MEDSTREAMING MEDICAL OFFICE SOFTWARE

K072972 · Medstreaming, LLC · LLZ · Nov 6, 2007 · Radiology

Device Facts

• Record ID: K072972
• Device Name: MEDSTREAMING MEDICAL OFFICE SOFTWARE
• Applicant: Medstreaming, LLC
• Product Code: LLZ · Radiology
• Decision Date: Nov 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods. The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device. MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine. The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software. The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools. The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method. MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs. MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format. MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.

Device Story

Software-based PACS for clinical environments; inputs include medical images from DICOM-compliant modality acquisition devices and video signals via digitizing engine. Transforms inputs into viewable studies, quantitative measurements, and examination reports. Operates on a workstation; utilizes standard network connections for DICOM transfer and serial gateways for labeled measurements. Outputs include displayed images, AVI/BMP/JPG files, HL7 data, and reports generated via Microsoft Office tools. Assists clinicians in reviewing patient studies and documenting findings; facilitates clinical decision-making through image visualization and data management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PACS software; DICOM 3.0 compliant; supports JPEG compression. Integrates with Microsoft Office for reporting. Connectivity via standard network protocols and serial gateways. Operates on standard workstation hardware.

Indications for Use

Indicated for use by clinicians to open, display, retrieve, and manage medical images and patient studies from networked DICOM acquisition or archive devices. Supports quantification of image data and generation of examination and utilization reports.

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

• ProSolv Cardiovascular Viewer, Analyzer and Server

Submission Summary (Full Text)

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K072972
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## 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E. Section 807.92

#### 1) Submitter's name, address, telephone number, contact person

Karla Patten 4320 Leavelle Street NW Olympia, WA. 98502 Telephone: [phone] E-mail: [e-mail]

NOV - 8 2017

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

| Common/Usual Name: | Picture Archiving and Communications Systems (PACS) |
|----------------------|-------------------------------------------------------|
| Proprietary Name: | MEDStreaming Medical Office |
| Classification Name: | Picture Archiving and Communications System, Class II |

#### 3) Device Description

The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.

The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querving and retrieving patient studies from a networked DICOM server device.

The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software.

The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools.

The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method.

MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on the Medical Office workstation utilizing Microsoft standard text, spreadsheet and database programs.

MEDStreaming's Medical Office provides a means for export results in HL7 or standard graphic file format.

MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.

#### 4) Performance Standards

No performance standards for PACS systems or components have been issued under the authority of Section 514.

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KC72972
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The MEDStreaming Medical Office software has been designed to comply with the following voluntary standards:

ISO Joint Photographic Experts Group (JPEG) Image Compression Standard DICOM Standard 3.0 ICD-9 Finding Codes Exam Type CPT Codes Health Language 7 Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) Intersocietal Commission for the Accreditation of Echocardiographic Laboratories (ICAEL) Microsoft Office Interoperability Engine

## 5) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the MEDStreaming Medical Office software.

## 6) Substantially Equivalent Devices

MEDStreaming LLC believes that the capability and features of the MEDStreaming Medical Office software makes it substantially equivalent to other image display products commercially available. specifically the ProSolv Cardiovascular Viewer, Analyzer and Server.

#### 7) Software

Software development for the MEDStreaming Medical Office software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the software. Appropriate steps have been taken to control all identified risks for this type of image display and communication product.

#### 8) Conclusions

The MEDStreaming Medical Office software is designed and manufactured to meet United States and international standards for the display and transmission of images acquired on medical imaging devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and image transmission within a clinical setting. The MEDStreaming Medical Office software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is smaller than the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV - 6 2007

MEDStreaming LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K072972

Trade/Device Name: MEDStreaming Medical Offices Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2007 Received: October 22, 2007

#### · Dear Mr. Job:

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. Ilsting 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/cdrh/industry/support/index.html.

Sincerely vours,

Nancy Brogdon

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): K072973

Device Name: 3 MEDStreaming Medical Office Software

Indications for Use:

The MEDStreaming Medical Office software provides a means of opening and displaying image files.

The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server.

MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.

The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection.

The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device.

MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine.

The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software.

The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools.

The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device.

MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method.

MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs.

MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format.

MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.

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 OF NEEDED)

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