SMART SPOT

K961307 · Cmt Medical Technologies, Ltd. · LLZ · Jul 1, 1996 · Radiology

Device Facts

• Record ID: K961307
• Device Name: SMART SPOT
• Applicant: Cmt Medical Technologies, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 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 techniques. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.

Device Story

SMARTSPOT is a high-resolution digital imaging system for R/F X-ray rooms; replaces cassette filming and 105mm spot cameras to reduce radiation exposure and exam time. Inputs: X-ray/TV signals via high-resolution CCD camera. Processing: Advanced video processor on Windows NT workstation; performs image enhancement, digital subtraction (DSA), and roadmapping. Outputs: 1024x1024 pixel radiographic images displayed on control room monitors; hardcopy laser camera interface. Used in clinical settings by radiologists/technicians. Benefits: Improved image quality, reduced radiation dose, and advanced diagnostic capabilities compared to conventional analog techniques.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1 (safety and electromagnetic compatibility) and pre-production beta testing to verify specifications.

Technological Characteristics

High-resolution CCD camera; advanced video processor; Windows NT workstation; 2GB internal hard disk; X-ray/TV interfaces; Hardcopy Laser Camera interface. Compliance with IEC 601-1 (safety/EMC).

Indications for Use

Indicated for patients undergoing gastrointestinal, interventional, peripheral angiography, urology, and routine fluoroscopy examinations requiring high-resolution digital spot imaging.

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

• FC 2000 (K911454)

Submission Summary (Full Text)

{0}

K96/307
JUL - I 1996

# MEDICAL TECHNOLOGIES LTD

## 510(k) Summary of Safety and Effectiveness

### Submitter Information

**Submitter:** CMT Medical Technologies Ltd.
MATAM, Haifa 31905
Israel

**Establishment Reg.:** 9680763

**Contact:** Imre Farkash
Quality Assurance Manager

**Summary Date:** April 21, 1996

### Name of Device and Classification

**Proprietary Name:** SMARTSPOT

**Common Name:** High Resolution Digital Imaging System

**Classification:** Accessory to 21 CFR 892.1650, Class II

### Predicate Device

**Manufacturer:** S & S Inficon Inc.

**Predicate Name:** FC 2000

**510(k) number:** K911454

### Description of the Device

The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.

The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.

{1}

# Intended Use

The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 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 techniques.

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

# Comparison to the Predicate

Both systems have the same intended use. They have almost identical features, same spatial resolution and same digitization depth.

Both systems are computer controlled devices, although different platforms and different operating systems but both in the mainstream of today’s computer technology.

The main and almost only relevant difference is the TV camera used: the SMARTSPOT integrates a digital CCD camera vs. the Pick-up tube type used by the predicate device. CCD cameras are already widely used in fluoroscopic digital devices. These cameras show a comparable spatial resolution and dynamic range as the pick-up tube counterparts but they outperform them in terms of cost-effectiveness and long term stability.

# Safety information

The device is designed to comply at least with the minimum response requirements stated in the initial Hazard Analysis included in this notification, and with voluntary international standard IEC 601-1 for medical electrical equipment regarding both its safety (part 1) and electromagnetic compatibility (part 2) requirements.

After completion of the pre-production series, the device will be submitted for compliance tests with the above mentioned requirements in a certified laboratory. Prior to commercial distribution, the system will be β tested to meet specifications including safety requirements.

# Conclusion

We conclude that, once finished the development and testing phase as described, the SMARTSPOT will be as safe and effective as the predicate device.