(55 days)
No
The document describes standard image reconstruction and processing techniques for CT and PET imaging, and the updates listed are related to hardware, operating system, workflows, and image quality improvements, none of which explicitly mention or imply the use of AI/ML.
No
Explanation: The device is a diagnostic imaging system (CT and PET scanner) used to detect and localize diseases, not to treat them. While the images can aid in radiotherapy treatment planning, the device itself is not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function." It also mentions "single modality CT and / or PET diagnostic imaging." These phrases directly indicate its role in diagnosis.
No
The device description explicitly states it is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner with hardware components including a patient handling system and acquisition and processing workstations. While it includes software, it is not solely 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 mCT systems are imaging devices (CT and PET scanners). They work by using external energy sources (X-rays and detecting emitted radiation from radiopharmaceuticals) to create images of the inside of the body. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states the system is used to "aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function" by producing images. This is consistent with diagnostic imaging, not in vitro testing.
Therefore, the Siemens Biograph mCT systems fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Siemens Biograph mCT 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 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 and JAK
Device Description
The Biograph mCT family 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 mCT 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 mCT software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The updates to the Biograph mCT systems which are the subject of this application are considered substantially equivalent to the commercially available Biograph mCT software. Major modifications to the family of systems include:
- Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
- · Updated gantry control buttons, and patient call button;
- Updated computer hardware;
- Updated software including:
- updated operating system; 0
- additional user configurable options and workflows
- cardiac gating updates to provide for improved gating characteristics :; o
- updated workflows for ease of use; and ಂ
- improvements in image quality. o
The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Computed Tomography (CT) and 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 mCT systems, a 3 rinq 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: Pass (= 4.0 cps/kBq (3R) >= 8.5 cps/kBq (4R))
Count Rate peak NECR: Pass (86 kcps @ 36 kBq/cc (3R) 140 kcps@25 kBq/cc (4R))
Count Rate peak trues: Pass (280 kcps @ 42 kBq/cc (3R) 450 kcps @ 42 kBq/cc (4R))
Count Rate bias (mean): Pass (
§ 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
510(k) Summary
as required by 21 CFR Part 807.87(h)
Identification of the Submitter
ನ 2013 JAN
:: M. Alaine Medio, RAC Submitter: PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA, Inc. Molecular İmaging 810 Innovation Drive Knoxville, TN 37932
(865)218-2703 Telephone Number: : : : : ::::: (865)218-3019 Fax Number:
Date of Submission:
Identification of the product
.. .. Device Proprietary Name:
Biograph mCT. Family of PET/CT Systems
· Positron Emission Tomography (PET) System Common Name: Computed Tomography (CT) System
December 4, 2012
Classification Name:
: :
Emission Computed Tomography System per 21 CFR. 892.1200 Computed Tomography X-Ray System per 21 CFR 892.1750
: : : : : : : :
510(k) Number
. : . . . . :
90 KPS and 90 JAK Product Code: .
Classification Panel: Radiology Device Class: Class II
Marketed Devices to which Equivalence is claimed ...
. . . .
Manufacturer Device
:
Siemens Medical Solutions USA, Biograph mCT-X and lnc mCT · S
1
Device Description:
The Biograph mCT family 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 mCT 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 mCT software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The updates to the Biograph mCT systems which are the subject of this application are considered substantially equivalent to the commercially available Biograph mCT software. Major modifications to the family of systems include:
- Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
- · Updated gantry control buttons, and patient call button;
- Updated computer hardware;
- Updated software including:
- updated operating system; 0
- additional user configurable options and workflows
- cardiac gating updates to provide for improved gating characteristics :; o
- updated workflows for ease of use; and ಂ
- improvements in image quality. o
The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.
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.
PET Testing in accordance with NEMA NU2.2007 was conducted on two different configurations of the Biograph mCT systems, a 3 rinq version and a 4 ring version.
2
| Performance Criteria | Results | Acceptance |
|---|---|---|
| Transverse Resolution FWHM @ 1 cm | Pass | /= 4.0 cps/kBq (3R) |
/= 8.5 cps/kBq (4R) |
| Count Rate peak NECR | Pass | 86 kcps @ 36 kBq/cc (3R)
140 kcps@25 kBq/cc (4R) |
| Count Rate peak trues | Pass | 280 kcps @ 42 kBq/cc (3R)
450 kcps @ 42 kBq/cc (4R) |
| Count Rate bias (mean) | Pass |