(87 days)
Not Found
Not Found
No
The summary describes a rigid gas permeable contact lens and does not mention any AI or ML components or functionalities.
No
The device description indicates it is a contact lens, which is not typically classified as a therapeutic device.
No
The device description indicates it is a contact lens, which is a therapeutic or vision correction device, not a diagnostic one.
No
The device description explicitly states it is a "Rigid Gas Permeable Contact Lens," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section, which is crucial for identifying an IVD, is listed as "Not Found". IVDs typically have intended uses related to diagnosing, monitoring, or screening for diseases or conditions using samples from the human body.
- Device Description: The description clearly states the device is a "Rigid Gas Permeable Contact Lens". Contact lenses are medical devices used to correct vision, not for in vitro diagnostic testing.
- Lack of IVD-Specific Information: The document lacks any mention of typical IVD characteristics such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information
Therefore, based on the available information, this device is a contact lens and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Not Found
Product codes
86 HQD
Device Description
NOVALENS/NovaWet spherical and PERCEPTION and VANGUARD multifocal and/or bifocal (rosilfocon A) Rigid Gas Permeable Contact Lens (Clear and Blue Tinted) for Daily Wear (shipped in NovaSoak.
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
Not Found
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): 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.
Not Found
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.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1996
Dr. Alan J. Touch NovaVision, Inc. 2700-200 Gateway Centre Blvd. Morrisville, NC 27560
Re: K955900 Trade Name: NOVALENS/NovaWet spherical and PERCEPTION and VANGUARD multifocal and/or bifocal (rosilfocon A) Rigid Gas Permeable Contact Lens (Clear and Blue Tinted) for Daily Wear (shipped in NovaSoak. Regulatory Class: II Product Code: 86 HQD Dated: December 27, 1995 Received: December 29, 1995
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 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 prohibit ons against misbranding and adulteration.
If your device is classified (see above) into cither 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. 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 it the Ecderal Register. Please this response to your premarket notifi ation submission does not affect note: any obligation you might have under sections ?1 through 542 of the Act for devices under the Electronic Product Radiation ontrol provisions, or other Federal laws or regulations.
1
Page 2 - Dr. Alan J. Touch
This letter immediately will allow you to begin marketing your device as Inis lected in your 510(k) premarket notification. An FDA Tinding of described in your 310(K) premarked notiries to a legally marketed predicate device to proceed substantial equivalence of your device and permiss your device to proceed
results in a classification for your device and device . Therefore to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as you may not promote or in ally way represent for your device for your device on our being gpproxed by FDA. III you desire specific and additionally 809.10 for in xires labeling Fegulation (21 ork faron or advertising please contact the Office of
diagnostic devices), promotion, or advertising 2005 ar diagnostic devices), promotion or os advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information on your responsibilities under the (301) 594-4639. "Ocher general intoination of Small Manufacturers Assistance at Assistance at the capa ACC, may be obcarned 210m0) 638-2041 or at (301) 443-6597.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon
Nan \ C Brogdo Interim Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health