(55 days)
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No
The summary describes a standard intraoral camera for image capture and display, with no mention of AI, ML, or advanced image processing beyond basic image quality.
No.
The ElcaCam is an imaging device used for diagnosis and treatment planning by capturing images, not for providing therapy or treatment itself.
No
The device is described as assisting the dentist in examining teeth and facilitating treatment planning by providing images. It is also used to show "before" and "after" views. While these functions support the diagnostic process and treatment planning, the device itself is not performing a diagnostic function (i.e., it doesn't interpret images or provide a diagnosis). It is an imaging tool.
No
The device description explicitly states "intraoral camera system," which implies the presence of hardware (the camera itself) in addition to any potential software components. The intended use also describes capturing images, which is a hardware function.
Based on the provided information, the ElcaCam is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ElcaCam's Function: The ElcaCam directly images the inside of the human mouth and teeth. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes providing images to assist the dentist in examining, planning treatment, describing procedures, and showing before/after views. These are all related to direct visual inspection and communication, not laboratory analysis of specimens.
Therefore, the ElcaCam falls under the category of a medical device used for imaging and visualization within the body, not an IVD.
N/A
Intended Use / Indications for Use
The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient's teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a "before" view and an after "view" of the patient's mouth for visual confirmation of dental procedure results.
The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
intraoral camera
Anatomical Site
human mouth and teeth
Indicated Patient Age Range
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Intended User / Care Setting
dentist
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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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Mr. Tom Louisell Regulatory Affairs Scientist A-dec. Incorporated 2601 Crestview Drive Newberg, Oregon 97132
Re: K032070
Trade/Device Name: ElcaCam Intraoral Camera Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 26, 2003 Received: July 03, 2003
Dear Mr. Louisell:
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. Tom Louisell
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), 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) you may obtain. 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.
Suren Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K032070 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ElcaCam
Indications For Use:
The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient's teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a "before" view and an after "view" of the patient's mouth for visual confirmation of dental procedure results.
The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
.............................................................................................................................................................................. .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OROver-The-Counter Use (Optional Format 1-2-96)
Kein Muly for KSN
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032070