(23 days)
Not Found
No
The description focuses on the mechanical and data conversion aspects of the device, with no mention of AI or ML algorithms for analysis, decision-making, or adaptation.
Yes
The purpose of the device is to deliver a proton beam for clinical treatment of localized tumors and other conditions, which implies a therapeutic use to treat a medical condition.
No
Explanation: The device is described as a proton beam irradiation system for treatment of localized tumors, indicating its 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." While it includes a software component (MGCS), the core device is a hardware system for delivering radiation therapy.
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, not a diagnostic one.
- Device Description: The description focuses on the generation and delivery of a proton beam for treatment. While it mentions the creation of patient-specific apertures and compensators, this is part of the treatment delivery process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information about a patient's health status based on such analysis, which are hallmarks of IVD devices.
In summary, the PROBEAT with MGCS is a therapeutic radiation delivery system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROBEAT with MGCS 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 MGCS 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 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. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment.
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 performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications. Performance data demonstrate that the PROBEAT with MGCS is as safe and effective as the cleared PROBEAT.
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.
0
Attachment 7
APR 1 0 2006
510(k) SUMMARY PROBEAT with MGCS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Ko60834
Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, chiyoda-ku Tokyo, 101-8608 Japan
Phone : 011-81-3-4564-3565 Facsimile: 011-81-3-4564-2882
Contact Person: Naoya Nishimura
Date Prepared: March 27, 2006
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 MGCS is a modification to Hitachi's cleared PROBEAT.
Intended Use
The PROBEAT with MGCS 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 only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that
1
100150X 54
converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment, do not raise any new questions of safety or effectiveness.
Technological Characteristics
The PROBEAT with MGCS 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 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 with MGCS device has the same intended use and indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate PROBEAT. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment. The addition of the MGCS to the PROBEAT does not raise any new questions of safety or effectiveness. Performance data demonstrate that the PROBEAT with MGCS is as safe and effective as the cleared PROBEAT. Thus, the PROBEAT with MGCS is substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is a circular seal with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and its head turned to the right.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 0 2006
Hitachi, Ltd. Power Systems Group % Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P 555 Thirteenth Street, NW WASHINGTON DC 20004
Rc: K060834
Trade/Device Name: PROBEAT with MGCS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 27, 2006 Received: March 27, 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.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in cursive font, with three stars underneath. The logo is surrounded by text that reads "A Century of Consumer Protection & Public Health".
Protecting and Promoting Public Health
3
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 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" (21 CFR 807.97). 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 (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
Attachment 8
Indications for Use Statement
510(k) Number (if known): K060834
Device Name: PROBEAT with MGCS
Indications for Use: Hitachi's PROBEAT with MGCS 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
(Per 21 C.F.R. 801.109)
Over-The-C
(Per 21 C.F
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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David M. Heggem
いい)OC - 991508001 - 2279360 v2
(Division Sign-Off) 1
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K060834
HI 0076