VANTAGE 2.5

K991607 · Adac Laboratories · KPS · Jul 26, 1999 · Radiology

Device Facts

• Record ID: K991607
• Device Name: VANTAGE 2.5
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems. It includes scatter correction capability for

Device Story

Vantage 2.5 is a software-based modification to ADAC Laboratories Gamma Camera systems. It processes SPECT imaging data to provide anatomical information and attenuation correction. The system utilizes external radioactive scanning line sources with specialized collimation to minimize patient radiation exposure. New functionality includes Quality Assurance (QA) tools: Pre-Scan, Automatic Energy Window Checking, and Transmission QA Reference. The software is used in clinical nuclear medicine settings by trained operators to enhance image quality and ensure system performance. By providing automated QA and scatter correction, the device assists clinicians in obtaining accurate SPECT images, facilitating improved diagnostic assessment of patient anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified using protocols outlined in the Vantage user manual to confirm the functionality of the new QA tools and scatter correction features.

Technological Characteristics

Software-based enhancement for SPECT imaging. Utilizes external radioactive line sources for transmission scanning. Features include automated QA tools (Pre-Scan, Automatic Energy Window Checking, Transmission QA Reference) and scatter correction. Operates on existing ADAC Gamma Camera hardware. Reconstruction algorithms remain consistent with predicate device.

Indications for Use

Indicated for use as an enhancement to nuclear medicine images acquired via ADAC Laboratories Gamma Camera systems, specifically providing quality assurance and scatter 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 2.0 ExSPECT (K971878)

Reference Devices

• Vantage 1.0 (K943596)

Submission Summary (Full Text)

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JUL 26 1999

K991607

| Vantage 2.5 | |
|-------------------------------|--|
| ADAC Laboratories | |
| 510(k) Premarket Notification | |

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

## I. General Information

- ADAC Laboratories A. Submitted by: 540 Alder Drive Milpitas, California 95035 Tel: [phone] Fax: [phone] Dennis W. Henkelman at address above Contact Person: Vantage 2.5 B. Device Trade Name: Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
- C. Vantage 2.0 Predicate Device:
- D. Device Description:

Vantage 2.5 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 2.0 ExSPECT software package, cleared in 510(k) K971878.

Vantage 2.5 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 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.

The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.

- E. Indications for Use:
Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.

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- F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage 2.5 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 acquisition software.

## II. Testing

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Dennis W. Henkelman, R.A.C. Director, Regulatory Affairs & Quality Assurance ADAC Laboratories 540 Alder Drive Milipitas. California 95035

Re: K991607

> Vantage 2.5 Gamma Camera System Dated: May 7, 1999 Received; May 10, 1999 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Henkelman:

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 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). 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 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 requirements, 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 the Electronic Product 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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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Page

K991607 SIO(k) NUMBER (IF KNOWN): _

Vantage 2.5 DEVICE NAME:

INDICATIONS FOR USE:

Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems.
scatter correction capability for It includes scatter correction capability for

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96

David L. Segerson

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