GENESIS IMRT LINEAR ACCELERATOR

K982502 · Siemens Medical Solutions USA, Inc. · IYE · Jul 31, 1998 · Radiology

Device Facts

• Record ID: K982502
• Device Name: GENESIS IMRT LINEAR ACCELERATOR
• 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 GENESIS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The GENESIS IMRT Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The GENESIS delivers these treatments conformally, shaping the field of radiation to the tumor volume. The depth of penetration emulating from the GENESIS ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

Device Story

GENESIS IMRT Linear Accelerator is a single-energy, high-dose medical linear accelerator; delivers conformal megavoltage x-ray radiation for cancer treatment. Device shapes radiation fields to tumor volumes; provides skin-sparing effect for deep-seated tumors. System includes Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge, and PRIMEVIEW. Operated by clinical staff in radiation oncology settings. Electrons are accelerated along an axis perpendicular to the isocentric plane, aligned with the radiation axis, and strike a high-Z target to produce photons. Output is controlled radiation beam for therapeutic application. Clinical benefit includes precise tumor targeting while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Single-energy, high-dose medical linear accelerator. Components: Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge, PRIMEVIEW. Electron acceleration path is perpendicular to the isocentric plane. Target material: high-Z (high atomic number). Energy source: megavoltage x-ray.

Indications for Use

Indicated for therapeutic treatment of cancer in patients requiring megavoltage x-ray radiation. Used for conformal radiation therapy to shape radiation fields to tumor volumes, particularly deep-seated tumors.

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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JUL 3 | 1998

K982502

### SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | Submitter's Information: | Dated: July 17, 1998<br>Siemens Medical Systems<br>Oncology Care Systems Group<br>4040 Nelson Avenue<br>Concord, CA 94520 |
|----|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Kathryn B. Dodd<br>Vice President Regulatory Affairs and Quality Assurance |
| 2. | Common or Usual Name:<br>Proprietary Name:<br>Classification Name: | Linear Accelerator<br>GENESISTM IMRT Medical Linear Accelerator<br>Medical Charged Particle Radiation Therapy System<br>21 CFR § 892.5710<br>Class II, Product Code: RA 90 IYE |

MEVATRON M Class, 510(k) No. K882729 Predicate Device: 3.

- Description of Device: The GENESISTM Linear Accelerator is a single energy, high dose 4. medical linear accelerator. The GENESISTM includes a Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge™, and PRIMEVIEW.
- Statement of intended use: The intended use of the GENESIS™ is to deliver x-ray radiation for પં therapeutic treatment of cancer. The intended use of the GENESIS™ is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification
- Statement of technological characteristics: The GENESIS™ linear accelerator does not ર્. 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 6 MV MEVATRON M Class system and the GENESIS™ Linear Accelerator 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 GENESIS™ is perpendicular to the isocentric plane and is aligned with the radiation axis. Electrons in both types of accelerators produce photons by striking a target made from high-Z (i.e., high atomic number) material. From this point on, the design and functionality for the GENESISTM 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 GENESISTM 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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 ಿರಿದರೆ

Kathryn Berry Dodd Vice-President, RA & QA Siemens Medical Systems, Inc. Oncology Care Systems 4040 Nelson Avenue Concord, CA 94520

Re:

K982502 Genesis IMRT 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Onality System Regulation (OS) 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 S10%) 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 (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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SIEMENS

510(k) Number: Product:

K982502 GENESIS, IMRT LINEAR ACCELERATOR

## INDICATIONS FOR USE

The GENESIS IMRT Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The GENESIS delivers these treatments conformally, shaping the field of radiation to the tumor volume. The depth of penetration emulating from the GENESIS ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

h. Mian Yn..

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

### Siemens Medical Systems, Inc.

Oncology Care Systems

4040 Nelson Avenue Concord, CA 94520

Tel: [phone] FAX [phone]