VANTAGE 3.0 INSYNCH

K981291 · Adac Laboratories · KPS · Jun 29, 1998 · Radiology

Device Facts

• Record ID: K981291
• Device Name: VANTAGE 3.0 INSYNCH
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

Device Story

Vantage 3.0 InSynch™ is a software option for ADAC Gamma Camera systems; enables simultaneous acquisition of two emission isotopes plus a transmission image using external radioactive scanning line sources. Operates as an extension of the predicate Vantage 2.0 ExSPECT software. Used in clinical nuclear medicine settings by trained personnel. Transforms raw radiation detection signals into dual-isotope and transmission images. Output assists clinicians in diagnostic imaging and clinical decision-making by providing multi-isotope data in a single scan session, potentially improving workflow efficiency compared to sequential scanning.

Clinical Evidence

Bench testing only. A study compared simultaneous dual-isotope scanning to sequential dual-isotope scanning to demonstrate comparable image quality.

Technological Characteristics

Software-based image acquisition and reconstruction module for Gamma Camera systems. Utilizes external radioactive scanning line sources for transmission imaging. Operates on existing ADAC system hardware. No specific software architecture or connectivity standards detailed.

Indications for Use

Indicated for use with ADAC Gamma Camera Systems to produce simultaneous dual-isotope emission images and a transmission image. Patient population not specified.

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)

Submission Summary (Full Text)

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K981291

| Vantage 3.0 InSynch™ |
|-------------------------------|
| 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

#### I. General Information

Submitted By: A.

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

Contact Person:

Dennis Henkelman at address above

- Vantage 3.0 InSynch™ Device Trade Name: B. Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
- Vantage 2.0 ExSPECT C. Predicate Device:
- Device Description: D.

Vantage 3.0 InSynch™ 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 3.0 InSynch™ is a computer program that produces nuclear medicine

images of two isotopes acquired simultaneously, corresponding to specific energy levels and a transmission image from external radioactive scanning line sources. Vantage 3.0 InSynch™ is an extension of Vantage 2.0 ExSPECT which acquires a single isotope image with the transmission image produced by the external radioactive scanning line sources.

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#### Indications for Use: E.

The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

#### F. Technological Comparison:

The Vantage 3.0 InSynch™ and Vantage 2.0 ExSPECT devices have the same source type, source strength, source geometry, system hardware, and operating principles. Whereas the Vantage 2.0 ExSPECT device was intended for the acquisition and reconstruction of a single emission isotope in addition to a line source, the Vantage 3.0 InSynch™ is intended for the acquisition of dual isotopes simultaneously.

#### II. Testing

A study was conducted to demonstrate that Vantage 3.0 InSynch™ provides comparable images using simultaneous dual-isotope scanning to sequential dualisotope scanning. The quality of the images produced was similar to the quality of images produced by the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1998

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

Re:

K981291 Vantage 3.0 InSynch™M Dated: April 8, 1998 Received: April 9, 1998 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 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 II (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/odrh/dsma/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa 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 3.0 InSynch™ Device Name:

ADAC Laboratories Sponsor Name:

### Indications for Use

The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Slyman

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

ਲ Prescription Use Over-The-Counter Use 0