VANTAGE EXSPECT II

K992078 · Adac Laboratories · KPS · Sep 1, 1999 · Radiology

Device Facts

• Record ID: K992078
• Device Name: VANTAGE EXSPECT II
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.

Device Story

Vantage ExSPECT II is a software program designed as an optional add-on for ADAC Laboratories Gamma Camera systems. It processes nuclear medicine image data to provide quality assurance (QA) feedback. The software alerts users to potential issues such as image banding, data truncation, and count levels within acquired datasets. Additionally, it incorporates two user-selectable iterative reconstruction methods specifically for reducing noise in transmission images. The device is intended for use by clinical staff operating ADAC Gamma Camera systems. By providing automated QA feedback and improved image reconstruction, the software assists clinicians in ensuring image consistency and usability, ultimately supporting more reliable diagnostic interpretation of nuclear medicine scans.

Clinical Evidence

Bench testing only. The manufacturer performed image processing evaluations using the new Post Acquisition QA tool and the updated transmission iterative reconstruction methods to verify performance improvements.

Technological Characteristics

Software-based enhancement for Gamma Camera systems. Features a Post Acquisition QA tool for image quality monitoring (banding, truncation, count levels) and two user-selectable iterative reconstruction algorithms for transmission image noise reduction. Operates as an optional software module integrated with existing ADAC Gamma Camera hardware and acquisition electronics.

Indications for Use

Indicated for use in nuclear medicine imaging to provide quality assurance enhancements for images acquired using ADAC Gamma Camera Systems.

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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SEP - 1

K992078

| Vantage ExSPECT II |
|-------------------------------|
| ADAC Laboratories |
| 510(k) Premarket Notification |

Appendix IX, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2

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

#### General Information I.

Submitted By: A.

ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: [phone] Fax: [phone]

Dennis W. Henkelman at address above Contact Person:

B. Device Trade Name: Vantage ExSPECT II Common Name: Gamma Camera Systems System, Emission Computed Tomography Classification Name:

C. Predicate Device: Vantage 2.0 ExSPECT

#### D. Device Description:

Vantage ExSPECT II 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 510k K971878.

Vantage ExSPECT II is a computer program that provides a patient's functional information, which is further improved by using the anatomical information, obtained 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.

Vantage ExSPECT II is a modification of Vantage 2.0 ExSPECT and is designed to provide the user with additional quality assurance (QA) to improve the consistency and usability of the Vantage 2.0 ExSPECT product. The Post Acquisition QA tool provides the user with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts acquired in each data set. The other improvement is two

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user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.

- E. Indications for Use:
Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.

- F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage ExSPECT II devices have the same indications for use, source type and geometry, system hardware, operating principles, and emission reconstruction algorithm, with the exception of the Post Acquisition QA tool and minor modifications to the transmission reconstruction algorithm.

- II. Testing
Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 1 1999

Ms. Genine M. Grant Sr. Software Engineer ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re: K992078

Vantage ExSPECT II Dated: June 18, 1999 Received: June 18, 1999 Product Code: 90 KPS Requlatory Class: Il (two) 21 CFR 892.1200

Dear Ms. Grant:

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, 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 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/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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Vantage ExSPECT II Device Name:

ADAC Laboratories Sponsor Name:

Indications For Use:

Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

David k. Skymm
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number

ખ Prescription Use Over-The-Counter Use 0

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