(30 days)
Not Found
No
The description focuses on image acquisition, viewing, handling, and storage, with no mention of AI or ML algorithms for image analysis or interpretation.
No.
The device is used for acquiring, viewing, handling, and storage of dental color images and radiographs, which is for diagnostic purposes, not therapeutic.
Yes
The device description explicitly states: "The generated image is used for the patient's information and to support the diagnosis." This indicates that the device assists in the diagnostic process.
No
The device description explicitly lists multiple hardware components, including a video control box, cameras, a video display, and a PC compatible computer, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For acquiring, viewing, handling, and storage of dental color images and radiographs." This describes a system for capturing and managing images of the patient's oral cavity.
- Device Description: The description details a system involving a camera, control box, display, and software for image acquisition and management. It explicitly states the generated image is used for "the patient's information and to support the diagnosis."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly images the patient's oral cavity, which is not an in vitro process.
The device is clearly intended for in-vivo imaging and image management within a dental setting, not for analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
For acquiring, viewing, handling, and storage of dental color images and radiographs.
Product codes
LLZ, MUH
Device Description
KaVo ERGOcom®/ERGOcam® system consists of four main components:
- The ERGOcom® Video control box. .
- One of two versions of the ERGOcam® Cameras: The ERGOcam® 3 of the ERGOcam® 4 . camera.
- A video display, flat panel color from 15 to 19" with touch screen control .
- A PC compatible computer with the KaVo Device Interface System Software installed. The . Device Interface System has the following components:
-
- CCCDIS. The CCCDIS software is used to administer and configure the software components in the KaVo Device Interface System . The CCCDIS acts as the interface of the KaVo Device Interface System with third party applications
- ERGOcam Control The ERGOcam Control software is used to configure individual 2. parameters of the ERGOcam 4
- ERGOcom Control The ERGOcom Control software is used for the PC-assisted status 3. display, configuration and service support of the ERGOcom 3.
- ERGOvideo Control The ERGOvideo Control software is used for generating and 4. displaying video imaging data created with ERGOcom 2 / ERGOcom 3 andERGOcam 3 / ERGOcam 4
- ERGOcam Viewer The ERGOcam Viewer is used for demonstrating the use of the 5. ERGOvideo Control, ERGOcam Control and ERGOcom Control. The ERGOcam Viewer is used to store and administer imaging data that have been generated with the software components referred to above.
- VirtualCom2 VirtualCom2 is used to convert the foot starter and camera cradle signals 6. from ERGOcom 3 to a format that is compatible with ERGOcom 2 .These signals are only used to control program modules within a practice management software that allows the recording of images with a KaVo intraoral camera, thereby meeting the interface specification for the serial interface of ERGOcom 2
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The intraoral camera emits video signals which generate an image of the area under inspection (the patient's oral cavity for instance) on a screen or other visual display medium. The generated image is used for the patient's information and to support the diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video signals from intraoral camera, radiographs
Anatomical Site
patient's oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR 2 1 2005
EXHIBIT 2 510(k) Summary
KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 Contact: John Miller, Director of RA/QA March 7, 2005
- Identification of the Device:
Proprietary-Trade Name: KaVo ERGOcom®/ERGOcam® Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes Picture archiving and communications system, 90 LLZ or System, x-ray, extraoral source, digital Product Code MUH Common/Usual Name: Dental Image Management System
- Equivalent legally marketed device: DentalEye 2, K012439.
- Indications for Use (intended use): For acquiring, viewing, handling, and storage of dental 3. color images and radiographs.
- Description of the Device: KaVo ERGOcom®/ERGOcam® system consists of four main ধ components:
- The ERGOcom® Video control box. .
- One of two versions of the ERGOcam® Cameras: The ERGOcam® 3 of the ERGOcam® 4 . camera.
- A video display, flat panel color from 15 to 19" with touch screen control .
- A PC compatible computer with the KaVo Device Interface System Software installed. The . Device Interface System has the following components:
-
- CCCDIS. The CCCDIS software is used to administer and configure the software components in the KaVo Device Interface System . The CCCDIS acts as the interface of the KaVo Device Interface System with third party applications
- ERGOcam Control The ERGOcam Control software is used to configure individual 2. parameters of the ERGOcam 4
- ERGOcom Control The ERGOcom Control software is used for the PC-assisted status 3. display, configuration and service support of the ERGOcom 3.
- ERGOvideo Control The ERGOvideo Control software is used for generating and 4. displaying video imaging data created with ERGOcom 2 / ERGOcom 3 andERGOcam 3 / ERGOcam 4
- ERGOcam Viewer The ERGOcam Viewer is used for demonstrating the use of the 5. ERGOvideo Control, ERGOcam Control and ERGOcom Control. The ERGOcam Viewer is used to store and administer imaging data that have been generated with the software components referred to above.
- VirtualCom2 VirtualCom2 is used to convert the foot starter and camera cradle signals 6. from ERGOcom 3 to a format that is compatible with ERGOcom 2 .These signals are only used to control program modules within a practice management software that
-
1
allows the recording of images with a KaVo intraoral camera, thereby meeting the interface specification for the serial interface of ERGOcom 2
The intraoral camera emits video signals which generate an image of the area under inspection (the patient's oral cavity for instance) on a screen or other visual display medium. The generated image is used for the patient's information and to support the diagnosis.
| Description | DentalEye 2 K012439 | KaVo ERGOcom®/ERGOcam® |
|---|---|---|
| Implementation | Software only | Hardware and Software supplied |
| Host platform | Intel or AMD based Personal Computer | PC Pentium, 1800 MHz or higher. |
| Operating system | Windows 95 Windows 98 | |
| Windows ME | ||
| Windows 2000 | ||
| Windows NT | Windows 2000, Windows XP. And Microsoft .NET Framework. | |
| Host RAM | 32 MB minimum | 256 MB |
| Host Magnetic Storage | At least 500 MB | Sufficient hard disk space to store imaging data., Usually 20 GB |
| Host Floppy Drives: | Not required | Not required |
| CD ROM | Yes (for installation) | Yes (for installation) |
| Host Processor Speed | Pentium II 233 MHz or better | PC Pentium, 1800 MHz or higher. |
| Host Monitor Size | Any VGA or better PC color monitor | XGA or better, 15" or 19" Touch Display. |
| Display Resolution | Minimum 800 X 600 | |
| Recommended | ||
| 1024 X 768 | Screen resolution 1024 X 768, with min. true color depth (32 bit). | |
| User Display Preferences | Yes | Yes |
| USB and S Video support | NO | Yes |
| Receive Images from other Systems | Yes | Yes |
| Images Displayed | Dental X-Rays, Intraoral Images, Extraoral Images (face, etc) | Dental X-Rays, Intraoral Images, Extraoral Images (face, etc), Entertainment (TV) for patients, Instructional Video, Patient Administration. |
| Safety Standards | Not applicable. Software only supplied. | UL/CSA standards for safety met. |
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- Safety and Effectiveness, comparison to predicate device:
-
- Conclusion: In all important respects, the KaVo ERGOcom®/ERGOcam® Dental Image System is substantially equivalent to one or more predicate systems, including the one named above. The system has been thoroughly tested to IEC/UL/CSA standards including electrical safety and electromagnetic compatibility and has been found to comply with those standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form, with three figures connected in a flowing design.
Public Health Service
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KaVo America Corporation % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K050744
Trade/Device Name: KaVo ERGOcom® / ERGOcam® Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system ﺎ Regulatory Class: II Product Code: MUH and LLZ Dated: March 17, 2005 Received: March 25, 2005
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced abone 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 rear 20, 1770, and coance 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 1 oderal building, 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manusing of substantial equivalence of your device to a legally prematRet notification: "The PDF maning of our 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 If you desire specific advice for your de received in the regulation the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Alls, please note the regulation on your responsibilities under the Act from the 807.97). Tou may outlar other general 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
ﯿﮟ
050744 510(k) Number (if known):
Device Name:_________________________________________________________________________________________________
Indications For Use:
For acquiring, viewing, handling, and storage of dental color images and radiographs.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
్లో
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Nancy C Brogdon
(Division Sign-Off)
Division of Reprodu
and Radiological
510(k) Number
K050744
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