(51 days)
Not Found
No
The description focuses on a new interface and control mechanism for existing hardware based on external position data, without mentioning any AI/ML algorithms for data processing or decision making.
Yes
The device is described as a "Linear Accelerator System" intended for "radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated," which directly implies its use in treating diseases or conditions.
No
The device is a linear accelerator system intended for radiation therapy of lesions, tumors, and conditions, which is a treatment modality, not a diagnostic one.
No
The device is a linear accelerator system, which is a complex piece of hardware used for radiation therapy. While it includes new software functionality for remote control and alignment, the core device is a physical machine.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description: The MHI-TM2000 Linear Accelerator System is a device used for radiation therapy. It generates radiation to treat lesions, tumors, and other conditions within the body.
- Intended Use: The intended use clearly states "radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated." This involves direct treatment of the patient's body, not testing of samples.
The device's function is to deliver radiation for therapeutic purposes, which is fundamentally different from the diagnostic testing performed by IVDs.
N/A
Intended Use / Indications for Use
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)").
MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets.
The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals".
The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target.
A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0).
The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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 verification testing results from bench testing support the substantial equivalence of the MHI-TM2000 (Ver. 3.0) with the predicate devices.
The result also ensured conformance to system specifications, functional requirements, use cases, hazard mitigation, as well as compliance with applicable standards.
Accuracy of gimbaled (pan and tilt) motion of X-ray tube and MLC (treatment beam axis) to continuously align with moving target, has also been tested because this is the key function for the new functionality. The results also showed that MHI-TM2000 (Ver.3.0) meet the 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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K12245D
Image /page/0/Picture/1 description: The image shows the Mitsubishi logo, which consists of three red diamonds arranged in a triangular shape. Two diamonds are placed horizontally at the bottom, and one diamond is placed above them in the center. The logo is simple and recognizable, representing the company's brand identity.
MITSUBISHI HEAVY INDUSTRIES. LTD. MACHINERY & STEEL INFRASTRUCTURE SYSTEMS
MACHINERY & STEEL INFRASTRUCTURE SYSTEMS
6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN
OCT 3 2012
FI FPHONE +80-82-291-2153 FAX : +80-82-294-9888
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the MHI-TM2000 Linear Accelerator System.
-
- Submitter: Mitsubishi Heavy Industries, Ltd. Machinery & Steel Infrastructure Systems 4-6-22 Kan-on-shin-machi. Nishi-ku, Hiroshima 733-8553 Japan
- Contact person: Yoichi Wakiyama, Manager Quality Management Team Phone: +81-82-291-2135 Fax: +81-82-294-9878 E-mail: yoichi_wakiyama@mhi.co.jp
Establishment Registration Number: 3006942329
Date prepared: July 20, 2012
-
- Name of the Device: Trade / Proprietary Name: Common or Usual name: Classification Name:
MHI-TM2000 Linear Accelerator System MHI-TM2000 Linear Accelerator System Clinical Linear Accelerator Medical Charged Particle Radiation Therapy System 21CFR 8892.5050 Class II Product Code: IYE
- Name of the Device: Trade / Proprietary Name: Common or Usual name: Classification Name:
3. Predicate devices to claim substantial equivalence:
- Mitsubishi Heavy Industries, Ltd.
MHI-TM2000 Linear Accelerator System - K072047
1
Image /page/1/Picture/0 description: The image shows the Mitsubishi logo, which consists of three red diamonds arranged in a triangular shape. One diamond is at the top, and the other two are at the bottom left and right. The logo is simple and recognizable, and it is often associated with the Mitsubishi brand.
MITSUBISHI HEAVY INDUSTRIES.
MACHINERY & STEEL INFRASTRUCTURE SYSTE
6-22, 4-CHOME, KAN-ON-SHIN-MACHI. NISHI-KU HIROSHIMA. 733-8553 JAPAN
TELEPHONE :
+80-82-291-2153
FAX :
+80-82-294-9888
4. Intended Use Statement:
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
5. Description of the Device:
The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)").
MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets.
The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals".
The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target.
A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0).
The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047).
6. Substantial equivalence:
The MHI-TM2000 (VER.3.0) is substantially equivalent to the predicate device: MHI-TM2000 Linear Accelerator System (K072047) of Mitsubishi Heavy Industries, Ltd., as Image-Guided Radiation Therapy Equipment. The intended use, indications for use, scientific technologies.
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2
Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of three diamond shapes arranged in a triangular pattern. One diamond is at the top, and two diamonds are at the bottom.
MITSUBISHI HEAVY INDUSTRIES, LTD.
MACHINERY & STEEL INFRASTRUCTURE SYSTEMS
6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU
HIROSHIMA, 733-8553 JAPAN
TELEPHONE 80-82-291-2153 480-82-294-9888
materials, principles of operation and labeling, are the same or equivalent to MHI-TM2000 Linear Accelerator System (K072047).
7. Summary of Performance Testing:
The verification testing results from bench testing support the substantial equivalence of the MHI-TM2000 (Ver. 3.0) with the predicate devices.
The result also ensured conformance to system specifications, functional requirements, use cases, hazard mitigation, as well as compliance with applicable standards.
Accuracy of gimbaled (pan and tilt) motion of X-ray tube and MLC (treatment beam axis) to continuously align with moving target, has also been tested because this is the key function for the new functionality. The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, human services, and the people served by the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES -
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Yoichi Wakiyama Manager, Quality Management Team Mitsubishi Heavy Industries, Ltd. Machinery & Steel Infrastructure Systems 4-6-22 Kan-on-shin-machi, Nishi-ku Hiroshima-shi 733-8553 JAPAN
OCT 3 2012
Re: K122450
Trade/Device Name: MHI-TM2000 Linear Accelerator System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 3, 2012 Received: August 13, 2012
Dear Mr. Wakiyama:
We have reviewed vour 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 1 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Bivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
MITSUBISHI HEAVY INDUSTRIES. LTD. MACHINERY & STEEL INFRASTRUCTURE SYSTEMS
6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN
TELEPHONE : +80-82-291-2153 FAX · +80-82-294-9888
Indications for Use Statement
K122450 510(k) Number (if known):
Device Name: MHI-TM2000 Linear Accelerator System
Indications for Use:
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Prescription Use _ X (Per 21 CFR § 801.109)
Over-the-counter
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
(Division of Radiological Devices
K122450
51uk