MX MEVATRON

K982513 · Siemens Medical Solutions USA, Inc. · IYE · Jul 31, 1998 · Radiology

Device Facts

• Record ID: K982513
• Device Name: MX MEVATRON
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 31, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

MEVATRON MX is a single-energy, high-dose medical linear accelerator; delivers megavoltage x-ray radiation for cancer therapy. Device utilizes high-atomic-number target to produce photons from electron beam; electron path is perpendicular to isocentric plane, aligned with radiation axis. Features include dual dose rate, asymmetric jaws, and Virtual Wedge or standard cross-plane wedges. Operated by clinical staff in radiation oncology settings. Output provides therapeutic radiation dose to deep-seated tumors; skin-sparing effect minimizes superficial tissue damage. Clinical decision-making relies on precise dose delivery to target volumes. Benefits include effective treatment of deep-seated malignancies.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-energy medical linear accelerator; high-A material target for photon production. Features dual dose rate, asymmetric jaws, and Virtual Wedge/standard cross-plane wedges. Electron path aligned perpendicular to isocentric plane. No significant changes in materials or energy source compared to predicate.

Indications for Use

Indicated for therapeutic treatment of cancer in patients requiring megavoltage x-ray radiation, specifically for deep-seated tumors where skin sparing is desired.

Regulatory Classification

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.

Predicate Devices

• MEVATRON M Class (K882729)

Submission Summary (Full Text)

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K982513

# SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | Submitter's Information: | Dated: July 17, 1998 |
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| | Contact Person: | Kathryn B. Dodd |
| | | Vice President Regulatory Affairs and Quality Assurance |
| 2. | Common or Usual Name: | Linear Accelerator |
| | | Proprietary Name: |
| | | Classification Name: |
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| 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.
- 7. 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.
- 8. 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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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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: [phone] FAX [phone]