(80 days)
Not Found
Stomavision, Vipercam, Telicam, Digital Doc, S555, S575, MiniCam and Smilie PC systems
No
The summary describes a standard intra-oral camera for image capture and display, with no mention of AI/ML terms, image processing beyond basic display, or performance studies related to algorithmic analysis.
No
The device is used for imaging and diagnostic purposes (allowing the dentist to examine teeth for "adequate planning in the treatment"), not for direct treatment or therapy.
No
Explanation: The device provides images for a dentist to examine teeth and plan treatment, which is a tool for observation and planning, not making a diagnosis itself. It aids in diagnosis by providing visual information, but it does not output a diagnostic result.
No
The description focuses on providing intra-oral images and compares the device to other "systems" which are likely hardware-based cameras. There is no mention of the device being solely software or processing existing images.
Based on the provided information, the OraCam is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide intra oral images for the dentist to examine teeth and plan treatment. This is a direct examination of the patient's anatomy, not an analysis of samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: While the description is "Not Found," the intended use clearly points to an imaging device used in vivo (on the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on samples, or providing diagnostic information based on the analysis of samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OraCam's function is to capture images of the inside of the mouth, which is a form of in vivo imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.
The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.
Product codes
EIA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intra oral images
Anatomical Site
human mouth and teeth
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)
Stomavision, Vipercam, Telicam, Digital Doc, S555, S575, MiniCam and Smilie PC systems
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Mr. Claude D. Berthoin President Video Dental Concepts 110 East Granada Boulevard, Suite 208 P.O. Box 36 Ormond Beach, Florida 32175-0036
Re: K020957
Trade/Device Name: OraCam Regulation Number: 872.6640 Regulation Name: Intra-Oral Camera Regulatory Class: I Product Code: EIA Dated: March 20, 2002 Received: March 25, 2002
Dear Mr. Claude:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Berthoin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Patricia Cucurullo for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 2_of 2
价020957
510(k) Number (if known): Applied for Device Name: __OraCam
Indications for Use:
The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.
The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.
Susan Rinn
(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infrection Continues
and General Hospital Devicess
E Lifki Number 510(k) Number ________________________________________________________________________________________________________________________________________________________________