K Number

Device Name

METRX WORKSTATION

Manufacturer

MEDICAL METRX SOLUTIONS, INC.

Date Cleared

2004-12-13

(31 days)

Product Code

LLZ

Regulation Number

892.2050

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K040852, K032748

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or processes that are characteristic of AI/ML, such as training data, performance metrics like AUC, or specific algorithms. The description focuses on user-driven segmentation and 3D model construction.

Therapeutic

No.
The "Intended Use / Indications for Use" section explicitly states, "The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach," indicating it does not directly treat or manage a disease or condition.

Diagnostic

No
The "Intended Use / Indications for Use" and "Device Description" explicitly state that "The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "The Metrx Workstation is a software product". The intended use and device description focus solely on software functionalities for image processing and 3D model construction. There is no mention of accompanying hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Metrx Workstation is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Metrx Workstation's Function: The Metrx Workstation processes imaging data (two-dimensional imaging data) to create 3D models of anatomical structures. It does not analyze biological samples.
Intended Use Statement: The intended use explicitly states it's for segmenting and differentiating tissues and anatomical structures from imaging data and constructing 3D models. It also explicitly states it is not intended to provide medical diagnosis or a recommended treatment approach.

Therefore, the Metrx Workstation falls under the category of medical imaging software, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LLZ

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

two-dimensional imaging data

Anatomical Site

tissues and anatomical structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K040852, K032748

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

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.

Characteristics

Page 2 of 24

2D = 2-Dimensional; 3D = 3-Dimensional

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.

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

Section 5.0

Indications for Use Statement

510(k) Number (if known):

K0/3134

Device Name:

Metrx Workstation

Indications for Use:

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