Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Device Description

This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of diagnostic accuracy or clinical outcomes. The document is a 510(k) premarket notification for a mobile X-ray system (MDR17 Mobile Direct Radiographic System), focusing on proving substantial equivalence to a predicate device (RadPRO® Mobile 40kW).

The "Performance Testing" section primarily discusses bench testing for electrical safety, mechanical safety, EMC, and software, and clarifies that clinical testing was not required for a determination of substantial equivalence because the digital X-ray receptor panel had already received FDA clearance.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details related to device performance in the context of diagnostic accuracy, human reader improvement, or standalone algorithm performance, as this information is explicitly stated as not being required or performed in this submission.

However, I can extract the information provided about the testing that was conducted:

Here's the relevant information based on the provided text, focusing on the evaluations performed for K173018, even though it highlights the absence of clinical performance studies:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission relying on bench testing for safety and electrical/mechanical performance, and not a clinical performance study measuring diagnostic accuracy, there are no specific "acceptance criteria" presented in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) for the device itself. Instead, the "acceptance criteria" are implied by adherence to recognized consensus standards for safety and electrical characteristics.

Acceptance Criteria (Implied by Standards Conformance)	Reported Device Performance
Conformance to AAMI ES60601-1 (Electrical Safety)	Conforms
Conformance to IEC 60601-1-2 (EMC)	Conforms
Conformance to IEC 60601-1-3 (Radiation Protection)	Conforms
Conformance to IEC 60601-1-6 (Usability)	Conforms
Conformance to IEC 60601-2-54 (X-Ray Equipment)	Conforms
Conformance to IEC 62366 (Usability Engineering)	Conforms
Conformance to FDA Guidance for Software in Medical Devices (Moderate Level of Concern)	Conforms (Testing for verification found acceptable)
Mitigation of EMC, mechanical, and electrical hazards	Mitigated

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as no clinical performance study or test set for diagnostic accuracy was conducted or required. The testing referred to is bench testing against engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as no clinical performance study requiring expert ground truth establishment was conducted or required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as no clinical performance study requiring adjudication was conducted or required.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical testing is not required for a determination of substantial equivalence." This device is a mobile X-ray system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done. This device is a hardware X-ray system, not an algorithm, and clinical testing was not required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as no clinical performance study requiring ground truth was conducted. For the bench testing, the "ground truth" was adherence to the specifications of the referenced international and national consensus standards.

8. The sample size for the training set

This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm.

Summary

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November 20, 2017

Image /page/0/Picture/1 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

Del Medical, Inc. % Daniel Kamm, P.E. Kamm and Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K173018

Trade/Device Name: MDR17 Mobile Direct Radiographic System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: September 22, 2017 Received: September 28, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

U .S. Food & Drug Administration 10903 New Hampshire Avenue Silv er Spring, MD 20993 w ww.fda.gov

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173018

Device Name

MDR17 Mobile Direct Radiographic System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary: Del Medical, Inc. MDR17 Mobile Direct Radiographic System K173018

Company:	Del Medical, Inc.241 Covington Dr.Bloomingdale, IL 60108
Date Prepared:	September 22, 2017

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

1. General Information:

Establishment/Manufacturer/Location of Manufacturing Site: Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Establishment Registration Number: 1418964

2. Contact Person:

Tony Bavuso c/o Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Phone: 847-288-7021

3. Device Name and Classification

Trade Name:	MDR17 Mobile Direct Radiographic System
Classification Name:	Mobile X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1720
Device Class:	Class II
Product Code:	IZL
Subsequent Product Code:	MQB

4. Legally Marketed Predicate Device

Trade Name:	RadPRO® Mobile 40kW
Manufacturer:	Sedecal
510(k) #:	K161345
Classification Name:	Mobile X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1720
Device Class:	Class II
Product Code:	IZL
Subsequent Product Code	MQB

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5. Indications for Use

Device Description: This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.
Substantial Equivalence The MDR17 Mobile Direct radiographic x-ray system is substantially equivalent to the commercially available RadPRO® Mobile 40kW radiographic x-ray system with identical indications for use. (See Table below).

Characteristic	RadPRO® Mobile 40kW;Sedecal. K161345	MDR17 Mobile Direct RadiographicSystem
Intended Use:	Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position. Not for mammography.	Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position. Not for mammography.(SAME)
PerformanceStandard	21 CFR 1020.30	SAME
Configuration	Motorized, battery operated	SAME
Generator	High frequency	High frequency (SAME)
Generatorpower level	40 kW (One power level)	40 kW (SAME)
kVp Range	40 to 150 kVp	40 to 130 kV in steps of 1 kV

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Characteristic	RadPRO® Mobile 40kW;Sedecal. K161345	MDR17 Mobile Direct RadiographicSystem
mA Range	10 - 500 mA Selectable	70 to 400 mA automatically associated to kV
Exposure TimeRange	0.001 - 10 sec	$0,001 ÷ 3$ sec according to set mAs
mAs Range	0.1 - 500 mAs	0,1 to 320 mAs
Collimator	Ralco R221 DHHS Manual Collimator	Ralco R108 F Manual Collimator
ImageacquisitionPanels(Both systemsuse alreadycleared digitalpanels)	Canon CXDI 801C Wireless (CSI) K131106Pixel size: 125 μm 2192 x 2800 pixels	Pixium 3543EZ Portable Wireless(K133534, K142718 and other clearances)Pixel size 148 μm, 2400 x 2880 pixels or thePixium 2430EZ Portable Wireless ,Pixel size 148 μm, 1920 x 1560 pixelsCompatible with film and CR systems as well.
Software	Canon control software CXDI-NE	DelWorks DR Software K140825
Connection	Wired or Wireless	SAME
DICOM	YES	YES
Power Source	Single Phase Line Regulationfrom 100 - 240 Vac (+/-10%)	115 or 230 VAC
Electricalsafety and EMC	IEC 60601-1 andIEC 60601-1-2	SAME
Standards(Other thanElectrical andEMC)	Wi-Fi 802.11b/g and:FCC Rules and Regulations	SAME
Wi-Ficommunicationwith detectors	Wi-Fi antenna system	SAME

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Image /page/6/Picture/0 description: This image shows two different mobile X-ray machines. The first machine is a RadPRO Mobile 40kW Sedecal K161345, which is white and blue. The second machine is an MDR17 Mobile Direct Radiographic System, which is also white and gray. Both machines are designed to be easily moved around a hospital or clinic.

Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device. The MDR17 Mobile Direct System uses similar radiographic x-ray system technology to the predicate device. The differences in the subject device, such as the x-ray generator, tube crane, collimator, and x-ray tube, do not affect the safety or effectiveness of the MDR17 Mobile Direct System can use a wireless flat panel detector similar to the predicate device, and the differences do not adversely affect the safety or effectiveness of the radiographic x-ray system.

The properties of the subject device presented in the comparison table above and described throughout this submission do not differ significantly from the legally marketed predicate device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management and through third-party evaluation using FDA-recognized consensus standards. The results of these efforts demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate.

Performance Testing (Bench). Del Medical claims conformance to a signed statement of performance standards. This submission contains performance data and test results to demonstrate conformance with special controls for medical devices containing software for a moderate level of concern per the FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. Testing for verification of the device was found acceptable to support the claims of substantial equivalence.

EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards (see Table below). In conclusion, the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. Clinical testing is not required for a determination of substantial equivalence.

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RecognitionNumber	ProductArea	StandardReferenceNumber	Standard Title and Edition
19-5	General	AAMIES60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012And, A2:2010/(R)2012 (Consolidated Text) Medical ElectricalEquipment -- Part 1: General Requirements For Basic SafetyAnd Essential Performance (IEC 60601-1:2005, Mod)
19-1	General	IEC60601-1-2	IEC 60601-1-2 Edition 3: 2007-03, Medical ElectricalEquipment - Part 1-2: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements And Tests
12-210	Radiology	IEC60601-1-3	IEC 60601-1-3 Edition 2.0 2008-01, Medical ElectricalEquipment - Part 1-3: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard: RadiationProtection In Diagnostic X-Ray Equipment
5-89	General	IEC60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10, Medical ElectricalEquipment - Part 1-6: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard: Usability
12-274	Radiology	IEC60601-2-54	IEC 60601-2-54 Edition 1.0 2009-06, Medical ElectricalEquipment - Part 2-54: Particular Requirements For The BasicSafety And Essential Performance Of X-Ray Equipment ForRadiography And Radioscopy [Including: TechnicalCorrigendum 1 (2010), Technical Corrigendum 2 (2011)]
5-87	General	IEC 62366	IEC 62366 Medical devices - Application of usabilityengineering to medical devices

Performance Testing (Clinical). Because the digital x-ray receptor panel has already received FDA clearance, clinical testing was not required.

10. General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including an emergency stop button, are incorporated into the system design. In addition, operation of the MDR17 Mobile Direct System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed. Furthermore, the intended operators of the MDR17 Mobile Direct System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

11. Conclusion as to Substantial Equivalence

The MDR17 Mobile Direct System is intended for the same use as the RadPRO® Mobile 40kW; (K161345.) It uses components similar to those cleared for the RadPRO® Mobile 40kW. It is Del Medical, Inc.'s opinion that the MDR17 Mobile Digital System is substantially equivalent to the cleared predicate device, the RadPRO® Mobile 40kW.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.