WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

K091073 · Ultraspect , Ltd. · KPS · May 14, 2009 · Radiology

Device Facts

• Record ID: K091073
• Device Name: WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
• Applicant: Ultraspect , Ltd.
• Product Code: KPS · Radiology
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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

Device Story

Xpress.cardiac and Xpress3.cardiac are image processing systems interfacing with gamma cameras. Systems ingest raw scintigraphy camera data; perform reconstruction using parallel and non-parallel beams; apply Attenuation and Scattering Corrections (ACSC). Output includes high-resolution images, pseudo 3D renderings, and animated sequences showing organ kinetics. Used in clinical settings by radiology staff. Processed images are compatible with DICOM or Interfile standards for transfer to PACS. System enables enhanced visualization of cardiac data, assisting clinicians in diagnostic assessment of organ function.

Clinical Evidence

Bench and clinical data provided. Comparison study demonstrated that reconstructed and ACSC-corrected images are equivalent to images processed by the predicate Xeleris device.

Technological Characteristics

Image processing system for gamma camera data. Utilizes parallel and non-parallel beam reconstruction algorithms. Includes Attenuation and Scattering Corrections (ACSC). Connectivity via DICOM or Interfile standards for PACS integration. Software-based processing system.

Indications for Use

Indicated for acquisition, formatting, and storage of scintigraphy camera output data for visualization of organ kinetic attributes. No specific patient population, age, or gender restrictions are defined.

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

• Xpress.cardiac (K080784)
• Xpress3.cardiac (K081201)
• Xeleris (K051673)

Submission Summary (Full Text)

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K091073

MAY 14 2009

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

#### Device Name

Proprietary Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

#### Establishment Name and Registration Number of Submitter

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

#### 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

Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673

#### Device Description

The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).

#### Intended Use of Device

The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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

#### 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 Xeleris device.

#### Substantial Equivalency

It is UltraSPECT opinion that the modified Xpress.cardiac & Xpress3.cardiac are 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

MAY 1 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UltraSPECT Ltd. % Mr. Dan Laor Quality & Regulatory Advisor Quasar Quality Ltd 6 Sireni. Haifa 32972 İSRAEL

Re: K091073

Trade/Device Name: Xpress.Cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

Regulation Number: 21 CFR 892.1200

Regulation Name: Emission computed tomography system

Regulatory Class: II

Product Code: KPS and LLZ

Dated: April 12, 2009

Received: April 14, 2009

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 wours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K 09/1073

Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

#### Indications For Use:

The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Heme
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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