(84 days)
No
The document describes standard SPECT and CT imaging technology and software for image processing and analysis. There is no mention of AI or ML in the intended use, device description, or enhancements.
No.
The device is used for diagnostic imaging to detect, localize, diagnose, and stage diseases, rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders". These actions are characteristic of a diagnostic device.
No
The device description clearly states that the Siemens Symbia system is a combined X-Ray Computed Tomography (CT) and Emission Computed Tomography (SPECT) scanner, which are hardware components. While it includes software (MI Applications software), the core device is a physical imaging system.
Based on the provided text, the Siemens Symbia series is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the Symbia system is used to image the distribution of radionuclides in the body or organ and produce cross-sectional images of the body. It does not involve the analysis of samples like blood, urine, or tissue outside of the body.
- The device description focuses on imaging modalities (SPECT and CT) and software for image processing and analysis. This aligns with the definition of an imaging device used for diagnostic purposes, not an IVD device.
Therefore, the Siemens Symbia series is an imaging device used for in vivo diagnostic purposes, not an in vitro diagnostic device.
N/A
Intended Use / 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 lesons, turnors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The innages produced by the system can also be used by the physician to aid in radiotherapy to atmont 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, tomographic imaging for isotopns 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 angles or spiral planes taken at different angles.
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 PERT CT and other imaging modalities.
Product codes
KPS, JAK
Device Description
The Siemens Symbia® system is combined X-Rav Computed Tomography (CT) and Emission Computed Tomography (SPECT) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
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 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 utilizes the CT for fast attenuation correction maps for SPECT studies and precise anatomical reference for the fused SPECT and CT images.
The system maintains independent functionality of the CT and SPECT devices, allowing for single modality CT and / or SPECT diagnostic imaging.
The Symbia E and Symbia S series are gamma cameras used to view and analyze images of the human body and the distribution of administered radionuclides.
The Symbia T series have an additional CT system designed to produce crosssectional 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 Symbia T series allows healthcare facilities to carry out SPECT and CT studies using the same instrument.
The MI Workplace is a software workstation for use with nuclear medicine applications. The MI Applications software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of dedicated SPECT, PET and SPECT/CT and PET/CT systems.
Enhancements in Symbia 4.0 include:
-
- New optional acquisition method IQ•SPECT* for cardiac imaging
- SMARTZOOM* collimator .
- Cardio-centric acquisition .
- IQ.SPECT reconstruction. .
-
- New optional accessories; pediatric pallet, scintimamography pallet and radiation therapy pallet.
-
- Single detector configuration of the commercially available Symbia E (K072567) gamma camera, Symbia E Single
-
- Upgraded version of the MI Applications software (2009A)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, CT, PET
Anatomical Site
Body, organ (general)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately trained health care professionals, physician.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041166, K072567, K063826, K952109
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
Symbia 4.0 Summary of Safety and Effectiveness (510(k)) Page 1 of 3
510(K) Summary as required by 21 CFR Part 807.87(H)
Identification of the Submitter
NOV 21 2008
| Submitter: | Gunhild Paulsen |
|---|---|
| Telephone Number: | 847-304-7516 |
| Fax Number: | (847)-304-6023 |
| Date of Submission: | August 25, 2008. |
Identification of the product
| Device Proprietary Name: | Symbia 4.0 |
|---|---|
| Common Name: | Emission Computed Tomography System |
| Classification Name: | Section 21 CFR 892.1200 |
| Product Code: | KPS |
| Classification Panel: | Radiology |
| Device Class: | Class II |
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Siemens Enhanced | ||
| Imaging | ||
| System | Siemens Medical | |
| Solutions USA, Inc | K041166 | |
| Symbia E | Siemens Medical | |
| Solutions USA, Inc | K072567 | |
| syngo MI Applications | ||
| 2007A | Siemens Medical | |
| Solutions USA, Inc | K063826 | |
| IP500 Nuclear Gamma | ||
| Camera System | Siemens Medical | |
| Solutions USA, Inc | K952109 |
:
1
Device Description:
The Siemens Symbia® system is combined X-Rav Computed Tomography (CT) and Emission Computed Tomography (SPECT) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
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 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 utilizes the CT for fast attenuation correction maps for SPECT studies and precise anatomical reference for the fused SPECT and CT images.
The system maintains independent functionality of the CT and SPECT devices, allowing for single modality CT and / or SPECT diagnostic imaging.
The Symbia E and Symbia S series are gamma cameras used to view and analyze images of the human body and the distribution of administered radionuclides.
The Symbia T series have an additional CT system designed to produce crosssectional 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 Symbia T series allows healthcare facilities to carry out SPECT and CT studies using the same instrument.
The MI Workplace is a software workstation for use with nuclear medicine applications. The MI Applications software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of dedicated SPECT, PET and SPECT/CT and PET/CT systems.
Enhancements in Symbia 4.0 include:
-
- New optional acquisition method IQ•SPECT* for cardiac imaging
- SMARTZOOM* collimator .
- Cardio-centric acquisition .
- IQ.SPECT reconstruction. .
-
- New optional accessories; pediatric pallet, scintimamography pallet and radiation therapy pallet.
-
- Single detector configuration of the commercially available Symbia E (K072567) gamma camera, Symbia E Single
-
- Upgraded version of the MI Applications software (2009A)
*) Registered Trademark will be applied for Safety and Effectiveness:
QRMI0097-T-01
2
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, mechnanical and radiation hazards.
Siemens considers that the proposed systems do not introduce new safety concerns, and is substantially the same in design, materials, energy sources and technology as the currently marketed systems. Siemens believes that the Symbia 4.0 systems are substantially equivalent to the predicate devices.
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 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: To detect or image the distribution of radionuclides in the body or organ. using the following techniques: planar imaging, whole body imaging, tomographic 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 angles or spiral planes taken at different angles.
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2008
Mr. Gunhild Paulsen Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K082506
Trade/Device Name: Symbia 4.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: August 28, 2008 Received: August 29, 2008
Dear Mr. Paulsen:
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, brug, 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, l'usting 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.
4
Page 2
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 complive th 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 wour 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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/odrh/industry/support/index.html.
Sincerely vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
KD82506
Device Name: Svmbia 4.0
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 lesons, turnors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The innages produced by the system can also be used by the physician to aid in radiotherapy to atmont 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, tomographic imaging for isotopns 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 angles or spiral planes taken at different angles.
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 PERT CT and other imaging modalities.
V 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 IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological De 510(k) Number
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