(11 days)
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No
The summary describes a standard linear accelerator for radiation therapy and does not mention any AI or ML components or capabilities.
Yes
The device is described as a linear accelerator intended for delivering megavoltage x-ray treatment for the therapeutic application in treating cancer, which is a therapeutic function.
No
The device description clearly states its purpose is for "delivering megavoltage x-ray treatment for therapeutic application in the treatment of cancer," specifically for "treating deep-seated tumors." This indicates a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a "medical linear accelerator," which is a hardware device used for radiation therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MEVATRON MX Linear Accelerator is for "delivering megavoltage x-ray treatment for therapeutic application in the treatment of cancer." This is a therapeutic device, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The MEVATRON MX does not perform this function. It delivers radiation to the body for treatment.
- Device Description: The description focuses on the technical aspects of delivering radiation (linear accelerator, dose rate, jaws, wedges), not on analyzing biological samples.
The information provided strongly indicates that this is a therapeutic medical device used for radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The depth of penetration emulating from the MEVATRON MX ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.
Product codes
90 IYE
Device Description
The MEVATRON MX is a single energy, high dose medical linear accelerator. The MEVATRON MX includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: July 17, 1998 |
|---|---|---|
| Contact Person: | Kathryn B. Dodd | |
| Vice President Regulatory Affairs and Quality Assurance | ||
| 2. | Common or Usual Name: | Linear Accelerator |
| Proprietary Name: | ||
| Classification Name: | ||
| 3. | Predicate Device: | MEVATRON M Class, 510(k) No. K882729 |
- Description of Device: The MEVATRON MX is a single energy, high dose medical linear 4. accelerator. The MEVATRON MX includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
- ર્જ Statement of intended use: The intended use of the MEVATRON MX is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the MEVATRON MX is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification
- ર્. Statement of technological characteristics: The MEVATRON MX linear accelerator does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
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- Differences: The main difference between the existing 6 MV MEVATRON M Class system and the MEVATRON MX is the path of the electrons prior to striking the target. In the MEVATRON M machine, the axis of the accelerator is parallel in the isocentric plane; thus electrons must exit the structure through a 270° bend. In contrast, the axis of the MEVATRON MX is perpendicular to the isocentric plane and is aligned with the radiation axis. Electrons in both types of accelerators product photons by striking a target made from high-A (i.e., high atomic number) material. From this point on, the design and functionality for the MEVATRON MX and 6 MV MEVATRON M Class are essentially the same.
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- Performance Standards: No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic ACT.
Siemens considers the MEVATRON M Class system and the MEVATRON MX to be equivalent.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1998
Kathryn Berry Dodd Vice-President, RA & QA Siemens Medical Systems, Inc. Oncology Care Systems 4040 Nelson Avenue Concord. CA 94520
Re:
K982513 MX Mevatron Linear Accelerator Dated: July 17, 1998 Received: July 20, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Dodd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Apporal), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your derice 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K982513 Product: MEVATRON MX LINEAR ACCELERATOR
INDICATIONS FOR USE
The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The depth of penetration emulating from the MEVATRON MX ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.
William Ch
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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Siemens Medical Systems, Inc.
Oncology Care Systems
4040 Nelson Avenue Concord, CA 94520
Tel: (510) 246-8200 FAX (510) 246-8284