SMARTSPOT PRIMAX

K080890 · Cmt Medical Technologies, Ltd. · LLZ · Apr 29, 2008 · Radiology

Device Facts

• Record ID: K080890
• Device Name: SMARTSPOT PRIMAX
• Applicant: Cmt Medical Technologies, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.

Device Story

SmartSPOT PrimaX is a high-resolution digital imaging system for digital spot imaging; functions as a PACS workstation. Input: fluoroscopic image data. Processing: digital image enhancement; digital subtraction (DSA); roadmapping. Output: 1024x1024 resolution radiographic images displayed on a PC workstation. Used in clinical settings (gastrointestinal, interventional, urology, angiography) by healthcare professionals. Redesigned from predicate SMARTSPOT (K961307) to improve cost-effectiveness via updated hardware and software components; core principle of operation remains unchanged. Benefits include improved image quality and advanced visualization capabilities for interventional procedures.

Clinical Evidence

Bench testing only. The device was verified and validated in accordance with 21 CFR 820.30 regulations. No clinical data or adverse effects reported.

Technological Characteristics

PC-based workstation running Windows XT. High-resolution digital imaging system (1024x1024 pixels). Functions as a Picture Archiving and Communication System (PACS). Class II device (21 CFR 892.2050).

Indications for Use

Indicated for patients undergoing gastrointestinal, interventional, peripheral angiography, urology, and routine fluoroscopy examinations requiring high-resolution (1024x1024) digital spot imaging and digital subtraction angiography (DSA) or roadmapping.

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

• SMARTSPOT (K961307)

Submission Summary (Full Text)

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# Koro890

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

#### Device Name

Proprietary Device Name: SmartSPOT PrimaX

#### Establishment Name and Registration Number of Submitter

APR 2 9 2008

Name: CMT Medical Technologies Ltd. (CMT hereafter) Registration: 8030112 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

#### Device Classification

| Product Code: | LLZ |
|----------------------|-------------------------------------------------|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |

# Reason for 510(k) Submission

Special 510(k) Submission

## Identification of Legally Marketed Equivalent Devices

K961307 SMARTSPOT

#### Device Description

The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

#### Indications for use

The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA that were not possible with conventional technique.

Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.

#### Safety & Effectiveness

The device has been designed verified and validated complying with 21 CFR 820.30 regulations. Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected.

#### Substantial Equivalency

It is CMT opinion that the SmartSPOT PrimaX is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2008

CMT Medical Technologies Ltd. c/o Mr. Dan Laor Quasar Quality Ltd. 6 Sireni HAIFA 32972, ISRAEL

Re: K080890

Trade/Device Name: SmartSPOT PrimaX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: March 27, 2008 Received: March 31, 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 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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## Indications for Use

510(k) Number (if known):

k osorqa

SmartSPOT PrimaX Device Name:

Indications For Use: The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique.

Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies

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

Over-the-Counter Use: NO (Part 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)

*(Division Sign-Off)*

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

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