(63 days)
CDMS is a Microsoft Windows based software application designed to record and manage physics data acquired during acceptance testing, commissioning and calibration of radiation therapy treatment devices. In addition, CDMS uses the same physics data to allow users to perform MU calculations based on treatment field parameters that are either imported from the treatment planning system or entered manually. CDMS is also used to manage linac calibration using standard protocols.
CDMS is a software program designed to record radiation beam data acquired during the commissioning, acceptance testing and calibration of a radiation therapy treatment device.
The provided text describes the D3 Radiation Planning's CDMS (Commissioning Data Management System). Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets and the reported device performance against those targets. Instead, it relies on a "side by side comparison" of monitor unit/dose calculations and linear accelerator calibration against established protocols (AAPM Task Group 51 and 40) as evidence of substantial equivalence to predicate devices (RadCalc V4.0 and IMSure).
The non-clinical tests involved:
- Importing measured physics data.
- Performing numerous monitor unit/dose calculations.
- Calibrating a linear accelerator according to TG-51.
The conclusion states that "Side by side comparison tables are shown in the supporting Validation & Verification documentation," implying that the device's calculations and data management capabilities were found to align with the expected performance as defined by these existing radiation therapy physics standards and predicate devices.
Implied Acceptance Criteria (based on comparison to predicate devices and standards):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accurate monitor unit/dose calculations (comparable to predicates and established physics data) | "Performed numerous monitor unit/dose calculations" showed "side by side comparison tables" match supporting Validation & Verification documentation. |
| Accurate linear accelerator calibration management (according to AAPM TG-51 and TG-40) | "Calibrated a linear accelerator according to TG-51." |
| Effective management of physics data (recording, storage, accessibility) | "Allowed for proper storage of calibration parameters as well as better management of calibration reports." |
| Substantial equivalence to predicate devices (RadCalc V4.0 and IMSure) | Concluded to be substantially equivalent based on intended use, technological characteristics, and non-clinical testing. |
Study Information
Due to the nature of the device (software for data management and calculation, not directly involved in patient treatment delivery), the study conducted was non-clinical.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the "numerous monitor unit/dose calculations" or the calibration tests. It refers to "measured physics data" being imported, suggesting the use of real-world or simulated clinical data.
- Data Provenance: Not explicitly stated, but the mention of "measured physics data acquired during the commissioning, acceptance testing and calibration of a radiation therapy treatment device" implies that the data would be typical of those used in radiation oncology departments. The comparison to "peer reviewed/published or manufacturer provided measured values" suggests a mix of external and internal data sources. It is implicitly retrospective as it involves existing measured physics data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth appears to be based on established physics principles (Khan (Classical) algorithm), "peer reviewed/published or manufacturer provided measured values," and compliance with American Association of Physicists in Medicine (AAPM) Task Group 51 and 40 recommendations. These are considered authoritative sources in medical physics.
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Adjudication method for the test set:
- Not applicable as it was not a reader study. The "adjudication" was effectively a comparison against established physical models, measured data, and existing predicate device performance (RadCalc V4.0 and IMSure).
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted. This device is a software tool for physics data management and calculation, not an AI-assisted diagnostic or interpretive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The non-clinical tests involved CDMS (the algorithm) importing data and performing calculations. The evaluation was of the software's output against known physical parameters and established methods, hence standalone performance. Human input is for data entry and reviewing results, but the core calculation is algorithmic.
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The type of ground truth used:
- Expert Consensus/Established Standards: The ground truth for calculations and calibration was based on:
- The Khan (Classical) algorithm for MU calculation.
- "Peer reviewed/published or manufacturer provided measured values."
- Recommendations from AAPM Task Group 51 (for linac calibration) and AAPM Task Group 40 (for monthly QA parameters).
- Comparison to the performance of predicate devices (RadCalc V4.0 and IMSure).
- Expert Consensus/Established Standards: The ground truth for calculations and calibration was based on:
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The sample size for the training set:
- This is not an AI/machine learning device that requires a training set in the conventional sense. The software uses established physics algorithms (e.g., Khan (Classical) algorithm) which are programmed based on physical laws and validated against measured data, rather than "trained" on a dataset. The "measured physics data" mentioned are used as input for calculations and management, not for training a model.
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How the ground truth for the training set was established:
- Not applicable, as it's not a machine learning device. The algorithms are based on established scientific principles and formulas in radiation physics.
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X082606
5-2
510(k) Summary
This summary is submitted in compliance with 21 CFR 807.92
NOV 1 0 2008
| (a) (1) Submitted by: | D3 Radiation Planning5750 Centre Avenue, Suite 500Pittsburgh, PA 15206 |
|---|---|
| Trade name of the company: | D3 |
| Contact Persons: | Nabil Adnani, Ph.D, DABR412-365-0743 |
| Date of preparation: | 26 August - 2008 |
| (2) Trade name of device: | CDMS |
| Common name: | Commissioning Data Management System |
| Classification name: | (Accessory to) Radionuclide radiationtherapy, §892.5750; X-ray radiation therapysystem, §892.5900; and Medical charged-particle radiation therapy system,§892.5050. |
| (3) Identification of predicateMarketed device: | K010464 RadCalc V4.0. |
(4) Device Description:
CDMS is a software program designed to record radiation beam data acquired during the commissioning, acceptance testing and calibration of a radiation therapy treatment device.
IMSure.
A CDMS session would look like this:
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- A new treatment machine is installed. The commissioning physicist enters its technical specification in CDMS.
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- A third party FDA approved water phantom is used to measure the physics characteristics of each beam generated by the machine.
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- Measured physics data is imported to CDMS.
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- Measured data in CDMS is compared to peer reviewed/published or manufacturer provided measured values.
- Treatment plans generated by a radiation therapy treatment 5. planning system imported to CDMS via DICOM RT.
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- Imported treatment fields parameters are used in conjunction with CDMS stored measured physics data to calculate dose and/or monitor units.
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- The difference between planned and CDMS calculations is used as a measure of the quality of the treatment plan (QA).
The above workflow is only given as an example to illustrate how the application is used. Other steps may be added to the workflow or may be left out, for example performing a query of the measured physics data based on beam type, energy and field geometry and saving calibration parameters for use on a monthly QA basis.
Intended Use: (5)
CDMS is a Microsoft Windows based software application designed to record and manage physics data acquired during acceptance testing, commissioning and calibration of radiation therapy treatment devices. In addition, CDMS uses the same physics data to allow users to perform MU calculations based on treatment field parameters that are either imported from the treatment planning system or entered manually. CDMS is also used to manage linac calibration using standard protocols.
(6) Technological Comparison:
The intended use of CDMS is the same as the predicate devices with a few additions that do not affect the safety and effectiveness of the device.
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:
| System Component | LifeLine Sofware, Inc.RadCalc, Model V.4.0 | D3 Advanced Planning ServiceCDMS |
|---|---|---|
| K number | K010464 | This filing |
| Application (use) | Utilized for the determination ofmonitor units or dose. Serves tovalidate those monitor units computedby the primary radiation therapyplanning system. Primary means ofcalculating monitor units in situationswhere the physician does not order theuse of a radiation therapy treatmentplan. | Independent dose and monitor unitcalculations for imported treatmentplans from a radiation therapytreatment planning system. Performsmonitor unit calculations for simpleplan geometries based on a physicianprescribed dose. It also records andmanages measured beam data duringacceptance testing, commissioning andcalibration of radiation therapy devices. |
| Platform | Minimum Pentium II processor, MFSnetwork enabled | Minimum Pentium II processor |
| Operating System | Any MS Windows | Windows 2000, XP, VISTA |
| MU Calculation DoseAlgorithm | Khan (Classical) | Khan (Classical) |
| Algorithm - mapverification | Single Source model | Not Available |
| Algorithm - IMRTdose Calculation | Single Source model, Clarksonscatter algorithm based onUniversity of Chicago method | Not Available |
| Patient GeometrySpecification | Two dimensional, graphical userinterface based | Two dimensional, graphical userinterface based |
| Machines supported | Commercially available LinearAccelerators with multi-modalityenergies and both photon and electronparticles, including field blocking andlinear wedge applicators for photonfluence modulation, and with 52, 80,120 leaf Multi-leaf collimators | Commercially available LinearAccelerators with multi-modalityenergies and both photon and electronparticles, including field blocking andlinear wedge applicators for photonfluence modulation, and with 52, 80,120 leaf Multi-leaf collimators |
| Calculation Point for IMRTQA | Fixed, Iso-centric | Not Available |
| Calculation point for MUcalculations | Off axis and depth specified calculationpoints using measured physical data. | Off axis and depth specified calculationpoints using measured physical data. |
| Physics data | Measured, tabular database stored,multiple linear accelerators allowed. | Measured, tabular database stored,multiple linear accelerators allowed. |
| Import data | RTP link, DICOM RT for IMRT QAand MU Calculations | DICOM RT for independent MUCalculations |
| Network location for measured data. | ||
| Calibration methods | Iso-centric or fixed CalibrationDistance | Iso-centric or fixed CalibrationDistance. |
| Export Data | RTP link, DICOM RT, paperdocumentation | Paper or electronic in the form of word,excel or PDF document. |
| User security | Two levels of user, password enabled | Three levels of users, password enabled |
| System Component | Standard Imaging, Inc.IMSure | D3 Advanced Planning ServiceCDMS |
| K number | K031975 | This filing |
| Application (use) | Independent dose and fiuence mapverification software for IntensityModulated Radiation Therapy based onLinear accelerator plans containingmulti-leaf collimator leaf sequence dataand fluence maps from primary IMRTtreatment planning systems.Independent dose computation softwarefor standard, simple geometry radiationtherapy treatmentplanning and verification of monitorunits based on Linear Acceleratorparameters and physician prescribeddose information. | Independent dose and monitor unitcalculations for imported treatmentplans from a radiation therapytreatment planning system. Performsmonitor unit calculations for simpleplan geometries based on a physicianprescribed dose. It also records andmanages measured beam data duringacceptance testing, commissioning andcalibration of radiation therapy devices. |
| Platform | Minimum Pentium III processor, MFSnetwork enabled | Minimum Pentium II processor |
| Operating System | Windows 2000, XP | Windows 2000, XP, VISTA |
| MU Calculation DoseAlgorithm | Khan (Classical) | Khan (Classical) |
| Algorithm - mapverification | Single Source model | Not Available |
| Algorithm - IMRTdose Calculation | Single Source model, Clarkson scatteralgorithm based on University ofChicago method | Not Available |
| Patient GeometrySpecification | Two dimensional, graphical userinterface based | Two dimensional, graphical userinterface based |
| Machines supported | Commercially available LinearAccelerators with multi-modalityenergies and both photon and electronparticles, including field blocking andlinear wedge applicators for photonfluence modulation, and with 52, 80,120 leaf Multi-leaf collimcators | Commercially available LinearAccelerators with multi-modalityenergies and both photon and electronparticles, including field blocking andlinear wedge applicators for photonfluence modulation, and with 52,80 and120 leafMulti-leaf collimators |
| Calculation Point for IMRTQA | Off-Axis calculation pointsincorporating modeled head scatterinformation and measured fluenceperturbations | Not Available |
| Calculation point for MUcalculations | Off axis and depth specified calculationpoints using measured physical data. | Off axis and depth specified calculationpoints using measured physical data. |
| Physics data | Measured, tabular database stored,multiple linear accelerators allowed. | Measured, tabular database stored,multiple linear accelerators allowed. |
| Import data | RTP link, DICOM RT for IMRT QAand MU Calculations | DICOM RT for independent MUCalculationsNetwork location for measured data. |
| Calibration methods | Iso-centric or fixed CalibrationDistance | Iso-centric or fixed CalibrationDistance. |
| Export Data | RTP link, DICOM RT, paperdocumentation | Paper or electronic in the form of word,excel or PDF document. |
| User security | Three levels of user, password enabled | Three levels of user, password enabled |
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CDMS differs from the predicate devices by allowing for the management linear accelerators calibration according to American Association of Physicists in Medicine (AAPM) Task Group 51. This feature is equivalent to using an excel sheet to perform the required calibration and save the necessary parameters for future use on monthly basis following AAPM Task Group 40 recommendations. It is therefore not seen to be a threat to patient safety and effectiveness. In fact, it is seen as an enhancement because it will allow for proper storage of calibration parameters as well as better management of calibration reports in format that is easily accessible to external auditors, state and federal regulators.
(7) Non-Clinical tests:
The non-clinical tests involved using CDMS to import measured physics data, to perform numerous monitor unit/dose calculations and to calibrate a linear accelerator according to TG-51. Side by side comparison tables are shown in the supporting Validation & Verification documentation
Clinical tests: (8)
Due to the fact that the system is a software application that is not directly involved with patient treatment delivery, no clinical tests were performed.
Conclusion: (9)
According to the intended use, technological characteristics and non-clinical testing, CDMS is substantially equivalent to IMSure and RadCalc, Model V4.0 (the predicate devices). The documentation presented in this submission supports the claim of substantial equivalence.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which is the department's symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2008
Nabil Adnani, Ph.D., DABR Senior Medical Physicist D3 Radiation Planning 5750 Centre Avenue, Suite 500 PITTSBURGH PA 15206
Re: K082606
Trade/Device Name: CDMS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 29, 2008 Received: September 8, 2008
Dear Dr. Adnani:
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.
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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 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 894.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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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/odrh/industry/support/index.html.
Sincerely yours.
hoque Mr. Khang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: CDMS
Indications For Use:
CDMS is a Microsoft Windows based software application designed to record and manage physics data acquired during acceptance testing, commissioning and calibration of radiation therapy treatment devices. In addition, CDMS uses the same physics data to allow users to perform MU calculations based on treatment field parameters that are either imported from the treatment planning system or entered manually. CDMS is also used to manage linac calibration using standard protocols.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of OPRH, Office of Device Evaluation (ODE)
Hubert Humer
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082606
§ 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.