(7 days)
Not Found
No
The document describes a standard emission computed tomography system and its components. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance metrics. The image processing mentioned is standard computer reconstruction for tomography.
No
The device is described as an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides and produce images. Its primary function is diagnostic imaging, not treatment.
Yes
The device detects gamma ray radionuclides in the body and produces cross-sectional images to provide information for medical purposes, which is a diagnostic function.
No
The device description explicitly states it comprises a gantry, dual head detector, patient chair, acquisition PC, and hand controller, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Virgo device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Virgo's Function: Virgo is an emission computed tomography system. It works by detecting gamma rays emitted from radionuclides within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for detecting the location and distribution of radionuclides in the body and producing images. This is an in vivo (within the living body) diagnostic technique, not in vitro.
Therefore, Virgo falls under the category of medical imaging devices used for in vivo diagnosis, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Virgo is an emission computed tomography system 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. The device includes display equipment, patient and equipment parts, and accessories.
Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV
Product codes
90 KPS
Device Description
The Virgo system design comprises a gantry supporting a fixed 90 degree dual head detector and a patient chair. The Virgo system is operated through interaction with a graphical user interface situated on the acquisition PC and a dedicated Virgo hand controller.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
Anatomical Site
body, patient's chest region and body extremities, heart
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
Description of how the non clinical test results have been collected. In general, all non clinical test results have been collected following documented verification plans. Whenever possible, these plans are following relevant and recognized standards and guidelines like the NEMA Standard NU 1-1994. Below is a list of a subset of the more important specifications with a description of how these test results are collected.
Intrinsic Spatial Resolution, FWHM, UFOV: Less than or equal to plus or minus 3.7mm
Test equipment used, test setup and all calculations have all been performed according to the NEMA Standard NU 1-1994.
Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m: 180k cps with scatter > 290k cps w/o scatter
Test equipment used, test setup and all calculations have all been performed according to the NEMA Standard NU 1-1994.
Count rate @ 20 % loss. > 225k cps
Test equipment used, test setup and all calculations have all been performed according to the NEMA Standard NU 1-1994.
Detector Background Sensitivity, @180 degrees, 140 keV:
§ 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
10 June 2003
1PMN0397-C04
DDD
ADMINISTRATIVE INFORMATION в
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: | 29 April 2003 | |
| 2 | Device Trade Name: | Virgo | |
| | Common Name: | Gamma Camera System | |
| | Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | 3D, Danish Diagnostic Development A/S, CardioMD | |
| | 510(K) Number: | K011611 | |
| | | 3D, Danish Diagnostic Development A/S, Unicorn (K001888)
Refer to section C3 Comparison of the New and Predicate Device, subpart;
Indications for use statement. | |
| 4 | Device description: | The Virgo system design comprises a gantry supporting a fixed 90 degree
dual head detector and a patient chair. The Virgo system is operated through
interaction with a graphical user interface situated on the acquisition PC and a
dedicated Virgo hand controller. | |
| | Functional description: | The patient ascends the chair. When the acquisition setup has been completed
on the acquisition PC, preprogrammed motions declines the chair and patient
to slanted position and the detectors brought to a predetermined position. | |
| | | When a tomography is acquired, the handset is used to position the detector in
close proximity to the patient to enter contour marks to determine the detector
orbit for the acquisition. | |
| | | For planar imaging, the handset is used to position the detectors. | |
| | | When the detectors are in position, the acquisition is started. During
acquisition, the detector detects gamma photons emitted from the patient. For
each photon detected, the detector determines the energy and position (two-
dimensional) from where the photon originated within the patient. The
detector corrects for uniformity and linearity errors before sending energy and | |
| DDD | | VIRGO 510(K) SUBMISSION | |
| 1PMN0397-C04 | | 10 June 2003 | |
| | position data to the acquisition PC. The acquisition PC frames the received
data into images. Once the acquisition terminates, the resulting images and
data is stored in the acquisition PC database for later reviewing and export via
DICOM to the OEM customer provided processing station. | | |
| 5 | Intended use: | Virgo is an emission computed tomography system 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. The
device includes display equipment, patient and equipment supports,
component parts, and accessories.
Virgo is primarily intended for cardiac applications but the Virgo design also
supports non-cardiac procedures of the patient's chest region and body
extremities.
Virgo supports radionuclides within the energy range of 60 - 170 keV | |
| 6
a | Summary of technological
characteristics: | The device has the same technological and functional characteristics as the
predicate device. However, the gantry with patient support device is in design
significantly different: | |
| | Submitted device: Virgo | Predicate device: CardioMD | |
| | Design: | A gantry base on the floor supports a
console with electronics and a
robotic detector arm. The detector
arm serves as detector support in an
unbalanced design.
Detector motions for positioning the
detectors and for orbiting the
detectors circularly and non-
circularly around the patient is
achieved by a combination of:
Horizontal translation of the
console with detector arm and
detector towards the patient.
Rotation of the robotic arm with
the detector.
Rotation of the detector on the
robotic arm.
Further the gantry base supports a
patient chair in which the patient is
seated during acquisition and a stand
for the acquisition PC. | |
| | | A gantry base on the floor supports a
tower that holds the detector in an
unbalanced design.
Detector motions for positioning the
detectors and for orbiting the detectors
circularly and non-circularly around
the patient is achieved by a
combination of:
Horizontal translation of the tower
with the detector towards the
patient.
Vertical translation of the detector.
Rotation of the detector on the
tower.
Further the gantry base supports a
table console with electronics that acts
as support for a patient table on which
the patient is lying during acquisition.
The acquisition PC is located on a
separate rollable PC cart. | |
| | Material: | Painted and cromated iron and
aluminum plates and casts.
Aluminum plate covers. | |
| | | Painted and cromated iron and
aluminum plates and casts.
Aluminum plate covers. | |
| Energy source: | Mains supply.
100 VAC - 240 VAC | Mains supply.
100 VAC - 240 VAC | |
| Patient Support: | The patient support comprises a chair mounted on the gantry base in which the patient is seated supine during acquisition.
The chair consists of a back pad and a seat pad mounted onto an S-shaped iron frame.
The back pad has a cutout towards the detector to enable close detector proximity to small patients.
The chair includes a rotate motion capable of tilting the entire chair with patient between upright position (patient load) and a declined scan position about 20 degrees from horizontal.
By manual control, the seat of the chair (with patient) can be moved up and down to position the heart of both tall and short patients within the detector field of view. | The patient support comprises a table mounted on the table console on which the patient is lying horizontally supine or prone during acquisition.
The table consists of a thin aluminum plate with a mattress. The aluminum table has a cutout towards the detector to enable close detector proximity to small patients.
By manual control, the table can be translated manually to position patient's heart within the detector field of view. | |
| Detector: | The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.
Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC. | The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.
Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC. | |
| | Software: | The Virgo acquisition station is
based on a Windows PC platform
running a dedicated acquisition
software package. | The CardioMD acquisition station is
based on a Windows PC platform
running a dedicated acquisition
software package. |
| | | This software is formed by: | This software is formed by: |
| | | A graphical user interface package
including the patient database and
DICOM interface | A graphical user interface package
including the patient database and
DICOM interface |
| | | A camera control package designed
for the purpose of controlling system
setup, gantry/chair motions and
image framing. | A camera control package designed
for the purpose of controlling system
setup, gantry/patient table motions and
image framing. |
| 6
b | Description of how the non
clinical test results have
been collected. | In general, all non clinical test results have been collected following
documented verification plans. Whenever possible, these plans are following
relevant and recognized standards and guidelines like the NEMA Standard
NU 1-1994. Below is a list of a subset of the more important specifications
with a description of how these test results are collected. | |
| | Intrinsic Spatial Resolution,
FWHM, UFOV: $\leq \pm 3.7mm$ | Test equipment used, test setup and all calculations have all been performed
according to the NEMA Standard NU 1-1994. | |
| | Spatial Resolution, FWHM,
LEGP collimator @ 10cm,
Tc-99m: $ 180k cps with scatter
290k cps w/o scatter | Test equipment used, test setup and all calculations have all been performed
according to the NEMA Standard NU 1-1994. | |
| | Count rate @ 20 % loss.
225k cps | Test equipment used, test setup and all calculations have all been performed
according to the NEMA Standard NU 1-1994. | |
| | Detector Background
Sensitivity, @180 °,
140 keV: $