(63 days)
No
The description focuses on image acquisition, processing, archiving, and 3D reconstruction, without mentioning any AI or ML techniques for analysis or interpretation.
No.
The device is intended for image acquisition, processing, storage, and retrieval, as well as for assessment of pulmonary function and ECG. It is a diagnostic and information management tool, not a device that provides therapy.
Yes
The device explicitly states it "serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG" and is indicated for "assessment of pulmonary function." These functions directly support diagnosis.
No
The device description explicitly states that MDxNet consists of MDxPAC, which includes "limited hardware," and also mentions integrating FDA-approved Commercial Off-The-Shelf devices (COTS) and an electromagnetic sensor device attached to the ultrasound probe. This indicates the device is not solely software.
Based on the provided text, MDxNet is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- MDxNet's Function: MDxNet is primarily a system for acquiring, processing, storing, and retrieving medical images (specifically ultrasound, ECG, and spirometry data). It works with existing medical devices (ultrasound systems, spirometers, ECG machines) and processes the data generated by those devices.
- No Specimen Analysis: The description of MDxNet does not mention any analysis of biological specimens. Its function is centered around handling and processing data from medical imaging and physiological measurement devices.
Therefore, MDxNet falls under the category of medical imaging and data management systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MDxNet is intended for use under physician's orders and/or oversight and management.
MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images.
MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging.
MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG.
Product codes
LLZ
Device Description
MDxNet consists of MDxPAC, MDxStation (PC or Notebook, laptop computer), MDxServer, and the proprietary software component called MDxView. MDxPAC consists of limited hardware, that bundle and power FDA approved Commercial Off-The-Shelf devices (COTS). MDxNet features an integrated 2D/3D streaming engine which permits PC's or notebooks to control the server and to review 2D and 3D reconstructions. MDxNet is capable of image review, archiving, data collection, database maintenance, reporting and basic 3D capabilities including color rendering. Upon receipt of FDA approval to market MDxNet, finished devices will be distributed only under direction and/or orders of physicians.
MDxNct inherits and integrates concepts first pioneered in the National Aeronautics and Space Administration (NASA) sponsored Telemedicine Instrument Pack (TIP) project and the Defense Advanced Research Projects Agency (DARPA) sponsored Medical Ultrasound Three-dimensional, Portable with Advanced Communication (MUSTPAC) project, and its predecessors. It expands capability to include a server component, augments data acquisition to include wireless options, redesigns the Graphical User Interface (GUI) for more intuitive interaction and provides improved packaging for better usability.
MDxNet has the capability to record ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the FDA approved probe of the host Ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
IQmark Digital ECG and Spirometer both FDA approved devices have been integrated into MDxNet as requested by the end user of the validation study. The Midmark software for each of these devices and indications of use have not been altered, though permit the end user as demonstrated in both clinical studies to capture additional potentially key clinical results within MDxNet for data collection, review, comparison, reporting and archiving.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular
Indicated Patient Age Range
adult and pediatric patients, male/female adult and pediatric patients
Intended User / Care Setting
physician's orders and/or oversite and management, medical clinics, including though not limited to infirmary, hospital, military, remote and urban clinics.
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
Clinical testing was conducted according to an IRB approved protocol. Continual nonclinical testing is being conducted through internal company procedures according the FDA 21CFR820 Quality System and Current Good Manufacturing Practices. Additional nonclinical testing will be conducted by a third party laboratory. Test results to date included elsewhere support the conclusion that the actual device, software and hardware satisfies the design intent. Actual device performance as tested internally and by third parties (including controlled clinical trials) conforms to the system performance standards and has met expectations.
Key Metrics
Not Found
Predicate Device(s)
K012086, K994329, K972903, K013088
Reference Device(s)
K992505, K002499, K010436, IQmark ECG (Registration #2081230), IQmark Spiromcter K002499
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FDA; 510(k) Premarket Notification
Ko60035
CyberMDx, Inc. MDxNet
2006 MAR 9
| 510(k) Premarket Notification | MDxNet | Comments of the country of the program and the county of |
|---|---|---|
| Summary of Safety and Effectiveness Information | Call Concession Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Compan |
Section 5.0: 510K SUMMARY
| 5.1 Contact Information | |
|---|---|
| Establishment: | CyberMDx, Inc. |
| Richmond Square, Suite 166W | |
| Providence, RI 02906 | |
| Official Correspondent: | John Coleman, PhD |
| Chief Technology Officer (CTO) | |
| CyberMDx, Inc | |
| Richmond Square, Suite 166W | |
| Providence, RI 02906 | |
| Phone: (401) 274-5633 | |
| FAX: (401) 633-6544 | |
| Prepared By: | Bonne Farberow, RN, CCRA, CCRP |
| Regulatory Affairs Consultant | |
| 53 Meetinghouse Ct | |
| Shamong, NJ 08088 | |
| Date Summary Prepared: | December 24, 2005 |
| Section 5.2 Name of Device | |
| Proprietary: | MDxNet |
| Common/Usual Name: | Image Processing Server |
| Classification: | System, Image Processing, Radiological |
| Class II | |
| Product Code: | 90-LLZ |
1
Section 5.3 Substantially Equivalent Devices
Substantial equivalence to the following Icgally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for the predicate devices. In addition, bench testing was conducted to establish MDxNet's accuracy, performance to specification, as well as testing to accepted industry standards under Investigational Review Board (IRB) approval and in the laboratory setting. The predicate devices are as follows
- 트 AquariusNet Server, Teracon, Inc., K012086
- . TeraRecon IiVS, TeraRecon, Inc., K994329
- l Imatron Ultra Access, Acculmage, 972903
- " EchoTech 3D Imaging Systems, K013088
- 피
These devices are substantially equivalent in terms of basic design, features and intended use, though MDxPAC and MDxServer have the additional capability pending end user necds and requirements of integration of FDA approved devices such as the IQmark Spirometry and ECG.
Table 5-1 compares MDxNet with features of its Predicate Devices.
2
| Feature | MDxNet
Submission - Pending | Aquarius Net
Server K012086 | Imatron Ultra
Access 972903 | TeraRecon IiVS
K994329 | EchoTech 3D
Imaging Systems
K013088 |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------|--------------------------------|---------------------------|-------------------------------------------|
| 2 D Image Review | Yes | Yes | Yes | Yes | Yes |
| Multiplanar reformatting | Yes | Yes | Yes | Yes | Yes |
| 3D Volume Rendering | Yes | Yes | Yes | Yes | Yes |
| Maximum Intensity
Projection | Yes | Yes | Yes | Yes | Yes |
| Image Archiving | Yes | Yes | Yes | Yes | Yes |
| Image Filming | Yes | Yes | Yes | Yes | Yes |
| Lossy Image
Compression | No | Yes | Yes | Yes | Yes |
| Image Transfer or
Network Connectivity | Yes | Yes | Yes | Yes | Yes |
| Examination of 2D
image as a 3D volume | Yes | Yes | Yes | Yes | Yes |
| CT and Calcium Scan | No | Yes | Yes | Yes | No |
| Comparison of Multiple
Scans or Side by Side
Comparison | Yes | Yes | Yes | Yes | Yes |
| Indications of use –
general medical imaging
units or sites; acquisition,
analysis, store and
retrieve digital ultrasound | Yes | Yes | Yes | Yes | Yes |
| Computer Platform | Yes | Yes | Yes | Yes | Yes |
| Image Display | Yes | Yes | Yes | Yes | Yes |
| Operating System | Yes | Yes | Yes | Yes | Yes |
| *Capture and store ECG
Indication (s); Assess
heart wall and/or
function for
abnormalities | Yes | No | No | No | No |
| *Capture and store
Spirometry (VC, etc.)
Indication (s); Assess
Pulmonary function | Yes | No | No | No | No |
Table 5-1: Predicate Devices
*Utilizing FDA approved devices; Terason K992505, IQmark ECG (Registration #2081230) and IQmark Spiromcter K002499
Note - Tempus 2000; K010436 (for integration of COTs)
3
5.4 Device Description and Function
MDxNet consists of MDxPAC, MDxStation (PC or Notebook, laptop computer), MDxServer, and the proprietary software component called MDxView. MDxPAC consists of limited hardware, that bundle and power FDA approved Commercial Off-The-Shelf devices (COTS). MDxNet features an integrated 2D/3D streaming engine which permits PC's or notebooks to control the server and to review 2D and 3D reconstructions. MDxNet is capable of image review, archiving, data collection, database maintenance, reporting and basic 3D capabilities including color rendering. Upon receipt of FDA approval to market MDxNet, finished devices will be distributed only under direction and/or orders of physicians.
MDxNct inherits and integrates concepts first pioneered in the National Aeronautics and Space Administration (NASA) sponsored Telemedicine Instrument Pack (TIP) project and the Defense Advanced Research Projects Agency (DARPA) sponsored Medical Ultrasound Three-dimensional, Portable with Advanced Communication (MUSTPAC) project, and its predecessors. It expands capability to include a server component, augments data acquisition to include wireless options, redesigns the Graphical User Interface (GUI) for more intuitive interaction and provides improved packaging for better usability.
MDxNet has the capability to record ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the FDA approved probe of the host Ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
IQmark Digital ECG and Spirometer both FDA approved devices have been integrated into MDxNet as requested by the end user of the validation study. The Midmark software for each of these devices and indications of use have not been altered, though permit the end user as demonstrated in both clinical studies to capture additional potentially key clinical results within MDxNet for data collection, review, comparison, reporting and archiving.
4
FDA; 510(k) Premarket Notification
Hardware & Software Information:
The MDxNet utilizes standard "off the shelt" personal computer systems and Bluetooth wireless as its hardware platform. The MDxPAC component includes a Class B magnetic tracking as well as it's own power supply including rechargeable batteries. The software requires the minimum use of Windows XP operating system and a Pentium III - class processor or its equivalent. All hardware testing will be conducted and meet the specified acceptance criteria before the device is marketed.
The level of concern relative to the software has been determined as minor using the decision tree provided in the revised FDA Software Guidance, May 11, 2005.
5.5 Indications/Intended Use:
MDxNct is intended for use under physician's orders and/or oversite and management. MDxNet is indicated for acquisition of related sets of 2D ultrasound images, 3D reconstruction of ultrasound images. MDxNet system is indicated to acquire, digitize, archive and retrieve single and sequences of 2D ultrasound images.
The assessment of pulmonary function in male/female patients through Spirometry and to provide 12-lead resting electrocardiogram (ECG) utilizing FDA approved devices which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments.
Contraindications:
MDxNet is not intended for long term monitoring. MDxNet is not intended to be used in strong magnetic or electromagnetic fields which are generated for medical purposes, i.c. Magnetic Resonance Imaging (MRI).
Disposable pneumotach mouthpieces are clean though are not sterile and should not be placed over open wounds that are prone to infection. There are no other known medical contraindications other than the physical limitations of the patient.
5.6 Technological Comparison with Predicate Devices
Two MDxNet Systems were developed to acquire potential end user input and to allow validation of the software, hardware, server and integration under Investigational Review Board (IRB) approval in a medical clinic setting.
Clinical testing was conducted according to an IRB approved protocol. Continual nonclinical testing is being conducted through internal company procedures according the FDA 21CFR820 Quality System and Current Good Manufacturing Practices. Additional nonclinical testing will be conducted by a third party laboratory. Test results to date included elsewhere support the conclusion that the actual device, software and hardware satisfies the design intent. Actual device performance as tested internally and by third parties (including controlled clinical trials) conforms to the system performance standards and has met expectations."
5
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 2006
John Coleman, Ph.D. Chief Technology Officer cyberMDx, Inc. 1 Richmond Square, Suite 166W PROVIDENCE RI 02906
Re: K060035 Trade/Device Name: MDxNet Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2005 Received: January 5, 2006
Dear Dr. Coleman:
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.
6
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/industry/support/index.html.
Sincerely vours.
Nancy C. Brigton
Naney C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 4.0: Indications for Use
510(k) Number (if known): Device Name: MDxNet Indications for Use: MDxNet is intended for use under physician's orders and/or oversight and management.
MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images.
MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging.
MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG.
MDxNet intended use is for medical clinics, including though not limited to infirmary, hospital, military, remote and urban clinics.
Contraindications:
MDxNet is not intended to be used in strong magnetic or electromagnetic fields which are generated for medical purposes, i.e. Magnetic Resonance Imaging (MRI).
MDxNet is not intended for long term monitoring. This device is not intended to nor does it sound alarms for any physiological parameters. The ECG is not intended to be utilized on patients with prosthetic limbs.
Disposable pneumotach mouthpieces are clean though are not sterile, and should not be placed over open wounds that are prone to infection. There are no other known medical contraindications other than the physical limitations of the patient.
| 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)
(Division Sign-Off)
ff Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________