(46 days)
No
The device description focuses on standard digital radiography software functionalities and does not mention any AI/ML terms or capabilities.
No.
The device is used to generate radiographic images for diagnostic purposes, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "in all general purpose diagnostic procedures" and for "digital image capture use in general radiographic examinations." The "Device Description" also mentions its use to "acquire digital medical diagnostic X-ray images."
No
The device is described as Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. While the submission focuses on the software, its functionality is dependent on and integrated with a hardware component (the x-ray receptor panel) to acquire the images. Therefore, it is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a software used in conjunction with a digital X-ray receptor panel to generate radiographic images of human anatomy. It processes and manages these images for diagnostic purposes.
- Intended Use: The intended use clearly states it's for generating radiographic images of human anatomy and replacing film/screen systems in general diagnostic procedures. This involves imaging the body directly, not analyzing specimens taken from the body.
- Device Description: The description focuses on the software's functions related to patient information, image acquisition, processing (preview, acceptance/rejection), storage, and review of X-ray images.
- Input Modality: The input modality is X-ray, which is an imaging technique applied to the body, not a method for analyzing biological specimens.
The device is a medical imaging device used for diagnostic purposes, but it operates by capturing images of the body itself, not by analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.
Product codes
MQB
Device Description
This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
b. Edit existing patient information.
Emergency registration and edit Emergency settings. C.
d. Pick from a selection of procedures, which defines the series of images to be taken.
e. Adjust technique settings before capturing the X-ray image.
f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
h. Close a procedure when all images have been captured.
i. Review History images, resend and reprint images.
Re-exam a completed patient. j.
k. Protect patient records from being deleted by the system.
Delete an examined Study with all images being captured. .
m. Edit user accounts.
n. Check statistical information.
o. Image QC.
p. Image stitching.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic (X-ray)
Anatomical Site
skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Indicated Patient Age Range
Not Found (Pediatric use precautions have been added as a supplement to the User Manual, but no specific age range is indicated)
Intended User / Care Setting
qualified medical personnel
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)
Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device.
Clinical Testing: Not required for a showing of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K171353, K162687, K133139, K141440, K191813, K172007
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
LiverMoreTech, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K193644
Trade/Device Name: E-COM DR-2000 DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 24, 2019 Received: December 30, 2019
Dear Mr. Kamm:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193644
Device Name E-COM DR-2000 DR
Indications for Use (Describe)
Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Exhibit 5 510(k) Summary K193644 LiverMoreTech, Inc. 801 North Jupiter Rd, Suite 200, Plano, TX 75074, USA • TEL: 214-257-0113 • FAX: 214-257-0116 Date Prepared: January 22, 2020 Contact: Jay Kim, Development Manager
-
- Identification of the Device: Trade/Device Name: E-COM DR-2000 DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB.
-
- Predicate device: K130883 Trade/Device Name: Sedecal Digital Radiographic Upgrade Model SDRU-T Manufacturer: Sedecal SA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB.
-
- Description of the Device: This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
- a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
- b. Edit existing patient information.
- Emergency registration and edit Emergency settings. C.
- d. Pick from a selection of procedures, which defines the series of images to be taken.
- e. Adjust technique settings before capturing the X-ray image.
- f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
- g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
- h. Close a procedure when all images have been captured.
- i. Review History images, resend and reprint images.
- Re-exam a completed patient. j.
- k. Protect patient records from being deleted by the system.
- Delete an examined Study with all images being captured. .
- m. Edit user accounts.
- n. Check statistical information.
- o. Image QC.
- p. Image stitching.
4
-
- Indications for Use: Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
-
- Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. Specifications are for all intents and purposes identical. This submission represents the combination of two cleared devices: Software, and Digital X-Ray panel(s). The software is an updated version of the software supplied in the predicate device K130883 and is now compatible with more FDA cleared digital panels.
| 6. Comparison Table | |||
|---|---|---|---|
| -- | -- | --------------------- | -- |
| Characteristic | Predicate Device K130883
Sedecal Digital Radiographic Upgrade
Model SDRU-T | Proposed New Device E-COM DR-2000
DR |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Sedecal Digital Radiographic Upgrade
Model SDRU-T is intended for digital
image capture use in general radiographic
examinations, wherever conventional
screenfilm systems may be used,
excluding fluoroscopy. angiography and
mammography. The kit allows imaging of
the skull, chest, shoulders, spine.
abdomen, pelvis. and extremities. | Intended for digital image capture use
in general radiographic examinations,
wherever conventional screen-film
systems may be used, excluding
fluoroscopy, angiography and
mammography. The kit allows imaging
of the skull, chest, shoulders, spine,
abdomen, pelvis, and extremities.
(Identical) |
| Platform | Windows 7, 8, and 10 | Windows 10. Older Windows versions
are no longer supported by Microsoft |
| Compatible
Digital X-Ray
Receptor Panel(s) | Toshiba FDX4343R or FDX3543RP | Toshiba FDX4343R Detector
Toshiba FDX3543RP Detector
Toshiba FDX3543RPW Detector
Toshiba FDX2530RPW Detector
Toshiba FDX4343RPW Detector
Thales Pixium RAD 4143 Detector
Thales Pixium RAD 4343 Detector
Thales Pixium RAD 3543 Detector
Thales Pixium RAD 3543EZ Detector
Thales Pixium RAD 2430EZ Detector
Thales Pixium RAD 3543DR Detector
Varian PaxScan 4336R Detector
Varian PaxScan 4343R Detector
Varian PaxScan 4336X Detector
Varian PaxScan 4336W Detector |
| Compatible
Generator(s) | Sedecal | Sedecal, CPI, Siemens, Del. |
| DICOM 3
Compatibility | YES | YES |
5
Panel Clearance Table
| Panel ID | FDA Clearance |
|---|---|
| Toshiba FDX4343R Detector | K130883 |
| Toshiba FDX3543RP Detector | K130883 |
| Toshiba FDX3543RPW Detector | K171353 |
| Toshiba FDX2530RPW Detector | K162687 |
| Toshiba FDX4343RPW Detector | K162687 |
| Thales Pixium RAD 4143 Detector | K133139 |
| Thales Pixium RAD 4343 Detector | K133139 |
| Thales Pixium RAD 3543 Detector | K141440 |
| Thales Pixium RAD 3543EZ Detector | K141440 |
| Thales Pixium RAD 2430EZ Detector | K141440 |
| Thales Pixium RAD 3543DR Detector | K191813 |
| Varian PaxScan 4336R Detector | K172007 |
| Varian PaxScan 4343R Detector | K172007 |
| Varian PaxScan 4336X Detector | K172007 |
| Varian PaxScan 4336W Detector | K172007 |
-
- Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device. Software and labeling was developed in accordance with the following FDA guidance documents: Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Risk management was conducted in accordance with IEC 14971, Application of Risk Management to Medical Devices. Pediatric use precautions have been added as a supplement to the User Manual.
-
- Clinical Testing: Not required for a showing of substantial equivalence.
-
- Conclusion: Based on comparison to the 510(k) summary of the predicate device, its technical characteristics, the indications for use, and the near identical characteristics of the two products, we conclude that the E-COM DR-2000 DR is substantially equivalent to the named predicate device.