(84 days)
No
The description focuses on the hardware and software components for proton beam generation and delivery, including image gating for tracking fiducials, but does not mention any AI or ML capabilities.
Yes
The device is described as 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," indicating its therapeutic purpose.
No
The device is described as producing and delivering a proton beam for treatment of patients with localized tumors, not for diagnosis. While it uses imaging (Orthogonal X-ray, Cone Beam CT), this is for ensuring proper delivery of the therapeutic beam, not for diagnosing conditions.
No
The device description clearly outlines numerous hardware components including accelerators, beam transport systems, gantries, patient positioning systems, and imaging systems. While it mentions software verification and validation for a specific subsystem (RGS), the core device is a physical proton beam irradiation system.
Based on the provided information, the PROBEAT-CR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation." This describes a therapeutic device that directly treats patients.
- Device Description: The description details a system for generating and delivering a proton beam for radiation therapy. It involves physical components like accelerators, beam transport systems, and delivery systems.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. IVD devices perform tests on these types of samples.
The PROBEAT-CR is a therapeutic medical device used for radiation therapy.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LHN
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Orthogonal X-ray system, Cone Beam CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 .
Key results: The performance testing demonstrates that the device is as safe and effective as the predicate. Thus, the PROBEAT-CR is substantially equivalent.
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.
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.
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.
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July 13, 2020
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
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
1
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
2
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 (Subject
Device) | Hitachi PROBEAT-CR (K191801) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Accelerator | Synchrotron | Synchrotron |
| Particle | Protons | Protons |
| Variable Energy | 70-230 MeV | 70-230 MeV |
| Nozzles | Discrete Spot Scanning | Discrete Spot Scanning |
| Support for Patient
Positioning | Gantry built-in type Cone Beam
CT is used to verify patient
positioning.
A conventional x-ray system can
be also equipped in the same
treatment room.
A computer assisted patient
position system, (PIAS) is
available for use. | Gantry built-in type Cone Beam CT
is used to verify patient positioning.
A conventional x-ray system can
be also equipped in the same
treatment room.
A computer assisted patient
position system, (PIAS) is available
for use. |
| | Hitachi PROBEAT-CR (Subject
Device) | Hitachi PROBEAT-CR (K191801) |
| Treatment Room | Typically 3 rotating gantry rooms
and 1 fixed beam room (Maximum
5 total).
All rooms are dedicated
to the DSSS | Typically 3 rotating gantry rooms
and 1 fixed beam room (Maximum
5 total).
All rooms are dedicated to
the DSSS |
| Gantry rotating angle | 360 degrees
(-180-180degrees) | 360 degrees
(-180-180degrees) |
| Patient Positioner | Rotating gantry room and fixed
beam room,
(a) Patient Couch
Swing type Robotic Patient
Positioning System with 6 Degrees
of freedom
Isocentric rotating angle of the
couch is ±45 degrees for standard
base and extension configuration.
With the optional couch top
extension, isocentric rotating angle
can be extended to ±90 degrees
for short base and overlay
configuration, with a ±5 degree
movement range for the rolling and
pitching angles.
(b) Laser Alignment System | Rotating gantry room and fixed
beam room,
(a) Patient Couch
Isocentric rotating angle of the
couch is ±45 degrees for standard
base and extension configuration.
(b) Laser Alignment System |
| | | |
| | | |
| | | |
| Patient Positions
Supported | Head first-supine ("HFS"), head
first-prone ("HFP"), feet first-
supine ("FFS"), and feet first-prone
( | |
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