VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION

K963273 · Smv America · KPS · Mar 11, 1997 · Radiology

Device Facts

• Record ID: K963273
• Device Name: VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
• Applicant: Smv America
• Product Code: KPS · Radiology
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.

Device Story

VCAR option is an accessory upgrade for VISION FX-80 Gamma Camera/Power Station; enables electronic collimation for positron emission tomography (PET). System detects gamma rays from radioisotope decay via coincidence detection electronics; performs Coincident Photon Emission Computed Tomography (CPECT). Operator controls detector electronics/processors to acquire coincidence data; system performs 2-D and 3-D image reconstruction. Used in clinical settings by medical clinicians to interpret anatomical distribution of radioisotopes. Output images assist clinicians in diagnostic assessment of radioisotope distribution within the human body.

Clinical Evidence

Bench testing only. Major performance parameters measured using industry-standard test methods to verify system performance specifications against predicates. No clinical trial data provided.

Technological Characteristics

Accessory upgrade for gamma camera system. Utilizes proprietary coincidence detection electronics for electronic collimation. Performs 2-D and 3-D image reconstruction of emission data. Compatible with FDA-approved positron-emitting radioisotopes (e.g., FDG).

Indications for Use

Indicated for whole body nuclear imaging to depict anatomical distribution of radioisotopes in patients undergoing positron emission tomography (PET) using FDA-approved positron-emitting radioisotopes (e.g., FDG).

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

• Penn-PET (marketed as GE Quest 300) (K930428)
• MCD option to VERTEX Epic System (K952684)

Reference Devices

• VISION FX-80 Gamma Camera (K935273)
• Power Station (K912753)

Submission Summary (Full Text)

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K963273

SMV America

VCAR Option 510(k)

Appendices

Page 45 of 48

# Appendix X:

## 510(k) Summary of Safety and Effectiveness

MAR 11 1997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Prepared: August 20, 1996

Submitter: SMV America
8380 Darrow Rd.
Twinsburg, Ohio 44087
[phone]

Contact: W. K. McCroskey
Director of CPECT Imaging

Device: Classification Name: System, Emission Computed Tomography
Classification Number: 90 KPS
Common or Usual Name: Coincidence Imaging Gamma Camera System
Trade/Proprietary Name: VCAR option to VISION FX-80 Gamma Camera and Power Station

Predicate Devices:

| SPONSOR | PRODUCT | Preamendment Status or 510(k) Number |
| --- | --- | --- |
| UGM Medical Systems, Inc. | Penn-PET (marketed as GE Quest 300) | K930428 |
| ADAC Laboratories | MCD option to VERTEX Epic System | K952684 |

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SMV America
VCAR Option 510(k)
Appendices
Page 46 of 48

## Device Description Summary:

The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called “Coincident Photon Emission Computed Tomography” (CPECT).

The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.

## Intended Use:

The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.

## Technological Characteristics:

The FX-80&PS/VCAR has been designed to perform imaging of PET isotopes in a way which is very similar to traditional PET systems (e.g., the GE Quest 300) and gamma camera PET systems (e.g., ADAC's MCD option to the VERTEX Epic System). The FX-80&PS/VCAR is very similar to both predicate devices.

Each system detects radioisotope emissions from the human body and integrates the acquired emission data over time to produce an image representing a quantification of emissions from the imaged region. All three units utilize the same theory of operation.

In all three systems, detection events from opposing detectors are compared, to determine if both detected an event almost simultaneously. Coincident events undergo

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SMV America
VCAR Option 510(k)
Appendices
Page 47 of 48

additional processing to generate images which show the frequency of annihilation events due to radioisotopes in the area being imaged.

Each of the three systems have additional post-acquisition processing systems which further manipulate the image data to perform 2-dimensional and 3 dimensional reconstructions of the imaged area.

In addition, all three systems are able to utilize any FDA-approved positron-emitting radioisotope (e.g., Fluorodeoxyglucose [FDG]) to generate images.

## Summary of Testing:

Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices.

## Conclusion:

The VCAR option for the VISION FX-80 Gamma Camera and Power Station was developed and validated in accordance with the Company’s product and software development procedures. System testing and validation demonstrates that the system meets its published specifications, performs as well as or better than the currently marketed product, and is safe and effective for its intended use.