(106 days)
Not Found
No
The document describes a proton beam therapy 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 description explicitly states that the PROBEAT is a "therapeutic proton beam for clinical treatment" designed to "deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site." Its intended use is to treat "patients with localized tumors and other conditions susceptible to treatment by radiation," all of which are therapeutic applications.
No
Explanation: The device is described as a "proton beam irradiation system" intended for "treatment of patients with localized tumors and other conditions susceptible to treatment by radiation," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "proton beam irradiation system" comprised of a "beam delivery system" and "equipment necessary to generate the proton beam," indicating significant hardware components.
Based on the provided information, the Hitachi PROBEAT is not an In Vitro Diagnostic (IVD) device.
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 the patient.
- Device Description: The description focuses on the generation and delivery of a proton beam for clinical treatment, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The PROBEAT is clearly described as a therapeutic medical device used for radiation therapy.
N/A
Intended Use / Indications for Use
The PROBEAT 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 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 and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
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
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Summary of Performance Studies
The submission includes performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.
Key Metrics
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.
0
2006 MAR 9
510(k) SUMMARY
Hitachi's PROBEAT
Image /page/0/Picture/3 description: The image shows a sequence of alphanumeric characters, specifically 'K053280'. The characters are written in a clear, handwritten style, with each digit and letter distinctly formed. The sequence appears to be a code or identifier, possibly a serial number or reference code.
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 Japan
011-81-3-4564-3565 Phone: Facsimile: 011-81-3-4564-2882
Naoya Nishimura Contact Person:
November 21, 2005 Date Prepared:
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, chiyoda-ku Tokyo, 101-8608 Japan
Common or Usual Name
Proton Beam Therapy System ("PBTS")
Classification Name
Medical Charged-Particle Radiation Therapy System
1
Predicate Devices
ﺮ ﭘﺮ
- Optivus Technology, Inc.'s Proton Beam Therapy System (K992414) 1)
- Ion Beam Applications S.A.'s, Proton Therapy System (K983024) 2)
Intended Use / Indications for Use
The PROBEAT 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 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 and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed 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 performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.
Substantial Equivalence
The PROBEAT is substantially equivalent to the Optivus Technology, Inc.'s Proton Beam Therapy System (K992414), and the Ion Beam Applications S.A.'s, Proton Therapy System (K983024). The PROBEAT has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the PROBEAT and its predicate devices raise no new issues of safety or effectiveness. Thus, the PROBEAT is substantially equivalent to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird with three stylized wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hitachi, Ltd., % Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109
MAR 9 - 2006
Re: K053280
Trade/Device Name: PROBEAT Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: February 21, 2006 Received: February 21, 2006
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 (Premarket Approval), 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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Jagain This letter will anow you to begin harketing your united equivalence of your device to a legally premarket notification. The FDA inding of suestantial of a locked 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 If you desire specific advice for your device on our laboring 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" (21 CFR Also, please note the regulation entitled, "finisornation on your responsibilities under the Act from the 807.97). You may obtain other general information on John of
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
4
INDICATIONS FOR USE STATEMENT
3280 510(K) NUMBER (IF KNOWN):_
Device Name: PROBEAT
Indications for Use: Hitachi's PROBEAT is a medical device designed to produce and deliver a multations for USe. Intern of patients with localized tumors and other conditions susceptible to treatment by radiation.
Prescription Use __
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_X
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Sgroon
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number -