(12 days)
Not Found
No
The document describes a hardware device and a standard image processing technique (attenuation correction) without mentioning any AI or ML algorithms.
No
The device, c.cam-AC, is described as an "attenuation correction device" and its intended use is to compensate for attenuation of gamma rays in SPECT images. It is an optional accessory for a gamma camera system. It does not exert any therapeutic effect on the patient.
No
The device is an attenuation correction device designed to improve the quality of SPECT images by compensating for gamma ray attenuation, not to diagnose a condition itself.
No
The device description explicitly states that the c.cam-AC is an attenuation correction device that is "formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control." This describes physical hardware components, not just software.
Based on the provided information, 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 c.cam Attenuation Correction device works by using gamma rays to measure attenuation within the patient's body during a SPECT scan. It does not analyze samples taken from the patient.
- Intended Use: The intended use is to compensate for attenuation of gamma rays within the patient during SPECT studies.
- Device Description: The device is mounted on a gamma camera and uses line sources to generate gamma rays that pass through the patient.
While the device is used in a medical context and involves data acquisition and processing, its function is related to the imaging process itself (compensating for physical effects within the body) rather than analyzing biological samples.
N/A
Intended Use / Indications for Use
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure r he attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for the attendation of gamina his or want the 800 man into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
Product codes
KPS
Device Description
The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera.
C.cam gamma camera is a dual detector system and the attenuation correction device (two units) will be mounted opposite of the two detectors, one device on each detector. The attenuation correction device is formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control.
When the scanning is initiated the emission image and the transmission images are acquired sequentially. When the emission image has been acquired, a shutter, common for all sources, located in the device housing will open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total of max. 96 mCi). A collimated beam of gamma ray photons is focused on the opposite detector field of view to create the transmission images of the patient placed in the field of view of the detector. Having acquired both emission and transmission images, the data for emission, transmission, emission scatter and transmission scatter are stored in one dataset. A scaled version of the blank transmission scan is stored in another dataset. The complete study can be export via DICOM to the OEM customer provided processing station for later processing and reviewing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data has been collected by acquiring Myocardial Perfusion stress studies on a Siemens e.cam system. Refer to section C-4-2 Phantom Data Images and to C-6-1 A brief description of how the clinical data has been obtained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN 1 5 2005
DDD
1PMN0638-A03
C.cam AC 510(K) SUBMISSION
2 March 2005
ADMINISTRATIVE INFORMATION B
B-1 Summary of Safety and Effectiveness Statement
Ref. CFR 807.92 B-1-1
| 1 | Submitted by: | 3D, Danish Diagnostic Development A/S
Dr. Neergaardsvej 5F
2970 Horsholm, Denmark
Tel: + 45 45 768888
Fax: + 45 45 164659 | |
|---|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact person: | Niels Sorensen
Tel: + 45 45 768888
Fax: + 45 45 164659
E-mail: nes@3dnm.dk | |
| | Preparation date: | 2 March 2005 | |
| 2 | Device Trade Name: | c.cam-AC | |
| | Common Name: | Attenuation Correction Device | |
| | Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | 1. CardioMD-AC. 3D, Danish Diagnostic Development A/S. | |
| | 510(K) Number: | K040616. | |
| | | 2. E.cam-AC. Siemens Medical Solutions USA, Inc.
K963983. | |
| | | Refer to section C3 Comparison of the New and Predicate Device, subpart;
Radioactive source, and to section C3 Comparison of the New and
Predicate Device, subpart; Performance. | |
| 4 | Device description: | The c.cam-AC is an attenuation correction device, which will be marketed as
an optional device for the c.cam gamma camera. | |
| | Functional description: | C.cam gamma camera is a dual detector system and the attenuation correction
device (two units) will be mounted opposite of the two detectors, one device
on each detector. The attenuation correction device is formed as two housings
each containing 14 line sources in fixed positions, shutter and all shutter
control. | |
| | | The following described functions are performed on both detectors
simultaneously.
When the scanning is initiated the emission image and the transmission
images are acquired sequentially. When the emission image has been
acquired, a shutter, common for all sources, located in the device housing will
open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total | |
:
1
C.cam AC 510(K) SUBMISSION
2 March 2005
1PMN0638-A03
| of max. 96 mCi). A collimated beam of gamma ray photons is focused on the |
|---|
| opposite detector field of view to create the transmission images of the patient |
| placed in the field of view of the detector. Having acquired both emission and |
| transmission images, the data for emission, transmission, emission scatter and |
| transmission scatter are stored in one dataset. A scaled version of the blank |
| transmission scan is stored in another dataset. The complete study can be |
| export via DICOM to the OEM customer provided processing station for later |
| processing and reviewing. |
| 5 Intended use: | Attenuation correction is a method where the emission images acquired
during SPECT acquisitions are compensated for attenuation within the
patient. The purpose of attenuation correction is to compensate for varying
attenuation of gamma rays in the body. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The intended use of the c.cam Attenuation Correction option is to provide the
customer with means to measure the attenuation of gamma rays within the
body of a patient, when using a c.cam gamma camera system for SPECT
studies, and to map the measured attenuation into images that can be used to
compensate emission images for the attenuation. The c.cam-AC includes
additional acquisition of data for scatter correction of these images. |
| 6
a | Summary of technological
characteristics: | The device has the same technological and functional characteristics as the
predicate device. However the design of the submitted device is different on
the following points: 1. Manually positioning of the device housing. 2. The
use of 14 fixed positioned sources. | | |
|--------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Submitted device:
c.cam-AC | Predicate device:
CardioMD-AC | Predicate device:
e.cam-AC
(equivalence claimed to
radioactive source only) |
| | Design: | The submitted attenuation
correction device is formed
as a single housing
containing 14 line sources
in fixed positions, shutter
and all shutter control. | The predicate attenuation
correction device is formed
as a single housing
containing all motion
control, electronics and
motors including the
scanning line source. | |
| | | The device is secured to the
side of the detector casting
by means of a bracket. The
bracket is designed for
manual positioning of the
device housing to enable
patient access to the system. | The device is secured to the
side of the detector casting
by means of a bracket that
enables the device housing
to slide in and out. | |
| | | In operation the device
housing is manually
positioned opposite to the
detector. When not in use
the device housing can
manually be rotated to its
park position enabling
access for patient loading
and un-loading. | In operation the device
housing is positioned
opposite to the detector
(motorized motion). When
not in use the device
housing can slide to its park
position enabling access for
patient loading and un-
loading. | |
| | Radioactive
source: | The submitted device
utilises 14 fixed positioned
line sources exposing the
complete detector field of
view. Each source is
collimated to minimize
exposure to the
surroundings and the patient
exposure is controlled by an
electrical controlled shutter
common for all 14 sources. | The predicate device
utilises one collimated line
sources exposing by
scanning over the detector
field of view. The shutter
controlling the patient
exposure is an integrated
part of the source holder. | The predicate device
utilises 14 fixed
positioned line sources
exposing the complete
detector field of view.
Each source is collimated
to minimize exposure to
the surroundings and the
patient exposure is
controlled by an electrical
controlled shutter
common for all 14
sources. The two devices
utilises the same line
sources type from the
same supplier in the same
housing. |
| | Material: | Anodized aluminium plates,
lead and lead alloy
shielding.
Painted aluminium plate
covers. | Anodized aluminium plates,
lead and lead-bronze alloy
shielding.
Painted aluminium plate
covers. | |
| | Energy source: | Powered from an isolated
power outlet on the mains
supply.
120 VAC | Powered from an isolated
power outlet on the mains
supply.
120 VAC | |
| 6
b | Description of how
the non clinical test
results have been
collected. | Clinical data has been collected by acquiring Myocardial Perfusion stress studies on a
Siemens e.cam system.
Refer to section C-4-2 Phantom Data Images and to C-6-1 A brief description of how
the clinical data has been obtained. | | |
| | Radiation Leakage | Exposure from surface of housing, shutter closed: