(149 days)
N/A
No
The document mentions a "global optimization algorithm" but does not explicitly state or imply the use of AI or ML techniques. The description focuses on standard treatment planning software functionalities.
No.
The device is a software system intended for treatment planning and analysis, which directly supports the administration of a therapeutic treatment but is not a therapeutic device itself.
No
This device is a treatment planning system for radiation therapy, which helps in planning and analyzing the delivery of radiation. It does not diagnose medical conditions.
Yes
The device is described as a "software system" and a "multi-functional, integrated software suite." While it is dedicated for use with a specific hardware system (Sensus Healthcare IORT System), the 510(k) summary focuses entirely on the software's functionality for treatment planning and analysis, with no mention of hardware components or hardware-specific verification/validation for the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "treatment planning and analysis of intraoperative radiation therapy." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on features related to radiation oncology management, treatment planning, and beam geometry planning. These are all related to delivering therapy, not diagnosing a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory tests.
The device is clearly a treatment planning system for radiation therapy, which falls under the category of medical devices used for therapeutic purposes.
N/A
Intended Use / 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 users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Externally acquired patient medical images and user input. Calibration files and beam modeling measurements for Sensus IORT System
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinically qualified radiation therapy staff trained in using the system.
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)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Radiance V4 (K171885)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
N/A
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
[As Required by 21 CFR 807.92(c)]
| Submitter's Name & Address: | Sensus Healthcare
851 Broken Sound Parkway NW
Suite 215
Boca Raton, FL 33487 |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Kal Fishman, COO
Telephone (561) 922-5808
Fax (561) 948-2071
kal@sensushealthcare.com) |
| 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
Radiation Therapy |
| Predicate Device: | Radiance V4 (K171885) |
| Reference Device: | N/A |
4
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.
5
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)
6
- 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.
7
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.
5
8
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.
9
| 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
(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.
10
| Attributes | Sensus
TPS Workstation
(K182665) | Radiance V4
(K171885) | Discussion |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sensus Healthcare | GMV Soluciones
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
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. | Radiance V4 is a software
system intended for
treatment planning and
analysis of intraoperative
radiation therapy
administered with devices
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 Radiance V4 shall be
clinically qualified
radiation therapy staff
trained in using the
system. | Equivalent |
| System Design | Software only | Software only | Equivalent |
| Calculation for electrons | N/A | Dose distributions
computed
using a three dimensional
dose
engine.
Pencil Beam computation
and
Monte Carlo Computation
for
electrons | Although the predicate is
compatible with both
IORT and IOERT devices,
the Sensus Healthcare TPS
Workstation is only
compatible with the Sensus
IORT device, and so does
not support calculations for
electrons. |
| Calculation for photons | Use of pre-calculated
Monte Carlo simulations
for the Sensus IORT
System | Dose Painting (Planning
calculation interpolation
of PDD
measurements) and
Hybrid Monte Carlo
computation
for INTRABEAM. | A set of Monte Carlo
simulations has been
performed to predict the
dose distribution produced
by each operating point of
the Sensus IORT device
with high accuracy. These
pre-calculated dose |
| Attributes | Sensus
TPS Workstation
(K182665) | Radiance V4
(K171885) | Discussion |
| Input | Externally acquired
patient medical images
and user input. Calibration
files and beam modeling
measurements for Sensus
IORT System | Externally acquired
patient medical images
and user input.
Calibration files and beam
modeling measurements
for INTRABEAM | Equivalent |
| Output | Treatment plans with
corresponding dose
distributions | Treatment plans with
corresponding dose
distributions | Equivalent |
| Plan review and approval | Allows electronic
approval of treatment
plans by trained and
authorized staff | Allows electronic
approval of treatment
plans by trained and
authorized staff | Equivalent |
| Dose calculation
algorithm confirmation | Algorithms confirmed for
a wide
variety of field
geometries,
treatment units, treatment
setups
and patient positions,
including
different dose grid
resolution
settings. | Algorithms confirmed for
a wide
variety of field
geometries,
treatment units, treatment
setups
and patient positions,
including
different dose grid
resolution
settings. | Equivalent |
| Beam modeling tool | Beam modeling of the
treatment
unit based on relative
measurements and output
factors. | Beam modeling of the
treatment
unit based on relative
measurements and output
factors. | Equivalent |
| distributions are used by
the Sensus Healthcare TPS
Workstation to calculate
the combination of
operating points that most
closely matches the target
treatment dose distribution.
This calculation is
performed using a global
optimization algorithm. | | | |
11