(150 days)
Not Found
No
The description mentions "Cybernetic Respiratory Motion Tracking" using a robotic arm and joint torque sensors, which suggests advanced control and sensing, but it does not explicitly state or imply the use of AI or ML for this function or any other part of the system. The focus is on robotic control and sensing for positioning and tracking, not on learning or intelligent decision-making based on data.
Yes
The device is specifically indicated for "radiation therapy treatments" to "treat lesions, tumors, and conditions" in or on the body where radiation is indicated, which directly describes a therapeutic function.
No
The device is described as an intraoperative radiotherapy device used for radiation therapy treatments, specifically for treating lesions, tumors, and conditions where radiation is indicated. It emits radiation to treat, not to diagnose.
No
The device description clearly outlines multiple hardware components including an electron linear accelerator, robotic arm, X-ray source, cooling module, power supplies, and a base unit with a drive/propulsion system. While software controls these components, the device is fundamentally a hardware system.
Based on the provided text, the Sensus IORT System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "radiation therapy treatments" to "treat lesions, tumors, and conditions in or on the body where radiation is indicated." This describes a therapeutic device that delivers radiation directly to the patient's body.
- Device Description: The description details an "electron linear accelerator with a beam-forming x-ray target" and a "mobile robotically-guided low-energy intraoperative radiotherapy device." It focuses on the generation and delivery of X-rays for treatment.
- Mechanism of Action: The device works by accelerating electrons onto a target to produce X-rays, which are then used to treat tissue. This is a physical process applied to the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's purpose is treatment, not diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sensus IORT System does not fit this definition.
N/A
Intended Use / Indications for Use
The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.
Product codes
JAD
Device Description
The Sensus IORT System is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery. The Xray source with beam shaping Morpheus provides radiation emission in the low energy therapy ranges of 50, 60, and 70 kV (a total of 3 kV modes) and is held and moved in place by an IEC 60601 medical certified robotic-arm. The robotic-arm uses a 7-axis motion system and is designed for human-robot collaboration for optimized treatment delivery and dosimetry.
The robotic-arm and its control cabinet mounted in the base of the Sensus IORT System contains multiple sensory capabilities for safety and simple operator control that allows it to act as an assistant to the doctor. The robot's joint torque sensors allow it to touch the patient with enough sensitivity to move with respiratory tracking (dubbed Cybernetic Respiratory Motion Tracking, or CRMT) and allow hand-guided movement by the doctor to control and place the xray source into position to deliver therapy.
The X-ray source held by the robotic arm consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern.
The Morpheus x-ray gun enables the Sensus IORT System to deliver an optimal and effective therapy beam to the targeted tissue bed that requires localized treatment. The Morpheus x-ray gun is operated by the system's control circuits and software and it is being fed by the high voltage power supply (HVPS), which provides the high voltage through the HV Feedthrough to the Morpheus x-ray gun and the integrated cooling module, which circulates the cooling fluid in order to maintain the Morpheus x-ray gun at a stable and optimal thermodynamic condition. The currently available kV modes of the Morpheus x-ray gun are 50kV, 60kV, and 70kV (Gen 1.0). The high voltage potential from the HVPS is fed to the Cathode by the HV Feedthrough onto the Cathode Assy.
Once the electron beam hits the Diamond-Tungsten-Molybdenum (CW-Mo) target, x-ray photons are generated in an isospheric pattern that is emitted towards the front and back of the target. The x-ray photons have no attenuating barrier in the front of the target (the attached Cooling Jacket is x-ray translucent) and the x-ray photons that are emitted from the back side of the target are emitted out with no significant attenuation through the SiC Window Sleeve. This allows the x-ray photons to be effectively generated and emitted from both sides of the target, thus rendering an optimal geometric distribution and coverage of the generating x-ray beam to deliver therapy.
The system base unit is self-propelled with full battery backup, which allow the operators to move it between surgical suites and hospital facilities. It also features a 3KW back up UPS, which allows the operators to complete a full treatment, even if the hospital power grid goes off line.
The Sensus IORT System is a stand-alone system that incorporates its own cooling module, power supplies, and networking. It consists of five separate core components:
- Computer Control Console
- Beam Shaping Morpheus / X-Ray Source (to delivery X-ray radiation)
- Cybernetic Respiratory Motion Tracking (using the Robotic Arm)
- Base Unit with Drive/Propulsion System (device cabinet with motor)
- Red-Diode laser for positioning
The Sensus IORT System X-ray source interacts with a sterile tissue volume management (TVM) Balloon Catheter to act as a barrier between the X-ray source and the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
in or on the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician and other specially-qualified individuals
Operating room or practitioner's office
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)
Summary of Non-Clinical Performance Testing
The Sensus Healthcare Sensus IORT System, as configured, has been engineered and tested to meet Sensus Healthcare product requirements, required electrical and mechanical safety standards, and meet clinical expectations. All testing of the Sensus IORT System was performed in accordance with defined test cases with clearly delineated acceptance criteria. Additionally, FDA consensus standards and recognized ISO and IEC standards (e.g., IEC 60601-1 3rd edition) were employed for the bench testing, functional testing, and overall system performance testing of the Sensus IORT System. Furthermore, all testing was commissioned to qualified and accredited independent laboratories.
Non-clinical Safety Tests
The Sensus Healthcare IORT System has been designed and constructed to meet the following electrical and mechanical safety standards:
- IEC 60601-1:2005 Ed.3+A1; C1: 2014 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- AAMI ES60601-1:2005 +A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- CSA C22.2#60601-1:2014 Ed.3 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2007 Part 1: General requirements for safety. Collateral standard: Electromagnetic compatibility - requirements and tests
- IEC 60601-1-6:2010 Ed.3+A1 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-2-8:2010 Ed.2+A1 Medical Electrical Equipment Part 2-8: Particular Requirements For Basic Safety And Essential Performance Of Therapeutic X-Rav Equipment Operating In The Range 10 Kv To 1 Mv
- IEC 62366:2007 Ed.1+A1 Medical Devices Application Of Usability Engineering To Medical Devices
- IEC 60825-1:2007 Safety of laser products Part 1: Equipment classification and requirements
The Sensus IORT system has been tested to the following safety tests for IEC 60601:
- IEC 60601-1:2005 Ed.3+A1;C1:2014: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (REPORT: 103306090MIN-001)
- IEC 60601-2-8:2010Ed.2+A1: Medical Electrical Equipment - Part 2-8: Particular Requirements For Basic Safety And Essential Performance Of Therapeutic X-Ray Equipment Operating In The Range 10 Kv To 1 Mv (REPORT: 103306090MIN-002)
- IEC 60601-1-6:2010Ed.3+A1: Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (REPORT: 103306090MIN-003)
- IEC 60601-1-2 Issued: 2007/03/30 Ed: 3: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements & Tests (REPORT: 103306090MIN-009)
- IEC 60825-1:2007: Safety of laser products – Part 1: Equipment classification and requirements (REPORT: 101125082BOX-009)
Verification and Validation Testing:
- Cybernetic Respiratory Motion Tracking (CRMT) Testing Protocol (REPORT: 6-2-5400-0000)
- Cybernetic Respiratory Motion Tracking Testing Report (REPORT: 6-2-5401-0000)
- Sterile drape compatibility testing protocol (REPORT: 6-2-5410-0000)
- Sterile drape compatibility testing report (REPORT: 6-2-5411-0000)
- Verification & Validation report (REPORT: 6-2-5380-0000)
- IORT Base Software Verification & Validation Test Plan (REPORT: 6-2-5381-0000)
The Sensus IORT system utilizes a Robotic Arm to hold and position the X-ray source to help assist in delivering treatment. The robotic arm has been tested to the following safety tests for IEC 60601:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (REPORT: 215755-CI2-2)
- IEC 62304:2006: Medical device software - Software life-cycle processes (REPORT: 215755-CI2-3)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.
0
February 21, 2019
% Mr. Nicolas Soro QA/RA Manager 851 Broken Sound Parkway NW
Suite 215 BOCA RATON FL 33487
Re: K182641
Trade/Device Name: Sensus IORT System Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: Class II Product Code: JAD Dated: December 27, 2018 Received: January 22, 2019
Dear Mr. 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 May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 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
1
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.htm); 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 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.'Hara
Robert 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) K182641
Device Name
Sensus IORT System
Indications for Use (Describe)
The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy to treat lesions, tumors, and conditions in or on the body where radiation is indicated.
Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.
| 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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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, CTO
Telephone (561) 922-5808
Fax (561) 948-2071
kal@sensushealthcare.com |
| Date Summary Prepared: | September 18, 2018 |
| Device Name: | Trade/Proprietary Name – Sensus IORT System
Common/Usual Name – Intraoperative Radiation Therapy System
Classification Name – X-ray Radiation Therapy System (892.5900) |
| Classification: | Class II |
| Product Code: | JAD |
| Regulation Number: | 892.5900 |
| Predicate Device: | Xoft Axxent Brachytherapy System (K153570) |
4
Device Description
The Sensus IORT System is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery. The Xray source with beam shaping Morpheus provides radiation emission in the low energy therapy ranges of 50, 60, and 70 kV (a total of 3 kV modes) and is held and moved in place by an IEC 60601 medical certified robotic-arm. The robotic-arm uses a 7-axis motion system and is designed for human-robot collaboration for optimized treatment delivery and dosimetry.
The robotic-arm and its control cabinet mounted in the base of the Sensus IORT System contains multiple sensory capabilities for safety and simple operator control that allows it to act as an assistant to the doctor. The robot's joint torque sensors allow it to touch the patient with enough sensitivity to move with respiratory tracking (dubbed Cybernetic Respiratory Motion Tracking, or CRMT) and allow hand-guided movement by the doctor to control and place the xray source into position to deliver therapy.
The X-ray source held by the robotic arm consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern.
The Morpheus x-ray gun enables the Sensus IORT System to deliver an optimal and effective therapy beam to the targeted tissue bed that requires localized treatment. The Morpheus x-ray gun is operated by the system's control circuits and software and it is being fed by the high voltage power supply (HVPS), which provides the high voltage through the HV Feedthrough to
5
the Morpheus x-ray gun and the integrated cooling module, which circulates the cooling fluid in order to maintain the Morpheus x-ray gun at a stable and optimal thermodynamic condition. The currently available kV modes of the Morpheus x-ray gun are 50kV, 60kV, and 70kV (Gen 1.0). The high voltage potential from the HVPS is fed to the Cathode by the HV Feedthrough onto the Cathode Assy.
Once the electron beam hits the Diamond-Tungsten-Molybdenum (CW-Mo) target, x-ray photons are generated in an isospheric pattern that is emitted towards the front and back of the target. The x-ray photons have no attenuating barrier in the front of the target (the attached Cooling Jacket is x-ray translucent) and the x-ray photons that are emitted from the back side of the target are emitted out with no significant attenuation through the SiC Window Sleeve. This allows the x-ray photons to be effectively generated and emitted from both sides of the target, thus rendering an optimal geometric distribution and coverage of the generating x-ray beam to deliver therapy.
The system base unit is self-propelled with full battery backup, which allow the operators to move it between surgical suites and hospital facilities. It also features a 3KW back up UPS, which allows the operators to complete a full treatment, even if the hospital power grid goes off line.
The Sensus IORT System is a stand-alone system that incorporates its own cooling module, power supplies, and networking. It consists of five separate core components:
- Computer Control Console .
- . Beam Shaping Morpheus / X-Ray Source (to delivery X-ray radiation)
- Cybernetic Respiratory Motion Tracking (using the Robotic Arm) .
510(k) Summary (Sensus Healthcare Sensus IORT System)
6
- Base Unit with Drive/Propulsion System (device cabinet with motor) .
- . Red-Diode laser for positioning
The Sensus IORT System X-ray source interacts with a sterile tissue volume management (TVM) Balloon Catheter to act as a barrier between the X-ray source and the patient.
Indications for Use:
The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy radiation therapy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.
Prescriptive Statement
The Sensus IORT System is intended for use by a physician and other specially-qualified individuals properly trained in the system's use and application.
Caution: Federal law restricts this device to sale by or on the order of a physician.
7
Technological Characteristics/Principles of Operation
The Sensus IORT System produces and emits filtered, low energy (50, 60, and 70 kV) xray radiation, which is electrically generated using the onboard Kimball Power Supply and HV Generator (also referred to as HV Power Supply).
The X-ray source consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern.
For the Sensus IORT System IORT, the x-ray target is located inside the drift tube at the tip, which is placed inside the patient enabling direct exposure of the tissue under treatment. It is generally desirable to irradiate the tissue bed under treatment while sparing other anatomical structures that are not under treatment.
To hold the x-ray source in place, the Sensus IORT System utilizes a medical robot which was designed for human collaboration and incorporates numerous safety features built-in. This robot has been tested to and passed the ISO 13849 standard of safety for machinery, and IEC 60601-1 safety tests for medical devices. Torque settings of the 7-axis arm will allow for tracking of patient respiration and will vield if it encounters excessive force utilizing a collision detection mechanism. The robot also allows for extreme accuracy with a position repeatability of + 0.15 mm (ISO 9283). Once the robot is activated for "hold position", the robot will return to this position within this tolerance.
8
Summary of Non-Clinical Performance Testing
The Sensus Healthcare Sensus IORT System, as configured, has been engineered and tested to meet Sensus Healthcare product requirements, required electrical and mechanical safety standards, and meet clinical expectations. All testing of the Sensus IORT System was performed in accordance with defined test cases with clearly delineated acceptance criteria. Additionally, FDA consensus standards and recognized ISO and IEC standards (e.g., IEC 60601-1 3rd edition) were employed for the bench testing, functional testing, and overall system performance testing of the Sensus IORT System. Furthermore, all testing was commissioned to qualified and accredited independent laboratories.
Non-clinical Safety Tests
The Sensus Healthcare IORT System has been designed and constructed to meet the
following electrical and mechanical safety standards:
- o IEC 60601-1:2005 Ed.3+A1; C1: 2014 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- AAMI ES60601-1:2005 +A1:2012 Medical Electrical Equipment Part 1: General o Requirements For Basic Safety And Essential Performance
- CSA C22.2#60601-1:2014 Ed.3 Medical Electrical Equipment Part 1: General o Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2007 Part 1: General requirements for safety. Collateral standard: O electromagnetic compatibility - requirements and tests
- IEC 60601-1-6:2010 Ed.3+A1 Medical Electrical Equipment Part 1-6: General o Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-2-8:2010 Ed.2+A1 Medical Electrical Equipment Part 2-8: Particular o Requirements For Basic Safety And Essential Performance Of Therapeutic X-Rav Equipment Operating In The Range 10 Kv To 1 Mv
9
- o IEC 62366:2007 Ed.1+A1 Medical Devices Application Of Usability Engineering To Medical Devices
- IEC 60825-1:2007 Safety of laser products Part 1: Equipment o classification and requirements
The Sensus IORT system has been tested to the following safety tests for IEC 60601:
| TEST STANDARD | TEST | REPORT |
|---|---|---|
| IEC 60601-1:2005 | ||
| Ed.3+A1;C1:2014 | Medical Electrical Equipment - Part 1: General Requirements | |
| For Basic Safety And Essential Performance | 103306090MIN- | |
| 001 | ||
| IEC 60601-1:2005 | ||
| Ed.3+A1;C1:2014 | Medical Electrical Equipment - Part 1: General Requirements | |
| For Basic Safety And Essential Performance | 103306090MIN- | |
| 001 | ||
| IEC 60601-1:2005 | ||
| Ed.3+A1;C1:2014 | Medical Electrical Equipment - Part 1: General Requirements | |
| For Basic Safety And Essential Performance | 103306090MIN- | |
| 001 | ||
| IEC 60601-2- | ||
| 8:2010Ed.2+A1 | Medical Electrical Equipment - Part 2-8: Particular | |
| Requirements For Basic Safety And Essential Performance Of | ||
| Therapeutic X-Ray Equipment Operating In The Range 10 Kv | ||
| To 1 Mv | 103306090MIN- | |
| 002 | ||
| IEC 60601-1- | ||
| 6:2010Ed.3+A1 | Medical Electrical Equipment - Part 1-6: General | |
| Requirements For Basic Safety And Essential Performance - | ||
| Collateral Standard: Usability | 103306090MIN- | |
| 003 | ||
| IEC 60601-1-2 Issued: | ||
| 2007/03/30 Ed: 3 | Medical Electrical Equipment - Part 1-2: General | |
| Requirements for Safety - Collateral Standard: | ||
| Electromagnetic Compatibility - Requirements & Tests | 103306090MIN- | |
| 009 | ||
| IEC 60825-1:2007 | Safety of laser products – Part 1: Equipment classification | |
| and requirements | 101125082BOX- | |
| 009 |
Table 1 IEC 60601 Safety Testing Sensus IORT System
| REPORT | TEST NAME |
|---|---|
| 6-2-5400-0000 | Cybernetic Respiratory Motion Tracking (CRMT) Testing Protocol |
| 6-2-5401-0000 | Cybernetic Respiratory Motion Tracking Testing Report |
| 6-2-5410-0000 | Sterile drape compatibility testing protocol |
| 6-2-5411-0000 | Sterile drape compatibility testing report |
| 6-2-5380-0000 | Verification & Validation report |
| 6-2-5381-0000 | IORT Base Software Verification & Validation Test Plan |
Table 2 Verification and Validation Testing
10
The Sensus IORT system utilizes a Robotic Arm to hold and position the
X-ray source to help assist in delivering treatment. The robotic arm has been
tested to the following safety tests for IEC 60601:
| TEST STANDARD | TEST | REPORT |
|---|---|---|
| IEC 60601-1:2005 (Third | ||
| Edition) + CORR. 1:2006 + | ||
| CORR. 2:2007 + A1:2012 | Medical Electrical Equipment - Part 1: General | |
| Requirements For Basic Safety And Essential | ||
| Performance | 215755-CI2-2 | |
| IEC 62304:2006 | Medical device software - Software life-cycle processes | 215755-CI2-3 |
Substantial Equivalence Discussion
Sensus Healthcare has conducted a detailed comparison of the Sensus IORT System
IORT versus the predicate device. The results of the comparison are listed below in the
comparison table below.
| Attributes | Sensus Healthcare IORT
System | Xoft Axxent (Predicate) | Discussion |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Radiation therapy | Radiation therapy | Equivalent to predicate |
| Indications for
Use | The Sensus IORT System is high
dose rate Brachytherapy device for
use with Morpheus TVM
Applicators to treat lesions, tumors
and conditions in or on the body
where radiation is indicated. Only
Sensus TVM Balloon Applicators
can be used with the Sensus IORT
System. | The Axxent® Electronic Brachytherapy System
Model 110 XP 1200 is a high dose rate
Brachytherapy device for use with Axxent
Applicators to treat lesions, tumors and
conditions in or on the body where radiation is
indicated. | Equivalent to predicate |
| Regulation
Name | Electronic brachytherapy system | Electronic brachytherapy system | Equivalent to predicate |
| Regulation | 21 CFR 892.5900, Class II | 21 CFR 892.5900, Class II | Equivalent to predicate |
| Product Code | JAD: System, Therapeutic, X-Ray | JAD: System, Therapeutic, X-Ray | Equivalent to predicate |
| Use
Environment | Operating room or practitioner's
office | Operating room or practitioner's office | Equivalent to predicate |
| Therapy type | X-Ray Photon | X-Ray Photon | Equivalent to predicate |
| X-Ray source
operation mode | Electrons are emitted by cathode,
accelerated by an electrical field
along a drift tube inside the X-Ray
source and hit a tungsten target
resulting in the generation of X-rays | Electrons are emitted by cathode, accelerated
by an electrical field along a drift tube inside
the X-Ray source and hit a tungsten target
resulting in the generation of X-rays | Equivalent to predicate |
| Method of
treatment /
application | Intraoperative
Intracavitary
Interstitial
Post-Operative | Intraoperative
Intracavitary
Interstitial
Post-Operative | Equivalent to predicate |
| X-Ray Source
Kilo-Voltage | 50, 60, 70 kV | 30, 40, 50 kV | The kV impacts the dose rate but does
not change the penetration rate
according to the source dosimetric |
| Attributes | Sensus Healthcare IORT
System | Xoft Axxent (Predicate) | Discussion |
| X-Ray Source
Current | Beam currents of 720 uA at 70 kV
up to 1.00 mA at 50 kV | Up to 300uA, which
is the maximum current of the X-ray tube over
the entire kilovoltage range of 30, 40, and
50kV | characterization report. Reference
report SEN19068.
The 50-70 kV mode of the Sensus
IORT System has a similar penetration
rate as the predicate's 50 kV mode.
Similar to predicate; Enhanced.
Due to different source technology and
architecture between the predicate
and the Sensus IORT System, the x-ray
source current is different due to the
respective method, geometry, and
materials applied for each source
design.
In spite of the different source currents
between the Sensus IORT System and
the predicate, the resulting beam |
| Geometry of
dose emitted
(without
applicator) | Mostly spherical | Mostly spherical | output and physics are comparable.
Equivalent to predicate |
| Maximum
Radiation
Output | 400 - 1000 cGy/min (at 4cm - 3cm
from isocenter, respectively) | 60 cGy/min (at 3cm from isocenter) | Although the Sensus IORT System
employs equivalent beam-formation
physics and science, it has faster and
more effective dose rate due to avariable kV range, different electron
gun design, and target materials and
design. |
| Maximum
Power Range | 50W (70kV x 0.720 uA) | 15W (50kV x 300uA) | Due to different x-ray source
technology and architecture between
the predicate and the Sensus IORT
System, the power output of each
comparable source is different due to
the respective designs and
Bremsstrahlung beam generation
methods, geometry, and materials
applied in each respective x-ray
source
In spite of the different power ratings
between the Sensus IORT System and
the predicate, the resulting beam
output and physics are comparable. |
| kV Control | Microprocessor | Microprocessor | Equivalent to predicate |
| mA Control | Microprocessor | Microprocessor | Equivalent to predicate |
| Primary
Exposure Timer | Microprocessor | Microprocessor | Equivalent to predicate |
| Secondary
(Backup)
Exposure Timer | Yes - Microprocessor | Yes - Microprocessor | Equivalent to predicate |
| Timer
Monitoring and
Safety Shutoff | Yes - Hardware | Yes - Hardware | Equivalent to predicate |
| Safety
Interlocks | Interlock to prevent unintended
radiation
Interlock to prevent unintended
access to the controlled area
Interlock to prevent incorrect
radiation data transmission
Robotic manipulator safety
interlocks | Interlock to prevent unintended radiation
Interlock to prevent unintended access to the
controlled area
Interlock to prevent incorrect radiation data
transmission | Similar to predicate for the safety
interlocks on the device to deliver
therapy.
Additional safety interlocks for the
robotic manipulator are available on
the Sensus IORT System to help
ensure patient and operator safety
during operation, similar to reference
device. |
| X-ray Tube | Tungsten | Tungsten | Similar to predicate, both tungsten |
| Attributes | Sensus Healthcare IORT
System | Xoft Axxent (Predicate) | Discussion |
| Dose fall-off (in
water) | ~1/r³ | ~1/r³ | bremsstrahlung method for generation
of x-rays. Tungsten (W) is similar to
gold (Au) and very common in the
industry for production of x-rays.
Equivalent to predicate |
| Mobility | Yes - propulsion drive | Yes - manual | Similar to predicate; enhanced
Both devices are mobile, however the
Sensus IORT System features a self-
propulsion system. |
| Robotic
manipulator
arm delivery
system | 7-axis robotic manipulator mounted
at the front of the Sensus IORT
System's base. Load capacity of the
robotic manipulator is 14 kg (31.86
lbs).
Robotic manipulator developed by
Kuka Robotics. | N/A
Note: X-ray source is inserted manually into
the Axxent applicator. | Different from predicate.
Sensus IORT System uses a 7-axis
portable robotic manipulator with a
load capacity of 31.86 lbs vs the
predicate device, which requires
manual insertion and manipulation.
The Sensus IORT System's
integration of robotics enhances the
precision and radiation treatment
delivery means vs. the predicate
device through the introduction of the
dexterity and accuracy of the robot. |
| Performance
Standards
Tested | IEC60601-2-8 Standard for
Radiation Therapy Devices | IEC60601-2-8 Standard for Radiation Therapy
Devices | Equivalent to predicate |
| Electrical
Safety
Standards
Tested | IEC60601-1-2 | IEC60601-1-2 | Equivalent to predicate |
| Applicators Use | Disposable | Disposable | Equivalent to predicate |
| Compatible
Applicators | Sensus Morpheus TVM Balloon
Catheter Applicator (concurrent
separate 510(k) submission) | Xoft Axxent Applicators (separate 510(k)
submission - K090914) | Equivalent to predicate |
| Red-Diode
Laser Pointing
Capability | Red-Diode Laser
U.S. Laser, Inc. (Item M650-5CH-
V2)
FDA Laser Class: 3A; IEC Laser
Class: 3R
FDA Accession #: 95R2254
Wavelength: 650nM
Max Power: 5mW
Beam Divergence: 15 deg max | N/A | The laser on the Sensus IORT System
is only to aide physicians/operators in
positioning and placement of the x-ray
source apparatus during preparation
for treatment. |
| Treatment
Planning | Yes | Yes | Equivalent to predicate |
11
510(k) Summary (Sensus Healthcare Sensus IORT System)
12
Table 3 Substantial Equivalent Comparison
The Sensus IORT System is substantially equivalent to the predicate, the Xoft Axxent Brachytherapy System, due to the amount of similar key performance characteristics such as the indications for use, x-ray photons therapy modality, the emission of electrons using cathodes, and the spherical geometry of the emitted dose.
13
The primary differences of the Sensus IORT System vs the predicate include a broader energy kV range of 50, 60 and 70 kV, a tungsten target vs a gold target on the predicate (which are both widely used as x-ray generation target materials employing the bremsstrahlung phenomenon), a higher dose rate, and an x-ray source mounted on a robotic manipulator arm vs the source mounted on a manually manipulated mechanical arm on the predicate.
In addition to helping the physician manipulate and positioning the x-ray source, the robotic manipulator arm offers a respiratory motion tracking functionality to follow the patient's respiratory motion during the procedure, thus optimizing the therapy delivery.
Conclusion Statement
All the Sensus IORT System's intended use can be found in the intended use of the predicate device and reference device. Any technological changes to the device are minor. primarily as it pertains to industrial design, and do not raise new questions of safety or effectiveness. The primary difference between the Sensus IORT System and its predicate is the use of the robotic manipulator arm to control and provide a stable delivery of the radiation therapy. 0Safe use and approval of a similar robotic manipulator with a radiation delivery system are found in the reference device which utilizes a 6-axis robotic manipulator developed by the same robotics manufacturer as utilized by Sensus Healthcare. Performance testing, along with verification and validation activities demonstrate that Sensus IORT System is as safe and effective, and performs as well as the predicate device. Therefore, Sensus IORT System can be considered substantially equivalent to the predicate device.