(64 days)
Not Found
No
The document describes software updates focused on safety features, dose monitoring, and treatment timing. There is no mention of AI, ML, or related concepts.
Yes
The "Intended Use / Indications for Use" section explicitly states that the linear accelerator systems deliver "radiation for the therapeutic treatment of cancer." and are "optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy".
No
The device is described as a linear accelerator system used for the therapeutic treatment of cancer by delivering radiation. While it includes tools for localization, contouring, and image review, these functions are described as aiding in the diagnosis, staging, and prescription of radiation therapy, rather than being the primary diagnostic function of the device itself. The main purpose is treatment delivery.
No
The device is described as a modification to a linear accelerator system, which is a hardware device. While the submission focuses on software updates, the device itself is the linear accelerator system with the updated software, not the software in isolation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering radiation for the therapeutic treatment of cancer. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the components and software used to control and deliver radiation therapy. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens to diagnose a disease or condition.
Therefore, this device falls under the category of a therapeutic medical device, specifically a linear accelerator system for radiation therapy.
N/A
Intended Use / Indications for Use
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The linear accelerator systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.
The Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup. patient positioning verification, treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1 MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The subject device is a modification of the previously cleared ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1 MR1 (K142434). The modification consists of an update to the LINAC Control Console Software (v13.1.010) to enhance the safety of the Automatic Movement Protection feature.
Listed below are additional minor software updates:
- IBL: enabling pressure & temperature compensation for imaging beams
- MON 2: adjustments to the secondary dose monitoring system for small . total doses to terminate radiation when the selected number of MUs is exceeded by not more than 10% (valid for
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a square. The full name reads "U.S. Food & Drug Administration".
October 3, 2018
Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN, PA 19355
Re: K182050
Trade/Device Name: Linear Accelerator Control Console Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 30, 2018 Received: July 31, 2018
Dear Martin Rajchel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K182050
Device Name
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3
Indications for Use (Describe)
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The linear accelerator systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.
The Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup. patient positioning verification, treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1 MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) | X | Prescription Use (Part 21 CFR 801 Subpart D) | |
| X | Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Date Prepared July 30, 2018
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens AG, Medical Solutions Radiation Oncology Doris-Ruppenstein-Str. 4 Erlangen, Germany, 91052 Registration Number: 3006894636
2. Contact Information
Martin Rajchel Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 Email: martin.rajchel@siemens-healthineers.com Rolf Meisel Requlatory Manager Siemens Healthcare GmbH Roentgenstr. 19-21 Kemnath, Bavaria, 95478. Germany Phone: +49 (9642) 18-7424 Fax: +49 (9642) 18-1424 Email: rolf.meisel@siemens-healthineers.com
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3. Device Name and Classification
| Trade name | ccNode Software v13.1.010 Update for Siemens PRIMUS™,
ONCOR™, ARTISTE™, and syngo® RT Therapist & RT
Oncologist Workspaces, v4.3.1_MR3 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Medical charged-particle radiation therapy system |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.5050 |
| Device Class: | II |
| Product Code: | IYE |
4. Legally Marketed Predicate Device
| Trade Name | ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with
syngo RT Therapist & RT Oncologist Workspaces,
V4.3.1_MR1 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K142434, Cleared November 21, 2014 |
| Classification Name: | Medical charged-particle radiation therapy system |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.5050 |
| Classification: | Class II |
| Product Code: | Primary: IYE |
5. Device Description
The subject device is a modification of the previously cleared ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1 MR1 (K142434). The modification consists of an update to the LINAC Control Console Software (v13.1.010) to enhance the safety of the Automatic Movement Protection feature.
Listed below are additional minor software updates:
- IBL: enabling pressure & temperature compensation for imaging beams ●
- MON 2: adjustments to the secondary dose monitoring system for small . total doses to terminate radiation when the selected number of MUs is exceeded by not more than 10% (valid for