfocon A) Rigid Gas Permeable Lenses Regulatory Class: II Product Code: 86 HQD Dated: May 12, 1996 Received: May 17, 1996
Dear Dr. Touch:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
1
Page 2 - Dr. Alan J. Touch
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 at (301) 443-6597.
Sincerely yours,
AlhepL. Rriettal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
. I
Page I of I
510(k) Number (if known): K960584
Device Name: NOVANBW Re-hydrophilization System for Professional In-Office Use on DOWCE NAME: NOVIETED AND PERCEPTION Rigid Gas Permeable Lonses for Daily Wear (rosilfocon A).
Indications For Use:
The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only The Nova-Now Leas Now How AWET, PERCEPTION and VANGUARD igas a permeable contact lenses for daily wear. The Nova-New Leas Re-hydrophilibation System permisable contact reases for daily weat. "Inconomines that he wishes to modify the surface of the contact lens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
yra smith
Bureau of ophthalmic Device
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)