WBR XPRESS3.CARDIAC

K081201 · Ultraspect , Ltd. · KPS · May 28, 2008 · Radiology

Device Facts

• Record ID: K081201
• Device Name: WBR XPRESS3.CARDIAC
• Applicant: Ultraspect , Ltd.
• Product Code: KPS · Radiology
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Xpress3.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera 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 image organs

Device Story

Xpress3.cardiac is an image processing system interfacing with gamma cameras; reconstructs fast-acquired cardiac scintigraphy data. Utilizes parallel and non-parallel beams to produce high-resolution images. System displays data in traditional formats, pseudo-3D renderings, and animated sequences showing organ kinetic attributes. Images are transferable to DICOM or Interfile-compatible PACS. Used in clinical settings to assist healthcare providers in visualizing cardiac data; aids in clinical decision-making by providing enhanced image resolution compared to traditional Filtered Back-Projection.

Clinical Evidence

Bench and clinical data provided. Validation performed per 21 CFR 820.30. Results demonstrate that reconstructed images achieve equivalent or better resolution compared to images reconstructed via Filtered Back-Projection.

Technological Characteristics

Image processing system for gamma cameras; utilizes parallel and non-parallel beam reconstruction algorithms. Connectivity via DICOM or Interfile standards for PACS integration. Software-based reconstruction system.

Indications for Use

Indicated for the acquisition, formatting, and storage of scintigraphy camera output data for clinical imaging, including 3D renderings and animated sequences of organ kinetics.

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 Xact.cardiac & Xpress.cardiac (K050815)
• Half Dose (K080784)

Submission Summary (Full Text)

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K08120/

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

#### Device Name

Proprietary Device Name: Xpress3.cardiac.

# Establishment Name and Registration Number of Submitter

MAY 2 8 2008

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

WBR Xact.cardiac & Xpress.cardiac - K050815 including Half Dose K080784

#### Device Description

The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes 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.

## Intended Use of Device

The Xpress3.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera 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 image organs

## Safety & Effectiveness

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by Filtered Back - Projection.

### Substantial Equivalency

It is UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 8 2008

UltraSPECT, Ltd. % Mr. Dan Laor Managing Director Quasar Quality, Ltd. 6 Sireni. Haifa. 32972 ISRAEL

Re: K081201

Trade/Device Name: Xpress3.Cardiac Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and LLZ Dated: April 22, 2008 Received: April 28, 2008

### 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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.

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 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours.

Nancy C.Bridgton

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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# Indications for Use

510(k) Number (if known):

Device Name: Xpress3.Cardiac

Indications For Use:

The Xpress3.Cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, ind in various forms of animated sequences, showing kinetic attributes of the image organs.

K08/201

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)

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Arzu In Khang
(Division Sign-Off)

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