Source: http://docplayer.net/9525471-0-ec2-92011-v-133-lj9a.html
Timestamp: 2019-12-10 07:31:58
Document Index: 626246761

Matched Legal Cases: ['arts 800', 'art 807', 'arts 801', 'art 820', 'arts 801', 'art 803', 'art 21']

0 EC V-,) 133 Lj9a - PDF Free Download
0 EC V-,) 133 Lj9a
Download "0 EC2 92011 V-,) 133 Lj9a"
1 0 EC V-,) 133 Lj9a Section 5: 5 1 0(k) Summar 5 10(K) SUMMARY FOR SOMATOM DEFINITION Flash (with Stellar Detector) Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA Novemberr 9, 2011 This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Contact Person: Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA Phone:(610) Fax: (610) Device Name and Classification Product Name: Propriety Trade Name: Classification Name: Classification Panel: SOMATOM Definition Flash (with Stellar Detector) SOMATOM Definition Flash Computed Tomography X- ray System Radiology CER Section: 21 CFR Device Class: Class 11 Product Code: 90 JAK Siemens Medical Solutions, Inc. USA Page (k) for SOMATOM DEFIN11TION FLAS QSystemi ~vt~tiaetectorszellar Detector 18 of 1720
2 Section 5: 510(k) Summary 3. Substantial Equivalence: Siemens SOMATOM Definition Flash (with Stellar Detector) Computed Tomography X- ray system, configured with software SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution: Predicate Device Name FDA Clearance Number FDA Clearance Date Siemens SOMATOM FLASH DS K /1 0/ Device Description: The Siemens SOMATOM Definition Flash (with Stellar Detector) is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image arch ive/evalunation. The SOMATOM Definition Flash (with Stellar Detector) produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run such post processing applications optionally. 5. Indications for Use: The Siemens SOMATOM Definition Flash (with Stellar Detector) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. In addition the SOMATOM Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x- ray tube, and the simultaneous translation of the patient.) Siemens Medical Solutions, Inc. USA Page (k) for SOMATOM DEFINLTION 1 FLASH QTc~ystem jh~eia~tctrt1a Detector 19 of 1720
3 6 W KSection t~ti 5: 510(k) Summary 6. General Safety and Effectiveness Concerns: 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 hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards. Siemens Medical Solutions, Inc. USA Page (k) for SOMATOMDENT[N AHQcy51 ihsearqecrserlxctv 0412
4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Room - W Silver Spring, MD Ms. Kim Mangum DC2321 Regulatory Affairs Technical Specialist DC 21 Siemens Medical Solutions, USA Inc. 51 Valley Stream Parkway Mail Code D02 MALVERN PA Re: K Trade/Device Name: SOMATOM Definition Flash (with Stellar Detector) Regulation Number: 21 CFR Regulation Name: Computed tomography x-ray system Regulatory Class: 11 Product Code: JAK Dated: November 9, 2011 Received: November 14, 2011 Dear Ms. Mangum: We have reviewed your Section 5 10(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 fuirther 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 Page 2 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 5 10(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 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) or (301) or at its Internet address Sincerely Yours, Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure
6 IE R/ 5Section [EHo 4: Indication for Use Statement 5 10(k) Number (if known): Product Name: SOMA TOM Definition Flash (with Stellar Detector) Indications for Use: The Siemens SOMATOM Definition Flash (with Stellar Detector) system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. In addition the SOMATOM Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.) Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Diviso Si Off Office of In Vitro Diagnostic Device Evaluation and Safety 5 10(k) ('34 Siemens Medical Solutions, Inc. USA 10(k) for SOMATOM DEF1Ntkk0,NF6Akij C '~ystgn wjh Page I -~Uretecto ' iar Detector 16 of 17120