(21 days)
No
The summary describes a linear accelerator system with advanced mechanical and imaging features for radiation therapy, including a new "Dynamic WaveArc" method. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies summary. The focus is on hardware modifications and a new delivery technique.
Yes
The device is described as an "Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated," and its intended use is for "radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated." This directly states its purpose is for treatment.
No
The device is described as a "Linear Accelerator System" intended for "radiation therapy of lesions, tumors and conditions," explicitly stating its purpose for "precision radiation therapy of tumors and conditions." Its function is to generate X-rays for treatment, not for diagnosis.
No
The device description explicitly lists multiple hardware components including a linear accelerator, multi-leaf collimator, electric portal imaging device, couch, O-ring-type gantry platform, X-ray-head-mounted gimbals, and a Built-in Imaging System.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details a "Linear Accelerator System" which is a type of medical device used to generate high-energy X-rays for external beam radiation therapy. It focuses on the physical components and how it delivers radiation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly described as a therapeutic device for delivering radiation treatment, not a diagnostic device that analyzes samples.
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
IYE
Device Description
The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated.
It includes a linear accelerator, multi-leaf collimator, electric portal imaging device and couch. It also includes O-ring-type gantry platform, X-ray-head-mounted gimbals, Built-in Imaging System, and function to continuously align treatment beam with moving target for precise radiotherapy of moving targets, as notable characteristics.
The MHI-TM2000 (Ver. 3.5) has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K122450 (hereinafter called "MHI-TM2000 (K122450)'').
Modification was made for introducing a method of radiation therapy called "Dynamic WaveArc" ("DWA") that delivers radiation while rotating both O-ring-shaped gantry (Gantry rotation) and rotational floor of the gantry that moves entire gantry (Ring rotation), or rotating the Ring rotation only.
Radiation type, energy, and the method of generating radiation are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450)
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
Prescription Use
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
The design control procedures applied to the development of MHI-TM2000 (Ver. 3.5) includes requirements reviews, risk analysis, and verification and validation testing according to:.-ISO14971: Risk Management Standard -FDA Quality System regulation (21 CFR 820) and ISO13485: Quality Management System Standard -Other international standards listed in "8. Standards conformance" below in 8. Result of verification testing, including regression testing, showed conformance to applicable requirements specifications, assured hazard safeguards functioned properly. Result of validation testing showed conformance to customer needs and intended use of the MHI-TM2000 (Ver. 3.5).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
A special 510(k) is applicable to this application due to the following reasons:
-Change/ modification does not significantly affect safety and effectiveness of MHI-TM2000 (K122450);
-There is no change in basic design control activities specified in 21CFR 820.30;
-There is no change in the medical device information specified in 21CFR 807.87;
-There is no change in all Labeling including Indications for Use;
-There is no change in fundamental scientific technologies; and
-There is no change in material used.
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Mitsubishi Heavy Industries, Ltd. % Mr. Katsuhisa Toyama Senior Administrator, Business Development Department 4-6-22 Kan-on-shin-machi, Nishi-ku Hiroshima-shi, Hiroshima-ken 733-8553 JAPAN
Re: K152867
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: September 28, 2015 Received: September 30, 2015
Dear Mr. Toyama:
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.
1
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,
Robert Ochs
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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Indications for Use
510(k) Number (if known) K152867
Device Name
MHI-TM2000 Linear Accelerator System
Indications for Use (Describe)
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
---|
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image displays the logo and contact information for Mitsubishi Heavy Industries, LTD. The logo is a red emblem consisting of three diamond shapes arranged in a triangular formation. Below the logo, the text reads "MITSUBISHI HEAVY INDUSTRIES, LTD." followed by "MACHINERY, EQUIPMENT & INFRASTRUCTURE" and the address "6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN".
510(k) Summary MHI-TM2000 Linear Accelerator System
The following information is provided following the format of 21 CFR 807.92 for the MHI-TM2000 Linear Accelerator System.
Date prepared: September 17, 2015
-
- Submitter: Mitsubishi Heavy Industries, Ltd. Machinery, Equipment & Infrastructure 4-6-22 Kan-on-shin-machi, Nishi-ku, Hiroshima 733-8553 Japan Establishment Registration Number: 3006942329 Contact person: Shuji Kaneko Manager, Medical System Engineering Section Phone: +81-82-291-2146 Fax: +81-82-294-9888
2. Name of the Device:
Trade Name: | MHI-TM2000 Linear Accelerator System/ Vero/ Imavis |
---|---|
Common or Usual name: | Clinical Linear Accelerator |
Classification Name: | Medical Charged Particle Radiation Therapy System |
21CFR §892.5050, Class II | |
Product Code: IYE |
3. Predicate devices to claim substantial equivalence:
MHI-TM2000 Linear Accelerator System: K122450
4. Description of the Device:
The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated.
It includes a linear accelerator, multi-leaf collimator, electric portal imaging device and couch. It also includes O-ring-type gantry platform, X-ray-head-mounted gimbals, Built-in Imaging System, and function to continuously align treatment beam with moving target for precise radiotherapy of
4
Image /page/4/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red emblem consisting of three diamond shapes arranged in a triangular formation. Below the logo is the company name in bold, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN.
moving targets, as notable characteristics.
The MHI-TM2000 (Ver. 3.5) has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K122450 (hereinafter called "MHI-TM2000 (K122450)'').
Modification was made for introducing a method of radiation therapy called "Dynamic WaveArc" ("DWA") that delivers radiation while rotating both O-ring-shaped gantry (Gantry rotation) and rotational floor of the gantry that moves entire gantry (Ring rotation), or rotating the Ring rotation only.
Radiation type, energy, and the method of generating radiation are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450)
5. 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.
Indications for 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.
6. Technological Characteristics:
Comparison to the predicate device is listed below:
Feature | MHI-TM2000 (Ver. 3.5) | MHI-TM2000 (K122450) |
---|---|---|
"Dynamic WaveArc" radiation | ||
therapy method | Yes | No |
This is the only modification and all other technological characteristics are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450), such as Indications for use, Operation principles and Method of operation.
7. Summary of Performance Testing:
The design control procedures applied to the development of MHI-TM2000 (Ver. 3.5) includes requirements reviews, risk analysis, and verification and validation testing according to:.
-ISO14971: Risk Management Standard
-FDA Quality System regulation (21 CFR 820) and ISO13485: Quality Management System Standard
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Image /page/5/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red, three-diamond shape. Below the logo is the company name, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN.
-Other international standards listed in "8. Standards conformance" below in 8.
Result of verification testing, including regression testing, showed conformance to applicable requirements specifications, assured hazard safeguards functioned properly.
Result of validation testing showed conformance to customer needs and intended use of the MHI-TM2000 (Ver. 3.5).
8. Standards conformance:
The MHI-TM2000 (Ver. 3.5) conforms with the FDA recognized consensus standards and other international standards listed below.
IEC 60601-1, IEC 60601-1-2, IEC 60601-2-28, IEC 60825-1, IEC 60976, IEC 62304 ISO13845, ISO13845, ISO14971
9. Conclusion:
The verification and validation testing results from bench testing, including regression testing, support the substantial equivalence of the MHI-TM2000 (Ver. 3.5) with MHI-TM2000 (K122450)
A special 510(k) is applicable to this application due to the following reasons:
-Change/ modification does not significantly affect safety and effectiveness of MHI-TM2000 (K122450);
-There is no change in basic design control activities specified in 21CFR 820.30;
-There is no change in the medical device information specified in 21CFR 807.87;
-There is no change in all Labeling including Indications for Use;
-There is no change in fundamental scientific technologies; and
-There is no change in material used.