(310 days)
Not Found
No
The description focuses on standard treatment planning calculations based on user input and imported images, with no mention of AI/ML algorithms for tasks like automated contouring, dose optimization beyond standard calculations, or predictive modeling.
No
The device is a treatment planning system for brachytherapy and does not directly deliver therapy; it prepares the plan that another device (brachytherapy afterloader radiation device) will execute.
No
SagiPlan is a treatment planning system used to calculate a proposed treatment course and the optimal dose distribution for a tumor volume in brachytherapy. It does not diagnose diseases or conditions.
No
The device description explicitly states that the SagiPlan System comprises a Personal Computer, Monitor, Keyboard, and Mouse, in addition to the software package. While the core functionality is software-based, it is presented as a system including hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- SagiPlan's Function: SagiPlan is a software system used for treatment planning in brachytherapy. It uses medical images and user input to calculate radiation doses and plan the delivery of radiation to a target volume within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "creation of treatment plans for remote afterloader based HDR brachytherapy" and "calculating a proposed treatment course based on imported clinical images and other user entered data." This is a therapeutic planning function, not a diagnostic one based on in vitro analysis.
Therefore, SagiPlan falls under the category of medical device software used for treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.
SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
SagiPlan 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 manually 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) remote afterloaders.
The main use of SagiPlan 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).
SagiPlan can reconstruct one or more applicators.
Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device.
The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.
The SagiPlan System comprises subjoined listed subsystems:
- . Personal Computer to execute the SagiPlan 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 SagiPlan software and runs under 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Clinical images, X-Ray image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals / 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Eckert & Ziegler BEBIG GmbH % Mr. Hub van de Bergh Consultant OA & RA Medical Devices Traceability QA & RA Services Muurzwaluw 30 3905 RZ Veenendaal THE NETHERLANDS
Re: K141900
Trade/Device Name: SagiPlan Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide Applicator system Regulatory Class: II Product Code: MUJ Dated: April 24, 2015 Received: April 27, 2015
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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
echon D'Hara For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141900
Device Name SagiPlan
Indications for Use (Describe)
SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.
SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Eckert & Ziegler logo. The logo consists of a pink oval shape with a white outline, placed between two pink rectangles. To the right of the shapes, the text "Eckert & Ziegler" is written in black.
7 510(k) Summary as required by 21 CFR 807.92
Submitter of 510(k) 7.1
| 510(k) owner's name
address | : | Eckert & Ziegler BEBIG GmbH
Robert-Rössle-Strasse 10
13125 Berlin
Germany |
|--------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------|
| phone | : | +49 30 94 10 84 119 |
| fax | : | +49 30 94 10 84 112 |
| company's contact person | : | Michel Lafuente |
| For this 510(k) submission
name of contact person (consultant)
e-mail
date the summary was prepared | : | Hub van de Bergh
hubvandebergh@gmail.com
June 30, 2014 |
Device: SaqiPlan 7.2
name of the device / trade or proprietary name: SagiPlan common or usual name: Brachytherapy Treatment Planning System classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)
7.3 Legally Marketed Device(s)
SagiPlan can be shown to be substantial equivalent to the legally marketed predicate device cited in the table below.
| Device | Manufacturer | 510(k) # |
|---|---|---|
| HDRplus | Eckert & Ziegler BEBIG GmbH | K123263 |
Description of the Device 7.4
7.4.1 SagiPlan
SagiPlan 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 manually 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) remote afterloaders.
The main use of SagiPlan 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).
SaqiPlan can reconstruct one or more applicators.
Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device.
The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.
Eckert & Ziegler BEBIG GmbH
SagiPlan 510(k) PMN Section 7: 510(k) Summary
Robert-Rössle-Straße 10 13125 Berlin Germany
Phone +49 30 941084119 +49 30 941084112 Fax e-mail : info@bebig.eu
Company Confidential
4
Image /page/4/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon rectangle with a maroon oval inside of it. To the right of the shape is the company name, "Eckert & Ziegler".
The SagiPlan System comprises subjoined listed subsystems:
- . Personal Computer to execute the SagiPlan 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 SagiPlan software and runs under 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.
7.4.2 Accessory: Film Scanner
The Film Scanner allows the user to read an X-Ray image to present it on the screen to visualise the brachytherapy applicator implant.
7.4.3 Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.
Accessory: Pen Tablet 7.4.4
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.
7.4.5 Accessory: Touch Panel
The Touch Panel acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.
7.5 Intended use of the Device
SagiPlan is used for the creation of treatment plans for High Dose Rate remote afterloader based brachytherapy. SagiPlan calculates a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses.
7.6 Technological characteristics of device compared to the predicate device
The SagiPlan Brachytherapy Treatment Planning System has the same technological characteristics as the legally marketed predicate device from which it is derived and listed above which is cleared under 510(k) #K123263.
The SagiPlan technology is based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry. A film scanner is used to read available medical images. Optionally a frame grabber may be used with SagiPlan for capturing video images electronically. SagiPlan is designed to run in a Microsoft Windows run-time environment.
7.7 Substantial Equivalence
From the discussion in previous paragraphs it can be concluded that the SagiPlan Brachytherapy Treatment Planning System has the same technological characteristics compared to the legally marketed predicate device indicated in section 7.3.
The differences between SagiPlan and predicate device do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device.
The intended use of SagiPlan and predicate device are the same.
The conclusion is that SagiPlan is substantial equivalent to the legally marketed predicate device.
Eckert & Ziegler BEBIG GmbH
SagiPlan 510(k) PMN Section 7: 510(k) Summary
Robert-Rössle-Straße 10 13125 Berlin Germany
Phone +49 30 941084119 Fax +49 30 941084112 e-mail : info@bebig.eu
Company Confidential
Doc ID 0011-0008 | Rev 0 | Date June 30, 2014 | page 23 / 62