(168 days)
No
The description focuses on standard treatment planning calculations based on user input and imported images, without mentioning any AI/ML techniques for image analysis, contouring, or optimization.
No
This device is a treatment planning system (software) used by medical professionals to create radiation therapy plans, not to directly treat or diagnose a medical condition.
No
HDRplus is a treatment planning system used to create radiation therapy plans, calculate optimal dose distribution, and transfer the plan to a radiation device. It does not perform diagnosis of a disease or condition.
No
While the core functionality is software, the device description explicitly includes hardware components like a Personal Computer, Monitor, Keyboard, and Mouse as part of the "HDRplus System," and lists accessories like a Film Scanner, Printer, Pen Tablet, and Touch Panel. This indicates it is a system that includes both software and hardware.
Based on the provided information, the HDRplus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc.
- HDRplus Function: HDRplus is a software system used for treatment planning in brachytherapy. It uses medical images and user input to calculate radiation doses and create a treatment plan. It does not analyze biological specimens or provide diagnostic information based on such analysis.
- Intended Use: The intended use clearly states it's for "creation of treatment plans for remote afterloader based HDR and PDR brachytherapy." This is a therapeutic planning function, not a diagnostic one.
- Device Description: The description focuses on software tools for image manipulation, contouring, dose calculation, and plan transfer to a treatment device. This aligns with treatment planning, not in vitro testing.
Therefore, HDRplus falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.
Product codes
MUJ
Device Description
HDRplus is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input entered by the operator.
The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).
HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.
The HDRplus System comprises subjoined listed subsystems:
- Personal Computer. It executes the HDRplus software.
- Monitor. To visualise the treatment planning process.
- Keyboard. To enter treatment data.
- Mouse. To select objects on the screen
The PC is used to execute the HDRplus software and runs under Windows XP Professional or Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.
Accessory: Film Scanner: The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.
Accessory: Printer: The Printer allows for hard copy of the patients treatment plan and other stored data.
Accessory: Pen Tablet: The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.
Accessory: Touch Panel: The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, 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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Image /page/0/Picture/1 description: The image shows the logo for Eckert & Ziegler. The logo consists of a black graphic to the left of the company name. The graphic is a stylized image of a bullet. The text "Eckert & Ziegler" is written in a bold, sans-serif font.
510(k) Summary as required by 21 CFR 807.92 6
Submitter of 510(k) 6.1
| 510(k) owner's name | : | Eckert & Ziegler BEBIG GmbH |
|---|---|---|
| address | : | Robert-Rössle-Strasse 10 |
| : | 13125 Berlin | |
| : | Germany | |
| phone | : | +49 30 941084130 |
| fax | : | +49 30 941084112 |
| name of contactperson | : | Hub van de Bergh |
| : | hubvandebergh@gmail.com | |
| date the summary was prepared | : | August 10, 2012 |
6.2 Device: HDRplus
name of the device / trade or proprietary name: HDRplus common or usual name: Brachytherapy Treatment Planning System classification name: . Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)
Legally Marketed Device(s) 6.3
HDRplus can be shown to be substantial equivalent to the legally marketed predicate device cited in the table below.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device
1 | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A 66. J. B. B. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
oviniar
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17004 1 |
6.4 Description of the Device
HDRplus 6.4.1
HDRplus is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input entered by the operator.
The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined
dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).
HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.
Eckert & Ziegler BEBIG GmbH
HDRplus 510(k) PMN Section 6: 510(k) Summary
Robert-Rössle-Straße 10 13125 Berlin Germany
Phone : +49 30 941084130 +49 30 941084112 Fax e-mail : info@bebig.eu
Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 14 / 45
APR 0 4 2013
.
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Image /page/1/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a black oval shape with horizontal lines above and below it, followed by the text "Eckert & Ziegler" in a sans-serif font. The text is in black and appears to be slightly bolded.
The HDRplus System comprises subjoined listed subsystems:
- Personal Computer . It executes the HDRplus software.
- Monitor . To visualise the treatment planning process.
- Keyboard . To enter treatment data.
- Mouse . To select objects on the screen
The PC is used to execute the HDRplus software and runs under Windows XP Professional or Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.
Accessory: Film Scanner 6.4.2
The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.
6.4.3 Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.
6.4.4 Accessory: Pen Tablet
The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.
Accessory: Touch Panel 6.4.5
The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.
Intended use of the Device 6.5
The HDRplus is used for the creation of treatment plans for High Dose Rate and Pulsed Dose Rate remote afterloader based brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRpius also supports the evaluation of clinical images in calculating the local and global doses.
Technological characteristics of device compared to the 6.6 predicate device
The HDRplus Brachytherapy Treatment Planning System has the same technological characteristics as the legally marketed predicate device listed above which is cleared under 510(k) #K091145.
The HDRplus technology is based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry. Optionally a frame grabber may be used with HDRplus for capturing video images.
Substantial Equivalence 6.7
From the discussion in previous paragraphs it can be concluded that the HDRplus Brachytherapy Treatment Planning System has the same technological characteristics compared to the legally marketed predicate device indicated in section 6.3.
The differences between HDRplus and predicate devices do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device.
The intended use of HDRplus and predicate device are the same.
The conclusion is that HDRplus is substantial equivalent to the legally marketed predicate device.
Eckert & Ziegler BEBIG GmbH
HDRplus 510(k) PMN Section 6: 510(k) Summary
Robert-Rössle-Straße 10 13125 Berlin Germany
Phone : +49:30 941084130 +49 30 941084112 Fax e-mail : info@bebig.eu
Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 15 / 45
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2013
Hub van de Bergh Consultant ECKERT & ZIEGLER BEBIG GMBH C/O TRACEABILITY OA & RA SERVICES MUURZWALUW 30, 3905 RZ VEENENDAAL NETHERLANDS
Re: K123263
Trade/Device Name: HDRplus & Add in prostate Module for HDRplus Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: MUJ Dated: March 15, 2013 Received: March 20, 2013
Dear Mr. van de Bergh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2-Mr. Bergh
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MichaFDA Hara
for
Janine M. Morris, M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123263
Device Name:_________________ HDRplus
Indications for Use:
HDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Mishra EOA Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health .
510(k) K123263
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