(53 days)
The SOMATOM Definition AS/ ASt 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. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
The Siemens SOMATOM Definition AS/ AST is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system 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 archive/evaluation. The SOMATOM Definition AS/AS+ system produces CT images in DICOM format, which can be used by postprocessing 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.
This 510(k) summary for the SIEMENS SOMATOM Definition AS/AS+ Computed Tomography X-ray System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices already on the market. It covers:
- Contact Information: Details of the submitting company and regulatory contact.
- Device Name and Classification: Product name, proprietary trade name, classification name, panel, CFR section, device class, and product code.
- Substantial Equivalence: Identification of predicate devices (Siemens SOMATOM Sensation 64 and Toshiba Aquilion 64) with their FDA clearance numbers and dates.
- Device Description: A general description of the SOMATOM Definition AS/AS+ as a CT X-ray system, its function, software, and output format (DICOM).
- Indications for Use: The intended purpose of the device to produce cross-sectional images of the body.
- General Safety and Effectiveness Concerns: A statement that labeling provides instructions, cautions, and warnings, and that risk management (hazard analysis) is performed to minimize hazards.
- FDA Clearance Letter: Official correspondence from the FDA confirming the substantial equivalence determination.
Therefore, I cannot provide the requested information regarding acceptance criteria or the study that proves the device meets those criteria, as it is not present in the provided text.
If this information were available, it would typically be found in a separate section detailing performance testing, clinical validation, or engineering specifications. For a device like a CT scanner, acceptance criteria would likely relate to image quality parameters (e.g., spatial resolution, contrast resolution, noise, dose efficiency), dose limits, system reliability, and electrical/mechanical safety standards. The study proving these criteria would involve specific tests and measurements.
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SIEMENS
K081/0222
Section 5: 510(k) Summary
JUN - 2 2008
510(K) SUMMARY FOR SOMATOM Definition AS/ AS*
Submitted by:
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355
September 4, 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
I. Contact Person:
Mrs. Corrine McLeod Technical Specialist, Regulatory Affairs Submissions
Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1772 Fax: (610) 448-1778
2. Device Name and Classification
Product Name: SOMATOM Project P46 Propriety Trade Name: SOMATOM Definition AS/ AS+ Classification Name: Computed Tomography X- ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90 JAK
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Substantial Equivalence: 3.
Siemens SOMATOM Definition AS/ AS+ Computed Tomography X-ray systems, configured with software version SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Sensation 64 | K040665 | 04/02/2004 |
| Toshiba Aquilion 64 | K063189 | 11/03/2006 |
Device Description: 4.
The Siemens SOMATOM Definition AS/ AST is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system 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 archive/evaluation.
The SOMATOM Definition AS/AS+ system produces CT images in DICOM format, which can be used by postprocessing 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 SOMATOM Definition AS/ ASt 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.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2008
Ms. Corrine McLeod Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 51 Vallev Stream Parkway E-50 MALVERN PA 19355-1406
Re: K081022
Trade/Device Name: Somatom Definition AS/AST Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 9, 2008 Received: April 10, 2008
Dear Ms. McLeod:
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.
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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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon
Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SIEMENS
510(k) Number (if known): _
Device Name:
Somatom Definition AS/ AS+
Indications for Use:
The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of prome either the same axial plane taken at different angles or spiral planes* taken at different angles .
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)_
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.