(11 days)
Not Found
No
The summary describes a standard linear accelerator with features like MLC and Virtual Wedge, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer, which directly describes a therapeutic use.
No
This device is a linear accelerator that delivers radiation treatment for cancer; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "medical linear accelerator," which is a hardware device used for radiation therapy. It also lists hardware components like a Multileaf Collimator (MLC).
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 megavoltage x-ray treatment for therapeutic application in the treatment of cancer." This describes a therapeutic device used for treating a disease within the body, not a device used to examine specimens taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "medical linear accelerator" used for delivering radiation treatment. This aligns with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Mentioning reagents, assays, or laboratory procedures
In summary, the GENESIS IMRT Linear Accelerator is a therapeutic device used for radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
90 IYE
Device Description
The GENESISTM Linear Accelerator is a single energy, high dose medical linear accelerator. The GENESISTM includes a Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge™, and PRIMEVIEW.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K882729 MEVATRON M Class
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
JUL 3 | 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: July 17, 1998
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:
Proprietary Name:
Classification Name: | Linear Accelerator
GENESISTM IMRT Medical Linear Accelerator
Medical Charged Particle Radiation Therapy System
21 CFR § 892.5710
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.
-
- 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.
-
- 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 (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, "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 (800) 638-2041 or (301) 443-6597 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
್ಕೆ ನಿವ
2
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: (510) 246-8200 FAX (510) 246-8284