PRIMUS

K993425 · Siemens Medical Solutions USA, Inc. · IYE · Nov 26, 1999 · Radiology

Device Facts

• Record ID: K993425
• Device Name: PRIMUS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the PRIMUS™ is the same as the MEVATRON™ M and has not changed as a result of the modification.

Device Story

PRIMUS is a dual-energy, high-dose medical linear accelerator used in clinical oncology settings. It delivers x-ray radiation for cancer treatment. Key features include dual dose rate, asymmetric jaws, and either Virtual Wedge or standard cross-plane wedges. The device incorporates FIMRT (Fast Intensity Modulated Radiation Therapy), enabling delivery up to 40% faster than the predicate system. Operated by trained clinical staff, the device transforms electrical energy into high-energy radiation beams directed at tumor sites. The output is controlled radiation delivery, which clinicians use to execute treatment plans, potentially improving patient outcomes through more efficient therapy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-energy, high-dose medical linear accelerator. Features include dual dose rate, asymmetric jaws, and Virtual Wedge or standard cross-plane wedges. Incorporates FIMRT for accelerated radiation delivery. No significant changes in materials or energy source compared to the predicate device.

Indications for Use

Indicated for the delivery of x-ray radiation for the therapeutic treatment of cancer in patients requiring radiation therapy.

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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K993425

NOV 26 1999

## SIEMENS

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | Submitter's Information: | Dated: October 05,1999<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: | Linear Accelerator |
| | Proprietary Name: | PRIMUSTM |
| | Classification Name: | Medical Charged Particle Radiation Therapy System |
| | | 21 CFR § 892.5710 |
| | | Class II, Product Code: RA 90 IYE |

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

- Description of Device: The PRIMUS™ is a dual energy, high dose medical linear accelerator. 4. The PRIMUSTM includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
- Statement of intended use: The intended use of the PRIMUS™ is to deliver x-ray radiation for ನ. therapeutic treatment of cancer. The intended use of the PRIMUSTM is the same as the MEVATRON™M M Class and has not changed as a result of this modification
- Statement of technological characteristics: The PRIMUS™ linear accelerator does not have 6. 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 MEVATRON™ M system and the PRIMUS™ is new covers, name and inclusion of FIMRT (Fast Intensity Modulated Radiation The rationale for the 510K submission is to inform the FDA of the technical Therapy). advancement of the faster IMRT delivery. This delivery is up to 40% faster than what is provided today.
- 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 PRIMUS™ system and the MEVATRON™M M Class to be equivalent.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1999

Kathryn B. Dodd Vice President, RA&QA Siemens Medical Systems Oncology Care Systems Group 4040 Nelson Avenue Concord, California 94520

RE:

K993425 PRIMUS Medical Linear Accelerator Dated: October 8, 1999 Received: October 12, 1999 Regulatory Class: II 21 CFR 892.5710/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 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 redassified 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 III (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 Quality System Regulation (QS) for Medical Devices: General regulation (21 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 531 through 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 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 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, "Mishranding 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/dsma/dsmamain.html".

Sincerely yours,
Dan Sertic

CAPT Daniel G. Schultz, M.D. Acting 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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## INDICATIONS FOR USE:

The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the PRIMUS™ is the same as the MEVATRON™ M and has not changed as a result of the modification.

Prescription Use (Per 21 CFR 801.109)

Gerrit A. Koppen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 992420 510(k) Number