(27 days)
Not Found
No
The description focuses on standard gamma camera technology and image reconstruction, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions. The image processing is stated to be handled by existing commercially available software.
No.
The device is used for diagnostic imaging by detecting gamma ray emitting radionuclides and producing cross-sectional images; it does not directly treat a condition.
Yes
The device produces cross-sectional images of gamma ray emitting radionuclides in the body, which are used to detect the location and distribution of these radionuclides. This process aids in understanding a patient's condition, particularly for cardiac applications, thus serving a diagnostic purpose.
No
The device description clearly outlines hardware components such as a gamma camera, collimator, scintillating crystal, photomultiplier tubes, base, wall/track, dual head, and hand control. While software controls detector motions and data can be processed by external software, the core device is a physical imaging system.
Based on the provided information, the Cyclone 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. They are used outside of the body.
- Cyclone's Function: The Cyclone is an emission computed tomography system that detects gamma rays within the patient's body after a radiopharmaceutical is administered intravenously. It records the distribution of the tracer in vivo (within the living organism).
- No Sample Analysis: The device does not analyze samples taken from the patient. It directly images the distribution of a substance within the body.
Therefore, the Cyclone falls under the category of an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cyclone is an emission computed tomography system intended to detect the location and distribution of gamma ray emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The data can then be transmitted to, or retrieved by, existing commercially available image processing software packages and accompanying computer equipment.
The Cyclone intended use is for cardiac applications. The Cyclone supports radionuclides within the energy of 50-200keV.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The Cyclone camera is a dedicated Gamma Camera for nuclear cardiology. The intended use of Cyclone is to detect the location and distribution of gamma ray emitting radionuclides in the body and store the image data. This device includes accessories such as signal analysis and display equipment, patient and equipment supports. radionuclide anatomical markers, component parts, and accessories. Radiopharmaceuticals are administered intravenously. The Cyclone records the distribution of the tracer in vivo. Gamma rays are emitted from the tracer. A collimator is used to accept only the gamma rays with defined orientations, usually parallel for detection. The collimator is actually analogous to a camera lens. The gamma rays admitted into the scintillation camera detector interact with a scintillating crystal, causing a very small flash of light at each point of interaction. The crystal is large, flat and thin (see specifications for size). The pattern of light flashes is detected by photomultiplier tubes that convert the light into electrical signals, each signal proportional to the energy of the gamma ray and also carrying precise positional information. Only gamma rays with the correct energy for the tracer used and with meaningful orientation to the patient are imaged.
The Cyclone camera consists of a base which supports a wall or track that in turn supports and guides a fixed 90 degree dual head around a patient chair. The motions and set-up of the camera can be controlled with the hand control. Detector motions are controlled by software and are initiated by the hand control.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Emission Computed Tomography (Gamma Camera)
Anatomical Site
Body, Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical environment
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)
All tests have been performed based NEMA Standards. NU 1-2001, Performance Measurements of Scintillation Cameras.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 2 3 2006
Spectrica
KO160480
.
26 510(k) SUMMARY
As required by 21 CFR 807.92
26.1 Application Identification
Applicant's Name and Address:
Spectrica. 15 Antares Drive, Unit #2, Ottawa, Ontario, Canada K2E 7Y9 Tel: 613-225-5554 Fax: 613-225-3331
Contact Person:
Tel: (613) 225-5554 ext. 307 Fax (613) 225-3331 Email: sjude@spectrica.com
Steve Jude
Address of Manufacturing Site:
Same as Applicant's address above
Summary Date:
February 22, 2006
26.2 Device Identification
Device Name: Trade Name: Common Name: Regulation Name:
Cyclone maiCAM180 Gamma Camera System Emission Computed Tomography System as per 21 CFR 892.1200
26.3 Type of Submission
Traditional
26.4 Predicate Device
Manufacturer: Trade Name: 510(K) Number: Classification Code: 3D, Danish Diagnostic Development Virgo K031825 90 KPS
26.5 Device Description
Description:
The Cyclone camera is a dedicated Gamma Camera for nuclear cardiology. The intended use of Cyclone is to detect the location and distribution of gamma ray emitting radionuclides in the body and store the image data. This device includes accessories such as signal
1
analysis and display equipment, patient and equipment supports. radionuclide anatomical markers, component parts, and accessories. Radiopharmaceuticals are administered intravenously. The Cyclone records the distribution of the tracer in vivo. Gamma rays are emitted from the tracer. A collimator is used to accept only the gamma rays with defined orientations, usually parallel for detection. The collimator is actually analogous to a camera lens. The gamma rays admitted into the scintillation camera detector interact with a scintillating crystal, causing a very small flash of light at each point of interaction. The crystal is large, flat and thin (see specifications for size). The pattern of light flashes is detected by photomultiplier tubes that convert the light into electrical signals, each signal proportional to the energy of the gamma ray and also carrying precise positional information. Only gamma rays with the correct energy for the tracer used and with meaningful orientation to the patient are imaged.
The Cyclone camera consists of a base which supports a wall or track that in turn supports and guides a fixed 90 degree dual head around a patient chair. The motions and set-up of the camera can be controlled with the hand control. Detector motions are controlled by software and are initiated by the hand control.
26.6 Intended Use
The Cyclone is an emission computed tomography system intended to detect the location and distribution of gamma ray emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data.
The Cyclone intended use is for cardiac applications. The Cyclone supports radionuclides within the energy of 50-200keV.
26.7 Substantial Equivalence Comparison:
Summary: The device has the same technological and functional characteristics as the predicate device. The Cyclone and the predicate device are essentially diagnostic tools with the same indications for use. This comparison shows that no new safety and effectiveness concerns are raised concerning the Cyclone.
2
Comparison Table:
| Feature/Spec | Predicate - Virgo | Cyclone |
|---|---|---|
| FDA status | FDA 510k Clearance | n/a |
| FDA 510k # | K031825 | Unknown |
| Intended Use | The intended use is to | |
| detect the location and | ||
| distribution of gamma | ||
| ray emitting | ||
| radionuclides in the | ||
| body and produce | ||
| cross-sectional images | ||
| through computer | ||
| reconstruction of the | ||
| data. This device | ||
| includes accessories | ||
| such as signal analysis | ||
| and display equipment, | ||
| patient and equipment | ||
| supports, radionuclide | ||
| anatomical markers, | ||
| component parts, and | ||
| accessories. | The intended use is to | |
| detect the location and | ||
| distribution of gamma | ||
| ray emitting | ||
| radionuclides in the | ||
| body and produce | ||
| cross-sectional images | ||
| through computer | ||
| reconstruction of the | ||
| data. This device | ||
| includes accessories | ||
| such as signal analysis | ||
| and display equipment, | ||
| patient and equipment | ||
| supports, radionuclide | ||
| anatomical markers, | ||
| component parts, and | ||
| accessories. | ||
| Target Population | The Virgo is primarily | |
| intended for cardiac | ||
| applications in a | ||
| clinical environment. | Same | |
| Electrical Safety | Device is certified to | |
| electrical safety | ||
| standards by a third | ||
| party organization prior | ||
| to use on human | ||
| patients. | Same | |
| Energy used/delivered | There is no new energy | |
| source requirement. | ||
| The energy | ||
| requirement is 115 V, | ||
| 60 Hz (or 240 V, 50 | ||
| Hz) | Same | |
| Standards met | IEC 601 and UL544 | Same |
| User Instructions | User instructions | |
| contain the operating | ||
| instructions pertinent to | ||
| this system including | ||
| safety features, | ||
| warnings, system | ||
| calibration, and | ||
| processing and | ||
| workstation features | ||
| and instructions. | Same. | |
| Design | A gantry base on the | |
| floor supports a console | ||
| with electronics and a | ||
| robotic detector arm. | ||
| The detector arm serves | ||
| as a detector support in | ||
| an unbalanced design. | The gantry base on the | |
| floor supports a wall / | ||
| track that hold the | ||
| detectors in an | ||
| unbalanced design. | ||
| Material | Painted and cremated | |
| iron and aluminum | ||
| plates and casts. |
Aluminum plate
covers. | Painted and cremated
iron and aluminum
plates.
Sheet metal and plastic
covers. |
| Patient Support | The patient support
comprises a chair
mounted on the gantry
base in which the
patient is seated supine
during acquisition.
The chair includes a
rotate motion capable
of tilting the entire
chair with patient
between upright
position (patient load)
and a decline scan
position about 20 | The patient support
comprises a chair
mounted on the gantry
base in which the
patient is seated upright
during acquisition.
The chair is capable of
moving in the X and Y
axis relative to the
detector heads while
the detector rotate in
the Z axis around the
patient. |
| | degree from horizontal. | |
| Detector Design | By manual control, the
seat of the chair (with
patient) can be moved
up or down to position
the heart of the patient
within the detector
head. | By manual control, the
seat of the chair (with
patient) can be moved
up or down to position
the heart of the patient
within the detector
head. |
| | The two detector heads
are mounted into a
single copper / zinc/
lead alloy (UNS)
designation;C94300
casting covered by
aluminum plate covers
with collision sensor
pads. | The two detector heads
are mounted into a
separate lead /
aluminum bowl
covered by sheet metal
covers with collision
sensor 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. | Each detector
comprises a NaI crystal
and 35 2.3" square
photomultiplier tubes
and electronics for
position determination
and correction for
uniformity and linearity
errors. |
| Warnings | A warning label is
applied to all
collimators
highlighting
instructions. Caution
and high voltage labels
are applied in
appropriate areas and
as required by electrical
standards. | Same |
| Physical Description: | | |
| 1) Field of View | 14.6 x 8.4 inches | 14.8 x 9.5 inches |
| 2) PMT's | 24 tubes per head | 35 tubes per head |
| 4) Operator Interface | Hand-control and
keyboard used for
image acquisition,
detector head and
gantry control | Same |
| Performance: | | |
| 1) Energy range | 60 - 170 keV | 50 - 200 keV |
| 2) Count rate | 290 Kcps | 300 Kcps |
| 3) Energy resolution | ≤9.4 % FWHM | 9.2 % FWHM |
| 4) Intrinsic uniformity | ≤2.5 % integral
≤ 1.5 % differential | ≤2.5 % integral
≤ 1.5 % differential |
| 5) Intrinsic spatial
resolution | ≤3.7 mm FWHM
≤7.6 mm FWTM | ≤3.0 mm FWHM
≤6.2 mm FWTM |
| Acquisition Software: | Segami Mirage
Acquisition | Segami Mirage
Acquisition |
3
·
4
.
5
Performance
All tests have been performed based NEMA Standards. NU 1-2001, Performance Measurements of Scintillation Cameras.
26.8 Conclusion
In the opinion of Spectrica, the Cyclone camera is substantially equivalent in terms of safety and effectiveness to the legally marketed Virgo (K031825) system.
6
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Jude General Manager Spectrica 15 Antares Drive, #2 Ottawa, Ontario, K2E 7Y9 CANADA
Re: K060486 Trade/Device Name: Cyclone - maiCAM 180 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 23, 2006 Received: February 24, 2006
Dear Mr. Jude:
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.
MAR 2 3 2006
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (0)S) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
This letter will allow you to begin narketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
11 INDICATION FOR USE - OPTIONAL FORMAT 1-2-96
Indication for Use
KD60486 510(k) Number (if known): =
Cyclone - maiCAM180 Device Name:
Indication for Use:
The Cyclone is an emission computed tomography system intended to detect the location and distribution of gamma ray emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The data can then be transmitted to, or retrieved by, existing commercially available image processing software packages and accompanying computer equipment.
The Cyclone intended use is for cardiac applications. The Cyclone supports radionuclides within the energy of 50-200keV.
Prescription Use _ ` (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .............
Page 1 of
Spectrica
510(k) Premarket Notification Rev1.0