(126 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on the physical delivery of a proton beam.
Yes
The device is designed to deliver a proton beam for the treatment of patients with localized tumors and other conditions, which is a therapeutic application.
No
The device description clearly states its purpose is to "produce and deliver a proton beam for the treatment of patients" and that it is "a therapeutic proton beam for clinical treatment," indicating a treatment function, not a diagnostic one.
No
The device description clearly states it is a proton beam irradiation system composed of hardware components (beam delivery system and equipment to generate and direct the proton beam).
Based on the provided information, the PROBEAT-V is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that 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." This describes a therapeutic device that directly interacts with the patient's body for treatment.
- Device Description: The description details a "proton beam irradiation system" that delivers a "therapeutic proton beam for clinical treatment." This further reinforces its role in direct patient treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The PROBEAT-V does not perform any such analysis of specimens.
Therefore, the PROBEAT-V is a therapeutic radiation delivery device, 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.
The PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
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 treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
(1) Change to Minimum MU
The minimum MU of the PROBEAT-V 510(k) (K151132 and K152592) has been reduced to allow for more precise dose distribution utilizing the exact same spot size as previously cleared.
(2) High Accuracy Camera for Patient Positioning System
The high accuracy camera system is a supplemental system for the Patient Positioning System (PPS) which enables enhanced PPS positioning accuracy. The camera system used for enhanced PPS positioning accuracy provides additional feedback to the couch motion control and position correction functions to improve the positioning accuracy. The system comprises an Infrared (IR) camera (optical tracker) and multi-sided probes (MSP) with IR LEDs, and the MSPs are mounted on the couch. The couch position is measured by the camera and the data are then transmitted to the PPS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 company performed testing to evaluate the dose accuracy, tolerance confirmation for the reduction of minimum MU and the position accuracy for PPS accuracy upgrade. All the tests were successfully conducted and confirmed that the device meets the pre-defined acceptance criteria.
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a wing-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Hitachi Ltd., Health Care Company % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016
Re: K153614
Trade/Device Name: PROBEAT-V and Accessories Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 28, 2016 Received: March 28, 2016
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 D. O'Hara
For
Robert Ochs, Ph.D. 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 and Accessories
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.
The PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess 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
Accessories to the PROBEAT-V Proton Beam Therapy Systems
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: March 28, 2016
Name of Device and Name/Address of Sponsor
Accessories to the PROBEAT-V Proton Beam Therapy Systems
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-V (K151132, K152592)
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.
The PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess 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,
4
dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
(1) Change to Minimum MU
The minimum MU of the PROBEAT-V 510(k) (K151132 and K152592) has been reduced to allow for more precise dose distribution utilizing the exact same spot size as previously cleared.
(2) High Accuracy Camera for Patient Positioning System
The high accuracy camera system is a supplemental system for the Patient Positioning System (PPS) which enables enhanced PPS positioning accuracy. The camera system used for enhanced PPS positioning accuracy provides additional feedback to the couch motion control and position correction functions to improve the positioning accuracy. The system comprises an Infrared (IR) camera (optical tracker) and multi-sided probes (MSP) with IR LEDs, and the MSPs are mounted on the couch. The couch position is measured by the camera and the data are then transmitted to the PPS.
Performance Data
The company performed testing to evaluate the dose accuracy, tolerance confirmation for the reduction of minimum MU and the position accuracy for PPS accuracy upgrade. All the tests were successfully conducted and confirmed that the device meets the pre-defined acceptance criteria.
Substantial Equivalence
The PROBEAT-V with the alternate settings and optional accessories for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation is substantially equivalent to the cleared PROBEAT-V system as both the current and cleared devices have the same intended use, and substantially similar indications for use and technological characteristics. The addition of the optional settings and accessories to the system do not alter the intended therapeutic effect of the device system, and do not raise new or different questions of safety or efficacy. Specifically, the options are simply minor modifications to components of the cleared PROBEAT-V device to allow for greater precision in the positioning of the patient and the delivery of the treatment dose to the patient. Accordingly, the modified PROBEAT-V is substantially equivalent to the cleared PROBEAT-V.