(382 days)
Not Found
No
The document describes standard image processing techniques and tools for viewing, manipulating, and storing medical images. There is no mention of AI, ML, or related concepts like training or test sets for algorithms.
No.
The device is described as clinical imaging software that processes, stores, and displays medical images and is not intended for treatment or prevention of disease.
No
The device is an imaging software application that processes, displays, and manages medical images. While it aids in analysis and provides tools for measurement and annotation, it does not itself perform a diagnosis; rather, it provides tools for medical professionals to use in their diagnostic process.
Yes
The device is described as a "clinical software program" that runs on standard PC hardware and processes images from various imaging sources. While it interacts with hardware (DR/CR systems, cameras, etc.) for image acquisition, the device itself is the software application performing the image processing, display, and management functions. The description focuses solely on the software's capabilities and does not mention any proprietary hardware components included with the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The EponaTech Metron-CP/MD is described as a clinical imaging software application that processes, displays, analyzes, and manages medical images (radiographs, ultrasounds, photographs, etc.) acquired from various imaging systems.
- Lack of biological sample analysis: The device does not perform any analysis on biological samples taken from the body. Its function is centered around the manipulation and interpretation of medical images.
The device falls under the category of medical image processing and management software, which is distinct from in vitro diagnostics. The reference to 21 CFR 892.2050 further supports this, as this regulation pertains to Picture Archiving and Communications Systems (PACS), which are related to medical imaging, not IVDs.
N/A
Intended Use / Indications for Use
Metron-MD is a clinical software program that is intended to acquire, display, annotate, calibrate, mark-up, analyze, store, print, and distribute medical images using standard PC-compatible computers. Images can be acquired from image files and various image capture devices (e.g. computed radiography devices, digital radiography devices, digital video capture devices, and other imaging devices such as scanners). Metron-MD supports adding notes and other mark-up to images. Using Metron-MD, medical professionals can start with raw images, and quickly and easily produce formatted multi-page reports stored and organized in a searchable database. Metron-MD is not intended to provide medical diagnosis or a recommended treatment approach.
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD standard processes images using state of the art filtering techniques from various imaging sources and then makes them available to display, view, review, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs, ultrasounds, photographs, etc), and provides many various analysis tools all compiled and organized for review and analysis by trained medical practitioners. Advanced imaging algorithms produce the best image possible from the imaging hardware. The filters are customizable by the user and organized in Metron-CP/MD's searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate physical measurements, and producing other mark-ups to images to aid in analysis over time and produce formatted, multi-page reports.
Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intended for mammography use.
Metron-CP/MD's features advance imaging algorithms, calibration and measurement tools, multi-imaging stitching, report generation, and full compliance with voluntary Digital Imaging and Communications in Medicine (DICOM) Standards, which Metron-CP/MD supports. The report and running filters are customizable by the users and organized in Metron-CP/MD's searchable database for later review. Users then have the ability to put together multi-page formatted reports that can be used in connection with other medical documents. (See 21 CFR 892.2050)
In accordance with 21 CFR 801 Subpart D, the software is intended for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Metron-MD is a clinical software program that allows medical professionals to acquire, display, manipulate and archiving medical images. It offers features (e.g. annotation, zoom, calibration, mark-up, measurement, etc.) routinely used by medical professionals, such as radiologists and orthopedists. Metron-MD supports the DICOM standard and accepts file formats including JPEG, Bitmap, TIFF, avi, and DICOM. Metron-MD runs on Windows based PC-compatible computers, accepts existing image files, and captures images and videos from capture devices such as USB video cameras, CR and DR systems, Digital Camera Media, and TWAIN images sources, etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Radiography (CR), Digital Radiography (DR), digital video capture devices, scanners, USB video cameras, Digital Camera Media
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals, radiologists, orthopedists. Primarily focused on chiropractic and podiatry use.
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
Metron-MD is tested according to the specifications documented in this notification. Metron-MD is demonstrated to perform as intended.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K103554
P. 1 of 3
A. 510(k) Summary
DEC 2 0 2011
-
- Name and Address of Manufacturer
John. J Craig, Vice President/Manager EponaTech LLC 6720 Linne Road Paso Robles, CA 93446 (805) 239-3505
- Name and Address of Manufacturer
2. Establishment registration number
-
- Name, title and phone number of contact
K. Brian Matlock Attorney for Applicant Matlock Law Group, PC 1485 Treat Blvd, Suite 200 Walnut Creek, CA 94597 Phone: (925) 944-7131
- Name, title and phone number of contact
-
- Date Prepared
December 5, 2011
- Date Prepared
-
- Device Tradename
Metron-MD
- Device Tradename
-
- Device Common Name
Picture archiving and communications system (PACS)
- Device Common Name
-
- Product Code:
LLZ
- Product Code:
-
- Regulation No.
21 CFR 892.2050
- Regulation No.
-
- Device Classification
Class II, Image Processing System
- Device Classification
1
10. Predicate Devices
The Metron-MD imaging software application is substantially equivalent to the following devices.
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| Oehm and Rehbein | dicomPACS | K070618 |
| Viztek, Inc. | Onyx-RAD Telemedicine | |
| PACS | K003607 |
11. Device Description
Metron-MD is a clinical software program that allows medical professionals to acquire, display, manipulate and archiving medical images. It offers features (e.g. annotation, zoom, calibration, mark-up, measurement, etc.) routinely used by medical professionals, such as radiologists and orthopedists. Metron-MD supports the DICOM standard and accepts file formats including JPEG, Bitmap, TIFF, avi, and DICOM. Metron-MD runs on Windows based PC-compatible computers, accepts existing image files, and captures images and videos from capture devices such as USB video cameras, CR and DR systems, Digital Camera Media, and TWAIN images sources, etc.
12. Intended Use
Metron-MD is a clinical software program that is intended to acquire, display, annotate, calibrate, mark-up, analyze, store, print, and distribute medical images using standard PC-compatible computers. Images can be acquired from image files and various image capture devices (e.g. computed radiography devices, digital radiography devices, digital video capture devices, and other imaging devices such as scanners). Metron-MD supports adding notes and other mark-up to images. Using Metron-MD, medical professionals can start with raw images, and quickly and easily produce formatted multi-page reports stored and organized in a searchable database. Metron-MD is not intended to provide medical diagnosis or a recommended treatment approach.
13. Technological Characteristics
Metron-MD is a stand-alone software program that runs on Windows based operating system (Windows XP and 7) on any hardware platform meeting the minimum system requirements.
Metron-MD allows digital image processing and measurement capability. The program can transmit images to remote viewing stations over a medical imaging network.
Metron-MD does not contact the patient, nor does it control any life-sustaining devices. Medical professionals with adequate expert knowledge and ample opportunity for competent human intervention interpret displayed and/or printed images and information.
2
14. Testing
Metron-MD is tested according to the specifications documented in this notification. Metron-MD is demonstrated to perform as intended.
-
- Conclusions
Metron-MD is a medical device that is substantially equivalent to similar features in the Predicate Devices and has the same intended uses and technological characteristics. The different features included in the Metron-MD software do not affect the safety or effectiveness of the device.
- Conclusions
This premarket notification contains sufficient information to establish substantial equivalence to the Predicate Devices.
16. Applicable Mandatory and Voluntary Standards
-
Radiation Control for Health and Safety Act a.
Not applicable. -
b. CDRH Recognized Voluntary Standards
- i. DICOM
- (1) Metron-MD supports and conforms to the DICOM standard. See Exhibit 1 for "EponaTech Metron-MD DICOM Conformance Statement."
- i. DICOM
(2) Declaration of Conformance
Pursuant to Form FDA 3514 (3/08) and in my capacity as Vice President/Manager of EponaTech LLC, I certify that to the best of my knowledge I believe that Metron-MD conforms with DICOM standard Version 3.0.
- ii. JPEG
Metron-MD supports the JPEG (Joint Photographic Experts Group) standard, which specifies methods for the compression (reversible and irreversible) of digital medical images.
John Craig, Vice President
2 DEC. 2011
(Date)
(Date)
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
:【):
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Epona Tech LLC % Mr. K. Brian Matlock, Esq. Principal Matlock Law Group, P.C. 1485 Treat Boulevard, Suite 200 WALNUT CREEK CA 94597
DEC 2 0 2011
Re: K103554
Trade/Device Name: Epona Tech Metron-CP/MD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 14, 2011 Received: December 15, 2011
Dear Mr. Matlock: -
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements use obegin marketing your device as described in your Section 510(k) premarket with anow you to begin marketing your entil 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 11 you don't openite and resident In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 I vision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
ﺎﻳﺔ ﺍﻟﻘ
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and The Eponal econ Metron-Crimib is a cinnoul in chiropractic and podiatry use. Metron-CPMD
CR radiography systems, primarily focused on chiropractic and podiate imaging source CK radiography systems, primatily locused on filtering techniques from various imaging standard processes mages using state of the art mir clist review, store, print and distribute using standard and then makes them avanable to display, can, izes the images (radiographs, ultrasounds, PC nardware. Metron-CT NYD stores and organiese and organised for review and analysis by trained photographs, etc), and provides many vario algorithms produce the best image possible from the medical practitioners. Advance mugane migable by the user and organized in Metron-CPMMD's
imaging hardware. The filters are custom on and organized in Metron and on searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate searchable database for fact fevrew. Metron of the mages to ald in analysis over time.
physical measurements, and producing other mark-ups to al multi nece reports physical measurements, and producing of formatted, multi-page reports.
Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intended for mammography use.
Metron-CP/MD's features advance imaging algorithms, calibration and measurement tools, Metron-CPMD s leatures advance mule, and full compliance with voluntary Digital Imaging sti multi-imaging suiching, report generation, and running filters are customizable by the users and Communications in Metrone (DCCM) Startiable database for later review. Users then have the and organized in McTor-CF AMD's scaretal reports that can be used in connection with other
ability to put together multi-page formatted reports that Can GER AN GER AND 2050 ability to put together mails page sex ments. (See 21 CFR 892.2050)
In accordance with 21 CFR 801 Subpart D, the software is intended for prescription use.
X Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D) And/Or
Over-The-Counter Use: (21 CFR 807 Subpart C)
6
KIDSSEA
Michael D. O'Brien
610K 102554