XBeam (v2)

K240671 · Xstrahl, Ltd. · MUJ · Dec 4, 2024 · Radiology

Device Facts

• Record ID: K240671
• Device Name: XBeam (v2)
• Applicant: Xstrahl, Ltd.
• Product Code: MUJ · Radiology
• Decision Date: Dec 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

XBeam is standalone dose calculation software for Xstrahl superficial/orthovoltage radiotherapy and surface electronic brachytherapy systems. It calculates beam-on time or monitor units based on user-selected applicator/filter combinations, percent dose depth (PDD) curves, and absolute dose output. Used in clinical environments by medical physicists to validate hand-calculated or treatment planning system (TPS) doses, or as a primary calculation tool. Supports single or parallel-opposed beam parameters. Output is used by clinicians to verify treatment plans or set machine parameters, ensuring accurate dose delivery to patients. Benefits include reduced manual calculation errors and improved quality assurance in radiotherapy workflows.

Clinical Evidence

Bench testing only. Validation included dosimetric accuracy comparisons against hand calculations and RADCalc (v7.3). Results showed maximum difference of 0.7% (attributed to rounding). Measured vs. planned dose agreement was within 3.6% for energies <80kV (uncertainty 5.5%) and within 1.8% for energies >80kV (uncertainty 1.7%).

Technological Characteristics

Standalone dose calculation software. Operates via PDD curve-based algorithms for superficial/orthovoltage radiotherapy. Supports specific Xstrahl hardware (X80, Xstrahl 100/150/200/300). Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability).

Indications for Use

Indicated for patients requiring external beam radiation therapy using Xstrahl superficial, orthovoltage, or surface electronic brachytherapy systems. Intended for use by authorized medical physics personnel.

Regulatory Classification

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.

Predicate Devices

• RADCalc (K193381)

Submission Summary (Full Text)

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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"

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(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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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## 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) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <span style="font-size: 20px;">☑</span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
| <div style="display:flex; align-items:center;"> <span> <span style="font-size: 20px;">☐</span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# K240671

Xstrahl Ltd Unit 2 Maybrook Industrial Estate Maybrook Road, Brownhills, West Midlands, WS8 7DG United Kingdom T [phone] E [e-mail]

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: [phone] [e-mail]

#### 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

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#### 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.

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#### 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 /<br>Indications for Use | The XBeam Software can be used<br>for validating the monitor units or<br>radiation dose to a point that has<br>been calculated by hand or another<br>treatment planning system for<br>external beam radiation<br>therapy. In addition, the XBeam<br>Software can also be used as a<br>primary means of calculating the<br>monitor units or radiation dose to a<br>point for external beam radiation<br>treatments.<br>XBeam is only intended to be used<br>with Xstrahl's superficial and<br>orthovoltage radiotherapy and<br>surface electronic brachytherapy<br>systems. XBeam is intended to be<br>used by authorized personnel<br>trained in medical physics. | 1. RadCalc performs a secondary<br>dose calculation verification on the<br>treatment plan done by the<br>treatment planning software. This<br>is RadCalc's primary function.<br>Radiation therapy systems<br>typically calculate the monitor<br>units needed to deliver the desired<br>amount of radiation to a point of<br>reference within the patient. In this<br>situation, RadCalc will serve to<br>validate those monitor units<br>computed by the primary radiation<br>therapy planning system.<br>Additional verification activities<br>revolve around point dose<br>comparisons, 3D dose evaluation<br>via Gamma analysis, and DVH<br>comparisons. It is not the intention<br>of RadCalc to replace the<br>calculation performed by the<br>primary radiation therapy planning<br>computer but to validate its<br>calculation as a means of quality<br>assurance. The practice of<br>performing a secondary check is<br>recommended by the American<br>Association of Physicists in<br>Medicine (AAPM) Task Group 40<br>as part of a good quality assurance<br>program. This practice is an<br>important aspect in providing<br>quality patient care.<br>2. Import data from the treatment<br>planning software and export the<br>data from the treatment planning<br>system to the verify and record<br>system, which is the device that<br>actually controls the radiation<br>beam. This will reduce the number |
| | of errors that occur as a result of<br>manually inputting this data. | |
| | 3. In addition to performing the<br>secondary dose verification<br>calculation, RadCalc can also be<br>used as the primary means of<br>calculating monitor units in<br>situations where the physician<br>does not order the use of a<br>radiation therapy treatment plan.<br>RadCalc can independently<br>calculate the amount of radiation<br>the beam should produce (called<br>the MU or monitor unit) to deliver<br>to the patient the radiation dose the<br>doctor recommends. This function<br>is usually only used in urgent,<br>emergency situations. | |
| | 4. In addition, RadCalc performs<br>brachytherapy-type calculations.<br>Fo brachytherapy calculations,<br>High Dose Rate<br>(HDR), Low Dose Rate (LDR),<br>and Permanent type treatments can<br>be verified. Verification activities<br>revolve around point dose<br>comparisons, 3D dose evaluation<br>via Gamma analysis, and DVH<br>comparisons. RadCalc is not used<br>as a primary means of calculating<br>patient dose for brachytherapy<br>treatments. | |
| | 5. Analysis affluence and dose<br>maps can be performed via<br>percentage difference, distance to<br>agreement, or gamma analysis<br>methodologies. | |
| | 6.Interoperability with external<br>dose calculation engines (EDCE)<br>by sending them treatment plans<br>and associated information in their<br>necessary format so that the EDCE<br>can perform a 3D dose calculation<br>using its dose calculation<br>algorithm. The computed dose<br>volume is received back and the<br>3D analysis tools described above<br>are used to compare against the<br>treatment planning system. | |
| | Proposed Device<br>XBeam v2 (K240671) | Predicate Device<br>RADCalc (K193381) |
| Product Code | MUJ | MUJ |
| Class | II | II |
| Regulation Number | 21CFR 892.5050 | 21CFR 892.5050 |
| Classification Name | Medical Charged-Particle<br>Radiation Therapy System | Medical Charged-Particle<br>Radiation Therapy System |
| Common Name | System, Planning, Radiation<br>Therapy Treatment | System, Planning, Radiation<br>Therapy Treatment |
| Devices Supported | X80 (RADiant / RADiant Aura),<br>Xstrahl 100, Xstrahl 150, Xstrahl<br>200, Xstrahl 300 | X80 (RADiant / RADiant Aura),<br>Xstrahl 100, Xstrahl 150, Xstrahl<br>200, Xstrahl 300 |
| Treatment Types Supported | | |
| Brachytherapy | No | Yes |
| Superficial /<br>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 /<br>Monitor Units<br>Calculation | Yes | Yes |
| Print Reports | Yes | Yes |
| Beam Data Inputs / Setup | | |
| Machine Type | Yes | Yes |
| Filter (mm) | Yes | Yes |
| HVL (mm) | Yes | Yes…