SYMBIA 6.0
Device Facts
| Record ID | K142006 |
|---|---|
| Device Name | SYMBIA 6.0 |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | KPS · Radiology |
| Decision Date | Aug 21, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
Indications for Use
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: Planar imaging, whole body imaging for isotopes with energies up to 588 keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images. Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.
Device Story
Symbia 6.0 is a hybrid imaging system combining SPECT scanners with integrated X-ray CT; used in clinical settings by trained healthcare professionals. SPECT subsystem detects/images radionuclide distribution (physiology); CT subsystem produces cross-sectional anatomical images via computer reconstruction of X-ray transmission data. System enables standalone SPECT or CT imaging, or integrated SPECT+CT for attenuation correction and image registration. Software (syngo MI Applications) provides display/analysis tools for assessment and quantification of pathologies. Clinicians use output images to aid in diagnosis, staging, radiotherapy planning, and interventional procedures. Benefits include precise anatomical localization of metabolic activity and improved diagnostic accuracy. Modifications include new Evo/Evo Excel models, Windows 7 OS upgrade, and integration of IRIS CT software.
Clinical Evidence
Bench testing only. Performance testing conducted per IEC 60601-1 series and NEMA NU-1:2007. IRIS image quality testing performed using Catphan and water phantoms. All testing met predetermined acceptance values. No clinical data presented.
Technological Characteristics
Hybrid SPECT/CT system. SPECT: variable angle dual detector gamma camera. CT: 2, 6, or 16-slice spiral CT. Software: syngo MI Applications VB10A on Windows 7. Standards: IEC 60601-1, 1-2, 1-3, 2-44; NEMA NU-1:2007; 21 CFR 1020.30/33. Connectivity: Networked imaging system. Sterilization: N/A (non-invasive imaging).
Indications for Use
Indicated for appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging, and restaging lesions, tumors, disease, and organ function in patients with cardiovascular disease, neurological disorders, cancer, or other disorders. Used for radiotherapy planning and interventional procedures.
Regulatory Classification
Identification
An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Predicate Devices
- Symbia 5.0 (K131634)
Reference Devices
- syngo CT 2013A SOMARIS/5 VC20B (K133424)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Siemens Medical Solutions USA, Inc. % Cynthia Busch Regulatory Technical Specialist 2501 North Barrington Rd. HOFFMAN ESTATES, ILLINOIS 60192
Re: K142006 Trade/Device Name: Symbia 6.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography Regulatory Class: II Product Code: KPS, JAK Dated: July 22, 2014 Received: July 23, 2014
Dear Ms. Busch:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Busch
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
K142006
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Symbia 6.0
#### Indications for Use (Describe)
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: Planar imaging, whole body imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary
as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c)
#### Identification of the Submitter
| Submitter: | Cynthia Busch<br>Regulatory Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192<br>USA | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Telephone Number: | (847) 304-7095 | |
| Fax Number: | (847) 304-6023 | |
| Name / Address of Manufacturer: | Siemens Medical Solutions USA, Inc<br>Molecular Imaging<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192<br>USA | |
| Date of Submission: | July 22, 2014 | |
| Identification of the product | | |
| Device Proprietary Name: | Symbia 6.0 | |
| Common/Classification Names: | Emission Computed Tomography per 21 CFR 892.1200<br>Computed Tomography X-Ray System per 21 CFR 892.1750 | |
| Class: | II | |
| Product Code: | KPS and JAK | |
| Classification Panel: | Radiology | |
| Marketed Devices to which Equivalence is claimed | | |
| Device | Manufacturer | 510(k) Number |
| Symbia 5.0 | Siemens Medical Solutions USA, Inc. | K131634 |
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# Device Description:
The Siemens Symbia systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces 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. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.
For all systems, a new software version synqo MI Applications VB10A supports the upgrade to Windows® 7 Operating System, updates to 3rd party software, and optional LPHR collimator imaging are available.
| Symbia 6.0 Family | | |
|--------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPECT only systems | e.cam | variable angle, dual detector gamma camera |
| | Symbia E Single | variable angle, single detector gamma camera |
| | Symbia E Dual | variable angle, dual detector gamma camera |
| | Symbia S | variable angle dual detector SPECT system |
| | Symbia Evo | variable angle dual detector SPECT system |
| | Symbia Evo Excel | variable angle dual detector SPECT system |
| | | |
| SPECT/CT Systems | Symbia T series | a variable angle dual detector SPECT with a 2, 6, or 16-slice spiral CT |
| | Symbia Intevo Excel | SPECT/CT system with non-diagnostic CT support for only attenuation correction and anatomical localization |
| | Symbia Intevo Series | variable angle dual detector SPECT and 2, 6, or 16-slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications |
Modifications in Symbia 6.0 include:
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- Two new SPECT models: Evo and Evo Excel ●
- Software upgrade to Windows® 7 Operating System and 3rd party software ● upgrades to support Windows® 7
- o Implementation of commercially marketed CT software, IRIS (K133424, 'Synqo CT 2013A SOMARIS/5 VC20B')
- . Hardware upgrades including modifications to the Dedicated Reconstruction System (DRS), rotate motor, and computer upgrade
- o LPHR collimator
### Indications for Use:
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and orqan function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomoqraphic imaging for isotopes with energies up to 588keV
CT: The CT component 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 anqles or spiral planes taken at different anqles.
SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
### Technological Characteristics:
Symbia 6.0 systems are based on the commercially available Symbia 5.0 (K131634). The updates for the Evo Excel front bed, rotate motor and new optional LPHR collimator and software are based on the same fundamental technology of the predicate components. SPECT detector, existing collimators, and CT performance specifications do not change between the commercially available Symbia 5.0 systems and Symbia 6.0 systems The CT feature, IRIS, incorporated into the updated software, is a feature commercially available in 'syngo CT 2013A SOMARIS/5 VC20B' (K133424).
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# Performance Testing:
Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing.
Symbia 6.0 is designed in accordance with the 60601-1 series including all relevant collateral standards general (IEC 60601-1, 1-2, 1-3, etc) and specific (IEC 60601-2-44). LPHR performance testing is conducted according to NEMA NU-1:2007. IRIS Image Quality testing has been performed with Catphan® and water phantoms on the 6 and 16 slice SPECT/CT systems. All Performance testing met the predetermined acceptance values.
| LPHR Typical Values | 3/8" | |
|------------------------------|-----------------------------------------------|-------------|
| | Specification | Test Result |
| Intrinsic Spatial Resolution | | |
| FWHM in CFOV | $ \u2264 3.84mm $ | Pass |
| FWTM in CFOV | $ \u2264 7.54mm $ | Pass |
| FWHM in UFOV | $ \u2264 3.94mm $ | Pass |
| FWTM in UFOV | $ \u2264 7.74mm $ | Pass |
| Intrinsic Spatial Linearity | | Pass |
| Differential in CFOV | $ \u2264 0.24mm $ | Pass |
| Absolute in CFOV | $ \u2264 0.44mm $ | Pass |
| Differential in UFOV | $ \u2264 0.24mm $ | Pass |
| Absolute in UFOV | $ \u2264 0.69mm $ | Pass |
Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
### 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 in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.
Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.
Symbia 6.0 conforms to applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as required by the respective SPECT FDA Guidance Documents. SPECT detector and CT performance is conducted according to NEMA NU1:2007, and the performance does not change from the predicate device.
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# Substantial Equivalence:
Symbia 6.0 has the same intended use and utilizes the same fundamental scientific technology as the predicate device. Siemens considers Symbia 6.0 to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.
