Who is the manufacturer of METRX WORKSTATION?

Medical Metrx Solutions, Inc. filed the 510(k) submission for METRX WORKSTATION (K043134).

What is the FDA product code for METRX WORKSTATION?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for METRX WORKSTATION?

510(k) clearance (submission type: Traditional).

What are the predicate devices for METRX WORKSTATION?

Preview® Treatment Planning Software (Medical Metrx Solutions, Inc.); Vitrea 2 (Vital Images, Inc.).

Who can help prepare an FDA 510(k) submission like METRX WORKSTATION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

METRX WORKSTATION

K043134 · Medical Metrx Solutions, Inc. · LLZ · Dec 13, 2004 · Radiology

Device Facts

Record ID	K043134
Device Name	METRX WORKSTATION
Applicant	Medical Metrx Solutions, Inc.
Product Code	LLZ · Radiology
Decision Date	Dec 13, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.

Device Story

Metrx Workstation is a software-based image processing tool. It ingests 2D medical imaging data via DICOM network or hard media. Users perform segmentation and differentiation of tissues and anatomical structures to construct 3D models. The system provides interactive 2D and 3D visualization and analysis tools. Output data may be exported for use in Preview® Treatment Planning Software. The device is operated by clinicians to enhance visualization of patient-specific anatomy. It does not provide automated diagnosis or treatment recommendations; it serves as a planning aid to assist healthcare providers in visualizing processed scan data.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use analysis.

Technological Characteristics

Software-based image processing workstation. Operates on UNIX platform. Inputs: 2D DICOM imaging data. Outputs: 3D models and processed 2D/3D visualizations. Features interactive segmentation, differentiation, and measurement tools. Connectivity: DICOM network or hard media. No specific hardware requirements or material standards listed.

Indications for Use

Indicated for users to segment/differentiate tissues and anatomical structures from 2D imaging data and construct 3D models for visualization and analysis. Not intended for medical diagnosis or treatment recommendations.

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

Preview® Treatment Planning Software (Medical Metrx Solutions, Inc.)
Vitrea 2 (Vital Images, Inc.)

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K120361 — SYNAPSE 3D BASE TOOLS · Fujifilm Medical Systems U.S.A, Inc. · Apr 6, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ # DEC 1 3 2004 ### Metrx Workstation Summary of Safety and Effectiveness K043134 | Submitter Name: | Medical Metrx Solutions, Inc | 510(k) Number | | K040852 | K032748 | |--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 12 Commerce Avenue West Lebanon, NH 03784 | Manufacturer | Medical Metrx Solutions, Inc. | Medical Metrx Solutions, Inc. (formerly Medical Media Systems, Inc.) | Vital Images, Inc. | | Contact Person: | William F. Greenrose Senior Vice President | Classification # & Product Code | 21 CFR 892.2050 LLZ | 21 CFR 892.2050 LLZ | 21 CFR 892.2050 LLZ | | Phone Number: | 603-298-5509 x 303 | Indications for Use | The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two- dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach. | The Preview® Treatment Planning Software is intended to provide accurate, alternative two- dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® product offers the physician the capability to view existing scan data in a format that is more user friendly, and thus enhances the physician's capability to plan treatment. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach. | Vitrea™ 2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea™2 has the following specific indications: VScore™ (K990442); Automated Vascular Measurement (K002519; Tumor Volume Measurement (K002519; CT Brain Perfusion (K003639); ImageCheckerCT | | Fax Number: | 603-298-5055 | Product Components | Software | Software | Software & computer system | | Date Prepared: | November 9, 2004 | Read data in DICOM format | Yes | Yes | Yes | | Device Trade Name: | Metrx Workstation | Imaging | 2D and 3D | 2D and 3D | 2D and 3D | | Classification Name, Number & Product Code: | System, Image Processing, Radiological 21 CFR 892.2050 LLZ | Operating platform | Modeling done by user on UNIX. Viewing software run on DOS/ Windows | Modeling done at MMS on UNIX. | Windows XP | | Predicate Devices: | Preview® Treatment Planning Software; Medical Metrx Solutions, Inc. Vitrea 2; Vital Images, Inc. | Source of image data | Retrieval over network via DICOM or via hard media | Retrieval over network via DICOM or via hard media | Retrieval over network via DICOM | | Device Description and Statement of Intended Use | The Metrx Workstation is a software product that is intended for users to segment and differentiate tissues and anatomical structures from two- dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx Workstation product is not intended to provide medical diagnosis or a recommended treatment approach. | Viewing format | Multiple interactive 2D & 3D views | Multiple interactive 2D & 3D views | Multiple interactive 2D & 3D views | | Summary of Technological | A table comparing the Metrx Workstation to the predicate devices is attached. This comparison demonstrates the substantial equivalence of | Analysis | Measurements performed on image on workstation | Measurements performed on image on workstation | Measurements performed on image on workstation | | End user data manipulation | Data modeling performed by end user | Data modeling performed at MMS | Data manipulations performed by end user | | | | Model manipulation | In multiple planes and orientation | In multiple planes and orientation | In multiple planes and orientation | | | the Metrx Workstation to the predicate devices. 1 Characteristics Page 2 of 24 {1}------------------------------------------------ 2D = 2-Dimensional; 3D = 3-Dimensional {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and body. The eagle is facing to the left. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 1 3 2004 Medical Metrx Solutions, Inc. % Ms. Patsy J. Trisler Regulatory Consultant · 5610 Wisconsin Avenue, #304 CHEVY CHASE MD 20815 Re: K043134 Trade/Device Name: Metrx Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 10, 2004 Received: November 12, 2004 Dear Ms. Trisler: 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. 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. {3}------------------------------------------------ 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.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" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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 Enclosure {4}------------------------------------------------ #### Section 5.0 #### Indications for Use Statement 510(k) Number (if known): K0/3134 Device Name: #### Metrx Workstation Indications for Use: The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH; Office of Device Evaluation (ODE) | Prescription Use | X | OR | Over-The-Counter Use | |------------------|---|----|----------------------| |------------------|---|----|----------------------| (Per 21 CFR 801.109) | | Nancyc Brogdon | | |---------------------------------------------------------------|----------------|--------------------------| | (Division Sign-Off) | | (Optional Format 1-2-96) | | Division of Reproductive, Abdominal, and Radiological Devices | 4043134 | |