(84 days)
The PROBEAT-CR 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-CR 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-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems: Beam production system (Accelerator system (LINAC. Synchrotron), Beam transport system (Low/High Energy Beam Transport systems)), Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam. (Gantry Room (Scanning Nozzle, Rotating Gantry, Patient Positioning System, Orthogonal X-ray system, Cone Beam CT), Fixed Beam Room (Patient Positioning System, Orthogonal X-ray system, Treatment Control and Safety System)). The subject PROBEAT-CR is a modification to the cleared PROBEAT-CR to include the incorporation of the previously cleared Real Time Image Gating System for Proton Beam Therapy Systems ("RGS" or "RGPT") (K171049) for tracking implanted fiducials to qate the delivery of the proton beam, and the addition of an optional patient couch top extension as an accessory to allow for different patient positioning configurations.
The provided document is a 510(k) summary for a medical device (PROBEAT-CR Proton Beam Therapy System) seeking substantial equivalence to a predicate device. It does not contain the detailed information required to answer the specific questions about acceptance criteria, clinical study design, and ground truth establishment for an AI/ML powered device.
Based on the provided text, the device is a proton beam irradiation system, and the submission is for a modification to an already cleared device. The modifications include:
- Incorporation of a previously cleared Real Time Image Gating System (RGS or RGPT) for tracking implanted fiducials.
- Addition of an optional patient couch top extension.
The document explicitly states: "The following testing was performed to validate the modifications to the device: Design verification and validation testing for the addition of the optional top couch extension. Software verification and validation for the updated RGS (RGPT) software."
This implies that the testing was primarily focused on engineering validation of the new components and software, rather than a clinical effectiveness study of an AI/ML algorithm's diagnostic or prognostic performance. The document doesn't mention any AI/ML components performing tasks like image analysis or disease detection/classification, which would necessitate the detailed study information requested.
Therefore, I cannot provide the requested information about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth for an AI/ML device because:
- The document does not describe an AI/ML powered device with new functionality that would require such studies. The Real Time Image Gating System (RGS) is mentioned as previously cleared (K171049) and the current submission is for an "updated RGS (RGPT) software." It's likely this update pertains to changes in its existing functionality, not the introduction of new AI-driven diagnostic capabilities.
- The document does not specify acceptance criteria in the context of clinical performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML algorithm. The "performance data" section is very brief and refers to design and software verification and validation, which are typical for any medical device modification, not necessarily for an AI/ML component's effectiveness.
- No clinical study to evaluate AI/ML performance compared to human readers or standalone AI performance is described.
In summary, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and ground truth for an AI/ML powered device. The submission focuses on device modifications and internal verification/validation, not on the clinical performance evaluation of a new AI-driven diagnostic or prognostic capability.
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July 13, 2020
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Hitachi Ltd. % Mr. Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K201042
Trade/Device Name: PROBEAT-CR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN Dated: April 20, 2020 Received: April 20, 2020
Dear Mr. Kahan:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
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combination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
PROBEAT-CR
Indications for Use (Describe)
The PROBEAT-CR 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) | |
|---|---|
| ------------------------------------------------- | -- |
区 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-CR Proton Beam Therapy Device
Submitter
Hitachi Ltd., Healthcare Radiation Oncology Systems, Kashiwa 2-1 Shintoyofuta, Kashiwa-shi Tiba-ken, 277-0804, Japan Telephone: +81 (4) 7131-4280 Facsimile: +81 (4) 7132-6837
Contact Person: Tomoyuki Seino
Date Prepared: April 20, 2020
Name of Device:
PROBEAT-CR Proton Beam Therapy System
Common or Usual Name:
Proton Beam Therapy Device
Classification Name:
System, Radiation Therapy, Charged-Particle, Medical
Requlatory Class:
Class II
Product Code:
LHN
Predicate Devices
Hitachi Ltd., Healthcare Hitachi Works, PROBEAT-CR Proton Beam Therapy Device (K191801)
Reference Devices
Hitachi Ltd., Healthcare Hitachi Works, Real Time Image Gating System for Proton Beam Therapy Systems (K171049)
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Device Description
The PROBEAT-CR 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.
Intended Use / Indications for Use
The PROBEAT-CR 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
The PROBEAT-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems:
- . Beam production system
- Accelerator system (LINAC. Synchrotron). o
- Beam transport system (Low/High Energy Beam Transport systems). o
- Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a ● rotating gantry and 1 room will have a fixed beam.
- o Gantry Room
- . Scanning Nozzle
- . Rotating Gantry
- l Patient Positioning System
- l Orthogonal X-ray system
- . Cone Beam CT
- Fixed Beam Room o
- . Patient Positioning System
- . Orthogonal X-ray system
- . Treatment Control and Safety System
- o Gantry Room
The subject PROBEAT-CR is a modification to the cleared PROBEAT-CR to include the incorporation of the previously cleared Real Time Image Gating System for Proton Beam Therapy Systems ("RGS" or "RGPT") (K171049) for tracking implanted fiducials to qate the delivery of the proton beam, and the addition of an optional patient couch top extension as an accessory to allow for different patient positioning configurations.
A table comparing the key features of the subject and predicate devices is provided below.
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Performance Data
The following testing was performed to validate the modifications to the device:
- Design verification and validation testing for the addition of the optional top couch . extension
- Software verification and validation for the updated RGS (RGPT) software .
Conclusions
The company's subject PROBEAT-CR is as safe and effective as the predicate PROBEAT-The subject PROBEAT-CR has the same intended use and indications as the CR. previously cleared PROBEAT-CR. In addition, the subject PROBEAT-CR has very similar technological characteristics and principles of operation as its predicate. Although there are minor differences between the PROBEAT-CR and the predicate, namely the incorporation of the cleared RGS (RGPT) software system and the addition of an optional patient couch top extension, those differences do not raise new questions of safety or efficacy. The performance testing demonstrates that the device is as safe and effective as the predicate. Thus, the PROBEAT-CR is substantially equivalent.
Substantial Equivalence Table
| Hitachi PROBEAT-CR (SubjectDevice) | Hitachi PROBEAT-CR (K191801) | |
|---|---|---|
| Indications for Use | 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. | 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 Scanning | Discrete Spot Scanning |
| Support for PatientPositioning | 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. | Gantry built-in type Cone Beam CTis used to verify patient positioning.A conventional x-ray system canbe also equipped in the sametreatment room.A computer assisted patientposition system, (PIAS) is availablefor use. |
| Hitachi PROBEAT-CR (SubjectDevice) | Hitachi PROBEAT-CR (K191801) | |
| Treatment Room | Typically 3 rotating gantry roomsand 1 fixed beam room (Maximum5 total).All rooms are dedicatedto the DSSS | Typically 3 rotating gantry roomsand 1 fixed beam room (Maximum5 total).All rooms are dedicated tothe DSSS |
| Gantry rotating angle | 360 degrees(-180-180degrees) | 360 degrees(-180-180degrees) |
| Patient Positioner | Rotating gantry room and fixedbeam room,(a) Patient CouchSwing type Robotic PatientPositioning System with 6 Degreesof freedomIsocentric rotating angle of thecouch is ±45 degrees for standardbase and extension configuration.With the optional couch topextension, isocentric rotating anglecan be extended to ±90 degreesfor short base and overlayconfiguration, with a ±5 degreemovement range for the rolling andpitching angles.(b) Laser Alignment System | Rotating gantry room and fixedbeam room,(a) Patient CouchIsocentric rotating angle of thecouch is ±45 degrees for standardbase and extension configuration.(b) Laser Alignment System |
| Patient PositionsSupported | Head first-supine ("HFS"), headfirst-prone ("HFP"), feet first-supine ("FFS"), and feet first-prone( |
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§ 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.