WBR XPRESS PET

K103710 · Ultraspect , Ltd. · KPS · Jan 19, 2011 · Radiology

Device Facts

• Record ID: K103710
• Device Name: WBR XPRESS PET
• Applicant: Ultraspect , Ltd.
• Product Code: KPS · Radiology
• Decision Date: Jan 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in psevodo proc dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

Device Story

WBR Xpress.PET is an image processing system interfaced with PET/CT scanners. It accepts fast-acquired raw data as input; utilizes parallel and non-parallel beam reconstruction algorithms to produce high-resolution images. Includes Attenuation and Scattering Corrections (ACSC). System operates in clinical radiology environments; used by physicians/technicians to process and display scintigraphy data. Output is transferred to DICOM-compatible PACS. Enables visualization of organ kinetic attributes via 3D renderings and animations, assisting clinicians in diagnostic assessment.

Clinical Evidence

Bench and clinical data provided. Comparison of reconstructed and ACSC-corrected images against those from predicate PET/CT devices demonstrated equivalent performance.

Technological Characteristics

Image processing system for PET/CT. Utilizes parallel and non-parallel beam reconstruction algorithms. Includes Attenuation and Scattering Correction (ACSC) modules. DICOM compatible for PACS integration. Software-based processing.

Indications for Use

Indicated for acquisition, formatting, and storage of scintigraphy output data for patients undergoing PET/CT imaging. Used for processing and displaying information in traditional formats, pseudo 3D renderings, and animated sequences to show kinetic attributes of imaged organs.

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

• WBR Xpress. Bone (K040370 & K080784)
• WBR Attenuation and Scattering Correction (K091073)
• Work station of the GE Discovery LS (K040172)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

Device Name Proprietary Device Name: WBR Xpress.PET

#### Establishment Name and Registration Number of Submitter

Name: UltraSPECT Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

JAN 1 9 2011

103710

#### Device Classification

| Product Code: | KPS |
|-------------------------|-------------------------------------|
| Subsequent Product Code | LLZ |
| CFR section: | 892.1200 |
| Panel Identification: | Radiology |
| Device Description: | Emission computed tomography system |
| Classification: | Class II Product |

### Reason for 510(k) Submission

Special 510(k) Submission

## Identification of Legally Marketed Predicate Devices

WBR Xpress. Bone - K040370 & K080784 WBR Attenuation and Scattering Correction - K091073 Work station of the GE Discovery LS - K040172

#### Device Description

The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).

#### Intended Use of Device

The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in psevodo proc dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

#### Safety & Effectiveness

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device.

#### Substantial Equivalency

It is UltraSPECT opinion that the modified Xpress.PET is substantially equivalent in terms of safety and effectiveness to the predicate devices.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Dan Laor Quality & Regulatory affairs Advisor UltraSpect Ltd. 6 Sireni Haifa 32972 ISRAEL

JAN 19 201

Re: K103710

Trade/Device Name: WBR Xpress.PET Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: December 13, 2010 Received: December 20, 2010

Dear Mr. Laor:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely Yours,

Mary S. Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k103710 Device Name: WBR Xpress.PET

Indications for Use:

The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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***(Division Sign-Off)***

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

K103710
510K