(37 days)
No
The description focuses on standard treatment planning calculations and image processing tools, with no mention of AI or ML algorithms for tasks like automated contouring, dose optimization using learning models, or predictive analytics.
No
The device is a treatment planning system for brachytherapy, which is used by medical professionals to calculate a proposed treatment course and optimal dose distribution. It does not directly provide therapy or interact with the patient.
No.
Flexiplan is a treatment planning system that calculates radiation doses for brachytherapy based on imported clinical images and user-entered data. It does not diagnose diseases or medical conditions.
No
While the core functionality is software, the device description explicitly states that the "Flexiplan System comprises subjoined listed subsystems" which include a Personal Computer, Monitor, Keyboard, and Mouse. These are hardware components that are part of the described system.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Flexiplan's Function: Flexiplan is a treatment planning system for brachytherapy. It uses clinical images and user-entered data to calculate a radiation treatment plan. It does not analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's for "creation of HDR or PDR treatment plans for remote afterloader based brachytherapy." This is a therapeutic planning function, not a diagnostic one based on in vitro analysis.
- Device Description: The description focuses on software for calculating radiation doses and optimizing treatment delivery, not on analyzing biological samples.
Flexiplan is a medical device, specifically a treatment planning software, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.
Product codes
MUJ
Device Description
Flexiplan 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 the input entered by the operator. 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 software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk.
The main use of Flexiplan is to calculate the required dwell times at the pre – determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the pescribed dose while sparing the Organs At Risk (OAR).
Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan 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 Flexiplan to the Afterloader.
The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device.
The Flexiplan System comprises subjoined listed subsystems:
- Personal Computer . It executes the Flexiplan 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 Flexiplan software and runs under Windows XP Professional or Vista. 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.
Accessories:
- Frame Grabber: Allows for direct input of a video signal as available from Ultra Sound Imaging Devices in order to present the image on the screen to visualise the implant.
- Film Scanner: Allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.
- Printer: Allows for hard copy of the patients treatment plan and other stored data.
- Pen Tablet: Acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.
- Touch Panel: Acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.
Mentions image processing
The software offers tools to enhance imported images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
clinical images, Ultra Sound Imaging Devices, X-Ray image
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/0 description: The image shows a symbol and text related to isodose control. The symbol on the left consists of three concentric circles, with a small circle in the center and two larger circles surrounding it. To the right of the symbol, the text "isodose control" is written in a bold, sans-serif font.
KC91145
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6. 510(k) Summary as required by 21 CFR 807.92
6.1. Submitter of 510(k)
| 510(k) owner's name
address | Isodose Control BV
Maxwellstraat 16
6716 BX Ede
The Netherlands |
|--------------------------------|--------------------------------------------------------------------------|
| phone | +31 318 502950 |
| fax | +31 318 502528 |
| name of contactperson | Hub van de Bergh |
| e-mail | hvandebergh@isodosecontrol.com |
| date the summary was prepared | April 7, 2009 |
6.2. Device: Flexiplan
name of the device / trade or proprietary name: Flexiplan common or usual name: Brachytherapy Treatment Planning System classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)
6.3. Legally Marketed Device(s)
The Flexitron device can be shown to be substantial equivalent to the legally marketed devices cited in the table below.
| Device | Manufacturer | 510(k) # |
|---|---|---|
| Flexiplan | Isodose Control BV | K081112 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
6.4. Description of the Device
6.4.1. Flexiplan
Flexiplan 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 the input entered by the operator. 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 software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk.
The main use of Flexiplan is to calculate the required dwell times at the pre – determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the pescribed dose while sparing the Organs At Risk (OAR).
Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan 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 Flexiplan to the Afterloader.
The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device.
Company Confidential
1
Image /page/1/Picture/0 description: The image shows a symbol and the text "Isodose control". The symbol is a circle with three concentric circles inside it. The text is in a sans-serif font and is aligned to the right of the symbol.
K091145
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The Flexiplan System comprises subjoined listed subsystems:
- Personal Computer . It executes the Flexiplan 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 Flexiplan software and runs under Windows XP Professional or Vista. 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.
6.4.2. Accessory: Frame Grabber
The Frame Grabber allows for direct input of a video signal as available from Ultra Sound Imaging Devices in order to present the image on the screen to visualise the implant.
6.4.3. 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.
6.4.4. Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.
6.4.5. 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.
6.4.6. 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.
6.5. Intended use of the Device
The Flexiplan is used for the creation of treatment plans for High Dose Rate and Pulsed Dose Rate remote afterloader based brachytherapy. Flexiplan will calculate a proposed treatment course based on imported clinical images and other user entered data. Flexiplan also supports the evaluation of clinical images in calculating the local and global doses.
6.6. Technological characteristics of device compared to the predicate device
The Flexiplan V2.5 Brachytherapy Treatment Planning System has the same technological characteristics as the unmodified device which is cleared onder 510(k) # K08112.
The same as the unmodified device Flexiplan V2.5 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 Flexiplan V2.5 for capturing video images.
Company Confidential
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Kc91145
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Image /page/2/Picture/1 description: The image shows a symbol and the words "Isodose control". The symbol is a circle with two smaller circles inside it. The words "Isodose control" are written in a sans-serif font.
6.7. Substantial Equivalence
The modified Flexiplan software has the following similarities to the version that previously received 510(k) clearance.
- the same intended use, .
- the same operating principle, .
- . the same technological characteristics.
The differences between Flexiplan V2.5 and its cleared predecessor version do not concern the basic principle of operation nor does it adversely affects the safety or effectiveness of the device.
The conclusion is that Flexiplan V2.5 is, in our opinion, substantially equivalent to the previously cleared unmodified predecessor Flexiplan version.
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Image /page/3/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which includes a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem, indicating the organization it represents.
DEPARTMENT OF HEALTH & HUMAN SERVICES.
MAY 2 7 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Mr. Hub van de Bergh QA & RA Officer Isodose Control BV Maxwellstraat 16 Ede, 6716 BX THE NETHERLANDS
Re: K091145
Trade/Device Name: Flexiplan V2.5 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: MUJ Dated: April 10, 2009 Received: April 27, 2009
Dear Mr. Hub 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 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.
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Page 2 ·
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr1.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Isodose control
1091145 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ Flexiplan V2.5
Indications for Use:
Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.
Prescription Use (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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Company Confidential
Section 5: Indications for Use Statement - page 2 of 2 060-5003-20090407i_Flexiplanv2-5_510(k)PMNs
Isodose Control B.V. @ Maxwellstraat 16, 6716 BX Ede @ The Netherlands 431 318 502950 · & +31 318 502528 @@ info@isodosecontrol.com · KvK: 30191600 www.isodosecontrol.com