K Number
K102671
Device Name
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
Date Cleared
2010-10-12

(26 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace, v4.2, is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard. The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.
Device Description
The syngo® RT Therapist Connect Workspace v4.2 release is intend to update customers with the syngo® RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.1a (ONCOR / PRIMUS systems). The technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product. The syngo® RT Therapist Connect software utilizes the proprietary syngo® software architecture design provides a method of delivering customized software applications based on the modality as clinically supporting packages. From these applications SIEMENS utilizes, as part of the Oncology clinical focus package, multiple applications for patient set-up and position verification, treatment localization, treatment verification, portal imaging as well as data processing, image reformatting, display and printing. The currently cleared COHERENCE™ and synqo® products also include an array of image-oriented software tools, support for DICOM connectivity and Siemens Remote Service.
More Information

Not Found

No
The document describes software for managing and processing medical images and patient data for radiation therapy, but there is no mention of AI or ML technologies being used. The focus is on updating existing software and maintaining compatibility with third-party systems.

No.
The document states that the software is for "viewing, processing, filming, and archiving of medical images" and "permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording." It is an option to be used "in conjunction with the Siemens branded Linear Accelerator system," but it does not change the intended use of the linear accelerator, which is the therapeutic device. The software itself is not a therapeutic device.

No

The device is described as software that assists with the viewing, processing, filming, and archiving of medical images, as well as patient data management, selection/setup, positioning verification, treatment planning, treatment delivery/verification, and treatment recording for therapeutic cancer treatment using linear accelerator systems. Its purpose is to facilitate and record radiation therapy, not to diagnose medical conditions.

No

The device is described as a software application that is an "additional option" when used with third-party devices and is part of the "syngo® workspaces" which are integrated with Siemens branded Linear Accelerator systems. While the specific submission focuses on a software update, the context clearly indicates this software is a component of a larger hardware system (linear accelerators) and is not a standalone software-only medical device.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The primary intended use of the linear accelerator systems is to deliver radiation for the therapeutic treatment of cancer. The syngo® workspaces and the RT Therapist Connect Workspace are software applications that support this therapeutic process through image viewing, processing, patient management, treatment planning, and delivery.
  • Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
  • Focus on Treatment and Image Management: The description clearly focuses on the delivery of radiation therapy and the management of images and data related to that treatment.

While the device involves image processing, this is in the context of supporting radiation therapy, not for diagnostic testing of biological samples.

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 syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
The syngo® RT Therapist Connect Workspace, v4.2, is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard.
The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

The syngo® RT Therapist Connect Workspace, v4.2 is an update to existing versions (v4.1 for ARTISTE systems and v2.1a for ONCOR / PRIMUS systems) and its technological characteristics remain unchanged. The software utilizes the proprietary syngo® software architecture to deliver customized applications for patient set-up and position verification, treatment localization, treatment verification, portal imaging, data processing, image reformatting, display, and printing within the Oncology clinical focus package. It also includes image-oriented software tools, DICOM connectivity, and Siemens Remote Service.

Mentions image processing

Yes

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

Bench testing in the form of Unit. Integration and System Integration testing was performed to evaluate the performance and functionality of the software update for the RT Therapist Connect and the Control Console, version 12. All testable requirements in the Software Requirements Specifications (SRS), Sub-System Requirements Specifications (SSRS), and specifically, the Functional Specifications (FS) for the Control Console software and Function Controller firmware, have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP).
The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans.
Validation of the syngo® RT Therapist Connect Workspace, v4.2 and Control Console 12 has been performed at the System test level on production prototype devices by appropriately trained and knowledgeable test personnel. System level validation and regression testing has been performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing, including Unit, Integration, and System Integration testing, was performed to evaluate the performance and functionality of the software update for the RT Therapist Connect and Control Console, version 12. All testable requirements were successfully verified and traced. Software verification and regression testing successfully met acceptance criteria. System-level validation and regression testing demonstrated that the software meets acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090683, K072485, K060226

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 Medical Solutions USA, Inc. Oncology Care Systems

Section 5

OCT 1 8 2010

510(k) Summary

Date Prepared:

...

.

..

September 09, 2010

| Submitter: | Siemens Medical Solutions USA, Inc.
Oncology Care Systems
4040 Nelson Avenue
Concord, CA 94520 |
|-------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Christine Dunbar
Senior Regulatory Affairs Specialist |
| Phone: | (925)602-8157 |
| Fax: | (925)602-8008 |
| Email: | christine.dunbar@siemens.com |
| Proprietary Name: | syngo® RT Therapist Connect Workspace, v4.2 |
| Common Name: | Accessory To; Medical Charged-Particle Radiation Therapy System |
| Classification: | 892.5050 |
| Product Code: | IYE |

Substantial Equivalence Claimed To:

| Product | 510(k)
Clearance /
Date | Claim of Equivalence for: |
|----------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| syngo® RT Therapist
Connect Workspace with
RT Therapist version VA20 | K090683 /
May 08,
2009 | syngo® RT Therapist Connect Workspace, for RT
Therapist with Software update VB10 (RTTC v4.2) |
| ARTISTETM Solution (aka
ARTISTE MV) with Control
Console 11.0 | K072485 /
Dec. 27,
2007 | syngo® RT Therapist Connect Workspace for RT
Therapist with Software update VB10 (RTTC v4.2) and
Control Console 12 |
| ONCORTM Expression with
Control Console 9.0 | K060226 /
Mar. 15,
2006 | syngo® RT Therapist Connect Workspace for RT
Therapist with Software update VB10 (RTTC v4.2) and
Control Console 12 |

The update to the syngo® RT Therapist Connect Workspace, v4.2 as described in this premarket notification has the same intended use and fundamental scientific technical characteristics as the predicate devices listed above.

1

Description Summary

syngo® RT Therapist Connect Workspace, v4.2:

Technological Characteristics:

Zhe syngo® RT Therapist Connect Workspace v4.2 release is intend to update customers with

the syngo® RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.1a (ONCOR / PRIMUS systems). The technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product.

The syngo® Software Architecture:

The syngo® RT Therapist Connect software utilizes the proprietary syngo® software architecture design provides a method of delivering customized software applications based on the modality as clinically supporting packages. From these applications SIEMENS utilizes, as part of the Oncology clinical focus package, multiple applications for patient set-up and position verification, treatment localization, treatment verification, portal imaging as well as data processing, image reformatting, display and printing. The currently cleared COHERENCE™ and synqo® products also include an array of image-oriented software tools, support for DICOM connectivity and Siemens Remote Service.

Refer to Section 11- Design Description, for the Product and Sub-System Requirements Specifications regarding these specific requirements.

General Safety and Effectiveness:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards.

Intended 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 syngo® Suite for Oncology Workspaces:

The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The

2

workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Connect Workspace v4.2, is an additional option when third party OlS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace v4.2, is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, can be interfaced with third party OIS, TPS and other validated devices conforming to the DICOM Standard.

Substantial Equivalence:

The Substantial Equivalence comparison chart in Section 12 demonstrates the comparison of the technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 and Control Console 12 update to the currently cleared predicate devices.

The syngo® RT Therapist Connect Workspace v4.2, does not change the intended use of the original syngo® RT Therapist Connect Workspace or the Siemens branded Linear Accelerator Systems.

Bench Testing:

Bench testing in the form of Unit. Integration and System Integration testing was performed to evaluate the performance and functionality of the software update for the RT Therapist Connect and the Control Console, version 12. All testable requirements in the Software Requirements Specifications (SRS), Sub-System Requirements Specifications (SSRS), and specifically, the Functional Specifications (FS) for the Control Console software and Function Controller firmware, have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP).

The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans.

Non-Clinical Test Results:

Validation of the syngo® RT Therapist Connect Workspace, v4.2 and Control Console 12 has been performed at the System test level on production prototype devices by appropriately trained and knowledgeable test personnel. System level validation and regression testing has been performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans.

Testing to Consensus Standards:

The syngo® RT Therapist Connect Workspace, v4.2, Control Console and firmware have been tested to meet the requirements for conformity (where applicable) to the following standards:

  • IEC 60601-1-4:1996+ A1: 1999 Medical Electrical Equipment: Part 1-4: General . requirements for Collateral Standard: Programmable Electrical Medical Systems
  • IEC 62304:2006 Medical Device Software -- Software Life Cycle Processes .

510(k) for SIEMENS syngo® RT Therapist Connect Update

3

Substantial Equivalence to Predicates:

The verification testing to the software and component requirements (Control Console), validation of the intended use, and the regression testing to the existing RT Therapist Connect software and Control Console functional requirements, is intended to support the claim of substantial equivalence to the currently cleared syngo® RT Therapist Connect Workspace, v4.1 and v2.1a. (K090683), the currently cleared Control Consoles and Function controllers for the ARTISTE (K072485) and ONCOR (K060226) medical linear accelerators.

Summary:

In summary, it is SIEMENS' belief that the syngo® RT Therapist Connect Workspace v4.2 update and the Control Console version 12 do not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

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Public Health Service

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 4040 Nelson Avenue CONCORD CA 94520

K102671 Re:

Trade Name: syngo® RT Therapist Connect Workspace, v4.2 Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 09, 2010 OCT 12 2010 Received: September 16, 2010

Dear Ms. Dunbar:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of

5

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

6

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Section 4

Indication For Use Statement

510(k) Number (if known): __

K102671

Device Name: syngo® RT Therapist Connect Workspace, v4.2

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 syngo® Suite for Oncology Workspaces:

The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Connect Workspace, v4.2, is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard.

The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use
(Per 21 CFR 801.109)Over-the-Counter Use
OR
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K1026
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