INTERWORKS

K070755 · Avreo, Inc. · LLZ · May 8, 2007 · Radiology

Device Facts

• Record ID: K070755
• Device Name: INTERWORKS
• Applicant: Avreo, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

InterWorks™ product is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

Device Story

InterWorks™ is a scalable PACS software suite for hospitals and imaging centers; manages image capture, storage, distribution, enhancement, and display. Integrates Radiology Information System (RIS) and Dictation/Transcription modules. Inputs include medical images from various modalities and patient demographic data; supports DICOM 3.0 connectivity. Features include voice recognition (interSCRIBE VR) or digital dictation (interSCRIBE DD) for report creation; workflow management via customizable rules engine (interFLOW). Output consists of displayed images and finalized reports delivered to referring physicians via fax/email. Operated by trained medical professionals (radiologists, transcriptionists). Facilitates clinical decision-making by providing centralized access to patient imaging and diagnostic reports; improves workflow efficiency in radiology enterprises.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Software-based PACS; DICOM 3.0 compliant. Features include image management, RIS integration, and voice recognition/digital dictation modules. Connectivity via networked DICOM interfaces. Requires 5-megapixel resolution monitors for mammography interpretation. Operates as a scalable software solution for radiology workflow.

Indications for Use

Indicated for use by trained medical professionals in hospitals, imaging centers, and reading rooms to distribute, retrieve, archive, and display medical images and structured reports. Includes support for mammography images; contraindicates use of lossy compressed mammography or digitized film-screen images for primary interpretation.

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

• Horizon Medical Imaging (K043146)
• Sienet Cosmos (K042832)

Submission Summary (Full Text)

{0}------------------------------------------------

K070755

# MAY 8 2007

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92)

#### I. DATE PREPARED: 03/09/2007

II. SUBMITTER: Avreo, Inc. 336 Camp Street New Orleans, LA 70130

#### III. CONTACT PERSON:

Nancy Butcher VP of Quality Assurance Avreo, Inc. (214)-244-1798

#### IV. DEVICE NAME:

Classification Name: Trade/Proprietary Name: Picture Archiving and Communications System (PACS) InterWorks™

## DEVICE CLASSIFICATION V.

Class II CFR section: 892.2050 Product code: LLZ Panel: Radiology

#### VI. PREDICATE DEVICES:

K043146 Horizon Medical Imaging (McKesson Medical Imaging Company) Class II Decision Date: 1/04/05

K042832

Sienet Cosmos (Siemens Medical Solutions) Class II Decision Date: 10/28/04

{1}------------------------------------------------

#### VII. SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

Avreo, Inc. concludes that the intended use for the Avreo InterWorks™ System is that of the predicate devices, and that the technological characteristics demonstrate that they are equivalent to the predicate device. A comparison of the technological characteristics of the predicate and legally marketed devices available has been performed.

Thus, this premarket notification has demonstrated substantial equivalence.

#### DEVICE DESCRIPTION AND INTENDED USE: VIII.

Inter Works™ is comprised of software modules that can work together to deliver an integrated solution that provides image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.

The Image Management module that manages your imaging needs for a Radiology Enterprise. All of the different facets are unified under a single system that acquires, storages, displays and prints medical images. By interVIEW supporting DICOM 3.0 it can Plug-n-Play with other DICOM 3.0 compliant devices with minimal effort. For Practices that are in need of only Tele-Radiology functionality interVIEW TR will meet all the needs.

The Dictation/Transcription module that provides for reliable creation of Radiology reports for your Radiology Enterprise. Reports are created via Voice Recognition with interSCRIBE VR or Digital Dictation with interSCRIBE DD depending upon the individual preferences of the Radiologist and requirements of the Radiology Enterprise. In either case digital files are created by the Radiologist and sent to transcription worklists for transcribing or editing by transcriptionists using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians.

The Radiology Information System module manages your radiology workflow for your Front Desk, Back Office and Clinical operations. All of the different areas of operations are unified under a single system that extends beyond the physical walls to exchange information and perform transactions with important business partners. Most importantly, the rules engine that drives interFLOW can be tailored.

# Intended Use

InterWorks™ product is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

{2}------------------------------------------------

## IX. SAFETY INFORMATION:

The Avreo InterWorks™ System has no patient contact and is utilized only by trained professionals. Trained professionals allow sufficient review to afford identification and intervention in the event of a malfunction have evaluated the output of the device.

## X. CONCLUSION:

Avreo, Inc. believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective including the component and accessory devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "U.S. HEALTH & HUMAN SERVICES" in a circular arrangement. The symbol in the center consists of three curved lines that resemble a bird or a stylized wave pattern. The logo appears to be a government or organizational emblem related to health and human services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NAY 8 2007

Ms. Nancy Butcher Vice President of Quality Assurance Avreo, Inc. Corporate Headquarters 4050 Azalea Drive CHARLESTON SC 29405

Re: K070755

Trade/Device Name: Avreo InterWorks™ System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 1, 2007 Received: March 19, 2007

Dear Ms. Butcher:

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 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1806-1906" at the top. The letters "PA" are in the center of the logo, and the word "Centennial" is below the letters. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for a centennial celebration.

Protecting and Promoting Public Health

{4}------------------------------------------------

Page 2 -

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# 510(k) Number (if known): N/A K070755

Device Name: Avreo InterWorks™ System

Indications for Use:

InterWorks™ product is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICCM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primage interpretations. Mammographic images may only be interpreted using an FDA annroved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient junages, demographic information or other patient medical information captured in the system.

# (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

Nancy C. Broadhon

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