WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE

K080784 · Ultraspect , Ltd. · KPS · Apr 2, 2008 · Radiology

Device Facts

• Record ID: K080784
• Device Name: WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
• Applicant: Ultraspect , Ltd.
• Product Code: KPS · Radiology
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The WBR Half dose 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

WBR Half Dose is an image processing system interfaced with gamma cameras; processes acquired data using parallel and non-parallel beams to produce high-resolution images. System enables reduced-dose acquisition or fast acquisition while maintaining information density and image quality. Output includes traditional formats, pseudo-3D renderings, and animated sequences showing organ kinetics. Images are transferable to DICOM or Interfile-compatible PACS. Used in clinical settings by radiology staff to assist in diagnostic visualization; benefits patients by potentially reducing radiation exposure or acquisition time.

Clinical Evidence

Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution compared to images reconstructed by filtered back projection. No adverse effects detected.

Technological Characteristics

Image processing system for gamma cameras; utilizes parallel and non-parallel beam processing; DICOM and Interfile compatible; software-based reconstruction.

Indications for Use

Indicated for acquisition, formatting, and storage of scintigraphy camera output data for clinical imaging.

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)

Submission Summary (Full Text)

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K080784

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

#### Device Name

Proprietary Device Name: WBR Half Dose.

#### Establishment Name

UltraSPECT Ltd.

APR - 2 2008

Submission contact person: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

#### Device Classification

Product Code: Subsequent Product Code CFR section: Panel Identification: Device Description: Classification:

KPS LLZ 892.1200 Radiology Emission computed tomography system Class II Product

#### Reason for 510(k) Submission

Special 510(k) Submission

## Identification of Legally Marketed Equivalent Devices

WBR Xact.cardiac & Xpress.cardiac - K050815

#### Device Description

The WBR Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.

#### Intended Use of Device

The WBR Half dose 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 filter back projection. No adverse affects have been detected.

#### Substantial Equivalency

It is UltraSPECT's opinion that the WBR Half Dose and the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above rredicated aviace.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three wings, representing health, human services, and the well-being of the American people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

UltraSPECT Ltd. % Mr. Dan Laor Regulatory Consultant Sireni 6 Haifa 32972 ISRAEL

Re: K080784

Trade/Device Name: WBR Half Dose Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 9, 2008 Received: March 20, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I epp. o targe 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.

Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.

Protecting and Promoting Public Health

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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/cdrh/industry/support/index.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

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Enclosure

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# Indications for Use

510(k) Number (if known):

K080784

Device Name: WBR Half Dose

Indications For Use:

The WBR Half Dose 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.

Prescription Use X (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)

Page 1 of

Norma M. White

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