(53 days)
No
The summary describes updates to existing software for image acquisition, reconstruction, and workflow, but does not mention any features or components related to AI or ML. The focus is on system updates, operating system changes, and compliance features.
No
Explanation: The device is described as aiding in detecting, localizing, diagnosing, staging, and restaging of various conditions, and in radiotherapy treatment planning and interventional radiology procedures. These are diagnostic and planning functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be utilized 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". This directly indicates a diagnostic purpose.
No
The device description clearly states that the system includes hardware components such as CT and PET scanners, a patient handling system, and acquisition and processing workstations, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens Biograph TruePoint systems are imaging devices (CT and PET scanners). They produce images of the inside of the body using X-rays and radiopharmaceuticals. They do not analyze samples taken from the body.
- Intended Use: The intended use describes the system as aiding in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function through imaging.
- Device Description: The description focuses on the hardware (scanners, workstations) and software for image acquisition, reconstruction, and evaluation.
While the system is used for diagnostic purposes, it does so through imaging the body directly, not by analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) 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 PET subsystem images and measures the distribution of PET 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 PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized 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.
Product codes
KPS, JAK
Device Description
The Biograph TruePoint Family of systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph TruePoint systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph TruePoint PET/CT Family software is a command based program used for patient manaqement, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The updates to the Biograph TruePoint systems software which are the subject of this application are considered substantially equivalent to the commercially available Biograph TruePoint software. Major modifications to the family of systems include:
- . General
- Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
- Support for SolidCore implemented for chanqe protection and software O security.
- updates to address anomalies for CT and PET software o
- synqo software upgrade .
- o Update of the synqo software to the latest revision (drivers, etc...)
- . Somaris Software Update
- Upgrade to the latest revision Somaris Software (VB42) (K140232) O
- Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
- Improvements to scanning and reconstruction workflows o
- PETsynqo software .
- Update of software to provide for improved consistency of features between all O TruePoint models
- Update to add Variable Bed Time O
- Update of the software scatter correction and bed removal O
- Update of the TrueD software O
- Improvements to the service tools O
- O Improvements to workflow
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Computed Tomography (CT), Positron Emission Tomography (PET)
Anatomical Site
Body
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
PET Testing in accordance with NEMA NU2:2007 was conducted on two different configurations of the Biograph TruePoint systems, a 3 ring version and a 4 ring version. All Performance testing met the predetermined acceptance values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Transverse Resolution FWHM @ 1 cm: = 4.0 cps/kBq (3R), >= 7.0 cps/kBq (4R)
- Count Rate peak NECR: 86 kcps @ 42 kBq/cc (3R), 148 kcps@ 42 kBq/cc (4R)
- Count Rate peak trues: 306 kcps @ 42 kBq/cc (3R), 467 kcps @ 42 kBq/cc (4R)
- Count Rate bias (mean):
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
September 12, 2014
Siemens Medical Solutions USA, Inc. % Alaine Medio PET And PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932
Re: K141971
Trade/Device Name: Biograph TruePoint PET/CT Family Software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: August 26, 2014 Received: August 27, 2014
Dear Alaine Medio:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are simple and abstract, with only the outlines of the noses and chins visible. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
1
forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Biograph TruePoint PET/CT Family Software
Indications for Use (Describe)
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) 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 PET subsystem images and measures the distribution of PET 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 PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized 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.
Type of Use (Select one or both, as applicable)
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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
as required by 21 CFR Part 807.87(h) and 807.92 (c)
Identification of the Submitter
| Submitter: | M. Alaine Medio, RAC
PET and PCS Regulatory Projects Manager
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 | | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------|
| Telephone Number: | (865)218-2703 | | |
| Fax Number: | (865)218-3019 | | |
| Date of Submission: | September 3, 2014 | | |
| Identification of the product | | | |
| Device Proprietary Name: | Biograph TruePoint PET/CT Family Software | | |
| Common Name: | Positron Emission Tomography (PET) System
Computed Tomography (CT) 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 | | |
| Marketed Devices to which Equivalence is claimed | | | |
| Predicate | Device | Manufacturer | 510(k) Number |
| Primary Predicate | Biograph mCT Family
PET/CT scanner software | Siemens Medical
Solutions USA, Inc | K123737 |
| Reference Predicate | Biograph TruePoint
PET/CT scanner software | Siemens Medical
Solutions USA, Inc | K083852 |
5
Device Description:
The Biograph TruePoint Family of systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph TruePoint systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph TruePoint PET/CT Family software is a command based program used for patient manaqement, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The updates to the Biograph TruePoint systems software which are the subject of this application are considered substantially equivalent to the commercially available Biograph TruePoint software. Major modifications to the family of systems include:
- . General
- Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
- Support for SolidCore implemented for chanqe protection and software O security.
- updates to address anomalies for CT and PET software o
- synqo software upgrade .
- o Update of the synqo software to the latest revision (drivers, etc...)
- . Somaris Software Update
- Upgrade to the latest revision Somaris Software (VB42) (K140232) O
- Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
- Improvements to scanning and reconstruction workflows o
- PETsynqo software .
- Update of software to provide for improved consistency of features between all O TruePoint models
- Update to add Variable Bed Time O
- Update of the software scatter correction and bed removal O
- Update of the TrueD software O
- Improvements to the service tools O
- O Improvements to workflow
6
Intended Use:
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) 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 PET subsystem images and measures the distribution of PET 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 PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized 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 treatment planning and interventional radiology procedures.
Technological Characteristics
The Biograph TruePoint PET/CT Family software with modifications is based on the commercially available Biograph TruePoint and Biograph mCT Family software. There has been no introduction of features that are not already commercially available in the predicate systems introduced with these software modifications. All software has technological characteristics consistent with the predicate software.
Performance Testing / Safety and Effectiveness:
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.
| Performance Criteria (Standard) | Results | Acceptance |
|---|---|---|
| Transverse Resolution FWHM @ 1 cm | Pass | = 4.0 cps/kBq (3R) |
= 7.0 cps/kBq (4R) |
| Count Rate peak NECR | Pass | 86 kcps @ 42 kBq/cc (3R)
148 kcps@ 42 kBq/cc (4R) |
| Count Rate peak trues | Pass | 306 kcps @ 42 kBq/cc (3R)
467 kcps @ 42 kBq/cc (4R) |
| Count Rate bias (mean) | Pass |