(114 days)
No
The document does not mention AI, ML, or related terms, and the described functionalities (patient data management, treatment delivery/verification, image acquisition, and positioning verification) are typical for linear accelerators and do not inherently require AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's intended use is "to deliver x-ray radiation for therapeutic treatment of cancer."
No
The device is a linear accelerator system designed for therapeutic treatment of cancer by delivering x-ray radiation. While it includes imaging capabilities for patient positioning verification, its primary stated purpose is treatment delivery, not diagnosis.
No
The device description explicitly states that the ARTÍSTE MV SA™ is composed of upgraded hardware, firmware, and software, and includes hardware components like an Electronic Portal Imaging Device (EPID) and a multi-leaf collimator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The stated intended use is "to deliver x-ray radiation for therapeutic treatment of cancer." This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on the components of a linear accelerator system used for radiation therapy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information about a patient's health status based on such analysis, which are hallmarks of IVD devices.
The device is a medical device used for treatment, not for diagnosing a condition.
N/A
Intended Use / Indications for Use
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTISTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications with these embedded features:
- patient data management, selection and setup by use of a local, on-board database, .
- treatment delivery/verification and treatment recording by use of on-board applications, .
- Megavoltage Cone Beam acquisition method for acquiring projection data for 3D . reconstruction.
- Patient positioning verification by use of the OPTIVUE imaging system, including . MVision™(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).
Product codes
IYE
Device Description
The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Accelerator product lines. The newest member of the ACCEL systems is the ARTISTE MV SATM Linear Accelerator product. The ARTÍSTE MV SA™ is composed of upgraded hardware, firmware and software as standard features.
The ARTÍSTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Megavoltage Cone Beam acquisition method for acquiring projection data for 3D reconstruction.
OPTIVUE imaging system, including MVision™(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).
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)
ONCOR EXPRESSION with COHERENCE Workspaces (K060226)
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
SIEMENS
2007
Section 5 510(k) Summary and Statement
| Submitter: | Siemens Medical Solutions USA, Inc., Oncology Care Systems | |
|---|---|---|
| Address: | 4040 Nelson Ave. | |
| Concord, CA 94520 | ||
| USA | ||
| Phone number: | 925-246-8378 | |
| Fax number: | 925-602-8008 | |
| Contact person: | Bill Collins, Manager, Regulatory Affairs | |
| Date prepared: | 8/31/2007 | DEC 2 7 |
| Trade name: | ARTÍSTE MV SATM | |
| Device classification: | 892.5050/ IYE/Radiology | |
| Substantial equivalence claimed to: | ONCOR EXPRESSION with COHERENCE Workspaces (K060226) |
Device Description:
The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Accelerator product lines. The newest member of the ACCEL systems is the ARTISTE MV SATM Linear Accelerator product. The ARTÍSTE MV SA™ is composed of upgraded hardware, firmware and software as standard features.
Intended use:
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTÍSTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications.
Summary of technological characteristics:
The ARTISTE MV SA™ linear accelerator does not have significant changes in materials, energy source or technological characteristics as compared to the predicate device. The intended use, indication for use and the fundamental scientific technology are the same as the predicate device and therefore we believe it is substantially equivalent to the predicate device.
Substantial equivalence:
The ARTÍSTE MV SA™ linear accelerator is substantially equivalent to the ONCOR EXPRESSION with COHERENCE Workspaces (K060226) in that it provides x-ray radiation for therapeutic treatment of cancer.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines, possibly representing an eagle or a similar bird.
Public Health Service
DEC 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA, Inc. % Mr. Erik Rodriguez Senior Software Quality Engineer Certified Compliance Solutions, Inc. (CCS, Inc) 16787 Bernardo Center Drive SAN DIEGO CA 92128
Re: K072485
Trade/Device Name: ARTISTE MV SATM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 28, 2007 Received: November 28, 2007
Dear Mr. Rodriguez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdri/industry/support/index.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
SIEMENS
Indications for Use Statement Section 4 510(k) Number: K077403
Device Name: ARTÍSTE MV SATM
Indications for Use:
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTISTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications with these embedded features:
- patient data management, selection and setup by use of a local, on-board database, .
- treatment delivery/verification and treatment recording by use of on-board applications, .
- Megavoltage Cone Beam acquisition method for acquiring projection data for 3D . reconstruction.
- Patient positioning verification by use of the OPTIVUE imaging system, including . MVision™(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aruith Wh
luctive. Abdomin 510(k) Number