(27 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Cyclone maiCAM180 Gamma Camera System) demonstrates substantial equivalence to the predicate device (3D, Danish Diagnostic Development Virgo K031825) by meeting or exceeding performance metrics. The acceptance criteria essentially align with the performance of the predicate device, or improved upon it.
| Feature/Spec | Acceptance Criteria (Predicate - Virgo) | Reported Device Performance (Cyclone) |
|---|---|---|
| Energy range (keV) | 60 - 170 | 50 - 200 |
| Count rate (Kcps) | 290 | 300 |
| Energy resolution (% FWHM) | ≤9.4 | 9.2 |
| Intrinsic uniformity (integral) | ≤2.5 | ≤2.5 |
| Intrinsic uniformity (differential) | ≤1.5 | ≤1.5 |
| Intrinsic spatial resolution (FWHM) | ≤3.7 mm | ≤3.0 mm |
| Intrinsic spatial resolution (FWTM) | ≤7.6 mm | ≤6.2 mm |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of image data or patient data. Instead, the performance evaluation is based on technical specifications and physical measurements of the device's capabilities, compared against industry standards.
- Sample Size for Test Set: Not applicable in the context of a typical clinical test set with patient data. The evaluation is focused on the inherent physical and electronic performance of the gamma camera itself.
- Data Provenance: Not applicable for device performance specifications derived from NEMA standards testing. These tests are conducted on the device in a controlled laboratory environment. The country of origin of the data would be where Spectrica performed its NEMA-compliant testing, presumably Canada based on the applicant's address.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not provided in the document. The performance metrics are objective physical measurements based on established NEMA standards, not on expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" here refers to the device's technical specifications, which are assessed against standardized measurement protocols (NEMA NU 1-2001) rather than adjudicated by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or at least not reported in this 510(k) summary. This submission focuses on the technical and performance equivalence of the gamma camera system itself, not on the diagnostic accuracy of human readers using images generated by the device, with or without AI assistance. The document predates widespread AI integration in medical imaging.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm-only study was not done. This device is a gamma camera hardware system, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the acceptance criteria and performance evaluation is based upon NEMA Standards (NU 1-2001, Performance Measurements of Scintillation Cameras). These standards define the methods for measuring key performance parameters (e.g., energy range, count rate, spatial resolution, uniformity) of gamma cameras. The predicate device's performance, which the new device aims to meet or exceed, also acts as a reference.
8. Sample Size for the Training Set
This is not applicable. The Cyclone maiCAM180 is a physical gamma camera system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no AI model or training set involved in this 510(k) submission.
{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 todetect the location anddistribution of gammaray emittingradionuclides in thebody and producecross-sectional imagesthrough computerreconstruction of thedata. This deviceincludes accessoriessuch as signal analysisand display equipment,patient and equipmentsupports, radionuclideanatomical markers,component parts, andaccessories. | The intended use is todetect the location anddistribution of gammaray emittingradionuclides in thebody and producecross-sectional imagesthrough computerreconstruction of thedata. This deviceincludes accessoriessuch as signal analysisand display equipment,patient and equipmentsupports, radionuclideanatomical markers,component parts, andaccessories. |
| Target Population | The Virgo is primarilyintended for cardiacapplications in aclinical environment. | Same |
| Electrical Safety | Device is certified toelectrical safetystandards by a thirdparty organization priorto use on humanpatients. | Same |
| Energy used/delivered | There is no new energysource requirement.The energyrequirement is 115 V,60 Hz (or 240 V, 50Hz) | Same |
| Standards met | IEC 601 and UL544 | Same |
| User Instructions | User instructionscontain the operatinginstructions pertinent tothis system includingsafety features,warnings, systemcalibration, andprocessing andworkstation featuresand instructions. | Same. |
| Design | A gantry base on thefloor supports a consolewith electronics and arobotic detector arm.The detector arm servesas a detector support inan unbalanced design. | The gantry base on thefloor supports a wall /track that hold thedetectors in anunbalanced design. |
| Material | Painted and crematediron and aluminumplates and casts.Aluminum platecovers. | Painted and crematediron and aluminumplates.Sheet metal and plasticcovers. |
| Patient Support | The patient supportcomprises a chairmounted on the gantrybase in which thepatient is seated supineduring acquisition.The chair includes arotate motion capableof tilting the entirechair with patientbetween uprightposition (patient load)and a decline scanposition about 20 | The patient supportcomprises a chairmounted on the gantrybase in which thepatient is seated uprightduring acquisition.The chair is capable ofmoving in the X and Yaxis relative to thedetector heads whilethe detector rotate inthe Z axis around thepatient. |
| degree from horizontal. | ||
| Detector Design | By manual control, theseat of the chair (withpatient) can be movedup or down to positionthe heart of the patientwithin the detectorhead. | By manual control, theseat of the chair (withpatient) can be movedup or down to positionthe heart of the patientwithin the detectorhead. |
| The two detector headsare mounted into asingle copper / zinc/lead alloy (UNS)designation;C94300casting covered byaluminum plate coverswith collision sensorpads. | The two detector headsare mounted into aseparate lead /aluminum bowlcovered by sheet metalcovers with collisionsensor pads. | |
| Each detectorcomprises a NaI crystaland 24 3" squarephotomultiplier tubesand electronics forposition determinationand correction foruniformity and linearityerrors. | Each detectorcomprises a NaI crystaland 35 2.3" squarephotomultiplier tubesand electronics forposition determinationand correction foruniformity and linearityerrors. | |
| Warnings | A warning label isapplied to allcollimatorshighlightinginstructions. Cautionand high voltage labelsare applied inappropriate areas andas required by electricalstandards. | 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 andkeyboard used forimage acquisition,detector head andgantry 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 spatialresolution | ≤3.7 mm FWHM≤7.6 mm FWTM | ≤3.0 mm FWHM≤6.2 mm FWTM |
| Acquisition Software: | Segami MirageAcquisition | Segami MirageAcquisition |
{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
§ 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.