(82 days)
No
The description details a PC program for calculating and displaying radiation dose based on fixed parameters (format size, angulation, table position). It uses a commercially available dose measurement system and operates on older Windows versions with minimal hardware requirements. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The calculations are described as deterministic with a specified accuracy.
No.
The device is described as an accessory for recording, displaying, and documenting the regional distribution of the skin entry dose of a patient; it does not directly treat or diagnose a medical condition.
No
Explanation: The device, CAREGRAPH, is described as an accessory for an angiographic system that records, displays, and documents the regional distribution of the skin entry X-ray dose to a patient. It calculates and displays the radiation dose on a graphical patient body surface. It does not perform diagnosis of a disease or condition; its function is to monitor and display radiation exposure.
Yes
The device is described as a "PC program" delivered on CD-ROM that runs on standard operating systems and hardware. While it interfaces with existing hardware (dose measurement system, Siemens Angio/Fluoro systems), the device itself is the software that processes and displays the data. The description focuses on software features, calculations, and display capabilities, not on the hardware components it utilizes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record, display, and document the regional distribution of the skin entry dose of a patient during X-ray examinations. This is related to radiation exposure and patient safety during a medical imaging procedure.
- Device Description: The device is a PC program that processes data from a dose measurement system to display radiation exposure on a graphical representation of the patient's body surface. It focuses on calculating and visualizing radiation dose.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
The device is clearly focused on monitoring and managing radiation dose during an imaging procedure, which falls under the category of medical imaging accessories or radiation safety devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CAREGRAPH is an angiographic system accessory for recording, displaying and documenting the regional distribution of the skin entry dose of a patient, depending on the relevant angulations in X-ray examination. The dose is calculated depending on the format size, the angulation and the table position and displayed on a graphical patient body surface.
Product codes
90IZZ, 90JAA
Device Description
CAREGRAPH is a PC program which provides a graphical display of the dose exposure to the patient as measured by a commercially available dose measurement system whose sensor is mounted in the imaging chain. CAREGRAPH can be used with all Siemens Angio and Fluoro systems that are configured with the ACS-, or XCS-interface. The software, which is delivered on CD-ROM, runs on Windows 95/Windows NT 4.0, and is designed to operate with existing Siemens dose counter features in products such as the cardiac workstations (marketed as Siemens Quantcor and Siemens ACOM.PC). The program follows the Microsoft conventions and can be configured by the customer. Minimum PC requirements are:
- Pentium 133 MHz (or better), 16 Mbyte RAM (or more) for Windows 95 .
- Pentium 133 MHz (or better), 32 Mbyte RAM (or more) for Windows NT 4.0. ●
The standard display is a two dimensional presentation of the radiation impact in a scaled window, with numerical indications at foci of skin doses for certain limits. The numerical value of the "Hot Spot" is focused in the graphical presentation, which is updated every 10 seconds. The radiation field must be presented within 2 seconds if relevant parameters have been changed. Calculation is done with an accuracy of ±5%.
The "Hot Spot" resolution shall be ≤ 5x5 mm² and limits and colors for the indication of the spot is configurable by the user. The program is operated with keyboard and mouse. The customer can set the skin dose alarm limit, though not higher than 2000 mGy. When a critical dose is reached an alarm sounds. The display of the dose area is possible without radiation. Patient data can be set parallel to data survey. It is possible to process the patient data afterwards and also generate a report on the patient and examination data. As a minimum, one week's patient reports shall be storable. Data may then be transferred and stored on another media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image-Intensified Fluoroscopic X-ray System, Angiographic X-ray Systems
Anatomical Site
Skin entry dose (body surface)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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SEP 22 1998
Attachment 10
510(k) Summary
CAREGRAPH Software Program for Image-Intensified Fluoroscopic X-ray System
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830 Establishment Registration Number: 2240869
June 30, 1998
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Contact Person: 1.
Kathleen Rutherford Phone: (732) 321-4779 Fax: (732) 321-4841
2. Device Name and Classification:
| Trade Name: | CAREGRAΡΗ |
|---|---|
| Classification Name: | Angiographic X-ray Systems and Image Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1600 and 21 CFR §892.1650 |
| Device Class: | Class II |
| Device Code: | 90IZZ |
3. Intended Use:
CAREGRAPH is an angiographic system accessory for recording, displaying and documenting the regional distribution of the skin entry dose of a patient, depending on the relevant angulations in X-ray examination. The dose is calculated depending on the format size, the angulation and the table position and displayed on a graphical patient body surface.
4. Substantial Equivalence:
We believe within the meaning of the Safe Medical Devices Act of 1990, the CAREGRAPH Software Program for Angiographic X-ray Systems and Image Intensified Fluoroscopic X-ray Systems as addressed in this Premarket notification, is substantially equivalent to the following devices for Angiographic X-ray Systems and Image Intensified Fluoroscopic X-ray Systems currently in commercial distribution.
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Diamentor patient | ||
| x-ray exposure indicator | Manufacturer: PTW - Freiburg | |
| Importer: Nuclear Associates | K853753 | |
| Diamentor M1/M2/M3 | Manufacturer: PTW - Freiburg | exempt |
1
This statement is based on the fact that the CAREGRAPH system is based a similar PTW detector system and complies with the same or equivalent standards and has the same intended uses as the aforementioned predicate devices. The software raises no new safety or effectiveness concerns.
5. Device Description:
CAREGRAPH is a PC program which provides a graphical display of the dose exposure to the patient as measured by a commercially available dose measurement system whose sensor is mounted in the imaging chain. CAREGRAPH can be used with all Siemens Angio and Fluoro systems that are configured with the ACS-, or XCS-interface. The software, which is delivered on CD-ROM, runs on Windows 95/Windows NT 4.0, and is designed to operate with existing Siemens dose counter features in products such as the cardiac workstations (marketed as Siemens Quantcor and Siemens ACOM.PC). The program follows the Microsoft conventions and can be configured by the customer. Minimum PC requirements are:
- Pentium 133 MHz (or better), 16 Mbyte RAM (or more) for Windows 95 .
- Pentium 133 MHz (or better), 32 Mbyte RAM (or more) for Windows NT 4.0. ●
The standard display is a two dimensional presentation of the radiation impact in a scaled window, with numerical indications at foci of skin doses for certain limits. The numerical value of the "Hot Spot" is focused in the graphical presentation, which is updated every 10 seconds. The radiation field must be presented within 2 seconds if relevant parameters have been changed. Calculation is done with an accuracy of ±5%.
The "Hot Spot" resolution shall be ≤ 5x5 mm² and limits and colors for the indication of the spot is configurable by the user. The program is operated with keyboard and mouse. The customer can set the skin dose alarm limit, though not higher than 2000 mGy. When a critical dose is reached an alarm sounds. The display of the dose area is possible without radiation. Patient data can be set parallel to data survey. It is possible to process the patient data afterwards and also generate a report on the patient and examination data. As a minimum, one week's patient reports shall be storable. Data may then be transferred and stored on another media.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
The CAREGRAPH accessory has the same technological characteristics as the predicate PTW detector system and complies with the same or equivalent standards and has the same intended uses as the aforementioned predicate devices.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Kathleen Rutherford Manage Regulatory Submissions Siemens Medical Systems, Inc. Imaging Systems Group 186 Wood Avenue South Iselin, NJ 08830
K982319 Re:
Caregraph (Accessory to Angiographic X-ray Systems and Image Intensified Fluoroscopic Systems Dated: July 1, 1998 Received: July 2, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Ms. Rutherford:
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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 predicate device results in a classification for your device and thus, permits your device to preceed 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D
Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Hcalth
Enclosure
Image /page/2/Picture/17 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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Attachment 1
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Siemens CAREGRAPH Accessory for Angiographic X-ray Systems and Image Intensified Fluoroscopic X-ray Systems
Indications for Use:
CAREGRAPH is an angiographic system accessory for recording, displaying and documenting the regional distribution of the skin entry dose of a patient, depending on the relevant angulations in X-ray examination. The dose is calculated depending on the format size, the angulation and the table position and displayed on a graphical patient body surface.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use C (per 21 CFR 801.109) OR Over-The-Counter Use __________
David le. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number K982319