VANTAGE 2.1 EXSPECT

K971878 · Adac Laboratories · KPS · Aug 8, 1997 · Radiology

Device Facts

• Record ID: K971878
• Device Name: VANTAGE 2.1 EXSPECT
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Aug 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.

Device Story

Vantage 2.0 ExSPECT is a software enhancement for ADAC Gamma Camera systems. It utilizes external radioactive scanning line sources and special collimation to acquire patient anatomical data. The system performs Single Photon Emission Computed Tomography (SPECT) imaging. It processes raw emission data by applying corrections for attenuation, Photopeak scatter, Downscatter, and Resolution Recovery (RR). The software is used in clinical settings by trained operators to improve image quality. The resulting enhanced images assist healthcare providers in visualizing anatomical density, facilitating clinical decision-making by providing more accurate emission images.

Clinical Evidence

No clinical data provided. Bench testing was performed using protocols outlined in the Vantage user manual to validate image quality enhancements.

Technological Characteristics

Software-based enhancement for SPECT imaging. Utilizes external radioactive line sources and collimation. Reconstruction algorithm modified from predicate to include Photopeak scatter, Downscatter, and Resolution Recovery (RR) corrections. Operates on existing ADAC Gamma Camera hardware.

Indications for Use

Indicated for patients undergoing emission imaging via ADAC Gamma Camera Systems to depict anatomical density and provide attenuation correction.

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

• Vantage 1.0 (K943596)

Submission Summary (Full Text)

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524 118 18
AUG - 8 1997

System, Emission Computed Tomography

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

#### I. General Information

ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, CA 95035 Tel: [phone] Fax: [phone] Dennis Henkelman at address above Contact Person: Vantage 2.0 ExSPECT B. Device Trade Name: Gamma Camera Systems Common Name:

- C. Vantage 1.0 Predicate Device:
Classification Name:

- D. Device Description:
- . '

Vantage 2.0 ExSPECT is a software program which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 1.0 software package, cleared in 510k K943596.

Vantage 2.0 ExSPECT is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.

The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).

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### E. Indications for Use:

The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.

## F. Technological Comparison:

The Vantage 1.0 and Vantage 2.0 ExSPECT devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter.

#### II. Testing

.
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Images were acquired using the protocol outlined in the Vantage user manual.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH & HUM" is arranged in a semi-circle around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 1997

Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, California 95035

Dear Mr. Henkelman:

Re: K971878

Vantage 2.0 ExSPECT Gamma Camera Dated: May 19, 1997 Received: May 21, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

h.J.Liau Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Vantage 2.0 ExSPECT Device Name:

_ADAC Laboratories Sponsor Name:

Indications For Use:

:

The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ro Phillips

Prescription Use Over-The-Counter Use 0

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