Sensus TPS Workstation

K182665 · Sensus Healthcare, Inc. · MUJ · Feb 21, 2019 · Radiology

Device Facts

• Record ID: K182665
• Device Name: Sensus TPS Workstation
• Applicant: Sensus Healthcare, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Feb 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

Device Story

Sensus TPS Workstation is a software suite for intraoperative radiation therapy (IORT) planning. Inputs include patient medical images, user-defined parameters, and calibration/beam modeling data from the Sensus IORT System. The system uses a dose calculation engine (DCE) to perform volumetric dose distribution calculations based on pre-calculated Monte Carlo simulations. A global optimization algorithm determines the combination of operating points to match target dose distributions. Outputs include treatment plans with dose distributions, 3D reconstructions, and isodose visualizations. Used in clinical radiation oncology facilities by trained staff. The software runs on an iPad Pro (GUI) and PC-based daemons (DCE/MIE) and a node.js routing server. Clinicians review and approve plans before delivery to the IORT system. Benefits include accurate treatment setup parameters and dose estimation to support safe radiation delivery.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed system performance against design requirements. Fidelity testing compared treatment plan-to-beam generation, benchmarking computational output against measured beam output and yield from the Sensus IORT x-ray source. Results demonstrated accurate and consistent beam/dose output.

Technological Characteristics

Software-only system. Architecture includes an iPad Pro GUI, PC-based daemons (Linux/Windows) for dose calculation and image processing, and a node.js routing server. Dose calculation uses pre-calculated Monte Carlo simulations. Complies with IEC 62304 (software lifecycle) and ISO 14971 (risk management).

Indications for Use

Indicated for treatment planning and analysis of intraoperative radiation therapy in patients undergoing treatment with the Sensus IORT System. Intended for use by clinically qualified radiation therapy 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

• Radiance V4 (K171885)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Sensus Healthcare, Inc. Nicolas Soro QA/RA Manager 851 Broken Sound Parkway NW Suite 215 Boca Raton, Florida 33487

February 21, 2019

Re: K182665

Trade/Device Name: Sensus TPS Workstation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 17, 2019 Received: January 22, 2019

Dear Nicolas Soro:

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 Mav 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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182665

Device Name Sensus TPS Workstation

#### Indications for Use (Describe)

Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy.

The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

[As Required by 21 CFR 807.92(c)]

| Submitter's Name & Address: | Sensus Healthcare<br>851 Broken Sound Parkway NW<br>Suite 215<br>Boca Raton, FL 33487 |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Kal Fishman, COO<br>Telephone [phone]<br>Fax [phone]<br>[e-mail]) |
| Date Summary Prepared: | January 16, 2019 |
| Device Name: | Trade/Proprietary Name – Sensus TPS Workstation |
| | Common/Usual Name – Treatment Planning Station |
| | Classification Name – Medically Charged-Particle<br>Radiation Therapy |
| Predicate Device: | Radiance V4 (K171885) |
| Reference Device: | N/A |

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### Device Description:

The Sensus TPS Workstation is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for radiation oncology facilities. For radiation oncology users, the TPS Workstation provides image-enabled electronic patient charting and record management. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, beam geometry planning, treatment plan review, and verification and record treatment setup and delivery. The Sensus Healthcare TPS Workstation is dedicated for use with the Sensus Healthcare IORT System only. The software is not a general-use product compatible with other IORT systems.

# Indications for Use:

Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy.

The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

The intended user of Sensus TPS Workstation shall be clinically qualified radiation therapy personnel trained in using the system.

#### Prescriptive Statement

Caution: Federal law restricts this device to sale by or on the order of a physician.

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### Technological Characteristics/Principles of Operation - System Architecture

From a system architecture standpoint, the basis for the functionality of TPS Workstation is as follows.

### Architectural Design

The complete functionality of the TPS Workstation is achieved by partitioning the responsibilities of the system and assigning them to subsystems. The following diagram depicts the subsystems and their inter-relationships.

Image /page/5/Figure/4 description: The image shows a block diagram of the TPS components. The components include the user, graphical user interface, medical images engine, dose calculation engine, routing server, and sensus robotic IORT system. The graphical user interface is connected to the user, medical images engine, dose calculation engine, and routing server. The medical images engine, dose calculation engine, and routing server are connected to the TPS components.

The following modules are the subsystems associated with the TPS Workstation.

### Graphical User Interface

The software that is used to create the GUI is in the form of an iOS application running

on an iPad Pro. The responsibilities of this subsystem are:

- Communicate with the routing server to access the DB; ●
- List the required medical records to do the treatment planning: ●
- Provide graphical representation of the radiation source target; o
- Request medical images from MIE; ●
- Request dose calculations from DCE; ●

### 510(k) Summary (Sensus Healthcare - TPS Workstation)

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- o Provide multi planar medical viewer for the generated isodose;
- Provide graphical tools for contouring;
- Present 3D reconstruction of selected isosurfaces; and ●
- Send treatment plan to the IORT system.

## Dose Calculation Engine

The software that is used to create the DCE is in the form of daemon running on PC. It was designed to work on both Linux and Windows OS. The responsibilities of this subsystem are:

- Receive requests from the GUI; o
- o Perform volumetric dose distribution calculations; and
- o Provide calculated data to the GUI.

## Medical Images Engine

The software that is used to create the MIE is in the form of daemon running on PC. It was designed to work on both Linux and Windows OS. The responsibilities of this subsystem are:

- o Receive requests from the GUI:
- Perform interpolation on the medical image; and ●
- . Provide medical image to the GUI.

## Routing Server

The software that is used to create the Routing Server is in the form of node.js web service running on a PC. The responsibility of this subsystem is to provide an interface to access the DB of the IORT system.

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#### Non-Clinical Performance Testing:

The Sensus TPS Workstation has undergone thorough design verification and validation testing in accordance with the test protocols listed in Table 1 below. Verification and validation tests were written based on the full system requirements specifications and executed to ensure that the system was functioning in accordance with its design parameters.

The TPS Workstation underwent code Static Analysis and Cyclomatic Complexity, Unit Testing, and System Integration Testing. The software passed all of the requirements determined in the testing procedures.

Performance testing consisted of bench testing that has demonstrated that the performance of the TPS Workstation provided the same technical capabilities as the predicate device. Performance testing was executed to validate the operational characteristics associated with the TPS Workstation as defined in the System Requirements Specification (SRS). The TPS Workstation passed all performance testing, and premised on the test results, supports Sensus Healthcare's claims of system performance and equivalency.

### Non-clinical Safetv Tests:

The TPS Workstation verification and validation testing included various safety testing to ensure the device fulfilled all of the System Requirements Specifications. These V&V tests included test cases such as: locking down treatment plans to prevent unauthorized/erroneous modifications, approval and disapproval of treatment plans, user authentication and access level control, data integrity and management, and proper communication between the TPS Workstation and the Sensus IORT System.

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The TPS Workstation was developed in accordance with IEC 62304 Medical device software – Software life cycle processes to ensure proper design and development to all aspects of patient, operator, and device safety. A hazards analysis, risk assessment, and cybersecurity risk assessment were performed to ISO 14971 and FDA Guidance for Management of Cybersecurity in Medical Devices to identify and mitigate any potential causes that may be introduced that lead to a hazard.

The TPS Workstation underwent a comprehensive treatment plan-to-beam generation fidelity testing, which included the generation of several test treatment plans, benchmarking those treatment plans' output yield and results with the DCE's computational engine output and results, and then uploading those test treatment plans to the Sensus IORT System and measuring the actual beam output and yield from the system's x-ray source. The test results gathered proved that the TPS Workstation's performance and treatment plans generation yield accurate and consistent beam output and dose output, which further demonstrates its safety and clinical efficacy.

The TPS Workstation passed all safety testing, and premised on the test results, supports Sensus Healthcare's claims of system safety and efficacy.

## Test Standards Employed

Table 1 delineates the testing standards employed by Sensus Healthcare during the design and development of the TPS Workstation.

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| Document/Protocol | Name |
|-------------------|----------------------------------------------------------------------------------------------------|
| ISO 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices -- Application of risk management to medical devices |
| 6-2-7380-0000 | TPS Software Verification Validation Test Plan |
| 6-2-7381-0000 | TPS Software System Integration Testing |
| 6-2-7390-0000 | Static Analysis Report Summary |
| 6-2-7391-0000 | Unit Testing Report Summary |
| SEN18940_RPT | Comparison of the measured dose and the dose calculated by the radiation treatment planning system |

## Table 1 Test Standards & Protocols Employed

### Test Results

Table 2 delineates the test results obtained as a result of executing each test protocol.

### Table 2 Test Results

| Document/Protocol | Date Testing Performed | Results<br>(Pass/Fail) |
|-------------------|------------------------|------------------------|
| 6-2-7380-0000 | 1/16/2019 | Pass |
| 6-2-7381-0000 | 1/16/2019 | Pass |
| 6-2-7390-0000 | 1/16/2019 | Pass |
| 6-2-7391-0000 | 1/16/2019 | Pass |

#### Substantial Equivalence Conclusion Statement

The Sensus TPS Workstation has the same intended use as the predicate device. Any technological changes to the device do not raise new questions of safety or effectiveness. Performance testing, along with verification activities demonstrate that the Sensus Healthcare TPS Workstation is as safe and effective, and performs as well as the predicate device. Therefore, the Sensus Healthcare TPS Workstation can be considered substantially equivalent to the predicate device.

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| Attributes | Sensus<br>TPS Workstation<br>(K182665) | Radiance V4<br>(K171885) | Discussion |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sensus Healthcare | GMV Soluciones<br>Globales Internet S.A.U. | --- |
| Classification | 21 CFR 892.5050 | 21 CFR 892.5050 | Equivalent |
| Product Code | MUJ | MUJ | Equivalent |
| Indications for Use | Sensus TPS Workstation<br>is a software system<br>intended for treatment<br>planning and analysis of<br>intraoperative radiation<br>therapy administered with<br>the Sensus IORT System,<br>a device suitable for<br>intraoperative<br>radiotherapy.<br>The treatment plans<br>provide treatment unit set-up<br>parameters and<br>estimates of dose<br>distributions expected<br>during the proposed<br>treatment, and may be<br>used to administer<br>treatments after review<br>and approval by the<br>intended user. The system<br>functionality can be<br>configured based on user<br>needs.<br>The intended users of<br>Sensus TPS Workstation<br>shall be clinically<br>qualified radiation therapy<br>staff trained in using the<br>system. | Radiance V4 is a software<br>system intended for<br>treatment planning and<br>analysis of intraoperative<br>radiation therapy<br>administered with devices<br>suitable for intraoperative<br>radiotherapy.<br>The treatment plans<br>provide treatment unit set-up<br>parameters and<br>estimates of dose<br>distributions expected<br>during the proposed<br>treatment, and may be<br>used to administer<br>treatments after review<br>and approval by the<br>intended user. The system<br>functionality can be<br>configured based on user<br>needs. The intended users<br>of Radiance V4 shall be<br>clinically qualified<br>radiation therapy staff<br>trained in using the<br>system. | Equivalent |
| System Design | Software only | Software only | Equivalent |
| Calculation for electrons | N/A | Dose distributions<br>computed<br>using a three dimensional<br>dose<br>engine.<br>Pencil Beam computation<br>and<br>Monte Carlo Computation<br>for<br>electrons | Although the predicate is<br>compatible with both<br>IORT and IOERT devices,<br>the Sensus Healthcare TPS<br>Workstation is only<br>compatible with the Sensus<br>IORT device, and so does<br>not support calculations for<br>electrons. |
| Calculation for photons | Use of pre-calculated<br>Monte Carlo simulations<br>for the Sensus IORT<br>System | Dose Painting (Planning<br>calculation interpolation<br>of PDD<br>measurements) and<br>Hybrid Monte Carlo<br>computation<br>for INTRABEAM. | A set of Monte Carlo<br>simulations has been<br>performed to predict the<br>dose distribution produced<br>by each operating point of<br>the Sensus IORT device<br>with high accuracy. These<br>pre-calculated dose |
| Attributes | Sensus<br>TPS Workstation<br>(K182665) | Radiance V4<br>(K171885) | Discussion |
| Input | Externally acquired<br>patient medical images<br>and user input. Calibration<br>files and beam modeling<br>measurements for Sensus<br>IORT System | Externally acquired<br>patient medical images<br>and user input.<br>Calibration files and beam<br>modeling measurements<br>for INTRABEAM | Equivalent |
| Output | Treatment plans with<br>corresponding dose<br>distributions | Treatment plans with<br>corresponding dose<br>distributions | Equivalent |
| Plan review and approval | Allows electronic<br>approval of treatment<br>plans by trained and<br>authorized staff | Allows electronic<br>approval of treatment<br>plans by trained and<br>authorized staff | Equivalent |
| Dose calculation<br>algorithm confirmation | Algorithms confirmed for<br>a wide<br>variety of field<br>geometries,<br>treatment units, treatment<br>setups<br>and patient positions,<br>including<br>different dose grid<br>resolution<br>settings. | Algorithms confirmed for<br>a wide<br>variety of field<br>geometries,<br>treatment units, treatment<br>setups<br>and patient positions,<br>including<br>different dose grid<br>resolution<br>settings. | Equivalent |
| Beam modeling tool | Beam modeling of the<br>treatment<br>unit based on relative<br>measurements and output<br>factors. | Beam modeling of the<br>treatment<br>unit based on relative<br>measurements and output<br>factors. | Equivalent |
| distributions are used by<br>the Sensus Healthcare TPS<br>Workstation to calculate<br>the combination of<br>operating points that most<br>closely matches the target<br>treatment dose distribution.<br>This calculation is<br>performed using a global<br>optimization algorithm. | | | |

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