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

The Paragon 2 is a mobile x-ray unit 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 feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

AI/ML Overview

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with US Federal Safety Performance Standard (21 CFR 1020.30)	Complies with 21 CFR 1020.30
Electrical Safety (IEC 60601)	Meets Electrical Safety per IEC-60601
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Meets EMC per IEC 60601-1-2
Radiation Protection (IEC 60601-1-3)	Meets IEC 60601-1-3 Radiation protection
Basic Safety and Essential Performance of

Summary

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

October 21, 2016

Meridian Medical Systems, LLC % Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K162687

Trade/Device Name: Paragon 2 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: September 24, 2016 Received: September 27, 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,

Robert Oals

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) K162687

Device Name Paragon 2

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)

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FOR FDA USE ONLY

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

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510(k) Summary 510(k) Number K162687 MERIDIAN MEDICAL SYSTEMS LLC 352 Harris Drive Aurora , OH 44202 Date Prepared: October 17, 2016 Contact: Larry Cornell, Icornell@meridianmed.net

1. Identification of the Device:

Trade/Device Name: Paragon 2 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: K161345

Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR. Manufacturer: Sedecal SA (Spain) 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. Reference device: K143232 (The mobile device incorporates this device) Trade/Device Name: Universal Digital Interface 2W, UDI 2W. Manufacturer: MERIDIAN MEDICAL SYSTEMS LLC Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital X-ray panel and software
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 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: The Paragon 2 is a mobile x-ray unit 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 feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

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1. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, rick analysis and software validation and integration testing results 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	K161345 Trade/Device Name: RadPRO®Mobile 40kW; RadPRO® Mobile 40kWFLEXPLUS,	Meridian Medical Paragon 2
Intended Use:	Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull,spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. Not formammography	SAME
Configuration	Battery or line operated mobile	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Generator	High frequency made by Sedecal	SAME
Generatorpower level	One available power level: 40 kW	Four available power levels:20 KW, 32 KW, 40 KW, 50 KW. Thesefour power levels were cleared inSedecal's K101517 which was thepredicate for K161345. Those samegenerators are used in the Paragon 2.
Collimator	Ralco R221 DHHS Manual Collimator	SAME
Characteristic	K161345 Trade/Device Name: RadPRO®Mobile 40kW; RadPRO® Mobile 40kWFLEXPLUS,	Meridian Medical Paragon 2
Imageacquisition	Canon CXDI 401C Wireless (CSI) K133693Pixel size: 125 μm 3320 × 3408 pixelsCanon CXDI 701C Wireless (CSI) K131106Pixel size: 125 μm 2800 × 3408 pixelsCanon CXDI 701G Wireless (GOS) K131106Pixel size: 125 μm 2800 × 3408 pixelsCanon CXDI 801C Wireless (CSI) K131106Pixel size: 125 μm 2800 × 2192 pixelsCanon CXDI 801G Wireless (GOS) K131106Pixel size: 125 μm 2800 × 2192 pixels	Toshiba panels are employed:FDX4343R/RPW,Active Area 43 (H)×43 (V) cmPixel Matrix 3036 (H)×3040 (V)Pixel Pitch 140μ mFDX3543RP/RPWActive Area 345(H)×423(V)mmPixel Matrix 2466(H)×3040(V)Pixel Pitch 140μ mFDX2530RPW.Active Area 245 (H)×295 (V) mmPixel Matrix 1750 (H)×2108 (V)Pixel Pitch 140μ mThe Paragon 2 employs the digital x-raypanels and software employed in ourpremarket notification K143232.
Software	Canon control software CXDI-NE	ECOM DROC, cleared with Toshibapanels (Sedecal) in K130883 ANDK143232.
Connection	Ethernet or Wireless Wi-Fi	SAME
DICOM	YES	YES
Power Source	AC Line or Rechargeable Battery	SAME
Electricalsafety and EMC	Electrical Safety per IEC-60601. UL listed;EMC per IEC-60601-1-2;IEC 60601-1-3 Radiation protection indiagnostic X-ray equipmentIEC 60601-2-54 Particular RequirementsFor The Basic Safety And EssentialPerformance Of X-Ray Equipment forRadiography and Radioscopy	SAME

7. Substantial Equivalence Chart

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Image /page/6/Picture/0 description: This image shows the characteristics of the RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, as well as the Meridian Medical Paragon 2. There are photos of the RadPRO® Mobile, RadPRO® Mobile Flex Plus, Standard Column, and Telescopic Column. The trade/device name is K161345.

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. Software integration testing and risk analysis was performed to confirm proper implementation of the (already cleared) software. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, leakage testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition.
1. Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance.
1. Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Meridian Medical that the Paragon 2 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.