Source: http://docplayer.net/8800020-D-i-z1-510-k-summary-section-5-siemens-medical-solutions-usa-inc-oncology-care-systems-date-prepared-september-09-201-0.html
Timestamp: 2019-12-08 07:31:23
Document Index: 252277625

Matched Legal Cases: ['arty 015', 'arty 015', 'art 1', 'arts 800', 'art 807', 'arts 801', 'art 820', 'arts 801', 'art 803']

D I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09, - PDF Free Download
D I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09,
Download "D I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09, 201 0."
1 Section 5 D I Z1 510(k) Summary Date Prepared: September 09, Submitter: Contact: Siemens Medical Solutions USA, Inc Nelson Avenue Concord, CA Christine Dunbar Senior Regulatory Affairs Specialist Phone: (925) Fax: (925) christine~dunbaresiernens.com Proprietary Name: syngok RT Therapist Connect Workspace, v4.2 Common Name: Accessory To; Medical Charged-Particle Radiation Therapy System ClassIficatIon: Product Code: lye Substantial Equivalence Claimed To: Product 510(k) Claim of Equivalence for: ClearanceI Date syngo RT Therapist K090683/I syngo D RT Therapist Connect Workspace, for RT Connect Workspace with May 08, Therapist with Software update VB10 (RHOC v4.2) RT Therapist version VA ARTISTE"' Solution (aka K072485/ syngo D RT Therapist Connect Workspace for RT ARTISTE MV) with Control Dec. 27, Therapist with Software update VB1O0 (RTTC v4.2) and Console Control Console 12 ONCOR~h Expression with K( / syngo RT Therapist Connect Workspace for RT Control Console 9.0 Mar. 15, Therapist with Software update VB10 (RTTC v4.2) and 2006 Control Console 12 The update to the syngo RT Therapist Connect Workspace, v4.2 as described in this premnarket notification has the same intended use and fundamental scientific technical characteristics as the predicate devices listed above. 510(k) for SIEMENS syngo ) RT Therapist Connect Update Page Sect. 5/
2 Description Summary syngo RT Therapist Connect Workspac e, v4.2: Technological Characteristics: The syngol&rt Therapist Connect Workspace v4.2 release is intend to update customers with the syngock RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.l a (ONCOR I PRIMUS systems). The technological characteristics of the syn go D RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product. The syn go Software Architecture: The syngo RT Therapist Connect software utilizes the proprietary syngo D 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~ h and syngo products also include an array of image-oriented software tools, support for DICOM connectivity and Siemens Remote Service. Refer to Section 1 1- 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 workfiow 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' h, ONCORI ẖ and PRIMUS~ h family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The synizo Suite for Oncologry Workspaces: The syngo D workspaces includes a number of syngo based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The 510(k) for SIEMENS syn go RT Therapist Connect Update Page Sect. 5/
3 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 015, 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 D RT Therapist Connect Workspace v4.2, can be interfaced with third party 015, 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 syn go 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: a I EC :1996+ Al: Medical Electrical Equipment: Part 1-4: General requirements for Collateral Standard: Programmable Electrical Medical Systems a* lec 62304:2006 Medical Device Software - Software Life Cycle Processes 510(k) for SIEMENS syngo D RT Therapist Connect Update Page Sect
4 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.l a. (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 syngc RT Therapist Connect Workspace v4.2 update and the Control Console version 12 do not introduce any new potential safety risks and is substantially equirvalent to, and performs as well as, the predicate devices. 510(k) for SIEMENS syngo ) RT Therapist Connect Update Page Sect
5 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug, Administration New Hampshire Avenue Document Control Room - W066-G609 Silver Spring, MD Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions USA; Inc Nelson Avenue CONCORD CA Re: K Trade Name: syngog RT Therapist Connect Workspace, v4.2 Regulation Number: 21 CFR Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LYE Dated: September 09, 2010 Received: September 16, OCT 1 2 ZoIC Dear Ms. Dunbar: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determnined 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 contrbls 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 administefed 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
6 Page 2 medical device-related adverse events) (21 CER 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820). This letter will allow you to begin marketing your device as described in your Section 51 0(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) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go~to jzov/medicaldevices/safety/reportaproblem/default.htm for the CDRH' s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general infdrmation on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) or (301) or at its Internet address Sincerely yours, Enclosure 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
7 51 0(k) Number (if known): K102E67 I Section 4 Indication For Use Statement Device Name: syngo RT Therapist Connedt Workspace, v4.2 Indications for Use: The intended use bf the SIEMENS branded ARTISTET", ONCORT"' and PRIMUS T M family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The svnczo Suite for Oncoloav Workspaces: The.syngo workspaces includes a number of syngo based software applications whose indication for use include the viewing, processing, filming, and archivng 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 D 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 syn go RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient position~ing verification, treatment delivery/verification, and treatment recording. The syngo RY Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard. The additioh of the syngo RT Therapist Connect Workspace, v4.2, ddes 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) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (OR Over-the-Counter Use (Per 21 CFR ) (ivision Sign-Off) Divsion of Radiological Devices office of in Vitro Diagnostic Device Evaluation and Safety IDLoz 6f7 510(k) for SIEMENS syngo RT Th%7aptsTUcon-nect Up-date Page Sec 4/