CYCLONE, MODEL MAICAM 180

K060486 · Spectrica · KPS · Mar 23, 2006 · Radiology

Device Facts

• Record ID: K060486
• Device Name: CYCLONE, MODEL MAICAM 180
• Applicant: Spectrica
• Product Code: KPS · Radiology
• Decision Date: Mar 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

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 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.

Device Story

Cyclone is a dedicated nuclear cardiology gamma camera system. It utilizes a dual-head detector configuration mounted on a gantry base with a patient chair. Input consists of gamma rays emitted from intravenously administered radiopharmaceuticals; these are captured by a collimator and interact with a NaI scintillation crystal. Photomultiplier tubes convert light flashes into electrical signals containing energy and positional data. The system performs computer reconstruction to produce cross-sectional images. Operated by clinical staff in a clinical environment, the device uses hand controls for detector positioning and software for acquisition. Output is processed via Segami Mirage software to assist clinicians in visualizing cardiac radionuclide distribution, aiding in diagnostic decision-making for cardiac conditions.

Clinical Evidence

Bench testing only. Performance evaluated per NEMA NU 1-2001 standards. Key metrics: energy range 50-200 keV, count rate 300 Kcps, energy resolution 9.2% FWHM, intrinsic uniformity ≤2.5% integral/≤1.5% differential, and intrinsic spatial resolution ≤3.0 mm FWHM/≤6.2 mm FWTM.

Technological Characteristics

Dual-head gamma camera; NaI scintillation crystal; 35 photomultiplier tubes per head; energy range 50-200 keV. Materials: painted iron, aluminum, sheet metal, plastic. Connectivity: data transmission to external image processing software. Standards: IEC 601, UL544, NEMA NU 1-2001. Software: Segami Mirage Acquisition.

Indications for Use

Indicated for cardiac applications in patients requiring nuclear cardiology imaging to detect location and distribution of gamma ray emitting radionuclides (50-200keV).

Regulatory Classification

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.

Predicate Devices

• Virgo (K031825)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Contact Person:

Tel: [phone] ext. 307 Fax [phone] Email: [e-mail]

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

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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.

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#### 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<br>detect the location and<br>distribution of gamma<br>ray emitting<br>radionuclides in the<br>body and produce<br>cross-sectional images<br>through computer<br>reconstruction of the<br>data. This device<br>includes accessories<br>such as signal analysis<br>and display equipment,<br>patient and equipment<br>supports, radionuclide<br>anatomical markers,<br>component parts, and<br>accessories. | The intended use is to<br>detect the location and<br>distribution of gamma<br>ray emitting<br>radionuclides in the<br>body and produce<br>cross-sectional images<br>through computer<br>reconstruction of the<br>data. This device<br>includes accessories<br>such as signal analysis<br>and display equipment,<br>patient and equipment<br>supports, radionuclide<br>anatomical markers,<br>component parts, and<br>accessories. |
| Target Population | The Virgo is primarily<br>intended for cardiac<br>applications in a<br>clinical environment. | Same |
| Electrical Safety | Device is certified to<br>electrical safety<br>standards by a third<br>party organization prior<br>to use on human<br>patients. | Same |
| Energy used/delivered | There is no new energy<br>source requirement.<br>The energy<br>requirement is 115 V,<br>60 Hz (or 240 V, 50<br>Hz) | Same |
| Standards met | IEC 601 and UL544 | Same |
| User Instructions | User instructions<br>contain the operating<br>instructions pertinent to<br>this system including<br>safety features,<br>warnings, system<br>calibration, and<br>processing and<br>workstation features<br>and instructions. | Same. |
| Design | A gantry base on the<br>floor supports a console<br>with electronics and a<br>robotic detector arm.<br>The detector arm serves<br>as a detector support in<br>an unbalanced design. | The gantry base on the<br>floor supports a wall /<br>track that hold the<br>detectors in an<br>unbalanced design. |
| Material | Painted and cremated<br>iron and aluminum<br>plates and casts.<br><br>Aluminum plate<br>covers. | Painted and cremated<br>iron and aluminum<br>plates.<br><br>Sheet metal and plastic<br>covers. |
| Patient Support | The patient support<br>comprises a chair<br>mounted on the gantry<br>base in which the<br>patient is seated supine<br>during acquisition.<br><br>The chair includes a<br>rotate motion capable<br>of tilting the entire<br>chair with patient<br>between upright<br>position (patient load)<br>and a decline scan<br>position about 20 | The patient support<br>comprises a chair<br>mounted on the gantry<br>base in which the<br>patient is seated upright<br>during acquisition.<br><br>The chair is capable of<br>moving in the X and Y<br>axis relative to the<br>detector heads while<br>the detector rotate in<br>the Z axis around the<br>patient. |
| | degree from horizontal. | |
| Detector Design | By manual control, the<br>seat of the chair (with<br>patient) can be moved<br>up or down to position<br>the heart of the patient<br>within the detector<br>head. | By manual control, the<br>seat of the chair (with<br>patient) can be moved<br>up or down to position<br>the heart of the patient<br>within the detector<br>head. |
| | The two detector heads<br>are mounted into a<br>single copper / zinc/<br>lead alloy (UNS)<br>designation;C94300<br>casting covered by<br>aluminum plate covers<br>with collision sensor<br>pads. | The two detector heads<br>are mounted into a<br>separate lead /<br>aluminum bowl<br>covered by sheet metal<br>covers with collision<br>sensor pads. |
| | Each detector<br>comprises a NaI crystal<br>and 24 3" square<br>photomultiplier tubes<br>and electronics for<br>position determination<br>and correction for<br>uniformity and linearity<br>errors. | Each detector<br>comprises a NaI crystal<br>and 35 2.3" square<br>photomultiplier tubes<br>and electronics for<br>position determination<br>and correction for<br>uniformity and linearity<br>errors. |
| Warnings | A warning label is<br>applied to all<br>collimators<br>highlighting<br>instructions. Caution<br>and high voltage labels<br>are applied in<br>appropriate areas and<br>as required by electrical<br>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<br>keyboard used for<br>image acquisition,<br>detector head and<br>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<br>≤ 1.5 % differential | ≤2.5 % integral<br>≤ 1.5 % differential |
| 5) Intrinsic spatial<br>resolution | ≤3.7 mm FWHM<br>≤7.6 mm FWTM | ≤3.0 mm FWHM<br>≤6.2 mm FWTM |
| Acquisition Software: | Segami Mirage<br>Acquisition | Segami Mirage<br>Acquisition |

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#### 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.

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#### 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.

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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 [phone] or [phone] 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

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## 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