(76 days)
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Not Found
No
The summary describes a standard intra-oral video camera system for viewing and capturing images, with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions.
No
The device is used for viewing and capturing images of intraoral anatomies, which serves as an aid for practitioners but does not directly treat or prevent a disease or condition.
No
Explanation: The device is described as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images, not for diagnosing medical conditions. It helps practitioners view and record, but does not provide diagnostic interpretations or conclusions.
No
The device description explicitly states it is an "intra oral video camera system," which includes hardware (the camera) in addition to any potential software components for image capture and storage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist dental practitioners in viewing intra oral anatomies and capturing/storing images. This is a direct visualization and documentation tool for the human body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Device Description: The description confirms it's an intra oral video camera system, which is used for direct imaging within the mouth.
The device is a medical device, but it falls under the category of imaging or visualization devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Planmeca Intracam Station intra oral video camera system is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.
Product codes
EIA
Device Description
The Planmeca Intracam Station intra oral video camera system is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
video
Anatomical Site
intra oral anatomies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
practitioners in the dental field
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
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
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JAN 26 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu ર્ભ FIN-00810 Helsinki FINLAND
Re : K984013 Planmeca Intracam Station Trade Name: Requlatory Class: I Product Code: EIA Dated: November 9, 1998 Received: November 12, 1998
Dear Mr. Moring:
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 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 Requlations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Moring
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 diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PLANMECA OY
ENCLOSURE 11
November 9, 1998
Ref.: 510(k) Notification Accessory to Dental Operative Unit Planmeca Intracam Station
p. 11-1
INDICATIONS FOR USE
The Planmeca Intracam Station intra oral video camera system is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.
Lus
(Signature)
Lars Moring/Regulatory Affairs Manager (Typed name/Title)
November 9. 1998 (Date)
Number) (510(k)
Susan Reaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices rax (KI) -510(k) Number _
PRESCRIPTION
DEVICE
(TY)
ో... . . : 10.00 1 :4