(45 days)
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.
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.
This submission K993425 is for a conventional medical device (Linear Accelerator) and not an AI/ML device. Therefore, the requested information elements related to AI/ML device performance studies (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable and are not present in the provided document.
The document focuses on demonstrating substantial equivalence to a predicate device (MEVATRON™ M Class, K882729) based on intended use and technological characteristics, particularly the advancement in Faster Intensity Modulated Radiation Therapy (FIMRT).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Claim: Substantial Equivalence to Predicate Device (MEVATRON™ M Class, K882729) | The PRIMUS™ 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. |
| Intended Use: Deliver x-ray radiation for therapeutic treatment of cancer. | The intended use of the PRIMUS™ is to deliver x-ray radiation for therapeutic treatment of cancer, which is the same as the MEVATRON™ M. |
| Technological Characteristics: | The main difference between the existing MEVATRON™ M system and the PRIMUS™ is new covers, name, and inclusion of FIMRT (Fast Intensity Modulated Radiation Therapy). FIMRT offers up to 40% faster delivery. |
| Performance Standards: Compliance with applicable performance standards. | No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, MEVATRON™ M Class (K882729).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a conventional medical device submission based on substantial equivalence to a predicate device, not an AI/ML device requiring a test set for performance evaluation in artificial intelligence terms. The "test set" in this context refers to the comparison of technological specifications and intended use against the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth establishment by experts in the context of diagnostic or interpretive AI/ML is not relevant here. The evaluation relies on engineering and regulatory assessment of the device's design and function compared to a legally marketed predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in diagnostic studies. This submission is for a therapeutic medical device with a focus on engineering equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. MRMC studies are used to assess the impact of AI on human interpretative performance. This device is a linear accelerator for radiation therapy, not a diagnostic imaging AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question pertains to standalone performance of an AI/ML algorithm. The PRIMUS™ is a physical medical device, a linear accelerator, and does not operate as a standalone algorithm in the sense implied by this question.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/ML sense). The "ground truth" for this device's acceptance is its demonstrated equivalence in intended use and performance characteristics to the predicate device, as assessed by engineering specifications and regulatory review.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/ML model for this conventional medical device submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for it.
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NOV 26 1999
SIEMENS
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: October 05,1999Siemens Medical SystemsOncology Care Systems Group4040 Nelson AvenueConcord, CA 94520 |
|---|---|---|
| Contact Person: | Kathryn B. DoddVice 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.
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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
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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
§ 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.