(3 days)
No
The device description focuses on the physical components and performance characteristics of a collimator, a passive component used in gamma cameras. There is no mention of AI or ML in the device description, intended use, or performance studies. The image processing mentioned is described as conventional.
No.
The device is used for diagnostic imaging by detecting photons from a radioactive agent, not for treating or preventing disease.
Yes
The device is used to "detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent...in the human body," which is a diagnostic function.
No
The device description explicitly details physical components made of lead and other materials, including weight and dimensions. It is a hardware component for a gamma camera system. While it mentions compatibility with existing software, the device itself is not software-only.
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 description clearly states the device is a collimator used on a gamma camera. Its purpose is to detect and image the distribution of radioactive agents within the human body. This is an in vivo (within the living body) imaging procedure, not an in vitro test.
- Intended Use: The intended use is "to detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent (radionuclides) in the human body, specifically cardiac imaging." This directly describes an in vivo imaging application.
Therefore, the device falls under the category of medical imaging equipment used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Ultra-High Energy General Purpose Collimator (UHGP) is intended to be used to detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).
To detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent (radionuclides) in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).
Technique:
A. Planar Cardiac Imaging, Positron imaging without coincidence, 511 keV emitters
B. SPECT Cardiac Imaging, Positron imaging without coincidence, 511 keV emitters
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The Ultra-High Energy General Purpose Collimator (UHGP) is an optional device for the Forte™ and Vertex™ gamma camera systems, similar to conventional low energy collimators. It was developed to collimate the gamma rays emitted perpendicularly from a patient to a gamma ray detector, so that a proper image can be formed. This design concept is essentially the same as other conventional lower energy collimators used in Nuclear Medicine clinics, except that the current device is intended for ultra-high energy (511 keV) radiopharmaceuticals. Hence, the focus of the design elements are 1) proper hole size and thickness to provide proper spatial resolution and sensitivity for clinical use and 2) a proper mechanical mechanism to ensure safety.
The UHGP collimator consists of three major components: the collimation core, collimator frame, and collimator cover. The weight of this collimator is 300 pounds. The detailed parameters are shown on the following page in Table 4-1. The collimator core is made of lead. The hole size, the septal length, and septal thickness are 2.7, 60 and 2.3 mm, respectively. The collimator frame is used to support the core and connect to the detector buckets. For the Forte and Vertex systems, the frame and core size are the same as shown by the specification for the imaging Field of View (FOV). See the table below. The collimator cover is used to prevent direct patient contact with the lead core. More importantly, it has a collision sensor to prevent any unexpected detector motion resulting in collimator contact with patient, including un-intended detector radius move-in by operators.
Similar to other conventional low energy collimators, the UHGP collimator can be stored in a standard collimator storage device shipped with the base camera. The collimator storage devices are different for different base cameras (as shown in Figures 3 and 5), but all of the storage designs take the dimensions and mechanical strength of the UHGP into consideration.
The collimator exchange is done either manually as in the case of the Vertex manual camera , or semi-automatically as in case of the Forte camera and the Vertex auto camera. In all cases, the operator needs to activate the preprogrammed exchange motion program. The program will prompt the operator to proceed through the steps necessary for the exchange. In addition, the preprogrammed program will provide pre-cautionary warnings to the operator during the critical steps for safety precaution. These exchange procedures are the same as in the case of conventional collimator exchange.
The mechanical design of the gantry for the above named camera systems, Forte and Vertex, was reviewed for strength, deflection and motion control. It was deemed that these systems are capable of supporting the weights of collimators specified. A separate risk assessment is provided in Section 9.
The detector bucket in each of the above named cameras has the same design, and the detector bucket in each camera is well shielded against 511 kev. The shielding thickness varies from 0.9" close to the front of PMT tubes to 0.7" close to the back of PMT tubes. This provides enough shielding from both the random activity caused by other patients walking through the hall way and the scatter activity from the patient himself.
The UHGP collimator has two mechanisms to safeguard patients. The first one is the collimator collision sensor. It will halt any camera motion when the collimator surface is subjected to a pressure of 2 - 2.75 psi. The second safeguard is the fail-safe latching mechanism that locks the collimator all the time, unless it is activated intentionally by the operator. There is no additional software development for UHGP collimator itself. The pre-programmed collimator exchange program in the Forte camera and the Vertex camera is the exactly the same program used for the conventional collimator. Additionally, there is no new processing/display software for this collimator. Any processing and display software, which is used for other conventional collimators, can be used by trained medical professionals with their discretion.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintillation Cameras
Anatomical Site
Human body, specifically cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical 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)
System Performance Test: The Ultra-High Energy General Purpose Collimator (UHGP) performance was measured according to the NEMA NU1: Performance Measurements of Scintillation Cameras (1994). Clinical images were also examined.
In addition, a Verification Test was performed to test the functionality, as well as Risk Assessment and Stress Analysis were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
§ 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 2 0 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| A. | Submitted By:
ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: Charlene Brumbaugh
Tel: (408) 468-3619
Fax: (408) 468-3050 |
|----|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| B. | Device Trade Name: | Ultra-High Energy General Purpose Collimator
[for cardiac imaging] |
| | Models: | Ultra-High Energy General Purpose Collimator
(UHGP) |
| | Common Name: | Collimator |
| | Classification Name: | 511 keV Ultra-High Energy Collimator (UHEC) for
SPECT (21CFR 892.1200) |
| | Device Class: | 21CFR 892.1200, Class II |
| | Product Code: | 90 KPS |
| C. | Date prepared: | June 3, 2003 |
| D. | Predicate Device: | UHE Collimator (Option to the
PRISM 3000 Gamma Camera System) K963406 |
E. Intended Use:
The Ultra-High Energy General Purpose Collimator (UHGP) is intended to be used to detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).
1
Device Description: F.
The Ultra-High Energy General Purpose Collimator (UHGP) is an optional device for the Forte™ and Vertex™ gamma camera systems, similar to conventional low energy collimators. It was developed to collimate the gamma rays emitted perpendicularly from a patient to a gamma ray detector, so that a proper image can be formed. This design concept is essentially the same as other conventional lower energy collimators used in Nuclear Medicine clinics, except that the current device is intended for ultra-high energy (511 keV) radiopharmaceuticals. Hence, the focus of the design elements are 1) proper hole size and thickness to provide proper spatial resolution and sensitivity for clinical use and 2) a proper mechanical mechanism to ensure safety.
The UHGP collimator consists of three major components: the collimation core, collimator frame, and collimator cover. The weight of this collimator is 300 pounds. The detailed parameters are shown on the following page in Table 4-1. The collimator core is made of lead. The hole size, the septal length, and septal thickness are 2.7, 60 and 2.3 mm, respectively. The collimator frame is used to support the core and connect to the detector buckets. For the Forte and Vertex systems, the frame and core size are the same as shown by the specification for the imaging Field of View (FOV). See the table below. The collimator cover is used to prevent direct patient contact with the lead core. More importantly, it has a collision sensor to prevent any unexpected detector motion resulting in collimator contact with patient, including un-intended detector radius move-in by operators.
Similar to other conventional low energy collimators, the UHGP collimator can be stored in a standard collimator storage device shipped with the base camera. The collimator storage devices are different for different base cameras (as shown in Figures 3 and 5), but all of the storage designs take the dimensions and mechanical strength of the UHGP into consideration.
The collimator exchange is done either manually as in the case of the Vertex manual camera , or semi-automatically as in case of the Forte camera and the Vertex auto camera. In all cases, the operator needs to activate the preprogrammed exchange motion program. The program will prompt the operator to proceed through the steps necessary for the exchange. In addition, the preprogrammed program will provide pre-cautionary warnings to the operator during the critical steps for safety precaution. These exchange procedures are the same as in the case of conventional collimator exchange.
2
The mechanical design of the gantry for the above named camera systems, Forte and Vertex, was reviewed for strength, deflection and motion control. It was deemed that these systems are capable of supporting the weights of collimators specified. A separate risk assessment is provided in Section 9.
The detector bucket in each of the above named cameras has the same design, and the detector bucket in each camera is well shielded against 511 kev. The shielding thickness varies from 0.9" close to the front of PMT tubes to 0.7" close to the back of PMT tubes. This provides enough shielding from both the random activity caused by other patients walking through the hall way and the scatter activity from the patient himself.
The UHGP collimator has two mechanisms to safeguard patients. The first one is the collimator collision sensor. It will halt any camera motion when the collimator surface is subjected to a pressure of 2 - 2.75 psi. The second safeguard is the fail-safe latching mechanism that locks the collimator all the time, unless it is activated intentionally by the operator. There is no additional software development for UHGP collimator itself. The pre-programmed collimator exchange program in the Forte camera and the Vertex camera is the exactly the same program used for the conventional collimator. Additionally, there is no new processing/display software for this collimator. Any processing and display software, which is used for other conventional collimators, can be used by trained medical professionals with their discretion.
G. Comparison to Predicate Device:
Since collimators are very straightforward devices, the key performance index of the devices are the resolution, sensitivity, and mechanical safety. The current device provides a better resolution than the predicate device. This, in turn, will improve the image quality. However, the sensitivity for the current device is lower than the predicate device due to the better resolution. It is 174 cpm/uCi. But, this is very comparable to the low energy collimators. Hence, it is deemed adequate from the sensitivity point of view.
The table on the following page shows the specifications of the Picker UHE - the predicate device - compared to the UHGP. For comparison, a conventional collimator, HEGP - High Energy General Purpose, is also listed in the table. One item to note is the weight of the HEGP: it is heavier than the Picker Predicate Device.
3
ーー。 :
Comparison To Predicate Device
| Specifications | This application (Current device)
UHGP Collimator
For use on the
Forte Gamma Camera
and the Vertex Gamma
Camera | Predicate device
Picker UHE collimator
Triple head camera
K963406 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| intrinsic resolution= |