(102 days)
Not Found
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 beyond standard algorithms, or predictive modeling.
No
The device is a treatment planning system for brachytherapy, which aids medical professionals in creating a treatment plan. It calculates dose distribution and dwell times but does not directly deliver therapy or perform a therapeutic action.
No
Explanation: Flexiplan is a treatment planning system used for brachytherapy. It calculates a proposed treatment course and the required dose distribution, and evaluates the clinical images for treatment planning. It does not diagnose medical conditions.
No
While the core functionality is software, the device description explicitly includes hardware components (PC, Monitor, Keyboard, Mouse) as part of the "Flexiplan System," and also lists optional hardware accessories (Film Scanner, Printer, Pen Tablet, Touch Panel).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used 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 perform any tests on samples from the human body. Its purpose is to assist medical professionals in planning a therapeutic intervention (radiation therapy), not to diagnose or monitor a disease through in vitro testing.
The device description clearly outlines its role in calculating dose distributions and optimizing treatment plans based on imaging and user input, which falls under the category of medical device software used for treatment planning, not 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 prescribed 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 of the proposed treatment. The therapy planning is then transferred from the 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 / 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:
- 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.
- Printer: The Printer allows for hard copy of the patients treatment plan and other stored data.
- 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.
- 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.
Mentions image processing
The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk.
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
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.
0
KOSIII2
5. 510(k) Summary as required by 21 CFR 807.92
5.1. Submitter of 510(k)
| 510(k) owner's name
address | Isodose Control BV
Maxwellstraat 16
6716 BX Ede
The Netherlands | JUL 29 2008 |
|--------------------------------|--------------------------------------------------------------------------|-------------|
| 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 14, 2008 | |
5.2. 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)
5.3. 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) # |
|---|---|---|
| PLATO BPS | Nucletron B.V. | K983343 |
| BrachyVision | Varian Medical Systems Inc | K992762 |
5.4. Description of the Device
5.4.1. 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 prescribed 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 of the proposed treatment. The therapy planning is then transferred from the Flexiplan to the Afterloader.
The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device.
Company Confidential
Section 5: 510(k) Summary - page 1 of 2 060-5002-20080722c Flexiplan510(k)PMNsubmiss
Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands 2 +31 318 502950 | 김 +31 318 502528 | @ info@isodosecontrol.com | KvK: 30191600 www.isodosecontrol.com
1
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 / 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.
5.4.2. 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.
5.4.3. Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.
5.4.4. 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.
5.4.5. 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.
5.5. 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.
5.6. Technological characteristics of device compared to the predicate device
The Flexiblan Brachytherapy Treatment Planning System has similar technological characteristics compared to the legally marketed predicate devices listed above.
All these devices are based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry.
5.7. Substantial Equivalence
From the discussion in previous paragraphs it can be concluded that the Flexiplan Brachytherapy Treatment Planning System has similar technological characteristics compared to the legally marketed predicate devices listed in paragraph 5.3.
The differences between Flexiblan and predicate devices do not concern the basic principle of operation nor does it adversely affects the safety or effectiveness of the device.
The intended use of Flexiplan and predicate devices are the same.
The conclusion is that Flexiplan is substantial equivalent to the legally marketed predicate devices.
Company Confidential
Section 5: 510(k) Summary - page 2 of 2 060-5002-20080722c Flexiplan510(k)PMNsubmission
Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands ■ +31 318 502950 - 品 +31 318 502528 @ info@isodosecontrol.com KvK: 30191600 www.isodosecontrol.com
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hub van de Bergh Quality Assurance & Regulatory Affairs Officer Isodose Control B.V. PO Box 615, 3900 AP Vcenendaal Landjuweel 11, 3905 PE THE NETHERLANDS
JUL 2 9 2008
Re: K081112
Trade/Device Name: Flexiplan Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: MUJ Dated: April 14, 2008
Received: April 30, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 proceed to the market.
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.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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
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
510(k) Number (if known):
Device Name: ______________________________ Flexiplan
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)
Aont M Wham
(Division Sign Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Company Confidential
Section 4: Indications for Use Statement - page 2 of 2 060-5002-20080722c FiexIplan510/k)PMNsubmisslor
Isodose Control B.V. Maxwellstraat 16, 6716 BX Ede The Netherlands 2 +31 318 502950 8 +31 318 502528 @ info@isodosecontrol.com KvK: 30191600 www.isodosecontrol.com