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.

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.

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.
c. Emergency registration and edit Emergency settings.
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.
j. Re-exam a completed patient.
k. Protect patient records from being deleted by the system.
l. Delete an examined Study with all images being captured.
m. Edit user accounts.
n. Check statistical information.
o. Image QC.
p. Image stitching.

AI/ML Overview

This document describes the FDA 510(k) premarket notification for the E-COM DR-2000 DR, a stationary x-ray system. However, it does not provide details regarding specific acceptance criteria, a study proving the device meets those criteria, or information on AI/standalone performance, expert adjudication, or ground truth establishment typically associated with such studies.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. No specific test set for performance evaluation is mentioned. The submission states "Clinical Testing: Not required for a showing of substantial equivalence," implying a lack of a dedicated clinical test set for new performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Since no clinical testing or performance study is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no test set is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The device is a "Stationary X-ray System" with software for image acquisition and management. There is no indication that it includes AI for interpreting images or assisting human readers. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the document. As there is no mention of an algorithm for image interpretation or analysis, a standalone performance study is not applicable and not mentioned. The device's software functions are primarily for image acquisition, processing, and management.

7. The Type of Ground Truth Used

This information is not provided in the document. Since no clinical performance study is described, there's no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not provided in the document. The submission pertains to a conventional x-ray system and its control software. There is no discussion of machine learning or AI components that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. As no training set is discussed (see point 8), the establishment of its ground truth is also not mentioned.

Summary of the Document's Content Regarding Testing:

The K193644 submission's primary focus is on demonstrating substantial equivalence to a predicate device (K130883, Sedecal Digital Radiographic Upgrade Model SDRU-T). This is achieved by comparing the new device's indications for use and technological characteristics to the predicate.

The document states:

"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."

This indicates that the FDA clearance for E-COM DR-2000 DR was based on demonstrating similar technical specifications and safety/effectiveness profiles to an already cleared device, along with adherence to relevant software development and risk management guidance documents. It does not involve a new performance study with specific quantitative acceptance criteria or extensive clinical data as would be required for a novel device or one incorporating advanced AI algorithms.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K193644

Device Name E-COM DR-2000 DR

Indications for Use (Describe)

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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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

1. 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.
1. 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.
1. 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.

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1. 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.
1. 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 K130883Sedecal Digital Radiographic UpgradeModel SDRU-T	Proposed New Device E-COM DR-2000DR
Indications forUse	Sedecal Digital Radiographic UpgradeModel SDRU-T is intended for digitalimage capture use in general radiographicexaminations, wherever conventionalscreenfilm systems may be used,excluding fluoroscopy. angiography andmammography. The kit allows imaging ofthe skull, chest, shoulders, spine.abdomen, pelvis. and extremities.	Intended for digital image capture usein general radiographic examinations,wherever conventional screen-filmsystems may be used, excludingfluoroscopy, angiography andmammography. The kit allows imagingof the skull, chest, shoulders, spine,abdomen, pelvis, and extremities.(Identical)
Platform	Windows 7, 8, and 10	Windows 10. Older Windows versionsare no longer supported by Microsoft
CompatibleDigital X-RayReceptor Panel(s)	Toshiba FDX4343R or FDX3543RP	Toshiba FDX4343R DetectorToshiba FDX3543RP DetectorToshiba FDX3543RPW DetectorToshiba FDX2530RPW DetectorToshiba FDX4343RPW DetectorThales Pixium RAD 4143 DetectorThales Pixium RAD 4343 DetectorThales Pixium RAD 3543 DetectorThales Pixium RAD 3543EZ DetectorThales Pixium RAD 2430EZ DetectorThales Pixium RAD 3543DR DetectorVarian PaxScan 4336R DetectorVarian PaxScan 4343R DetectorVarian PaxScan 4336X DetectorVarian PaxScan 4336W Detector
CompatibleGenerator(s)	Sedecal	Sedecal, CPI, Siemens, Del.
DICOM 3Compatibility	YES	YES

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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

1. 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.
1. Clinical Testing: Not required for a showing of substantial equivalence.
1. 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.

Regulation Number and Section

N/A