(268 days)
No
The description details a deterministic dose calculation algorithm based on PDD curves and absolute dose output, with no mention of AI or ML terms or methodologies.
No
The device is a software for dose calculation for radiation therapy, but it does not directly deliver therapy. It assists in planning.
No
The device is a dose calculation software used in radiation therapy planning to determine beam-on time or monitor units. It does not diagnose medical conditions.
Yes
The device is explicitly described as "standalone dose calculation software" and its function is purely computational, calculating treatment parameters based on input data. It does not include any hardware components.
Based on the provided text, the XBeam Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- XBeam's Function: XBeam is a software used for calculating radiation dose and monitor units for external beam radiation therapy. It works with specific radiation therapy machines and is used by medical physicists to plan and validate treatment.
- No Specimen Analysis: The description of XBeam's intended use and device description clearly indicates it does not analyze any biological specimens from a patient. Its function is related to the physical delivery of radiation.
Therefore, XBeam falls under the category of a medical device used in radiation therapy planning and delivery, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments.
XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.
Product codes
MUJ
Device Description
XBeam is a standalone dose calculation software for Xstrahl's medical devices include:
- Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300 (K962613)
- X80 RADiant Photoelectric Therapy System (K172080)
- RADiant Aura (X80 RADiant Photoelectric Therapy System) (K230611)
XBeam's dose calculation algorithm can be used to determine the beam-on time or monitor units based on the applicator and filter selected for the specific device. The beam-on time / monitor units are calculated based on the percent dose depth (PDD) curve and the absolute dose output for the specified applicatorfilter combination. The software allows for calculating treatment parameters for single or two (parallel opposed) beams.
Mentions image processing
Not Found
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
XBeam is intended to be used by authorized personnel trained in medical physics. It is not intended to be used by patients or general public.
XBeam is intended to be used within a clinical environment where the patient is treated with Xstrahl's medical systems.
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)
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards.
Non-clinical testing, including verification of risk control measures, was completed. The details of the design verification and validation activities were performed as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices."
The verification activities included system tests, module tests, anomaly verification, code reviews, and run-through integration tests. Three hundred twenty-three (323) independent verification tests were executed. Tests that failed were re-executed. All the verification tests passed. The validation activities included clinical workflow, treatment planning, software usability, and dosimetric accuracy. The output of the dose calculation algorithm was validated by comparing it against two standard methods: hand calculations and RadCalc (version: 7.3). The results indicated that the output calculated by XBeam was the same as that calculated by hand calculation and by RADCalc. The maximum difference found was 0.7% which can be attributed to interpolation / rounding errors in calculation. The planned dose was also compared to the delivered dose to show that the treatment plan can be accurately delivered. The results indicate that the measured and planned dose values agree to within 3.6% for energies below 80kV. The overall measurement uncertainties were estimated at 5.5%, mainly due to the device used which has a 5% uncertainty on the measured dose. For energies above 80kV, the measured and planned dose values agree to within 1.8%, with measurement uncertainties estimated at 1.7%. This demonstrates that the errors in the measurements made fall largely within the expected uncertainties in the measurements. It also demonstrates that the XBeam-generated treatment times deliver the prescribed dose within the expected uncertainties, to accuracy levels acceptable within the radiotherapy community.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The maximum difference found was 0.7% which can be attributed to interpolation / rounding errors in calculation. The planned dose was also compared to the delivered dose to show that the treatment plan can be accurately delivered. The results indicate that the measured and planned dose values agree to within 3.6% for energies below 80kV. The overall measurement uncertainties were estimated at 5.5%, mainly due to the device used which has a 5% uncertainty on the measured dose. For energies above 80kV, the measured and planned dose values agree to within 1.8%, with measurement uncertainties estimated at 1.7%.
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
December 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
Xstrahl Ltd. Gupta Vineet Chief Technology Officer Unit 2 Maybrook Industrial Estate Maybrook Road Brownhills, West Midlands WS8 7DG United Kingdom
Re: K240671
Trade/Device Name: XBeam (v2) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: March 10, 2024 Received: March 11, 2024
Dear Gupta Vineet:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240671
Device Name XBeam (v2)
Indications for Use (Describe)
The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments.
XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.
| 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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4
K240671
Xstrahl Ltd Unit 2 Maybrook Industrial Estate Maybrook Road, Brownhills, West Midlands, WS8 7DG United Kingdom T +44 (0)1543 688920 E support@xstrahl.com
Xstrahl.com
510(K) SUMMARY
A. SUBMITTERS NAME
Xstrahl Ltd.
FDA Establishment Registration No. 3004561814
B. ADDRESS
Unit 2, Maybrook Industrial Estate Maybrook Road Brownhills, West Midlands WS8 7DG United Kingdom
C. CONTACT
Name: Designation: Vineet Gupta, Ph.D. Phone: Chief Technology Officer Email: (412) 320 5048 vineetgupta@xstrahl.com
D. DATE PREPARED:
03-December-2024
E. DEVICE NAME:
F. DEVICE CLASS:
Device Trade Name: Classification Name: Common Name:
XBeam Medical Charged-Particle Radiation Therapy System System, Planning, Radiation Therapy Treatment
Device Class: Panel: Product Code: Regulation Number:
II Radiology MUI 21CFR 892.5050
5
G. PREDICATE DEVICES:
RADCalc (K193381)
H. STATEMENT ON INDICATIONS FOR USE:
The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation therapy. In addition, the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments.
XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.
I. DEVICE DESCRIPTION:
XBeam is a standalone dose calculation software for Xstrahl's medical devices include:
- Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300 (K962613)
- X80 RADiant Photoelectric Therapy System (K172080)
- . RADiant Aura (X80 RADiant Photoelectric Therapy System) (K230611)
XBeam's dose calculation algorithm can be used to determine the beam-on time or monitor units based on the applicator and filter selected for the specific device. The beam-on time / monitor units are calculated based on the percent dose depth (PDD) curve and the absolute dose output for the specified applicatorfilter combination. The software allows for calculating treatment parameters for single or two (parallel opposed) beams.
XBeam is intended to be used within a clinical environment where the patient is treated with Xstrahl's medical systems. XBeam is intended to be used by authorized personnel trained in medical physics. It is not intended to be used by patients or general public.
J. PREDICATE DEVICE INFORMATION:
The XBeam software is substantially equivalent to its primary predicate device RADCalc (K193381; Decision Date: 31-Dec-2019).
The fundamental scientific technology of XBeam with respect to its predicate device (RADCalc) for dose calculation for Xstrahl's medical devices is the same. The intended use and indications for use of the XBeam software is similar to that of the RADCalc software.
6
K. COMPARISON TO THE PREDICATE DEVICE:
This section provides the summary of comparison of XBeam to its predicate device.
Table 1 Indications for Use Comparison
| Proposed Device | Predicate Device | |
|---|---|---|
| XBeam v2 (K240671) | RADCalc (K193381) | |
| Device Trade Name | XBeam | RADCalc |
| Intended Use / | ||
| Indications for Use | The XBeam Software can be used | |
| for validating the monitor units or | ||
| radiation dose to a point that has | ||
| been calculated by hand or another | ||
| treatment planning system for | ||
| external beam radiation | ||
| therapy. In addition, the XBeam | ||
| Software can also be used as a | ||
| primary means of calculating the | ||
| monitor units or radiation dose to a | ||
| point for external beam radiation | ||
| treatments. | ||
| XBeam is only intended to be used | ||
| with Xstrahl's superficial and | ||
| orthovoltage radiotherapy and | ||
| surface electronic brachytherapy | ||
| systems. XBeam is intended to be | ||
| used by authorized personnel | ||
| trained in medical physics. | 1. RadCalc performs a secondary | |
| dose calculation verification on the | ||
| treatment plan done by the | ||
| treatment planning software. This | ||
| is RadCalc's primary function. | ||
| Radiation therapy systems | ||
| typically calculate the monitor | ||
| units needed to deliver the desired | ||
| amount of radiation to a point of | ||
| reference within the patient. In this | ||
| situation, RadCalc will serve to | ||
| validate those monitor units | ||
| computed by the primary radiation | ||
| therapy planning system. | ||
| Additional verification activities | ||
| revolve around point dose | ||
| comparisons, 3D dose evaluation | ||
| via Gamma analysis, and DVH | ||
| comparisons. It is not the intention | ||
| of RadCalc to replace the | ||
| calculation performed by the | ||
| primary radiation therapy planning | ||
| computer but to validate its | ||
| calculation as a means of quality | ||
| assurance. The practice of | ||
| performing a secondary check is | ||
| recommended by the American | ||
| Association of Physicists in | ||
| Medicine (AAPM) Task Group 40 | ||
| as part of a good quality assurance | ||
| program. This practice is an | ||
| important aspect in providing | ||
| quality patient care. |
- Import data from the treatment
planning software and export the
data from the treatment planning
system to the verify and record
system, which is the device that
actually controls the radiation
beam. This will reduce the number |
| | of errors that occur as a result of
manually inputting this data. | |
| | 3. In addition to performing the
secondary dose verification
calculation, RadCalc can also be
used as the primary means of
calculating monitor units in
situations where the physician
does not order the use of a
radiation therapy treatment plan.
RadCalc can independently
calculate the amount of radiation
the beam should produce (called
the MU or monitor unit) to deliver
to the patient the radiation dose the
doctor recommends. This function
is usually only used in urgent,
emergency situations. | |
| | 4. In addition, RadCalc performs
brachytherapy-type calculations.
Fo brachytherapy calculations,
High Dose Rate
(HDR), Low Dose Rate (LDR),
and Permanent type treatments can
be verified. Verification activities
revolve around point dose
comparisons, 3D dose evaluation
via Gamma analysis, and DVH
comparisons. RadCalc is not used
as a primary means of calculating
patient dose for brachytherapy
treatments. | |
| | 5. Analysis affluence and dose
maps can be performed via
percentage difference, distance to
agreement, or gamma analysis
methodologies. | |
| | 6.Interoperability with external
dose calculation engines (EDCE)
by sending them treatment plans
and associated information in their
necessary format so that the EDCE
can perform a 3D dose calculation
using its dose calculation
algorithm. The computed dose
volume is received back and the
3D analysis tools described above
are used to compare against the
treatment planning system. | |
| | Proposed Device
XBeam v2 (K240671) | Predicate Device
RADCalc (K193381) |
| Product Code | MUJ | MUJ |
| Class | II | II |
| Regulation Number | 21CFR 892.5050 | 21CFR 892.5050 |
| Classification Name | Medical Charged-Particle
Radiation Therapy System | Medical Charged-Particle
Radiation Therapy System |
| Common Name | System, Planning, Radiation
Therapy Treatment | System, Planning, Radiation
Therapy Treatment |
| Devices Supported | X80 (RADiant / RADiant Aura),
Xstrahl 100, Xstrahl 150, Xstrahl
200, Xstrahl 300 | X80 (RADiant / RADiant Aura),
Xstrahl 100, Xstrahl 150, Xstrahl
200, Xstrahl 300 |
| Treatment Types Supported | | |
| Brachytherapy | No | Yes |
| Superficial /
Orthovoltage (kV) | Yes | Yes |
| Tomotherapy | No | Yes |
| Photons (MV) | No | Yes |
| Electrons | No | Yes |
| Workflow Comparison | | |
| Beam Data Input | Yes | Yes |
| Patient Information | Yes | Yes |
| Prescription | Yes | Yes |
| Treatment Time /
Monitor Units
Calculation | Yes | Yes |
| Print Reports | Yes | Yes |
| Beam Data Inputs / Setup | | |
| Machine Type | Yes | Yes |
| Filter (mm) | Yes | Yes |
| HVL (mm) | Yes | Yes |
| Applicator Type | Yes | Yes |
| Focal Spot Distance
(FSD) | Yes | Yes |
| kVp | Yes | Yes |
| mA | Yes | Yes |
| Prescription | | |
| Prescribed Dose (cGy) | Yes | Yes |
| Dose Per Fraction (cGy) | Yes | Yes |
| Number of Fractions | Yes | Yes |
| Number of Beams | 1 and 2 | 1 and 2 |
| Stand Off (cm)
(Optional) | Yes | Yes |
| Backscatter (Optional) | No | Yes |
| Cone / Custom Cutout
(Optional) | Yes | Yes |
7
8
Table 2 General Comparison
9
For the treatment type supported, XBeam supports the required features and workflow steps that are present in the predicate device (K193381).
XBeam's fundamental technical characteristics are the same as those of the predicate device (K193381). In addition, the target population and the indications for use are similar to that of the predicate device (K193381). Any minor differences in the features do not raise any concerns for safety, performance, or effectiveness of the device. The characteristics / features of XBeam with respect to the predicate device is described in the comparison chart above.
L. SUMMARY OF TESTING:
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards.
Non-clinical testing, including verification of risk control measures, was completed. The details of the design verification and validation activities were performed as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices."
The verification activities included system tests, module tests, anomaly verification, code reviews, and run-though integration tests. Three hundred twenty-three (323) independent verification tests were executed. Tests that failed were re-executed. All the verification tests passed. The validation activities included clinical workflow, treatment planning, software usability, and dosimetric accuracy. The output of the dose calculation algorithm was validated by comparing it against two standard methods: hand calculations and RadCalc (version: 7.3). The results indicated that the output calculated by XBeam was the same as that calculated by hand calculation and by RADCalc. The maximum difference found was 0.7% which can be attributed to interpolation / rounding errors in calculation. The planned dose was also compared to the delivered dose to show that the treatment plan can be accurately delivered. The results indicate that the measured and planned dose values agree to within 3.6% for energies below 80kV. The overall measurement uncertainties were estimated at 5.5%, mainly due to the device used which has a 5% uncertainty on the measured dose. For energies above 80kV, the measured and planned dose values agree to within 1.8%, with measurement uncertainties estimated at 1.7%. This demonstrates that the errors in the measurements made fall largely within the expected uncertainties in the measurements. It also demonstrates that the XBeam-generated treatment times deliver the prescribed dose within the expected uncertainties, to accuracy levels acceptable within the radiotherapy community.
Based upon the performance testing results for XBeam, the system is substantially equivalent to its predicate device (RADCalc) and raises no new issues related to safety or effectiveness.
Conclusion:
The verification and validation results demonstrate that the XBeam software met its design requirements and specifications, is substantially equivalent to its predicate device, and conforms to the applicable sections of standards that includes:
- IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices ●
- IEC 62304: Medical device software - Software life cycle processes
- ISO 14971: Medical devices Application of risk management to medical devices ●