(41 days)
Not Found
No
The summary describes a proton beam irradiation system and its components, focusing on beam delivery and generation. There is no mention of AI, ML, or related concepts in the provided text.
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 a "proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment" for "treatment of patients with localized tumors." Its primary function is therapeutic, not diagnostic.
No
The device description clearly states it is a "proton beam irradiation system" comprised of "equipment" to generate and deliver a proton beam, indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 treats patients.
- 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, tissue, or urine) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such activities or the analysis of biological samples.
Therefore, the Hitachi PROBEAT with DSSS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROBEAT with DSSS 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 with DSSS 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 PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system. The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System ("DSSS").
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 submission includes a summary of the performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi’s PROBEAT (K053280), PROBEAT with MGCS (060834), IBA Proton Therapy System - Proteus 235 (K060695)
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.
0
Attachment 6
510(k) SUMMARY PROBEAT with DSSS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, Chiyoda-ku Tokyo, 101-8608 DEC 1 0 2007 Japan
Phone : 011-81-3-4564-3565 Facsimile: 011-81-3-4564-2882
Contact Person: Naoya Nishimura
Date Prepared: 30 October, 2007
Name of Device and Name/Address of Sponsor
PROBEAT
Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, Chivoda-ku Tokyo, 101-8608 Japan
Common or Usual Name: Proton Beam Therapy System ("PBTS") Classification Name: Medical Charged-Particle Radiation Therapy System Predicate Device: Hitachi's PROBEAT (K053280) Purpose of the Special 510(k) notice.
The PROBEAT with DSSS is a modification to Hitachi's cleared PROBEAT.
Intended Use
The PROBEAT with DSSS 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.
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Technological Characteristics
The PROBEAT with DSSS 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 PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
Performance Data
The submission includes a summary of the performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.
Substantial Equivalence
PROBEAT with DSSS has the same intended use and indications, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT (K053280), PROBEAT with MGCS (060834), and IBA Proton Therapy System - Proteus 235 (K060695). The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System ("DSSS"). Thus, the PROBEAT with DSSS is substantially equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three lines representing human profiles, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2007
Hitachi, Ltd., Power Systems Group % Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K073059
Trade/Device Name: PROBEAT with DSSS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 30, 2007 Received: October 30, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 7
Indications for Use Statement
073059 510(k) Number (if known):
Device Name: PROBEAT with DSSS
Indications for Use: Hitachi's PROBEAT with DSSS 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.
Prescription Use I (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number KD/3059