BRIGHTVIEW VCT IMAGING SYSTEM

K080927 · Philips Medical Systems (Cleveland), Inc. · KPS · Apr 11, 2008 · Radiology

Device Facts

• Record ID: K080927
• Device Name: BRIGHTVIEW VCT IMAGING SYSTEM
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

BrightView VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Bright View VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same ofientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.

Device Story

BrightView VCT is a SPECT/CT imaging system; integrates gamma camera with flat-panel x-ray transmission components. Inputs: emission data from SPECT detectors; transmission data from x-ray tube/flat-panel detector. Processing: system performs attenuation correction and scatter correction using x-ray data; registers and fuses SPECT and CT images for anatomical localization. Output: fused SPECT/CT images displayed on workstation. Used in clinical settings by trained healthcare professionals. System includes gantry, patient table (500 lb capacity), detectors, and acquisition/processing software. Benefits: improved image quality via attenuation correction and precise anatomical localization of nuclear medicine data.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison and system performance characteristics relative to predicate devices.

Technological Characteristics

SPECT/CT system; 9-axis ring gantry; dual-detector SPECT; flat-panel x-ray detector; x-ray tube/generator. Supports 500 lb patient load. Connectivity: acquisition workstation with image processing/fusion software. Sterilization: N/A (non-invasive imaging).

Indications for Use

Indicated for use by trained healthcare professionals to perform SPECT imaging, including static, dynamic, gated, total body, and orbit studies. Provides attenuation-corrected and non-attenuation-corrected SPECT images, with x-ray transmission data for scatter correction and anatomical localization via fused image display.

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

• BrightView Gamma Camera System (K062298)
• GE 4 Option for Dual-Head Variable Angle Gamma Camera (K052434)

Submission Summary (Full Text)

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K080927

PMS (Cleveland) Inc. BrightView VCT Imaging System CONFIDENTIAL

510(k) Premarket Notification Section B Administrative Information

## 510(k) SUMMARY SAFETY AND EFFECTIVENESS

APR 11 2008

Submitted By:

Philips Medical Systems (Cleveland), Inc. 540 Alder Dr. Milpitas, CA 95035

- B. Device Trade Name: Common Name: Classification Name: Device Class: Product Code:
Contact: Coleen A. Coleman Tel: [phone] Fax: [phone]

BrightView™ VCT Imaging System Single Photon Emission Computed Tomography Emission Computed Tomography System 21CFR 892.1200, Class II 90 KPS

ে Date prepared: March 19, 2008

D. Predicate Devices: BrightView™ Gamma Camera System (K062298) GE 4 Option for Dual-Head Variable Angle Gamma Camera (K052434)

#### E. Intended Use:

BrightView™ VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Bright View VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same ofientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.

F. Device Description:

BrightView VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT is defined as a low dose, high resolution SPECT/CT system with CT-like image quality used to perform attenuation correction and localization. The overall system includes the SPECT gantry, patient table, detectors for emission, flat panel xray detector for attenuation correction and localization, acquisition system, processing workstation, image processing/analysis and fusion software, and all other accessories required for the functionality of the system.

The BrightView VCT is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require

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support. The flat panel x-ray detector can be folded into the gantry to accommodate collimator exchange or bed imaging.

The BrightView VCT is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), BrightView VCT can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, gated SPECT (circular and non-circular) studies. A flat panel x-ray detector and x-ray tube are mounted to the SPECT gantry to provide attenuation correction and localization capability.

#### Technological Comparison: G.

The BrightView VCT, the BrightView system (K062298) and GE Hawkeye Infinia (K052434) predicate devices have similar intended use and indications for use. The SPECT portion of the Bright View VCT and the predicate Bright View SPECT are technologically equivalent. The Bright View VCT and the predicate Bright View have similar main mechanical and electrical components. All the SPECT features provided on the Bright View SPECT system are provided on the Bright View VCT. New features include:

- . A flat panel detector, x-ray tube and generator for volumetric CT transmission imaging for attenuation correction and localization.
- Change to the BrightView gantry to accommodate mounting of the x-ray imaging . components
- Acquisition software for attenuation correction and localization .
- Patient table to support 500 lb. load (227 kg) .

As stated above the Bright View VCT Gamma Camera System offers the following new features: attenuation correction and localization. The predicate Hawkeye Infinia offers similar SPECT features as well as attenuation correction and localization. The Hawkeye Infinia uses a dental x-ray tube with CT style detectors in a separate plane from the SPECT detectors. The BrightView VCT SPECT and X-ray detectors share a common imaging plane. The Bright View VCT and the Hawkeye Infinia have the x-ray components mounted to the SPECT gantry. The Hawkeye Infinia has a slip ring gantry while the Bright View VCT has a 9-axis ring gantry to provide similar capabilities.

#### H. Conclusion:

The BrightView VCT is substantially equivalent to the predicate devices BrightView (K062298) and GE Hawkeye Infinia (K052434) based upon identical indications for use, technological comparison and overall system performance.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or a stylized flame.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems (Cleveland), Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230

APR 11 2008

Re: K080927

Trade/Device Name: BrightView VCT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 31, 2008 Received: April 2, 2008

Dear Mr. Christensen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/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

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# Indications for Use

510(k) Number (if known): 长 080927

Device Name:

BrightView VCT Imaging System

Indications For Use:

Bright View VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.

Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aomi Th Wh

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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