SAFECT MODEL VER 1.0

K100372 · Medic Vision Brain Technologies, Ltd. · LLZ · Dec 14, 2010 · Radiology

Device Facts

• Record ID: K100372
• Device Name: SAFECT MODEL VER 1.0
• Applicant: Medic Vision Brain Technologies, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.

Device Story

SafeCT is a PACS-based software package connected to a clinic's LAN. It receives, processes, and transfers CT images via DICOM protocol. The device performs image noise reduction to enhance image quality. It is operated by radiologists and specialists to assist in diagnostic interpretation. The output is an enhanced CT image, which the clinician reviews to support clinical decision-making. The device is not intended for mammography or for detecting abnormalities smaller than 3 mm.

Clinical Evidence

Bench testing only. Performance validated by comparing image quality of phantom and clinical data processed by the device against original (unprocessed) corresponding data. No clinical trials or human subject studies reported.

Technological Characteristics

Software-based image processing system. Operates on PACS server via LAN. Uses DICOM protocol for image communication. Designed to meet ISO 14971 safety standards. Software-based noise reduction algorithm.

Indications for Use

Indicated for assisting professional radiologists and specialists in the diagnosis of CT images. Not for use with mammography images. Not effective for lesions, masses, or abnormalities smaller than 3 mm.

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

• SharpView (K024028)

Submission Summary (Full Text)

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

Device Name Proprietary Device Name: SafeCT

#### Establishment Name and Registration Number of Submitter

Name: Medic Vision Brain Technologies Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

DEC 1 4 2010

<100372

## Device Classification

LLZ Product Code: 892.2050 CFR section: Panel Identification: Radiology Device Description: Picture archiving and communications system / Classification: Class II Product

## Reason for 510(k) Submission

Traditional 510(k) Submission

## Identification of Legally Marketed Predicate Device

K024028 SharpView, manufactured by ContextVision

## Device Description

The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.

#### Intended use and Indications for Use

The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images

## Safety & Effectiveness

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparing the image quality of phantom and clinical processed data to the image quality of the original (unprocessed) corresponding data. The results of the performance testing demonstrate the device safety and effectiveness.

## Substantial Equivalency

It is Medic Vision opinion that the SafeCT 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 logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Medic Vision Imaging Solutions, Ltd. % John J. Smith. M.D., J.D. Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street. NW WASHINGTON DC 20004

DEC 1 4 2010

Re: K100372

Trade/Device Name: SafeCT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2010 Received: November 19, 2010

## Dear Dr. Smith:

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 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.

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

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket, notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K100372

DEC 1 4 2010

510(k) Number (if known):

Device Name: SafeCT

Indications for Use:

The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.

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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Division of Radiological Office of In Vitro Diagnostic Device Evalua

510K K100372