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

RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

AI/ML Overview

This document is a 510(k) premarket notification for the RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR, a mobile X-ray system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in response to your request:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sedecal Mobile Digital Diagnostic X-Ray Systems, K101517) through technical and safety comparisons, and by showing that the device is as safe and effective. The performance is assessed through compliance with relevant standards and successful integration of previously cleared components.

The table below summarizes the comparison between the new device and the predicate, highlighting the "performance" implicitly defined by these comparisons:

Characteristic	Acceptance Criteria (Implied by Predicate Performance / Standard Compliance)	Reported Device Performance (RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR)
Intended Use	Capable of taking diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts on adult and pediatric subjects, with the patient sitting, standing, or lying in prone or supine position. Not for mammography. (Matching K101517 with added mammography exclusion)	SAME, with added FDA requested language: Not for mammography.
Configuration	Battery or line-operated mobile X-ray unit.	SAME, now with telescopic tube mount (FLEX PLUS) to enhance visibility.
Performance Standard Compliance	Compliance with 21 CFR 1020.30 (Federal Safety Performance Standard for Diagnostic X-ray Systems).	SAME. Product is UL listed.
Generator	High frequency generator made by Sedecal.	SAME.
Generator Power Level	Capable of at least 40 KW power output. (Predicate offered 20, 32, 40, 50 KW)	40 kW (One power level offered). (Meets or exceeds 40KW of predicate options)
Collimator	Ralco R221 DHHS Manual Collimator	SAME.
Image Acquisition	Use of FDA-cleared digital flat panel detectors for image acquisition, with documented pixel sizes. (Predicate used Trixell 3543pR or Varian 4336R)	Canon CXDI 401C Wireless (K133693), Canon CXDI 701C Wireless (K131106), Canon CXDI 801C Wireless (K131106). All Canon panels are previously FDA cleared. Pixel sizes: 125 μm.
Software	Functional image acquisition and control software. (Predicate used dicomPACS®DXR)	Canon control software CXDI-NE.
Connection	Ethernet or Wireless Wi-Fi functionality.	SAME.
DICOM Compliance	YES	YES.
Workflow	Basic X-ray system functionality (predicate's 'Not applicable' implies basic).	Enhanced Work Flow via second PC (provides additional functionality beyond predicate).
Power Source	AC Line or Rechargeable Battery operation.	SAME.
Electrical Safety & EMC	Compliance with IEC-60601, IEC-60601-1-2, IEC 60601-1-3, IEC 60601-2-54.	SAME.
Other Standards	Wi-Fi 802.11b/g connectivity.	Wi-Fi 802.11b/g and additional compliance with: FCC Rules and Regulations 47 CFR Chapter I Part 15 Subpart B; Part 18 Subpart C ICES-003 ISSUE 5 (2012) & ICES-001 ISSUE 4 (2014) & ANSI C63.4-2009.
Wi-Fi Communication with Detectors	Functional Wi-Fi communication with detectors (predicate used one single antenna).	"DAS" distributed Wi-Fi antenna system (enhances range and sensitivity for accompanying detectors, using 4 sector antennas).
Overall Safety and Effectiveness	"As safe and effective as the predicate devices." (Implied acceptance criterion for substantial equivalence).	"Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified." "After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

Study Proving Acceptance Criteria (Substantial Equivalence):

The study proving the device meets the acceptance criteria (i.e., is substantially equivalent to the predicate) is primarily a non-clinical bench and laboratory testing study, complemented by the fact that core components (digital panels) were previously FDA cleared.

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

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a "sample size" in terms of number of patient cases or images for testing the entire device system's imaging performance beyond general statements about "test images." However, the digital panels themselves (Canon CXDI series) were previously cleared by the FDA (K131106 and K133693), implying their performance was assessed in their respective submissions.
Data Provenance: Not explicitly stated for specific images. The testing was conducted by SEDECAL SA in Algete, Madrid, España (Spain). The nature of the testing described (laboratory, bench, test images, clinical image comparisons) suggests some data would be internally generated or acquired during testing. Given it's a 510(k) for an X-ray system, the "data" is primarily technical specifications, compliance with standards, and image quality demonstrations rather than a large clinical dataset for a diagnostic algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "Sample images were verified by a Board Certified Radiologist." This indicates at least one expert.
Qualifications: "Board Certified Radiologist." No details on years of experience.

4. Adjudication method for the test set:

Not specified. Given only one expert is mentioned for image verification, a formal adjudication method (like 2+1 or 3+1) is unlikely to have been employed for the specific "sample images." The primary method appears to be comparison against accepted standards and the predicate device's performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of the hardware system, not on evaluating human reader performance with or without AI assistance. The device is a mobile X-ray system, not an AI-powered diagnostic algorithm in the typical sense of needing MRMC studies to assess reader improvement.

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

This question is not directly applicable to this device in the context of a diagnostic AI algorithm. The device itself is a standalone X-ray imaging system. The submission details its performance, safety, and effectiveness without reliance on a human-in-the-loop performance for its core function of image acquisition. The "Enhanced Work Flow" is a separate software capability for facilitating client software, not an AI algorithm for interpreting images.

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

For the "sample images" mentioned, the ground truth was expert verification by a Board Certified Radiologist. The overall "ground truth" for the device's main function comes from compliance with established technical standards (e.g., electrical safety, radiation performance, image acquisition parameters) and the performance of the legally marketed predicate device.

8. The sample size for the training set:

This device is a hardware X-ray system, not an AI algorithm trained on a dataset of images. Therefore, there is no "training set" in the context of machine learning.

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

N/A, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

SEDECAL SA % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K161345

Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MOB Dated: June 28, 2016 Received: June 30, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael 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) K161345

Device Name

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary 510(k) Number K161345 SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: June 28, 2016 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device:

Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System

2. Equivalent legally marketed device: K101517

Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System

1. Indications for Use (intended use) 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, chest, abdomen, 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.
1. Description of the Device: RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed. The key differences between the modified device and the predicate device are as follows:
- 4.1. The FLEXPLUS version has a telescoping Tubestand which enhances visibility while transporting the unit.
- 4.2. We are offering updated versions of the Canon Digital X-Ray Panels, as listed above and shown in the comparison table below.

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4.3. We have added a second personal computer board which permits "Enhanced Work Flow" capability. The second, independent computer is configured to run a second, independent software system, (to be supplied by the user) to allow a user to toggle to a Work Flow environment for ease-of-use in mobile X-ray systems. This second computer is configured to be a "slave" to the X-ray system software, including both Canon CXDI and Sedecal Integration software (e.g., the second computer is turned on and off by the X-ray System's power status). The second computer and its Windows environment is specified with sufficient computing requirements to enable third-party client software to be installed that could include RIS, QC and PACS communications.
4.4. We have added what we call a "DAS", a distributed antenna system that enhances the detectability of the accompanying detectors, both in range and sensitivity, also increasing the overall wireless sensitivity by utilizing 4 sector antennas.
4.5. We have updated the User Manual to reflect the changes made to the device.
1. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.

Characteristic	Sedecal Easy Moving DigitalK101517	RadPRO® Mobile 40kW; RadPRO® Mobile40kW FLEXPLUS, Model SM-40HF-B-D-VIRK161345
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position.	SAME, adding FDA requested language:Not for mammography.
Configuration	Battery or line operated mobile	SAME, now with telescopic tube mount(FLEX PLUS) (see photo below)
PerformanceStandard	21 CFR 1020.30	SAME
Generator	High frequency made by Sedecal	SAME
Generatorpower level	Four available power levels:20 KW, 32 KW, 40 KW, 50 KW	40 kW (One power level)
Collimator	Ralco R221 DHHS ManualCollimator	SAME
Characteristic	Sedecal Easy Moving DigitalK101517	RadPRO® Mobile 40kW; RadPRO® Mobile40kW FLEXPLUS, Model SM-40HF-B-D-VIRK161345
Imageacquisition	Trixell 3543pR: (Wireless)Pixel size 144 $ μ $ m/2372 x 3000pixels orVarian 4336RPixel size 139 $ μ $ m/3072 x 2560pixels	Canon CXDI 401C Wireless (CSI) K133693Pixel size: 125 $ μ $ m 3320 × 3408 pixelsCanon CXDI 701C Wireless (CSI) K131106Pixel size: 125 $ μ $ m 2800 × 3408 pixelsCanon CXDI 801C Wireless (CSI) K131106Pixel size: 125 $ μ $ m 2800 × 2192 pixels
Software	dicomPACS®DXR	Canon control software CXDI-NE
Connection	Ethernet or Wireless Wi-Fi	SAME
DICOM	YES	YES
Workflow	Not applicable	Enhanced Work Flow via second PC.
Power Source	AC Line or Rechargeable Battery	SAME
Electricalsafety andEMC	Electrical Safety per IEC-60601. ULlisted; EMC per IEC-60601-1-2;IEC 60601-1-3 Radiation protectionin diagnostic X-ray equipmentIEC 60601-2-54 ParticularRequirements For The Basic SafetyAnd Essential Performance Of X-RayEquipment for Radiography andRadioscopy	SAME
Standards(Other thanElectrical andEMC)	Wi-Fi 802.11b/g	Wi-Fi 802.11b/g and:FCC Rules and Regulations 47 CFR Chapter IPart 15 Subpart B; Part 18 Subpart C ICES-003 ISSUE 5 (2012) & ICES-001 ISSUE 4(2014) & ANSI C63.4-2009.
Wi-Ficommunicationwith detectors	One single antenna	"DAS" distributed Wi-Fi antenna system
Characteristic	Sedecal Easy Moving DigitalK101517	RadPRO® Mobile 40kW; RadPRO® Mobile40kW FLEXPLUS, Model SM-40HF-B-D-VIRK161345
Photos	Image: Sedecal Easy Moving Digital K101517	Image: RadPRO® MobileImage: RadPRO® Mobile Flex Plus

6. Substantial Equivalence Chart

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1. Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. Software integration testing (enhanced workflow) was documented and a detailed risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hi-pot testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition. Additional Wi-Fi testing was done to verify the functionality of internal Wi-Fi antennas. Mechanical testing of the new telescoping Tubestand was performed.

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1. Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance. Sample images were verified by a Board Certified Radiologist.
1. Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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.