(79 days)
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No
The document describes standard clinical record-keeping and image editing software without mentioning AI or ML capabilities.
No
The device is described as a clinical software program for record-keeping and image management, intended for clinical and diagnostic use, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use."
Yes
The device is described solely as a "clinical software program" and its functions are related to record keeping, treatment planning, and image management (acquisition, editing, storage). While it interacts with external imaging devices, the device itself is presented as software.
Based on the provided information, EagleSoft's ChairSide is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EagleSoft's ChairSide Function: The description clearly states that EagleSoft's ChairSide is a clinical software program for managing dental records, treatment plans, clinical notes, and images acquired from dental imaging devices. It focuses on managing and processing data related to the patient's hard and soft tissue in situ or from images of these tissues.
- No Specimen Analysis: There is no mention of the software analyzing biological specimens from the patient. The images are acquired directly from dental imaging devices, not from laboratory analysis of bodily fluids or tissues.
Therefore, EagleSoft's ChairSide falls under the category of a clinical software program for managing patient data and images within a dental practice, not an IVD device.
N/A
Intended Use / Indications for Use
EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.
Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices, and Generic Image Devices such as scanners. Nondiagnostic images can then be edited (i.e. resized, contrast, cropped, etc.). Images can also be easily imported and exported.
Product codes
90 LLZ
Device Description
EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Digital Radiographic Devices, Digital Video Capture Devices, Generic Image Devices (such as scanners)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental offices / 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Craig W. Kabbes Vice President, Engineering EagleSoft 2202 Althoff Drive PO Box 1267 Effingham, IL 62401
Re:
K982422 EagleSoft ChairSide Software Application Dated: July 1, 1998 Received: July 13, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Kabbes:
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 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 practive, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing, Practice requirements. as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 predication 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-fire number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours,
Ki lian Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
1
Statement of Indication For Use 8.0
510(k) Number (if known): _ 4 9 82422
Device Name: ChairSide
Indication For Use:
EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.
Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices, and Generic Image Devices such as scanners. Nondiagnostic images can then be edited (i.e. resized, contrast, cropped, etc.). Images can also be easily imported and exported.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (DOE) | ||||
|---|---|---|---|---|
| Prescription Use | ||||
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982422