(189 days)
The PROBEAT-FR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site.
The PROBEAT-FR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The performance data presented in the 510(k) summary focuses on demonstrating that the PROBEAT-FR functions as intended and meets its specifications for various aspects, thus establishing substantial equivalence to its predicate device, the PROBEAT-CR.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (PROBEAT-FR) |
|---|---|
| Mechanical Performance | Functioned as intended and met specifications. (Evaluated through testing of rotating gantry, patient couch, and moving snout.) |
| Beam Performance | Functioned as intended and met specifications. (Evaluated through testing of beam dose shape and beam dose.) |
| Real Time Image Gated Particle Therapy Software | Functioned as intended and met specifications. |
| Imaging Guidance Function (CBCT & PIAS) | Functioned as intended and met specifications. |
| Safety Interlock Testing | Functioned as intended and met specifications. (Evaluated beam stop control, dose monitor, area safety, mechanical, and RGPT interlocks.) |
| Comprehensive Treatment Workflow | Functioned as intended and met specifications. |
| Electrical Safety (IEC 60601-1) | Compliant with IEC 60601-1. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant with IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of patients or cases. The performance data described refers to engineering and system-level testing rather than clinical trials with patient data.
- Sample Size: Not applicable in the context of clinical patient data for this submission. The tests performed are on the device itself and its components.
- Data Provenance: Not applicable in the context of clinical patient data. The tests are system-level and engineering evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of expert radiologists or other medical professionals to establish ground truth for a test set in the context of a diagnostic or therapeutic performance evaluation involving medical images or patient outcomes. The testing described is focused on the technical performance and safety of the proton beam therapy system.
4. Adjudication Method for the Test Set
Since there is no mention of a test set involving human interpretation or decision-making on patient data, an adjudication method (like 2+1 or 3+1) is not applicable to the described performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on the technical performance and safety of the device's features, not on improved human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The provided text does not describe a standalone algorithm-only performance study. The device is a proton beam therapy system, not an AI-driven diagnostic or image analysis algorithm that would typically undergo such a study. While it contains "Real Time Image Gating System software" and a "Positioning Image Analysis System (PIAS)," the performance testing described is at the total system level, not specifically isolating the performance of these software components as standalone algorithms.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on the engineering specifications and design requirements of the PROBEBEAT-FR system, as well as compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance:
- For mechanical performance, "ground truth" would be the specified movement ranges, precision, and stability.
- For beam performance, "ground truth" would be the specified dose accuracy, beam shape, and energy.
- For safety interlocks, "ground truth" would be the successful triggering of safety mechanisms under defined conditions.
8. Sample Size for the Training Set
The provided text does not mention a training set size. This type of information would typically be relevant for machine learning or AI-driven devices that learn from data. The PROBEAT-FR is a hardware-intensive proton beam therapy system with integrated control software, not an AI model that undergoes a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for an AI or machine learning model, the method for establishing its ground truth is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha % Lina Kontos Partner Hogan Lovells US LLP 555 THIRTEENTH STREET, NW WASHINGTON, DISTRICT of COLUMBIA 20004
Re: K232032
Trade/Device Name: Probeat-fr Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: LHN Dated: December 18, 2023 Received: December 19, 2023
Dear Ms. Lina Kontos:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Xin He -S Xin He -S
Lora Weidner Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K232032
Device Name
PROBEAT-FR
Indications for Use (Describe)
The PROBEAT-FR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
| 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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510(k) SUMMARY Hitachi Ltd.'s PROBEAT-FR Proton Beam Therapy Device
Submitter
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 226-44-141-1, Wakashiba, Kashiwa-shi, Chiba-ken, 277-0871, Japan Contact Person: Tomoko Irisa
Date Prepared: January 9, 2024
Name of Device:
PROBEAT-FR Proton Beam Therapy System
Common or Usual Name:
Proton Beam Therapy Device
Classification Name:
System, Radiation Therapy, Charged-Particle, Medical
Regulatory Class:
Class II
Product Code, Classification Regulation:
LHN, 21 C.F.R. § 892.5050
Predicate Device
Hitachi Ltd., Healthcare Radiation Oncology Systems, Kashiwa, PROBEAT-CR Proton Beam Therapy Device (K201042)
Device Description
The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site.
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Intended Use / Indications for Use
Hitachi's PROBEAT-FR is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Summary of Technological Characteristics
Consistent with the cleared PROBEAT-CR systems, the PROBEAT-FR comprises the following components and subsystems:
- . Beam production system
- Accelerator system (LINAC, Synchrotron).
- Beam transport system (Low/High Energy Beam Transport systems). O
- Beam delivery system in 4 separate treatment rooms. Each of 4 rooms will have a rotating ● qantry.
- o Gantry Room
- . Scanning Nozzle
- . Rotating Gantry
- . Patient Positioning System (Patient Couch)
- . X-ray Imaging System
- Cone Beam CT ●
- In-Room CT (Optional) .
- . Positioning Image Analysis System
- o Gantry Room
- . Treatment Control and Safety System
The PROBEAT-FR is a modification to the cleared PROBEAT-CR system to include a somewhat larger gantry, moving snout and also a rapid mode for the CBCT. The system comprises the same components and subsystems as outlined above, with minor differences in design as summarized in the table below.
| Comparison Item | Hitachi PROBEAT-FR | Hitachi PROBEAT-CR |
|---|---|---|
| 510(k) Number | K232032 | K201042 |
| Intended Use/Indications for Use | The PROBEAT-FR is a medicaldevice designed to produce anddeliver a proton beam for thetreatment of patients with localizedtumors and other conditionssusceptible to treatment byradiation. | The PROBEAT-CR is a medicaldevice designed to produce anddeliver a proton beam for thetreatment of patients with localizedtumors and other conditionssusceptible to treatment byradiation. |
| Accelerator | Synchrotron | Synchrotron |
| Particle | Protons | Protons |
| Variable energy | 70-230 MeV | 70-230 MeV |
| Nozzles | Discrete Spot ScanningMoving snout | Discrete Spot Scanning |
| Comparison Item | Hitachi PROBEAT-FR | Hitachi PROBEAT-CR |
| Support for patientpositioning | Gantry built-in type Cone BeamCT is used to verify patientpositioning. Rapid mode can beselected. A conventional x-raysystem can be also equipped inthe same treatment room.A computer assisted patientposition system (PIAS) isavailable for use. | Gantry built-in type Cone BeamCT is used to verify patientpositioning.A conventional x-ray system canbe also equipped in the sametreatment room.A computer assisted patientposition system (PIAS) isavailable for use |
| Treatment rooms | Typically 4 rotating gantry rooms. | Typically 3 rotating gantry roomsand 1 fixed beam room. |
| Gantry and rotatingangle | Large gantry360 degrees(0-180 degrees, 180-359 degrees) | Compact gantry360 degrees(-180 – 180 degrees) |
| Patient Positioner | Rotating gantry room. | Rotating gantry room and fixedroom. |
| a. Patient CouchSwing type Robotic PatientPositioning System with 6degrees of freedom.Isocentric rotating angle of thecouch is ± 95 degrees forstandard base and extensionconfiguration.b. Laser Alignment System | a. Patient CouchSwing type Robotic PatientPositioning System with 6degrees of freedom.Isocentric rotating angle of thecouch is ±95 degrees forstandard base and extensionconfiguration.With the optional couch topextension, isocentric rotatingangle can be extended to ±90degrees for short base andoverlay configuration, with a±5 degree movement rangefor the rolling and pitchingangles.b. Laser Alignment System | |
| Use of Image GatingSystem Software | Real Time Image Gating Systemsoftware is incorporated into thesystem. | Real Time Image Gating Systemsoftware is incorporated into thesystem. |
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Performance Data
The company performed testing, as follows:
- . The mechanical performance of the rotating gantry, patient couch and moving snout.
- Beam performance testing to evaluate beam dose shape and beam dose .
- Real time image gated particle therapy software test .
- . Imaging guidance function of CBCT and PIAS
- Safety interlock testing to evaluate beam stop control, dose monitor, area safety, . mechanical and RGPT interlocks.
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- . Comprehensive test depending on treatment workflow test.
Further, electrical safety and electromagnetic compatibility testing was also performed in accordance with IEC 60601-1 and IEC 60601-1-2.
In all instances, the PROBEAT-FR functioned as intended and met its specifications. Testing demonstrated substantial equivalence to the predicates.
Conclusions
The PROBEAT-FR is as safe and effective as the predicate PROBEAT-CR System. PROBEAT-FR has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the PROBEAT-FR that is the subject of this submission and the cleared PROBEAT-CR do not raise different questions of safety or effectiveness. Performance data demonstrate that the PROBEAT-FR is as safe and effective as the cleared PROBEAT-CR system. Thus, the PROBEAT-FR is substantially equivalent to its predicates.
§ 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.