(45 days)
No
The summary does not mention any AI or ML terms, image processing, or performance studies related to algorithmic performance. The description focuses on the hardware and basic functionalities of a linear accelerator.
Yes
The device "delivers x-ray radiation for therapeutic treatment of cancer," indicating its use for therapy.
No
The device is described as delivering x-ray radiation for therapeutic treatment of cancer, indicating a treatment rather than a diagnostic function.
No
The device description clearly states it is a "medical linear accelerator," which is a piece of hardware used for radiation therapy. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to deliver x-ray radiation for therapeutic treatment of cancer." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a medical linear accelerator used for radiation therapy, which aligns with a therapeutic purpose.
- Lack of IVD Characteristics: The description does not mention any components, processes, or intended uses related to examining specimens (like blood, tissue, or urine) outside the body to diagnose diseases or conditions.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to treat cancer with radiation, which is a therapeutic intervention.
N/A
Intended Use / 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.
Product codes
RA 90 IYE
Device Description
The PRIMUS™ is a dual energy, high dose medical linear accelerator. The PRIMUS™ includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 26 1999
SIEMENS
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: October 05,1999
Siemens Medical Systems
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 |
|----|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Kathryn B. Dodd
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.
-
- 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.
-
- 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.
1
:
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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 (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, "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 (800) 638-2041 or (301) 443-6597, 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
2
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