(50 days)
No
The document describes standard SPECT/CT imaging technology and software for display and analysis, without mentioning AI or ML capabilities. The performance studies focus on comparing the CT component to predicate devices based on technical parameters and performance standards, not AI/ML metrics.
No
The device is used for detection, localization, diagnosis, and staging of lesions, tumors, disease, and organ function, and for radiotherapy treatment planning. It is an imaging device, not one that delivers therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders." The "Device Description" also mentions its use as "stand-alone diagnostic imaging devices."
No
The device description clearly states that the Siemens Symbia systems consist of SPECT scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners, which are hardware components. While there is software involved for display and analysis, 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 Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- Symbia's Function: The Symbia series are imaging systems (SPECT and CT) that work by detecting and measuring radiation within the body or by using X-ray transmission data. They produce images of internal structures and the distribution of radiopharmaceuticals within the patient.
- Intended Use: The intended use clearly states that the system is used to "aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function" by producing images of the body. This is an in vivo (within the living body) diagnostic process, not an in vitro process.
The device description and intended use consistently describe an imaging system that operates on the patient directly, not on samples taken from the patient.
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 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 treal ment planning and interventional radiology procedures.
SPECT: To detect or image the distribution ofradionuclides 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 :MIApplications 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.
The following satement applies only to the Semens Symbia Intevo 16 and Symbia Intevo Bold systems. This CT system can be used for low dose lung cancer screening in high risk populations * ·As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (NEngl J Med 2011;365:395-409) and subsequent literature, for further information.
Product codes
KPS, JAK
Device Description
The Siemens Symbia systems consist of Sinqle 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 stand-alone diagnostic imaqing devices.
The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, CT, PET, X-Ray transmission data
Anatomical Site
Body, Organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
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
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.
Technical parameters used to test general CT use are applicable for lung cancer screening. The technical parameters of the CT subsystem for the Symbia SPECT/CT's and the commercially available SOMATOM standalone CT systems devices with the additional lung cancer screening indication (K142955) were compared, and no differences exist in the parameters. Included in this evaluation, are the following parameters:
- CT number accuracy
- . CT number uniformity
- Spatial resolution (MTF, maximum in-plane resolution)
- Slice thickness/sensitivity profile (minimum slice width)
- Noise properties (NPS and image Noise (standard deviation))
- Contrast to Noise Ratio
- Maximum scan speed
- o Minimum reconstructed slice interval
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems. No additional performance testing beyond what was cleared in the original Premarket Notifications is required.
CT Testing in accordance with the requirements of the following FDA Performance Standards for Ionizing Radiation Emitting Products and Light emitting products for CT equipment with a laser localizer was performed and documented in a Dosimetry and Imaging Performance Report. Further, each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment:
- 21 CFR 1020.30 (a)
- 21 CFR 1020.30 (b)(36)(iii)-(v) ●
- 21 CFR 1020.30 (b)(58)-(62) ●
- 21 CFR 1020.30 (h)(3)(vi)-(viii) ●
- 21 CFR 1020.33 ●
- 21 CFR 1040.10 ●
- 21 CFR 1040.11 ●
The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Symbia SPECT/CT systems is likewise suitable for lung cancer screening.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2017
Siemens Medical Solutions USA, Inc. % Ms. Tabitha Estes Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K173023
Trade/Device Name: Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: September 27, 2017 Received: September 28, 2017
Dear Ms. Estes:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Tabitha Estes
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510{k) Number (if known)
Device Name
Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
Indications for Use (Describe)
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting. localizing, diagnosing, staging 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 treal ment planning and interventional radiology procedures.
SPECT: To detect or image the distribution ofradionuclides 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 :MIApplications 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.
The following satement applies only to the Semens Symbia Intevo 16 and Symbia Intevo Bold systems. This CT system can be used for low dose lung cancer screening in high risk populations ** ·As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (NEngl J Med 2011;365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use(Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTNUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAILADDRESS BELOW.
The burden time for this collection of infonnation is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
هه agency may not conduct or sponsor. and a parson is not raquirad to raspond to, a col/action of infonnation unless it displays a currently valid OMB number. "
нн
3
510(k) Summary
as required by 21 CFR Part 807.92
Identification of the Submitter
| Submitter: | Tabitha Estes
Regulatory Affairs Specialist
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 | | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer: | Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 North Barrington Road
Hoffman Estates, IL 60192 | | |
| Telephone Number: | (865)218-2421 | | |
| Fax Number: | (865)218-3019 | | |
| Date of Submission: | September 27th, 2017 | | |
Identification of the product
| Device Proprietary Name: | Symbia T16
SPECT/CT | Symbia Intevo 16
SPECT/CT | Symbia Intevo
Bold SPECT/CT |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------|
| Common Name | Single-Photon Emission Computed Tomography (SPECT)
System | | |
| Classification Name: | Emission Computed Tomography System per 21 CFR
892.1200
Computed Tomography X-Ray System per 21 CFR
892.1750 | | |
| Product Code: | 90 KPS and 90 JAK | | |
| Classification Panel: | Radiology | | |
| Device Class: | Class II | | |
4
Marketed Devices to which Equivalence is claimed
Predicate:
| Device Proprietary Name: | SOMATOM CT Scanners |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | 90 JAK |
| Device Class: | Class II |
| 510(k) Number: | K142955 |
Reference Devices:
| Device Proprietary
Name: | Symbia T16
SPECT/CT | Symbia Intevo 16
SPECT/CT | Symbia Intevo Bold
SPECT/CT |
|-----------------------------|------------------------|------------------------------|--------------------------------|
| 510(k) : | K162337 | K162337 | K162483 |
Device Description:
The Siemens Symbia systems consist of Sinqle 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 stand-alone diagnostic imaqing devices.
The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems.
Intended Use:
The Symbia Intevo Excel, Intevo series and T series are radiological imaging systems that combine a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
The SPECT system is intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data, and the CT system is intended to produce cross-sectional images
5
of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The nuclear medicine images and the x-ray images may be reqistered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (that is, distribution of radiopharmaceuticals).
The SPECT and CT portions of the system may be used independently or in combination, and may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. The SPECT and CT imaqes may be transferred to other systems for radiation therapy planning or additional uses.
This submission was made to support an additional indication for use related to lung cancer screening within the subset of the overall intended use of the Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold SPECT/CT scanners:
The following statement is only applicable to Siemens Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold systems.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
This revised indication for use is cleared for the standalone SOMATOM CT systems (K142955) that are incorporated into the SPECT/CT systems.
In accordance with quidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, and presentation "FDA/MITA Meeting on LDCT Lung Cancer Screening", the modified more specific indication for use does not alter the intended use for the leqally marketed predicate devices with a general indication for use, nor does it alter the intended diagnostic effect in comparison to the predicate devices.
Based on the analysis conducted within the original 510(k) for the SOMATOM CT systems (K142955) and the integration of the CT subsystem, without altering the technological characteristics, into the Symbia SPECT/CT systems, the more specific use of low dose lunq cancer screening is a subset of the general use rather than a new intended use. Further, the updated specific indication is substantially equivalent to the inclusion of this specific indication within the predicate device.
Revised 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.
6
SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaqinq, whole body imaqing, 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 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.
The following statement is only applicable to Siemens Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold systems.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Performance Testing / Safety and Effectiveness:
The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems. No additional performance testing beyond what was cleared in the original Premarket Notifications is required.
CT Testing in accordance with the requirements of the following FDA Performance Standards for lonizing Radiation Emitting Products and Light emitting products for CT equipment with a laser localizer was performed and documented in a Dosimetry and Imaging Performance Report. Further, each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment:
- 21 CFR 1020.30 (a)
- 21 CFR 1020.30 (b)(36)(iii)-(v) ●
- 21 CFR 1020.30 (b)(58)-(62) ●
- 21 CFR 1020.30 (h)(3)(vi)-(viii) ●
- 21 CFR 1020.33 ●
- 21 CFR 1040.10 ●
- 21 CFR 1040.11 ●
Applicability Technique factors CT, Scan, Scan Time, Tomogram, Dose Information to be provided for users Computed Tomography (CT) equipment Laser Products Specific purpose laser products
7
The Symbia SPECT/CT systems were designed in accordance with Design Controls and in accordance with the following FDA recognized standards:
- o Recognition Number 19-1: IEC 60601-1-2 Edition 3: 2007-03
- Recognition Number 19-4: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012
- Recognition Number 5-67: AAMI ANSI IEC 62366:2007/(R)2013 ●
- Recognition Number 12-256: IEC 60601-2-44 Edition 3.1 2012-09
- Recognition Number 12-269: IEC 60601-1-3 Edition 2.1 2013-04 ●
- Recognition Number 5-40: ISO 14971 Second Edition 2007-03
- Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06 ●
- Recognition Number 12-265: NEMA NU 1
- Recognition Number 12-225: NEMA XR 25
- Recognition Number 12- 270: NEMA 61223-3-5 First Edition 2004
- Recognition Number 12-226: NEMA 61223-2-6 Second Edition: 2006
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.
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.
Technical parameters used to test general CT use are applicable for lung cancer screening. The technical parameters of the CT subsystem for the Symbia SPECT/CT's and the commercially available SOMATOM standalone CT systems devices with the additional lung cancer screening indication (K142955) were compared, and no differences exist in the parameters. Included in this evaluation, are the following parameters:
- CT number accuracy ●
- . CT number uniformity
- Spatial resolution (MTF, maximum in-plane resolution) ●
- Slice thickness/sensitivity profile (minimum slice width) ●
- Noise properties (NPS and image Noise (standard deviation))
- Contrast to Noise Ratio
- Maximum scan speed ●
- o Minimum reconstructed slice interval
The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Symbia SPECT/CT systems is likewise suitable for lung cancer screening.
Statement regarding Substantial Equivalence:
8
The Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold SPECT/CT systems are commercially available and no changes to technological, functional or clinical features have been made. There is no difference in the intended use of the device. The CT systems being referenced as predicate devices (K142955) are integrated into the SPECT/CT systems as a subsystem of the device and no differences in functionality have been made compared to the commercially available systems (with the exception of the tilt functionality). All parameters associated with low dose lunq cancer screening are the same between the devices subject to this application and the predicate devices referenced.
Based on the information provided in the Premarket Notification, Siemens Medical Solutions USA, Inc. considers the Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold SPECT/CT systems with the added low dose lung cancer screening indication to be substantially equivalent to the currently commercially available predicate device.