(34 days)
Not Found
No
The document describes a proton beam irradiation system and its components, focusing on mechanical and beam performance. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is 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 a proton beam irradiation system for the treatment of localized tumors and other conditions, indicating a therapeutic purpose rather than a diagnostic one. While it includes an X-ray imaging system, its primary function is to deliver radiation for treatment, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components, including a gantry room, fixed beam room, beam delivery system, beam production system, accelerator system, beam transport system, patient couch, and X-ray imaging system. The performance studies also focus on mechanical and beam performance testing, further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 proton beam irradiation system, including components like a gantry, scanning nozzle, patient couch, and accelerator. These are all components of a system used for external radiation therapy.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, tissue, and urine, from the human body to help diagnose diseases or conditions. This device does not perform such examinations on biological specimens.
The device is clearly a therapeutic medical device used for radiation therapy, not an IVD.
N/A
Intended Use / Indications for Use
The PROBEAT-V 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
LHN
Device Description
The PROBEAT-V 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-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The beam delivery system is composed of the following components":
- o Gantry Room
- · Rotating Gantry
- . Scanning Nozzle
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
- o Fixed Beam Room
- Scanning Nozzle .
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
The beam production system is composed of the following components":
- Accelerator system (LINAC, Synchrotron) O
- Beam transport system (Low/High Energy Beam Transport systems) O
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Imaging System
Anatomical Site
Localized tumors
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 company performed testing to evaluate,
- The mechanical performance of the rotating gantry and patient couch o
- o Beam performance testing to evaluate beam dose shape and beam dose
- Safety interface testing to evaluate beam stop control, dose monitor, area safety, o and mechanical interlocks.
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-V functioned as intended and met its specifications.
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
§ 892.5050 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2015
Hitachi, Ltd., Health Care Company % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016
Re: K151132
Trade/Device Name: PROBEAT-V Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: April 28, 2015 Received: April 28, 2015
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
PROBEAT-V
Indications for Use (Describe)
The PROBEAT-V 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)
X 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 PROBEAT-V
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hitachi, Ltd., Health Care Company 4-14-1 Sotokanda, Chiyodaku, Tokyo, 101-8010, Japan Telephone: +81 (3) 45643563 Facsimile: +81 (3) 45642882
Contact Person: Naoya Nishimura
Date Prepared: April 28, 2015
Name of Device and Name/Address of Sponsor
PROBEAT-V Proton Beam Therapy System
Hitachi, Ltd. Power Systems Company 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan
Common or Usual Name
Proton beam therapy system
Classification Name
Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN
Predicate Devices
Hitachi Ltd. PROBEAT with Discrete Spot Scanning System (K073059)
Intended Use / Indications for Use
The PROBEAT-V 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.
Technological Characteristics
The PROBEAT-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system
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properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The beam delivery system is composed of the following components"
- o Gantry Room
- · Rotating Gantry
- . Scanning Nozzle
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
- o Fixed Beam Room
- Scanning Nozzle .
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
The beam production system is composed of the following components"
- Accelerator system (LINAC, Synchrotron) O
- Beam transport system (Low/High Energy Beam Transport systems) O
Performance Data
The company performed testing to evaluate,
- The mechanical performance of the rotating gantry and patient couch o
- o Beam performance testing to evaluate beam dose shape and beam dose
- Safety interface testing to evaluate beam stop control, dose monitor, area safety, o and mechanical interlocks.
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-V functioned as intended and met its specifications.
Substantial Equivalence
The PROBEAT-V has the same intended use and indications for use, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT with DSSS (K073059). Both systems comprise the same components of the beam production and beam delivery subsystems. The minor differences between the PROBEAT-V and the cleared PROBEAT do not raise different questions of safety or effectiveness. Thus, the PROBEAT with DSSS is substantially equivalent to its predicate devices.