JUPITER PROCESSING AND REVIEW WORKSTATION

K024137 · Ge Medical Systems, Inc. · LLZ · Jan 15, 2003 · Radiology

Device Facts

• Record ID: K024137
• Device Name: JUPITER PROCESSING AND REVIEW WORKSTATION
• Applicant: Ge Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

Device Story

Jupiter is a PC-based workstation for display, processing, archiving, and communication of emission tomography (ET) and hybrid imaging data. Input consists of ET camera data; system performs image corrections (attenuation) and registers anatomical/physiological images. Output is displayed on a high-resolution monitor for clinical review. Used in clinical settings by healthcare professionals. Facilitates diagnostic decision-making by providing processed, registered, and archived images for review.

Clinical Evidence

Bench testing only. The device was evaluated for electrical, mechanical, and radiation safety, confirming conformance to applicable medical device safety and performance standards (CISPR 11, IEC 801, UL 2601-1, IEC 60601-1).

Technological Characteristics

PC-based workstation running Microsoft Windows 2000. Includes high-resolution color monitor, keyboard, mouse, and RW-CD for archiving. Optional DVD and optical disk drives. Connectivity via Ethernet. Conforms to CISPR 11, IEC 801, UL 2601-1, and IEC 60601-1 standards.

Indications for Use

Indicated for diagnostic radiology patients undergoing emission tomography procedures, including planar, whole body, SPECT, and positron imaging by coincidence, requiring image display, processing, archiving, or communication.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• GE eNTEGRA Processing and Review Workstation (K000395)

Submission Summary (Full Text)

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KO2 4137

Special 510{k} Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

JAN 1 5 2003

GE Medical Systems

ELGEMS Ltd. 10 Hayozma St., P.O. Box 170 Tirat Hacarmel, 30200, Israel

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

| Submitter: | GE Medical Systems<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hemy Neuman<br>Quality, Safety and Regulatory Manager<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | November 24, 2002 |
| Device Name: | Jupiter Processing and Review Workstation<br>System, Image Processing, Radiological, 21 CFR 892.2050, 90-KPS |
| Marketed Device: | GE Medical System's eNTEGRA Processing and Review Workstation<br>510(k) Number K000395, currently in commercial distribution (first<br>introduced under the name Einstein). |

## Device Description:

Jupiter is a computer workstation used for the display, processing, filming, and communication of Emission Tomography images (data) and hybrid imaging. It also includes capabilities to perform image corrections based on Attenuation Tomography and to provide registration of anatomical and physiological images. It consists of a Microsoft Windows 2000 based PC workstation (high resolution color monitor, keyboard, mouse, and RW-CD for archiving), an Ethernet network connection and system software. Optional DVD and optical disk archive devices are also available. The system conforms to the following mandatory and voluntary standards: CISPR 11; IEC 801, UL 2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J

## Indications for Use:

The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

### Comparison with Predicate Device:

The GE Jupiter Processing and Review Workstation is a modification of, and is comparable and substantially equivalent to the currently marketed GE eNTEGRA Processing and Review Workstation (first introduced under the name Einstein - K000395). This system has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

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Special 510(k) Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

#### Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

#### Conclusion:

Intended use and fundamental scientific technology are the legally marketed GE eNTEGRA Processing and Review Workstation. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the Jupiter Processing and Review Workstation is substantially equivalent to the currently cleared eNTEGRA Processing and Review Workstation.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure with three curved lines forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K024137

Trade/Device Name: Jupiter Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2002 Received: December 16, 2002

Dear Dr. Kroger:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification GE Medical Systems - Jupiter Processing and Review Workstation December 9, 2002

## STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K024137

Device Name: Jupiter Processing and Review Workstation

# Indications for Use

The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

(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

Daniel G. Glynn

(Division Sign-Off) Division of Reproductive and Radiological Devi 510(k) Numbe