K Number
K983739
Device Name
OPTUM, INTRAORAL CAMERA SYSTEM
Manufacturer
Date Cleared
1999-01-19

(89 days)

Product Code
Regulation Number
872.6640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intraoral camera system, Optum, of Camsight, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention any AI or ML terms, image processing capabilities beyond basic viewing, or performance studies related to algorithmic analysis. The intended use is purely for visualization and patient communication.

No
The device is used for observational and descriptive purposes (assisting the dentist in describing procedures and showing before/after views), not for treating or preventing a disease or condition.

No

The device is used to provide a view of the mouth to assist the dentist in describing dental procedures and showing before/after views to patients. It does not provide any analysis or interpretation of the images to diagnose a condition.

No

The device is described as an "intraoral camera system," which inherently includes hardware (the camera). The summary does not indicate that the device is solely software controlling an existing camera.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used to "provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views... showing the patient results of the dental procedures". This describes a device used for visualization and communication, not for performing tests on samples taken from the body to diagnose or monitor a medical condition.
  • Input Imaging Modality: The input is an "Intraoral camera", which captures images of the inside of the mouth. This is a direct imaging modality, not a method for analyzing biological samples.
  • Anatomical Site: The anatomical site is the "Mouth", which is being directly visualized.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Performing tests to diagnose or monitor a disease or condition
    • Any kind of laboratory analysis

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

N/A

Intended Use / Indications for Use

The intraoral camera system, Optum, of Camsight, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Product codes

EIA

Device Description

Optum, Intraoral Camera System

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist

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

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

0

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling a human figure or a symbol of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the central design. The logo is simple, clean, and easily recognizable.

JAN 1 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Camsight, Incorporated C/O Mr. W. Edward Johansen 11661 San Vicente Boulevard Los Angeles, California 90049

Re : K983739 Optum, Intraoral Camera System Trade Name: Requlatory Class: I Product Code: EIA October 21, 1998 Dated: Received: October 22, 1998

Dear Mr. Johansen:

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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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

1

Page 2 - Mr. Johansen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

2

PREMARKET NOTIFICATION

INDICATIONS FOR USE

510 (k) Number :_

Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use:

The intraoral camera system, Optum, of Camsight, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Concurrence of CDRH, Office of Device Evaluation (ODE)

.OR

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

Over - The - Counter - Use : _

(Per 21 CFR 801.109

Susan Puner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number