Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Device Description

Accuvue+ components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one (or more) of the following digital x-ray receptor panels: DRTech 4343A, (K192400); DRTech 4343W, (K193017); AcuityDR (K171137); AcuityDR 1417 (K162552 EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). We wish to offer for sale a subset of our recently cleared submission K200726. This in essence would be an upgrade kit. The indications for use remains unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the generator/tubestand combination.

AI/ML Overview

This document is a 510(k) summary for a medical device called Accuvue+. It describes the device and its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical or non-clinical study.

The document explicitly states:

"6. Clinical testing. Not required for a determination of substantial equivalence."
"5. Non clinical testing: Testing was performed in previous submssions according to the following standards:" (It then lists general safety and communication standards, not performance criteria for diagnostic accuracy or image quality.)

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The submission focuses on demonstrating substantial equivalence based on technological characteristics and adherence to general safety standards, rather than a performance study with acceptance criteria.

Summary

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Radmedix LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

May 6, 2020

Re: K201058

Trade/Device Name: Accuvue+ Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB, LLZ Dated: April 17, 2020 Received: April 21, 2020

Dear Daniel 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

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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 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 medical devices and radiation-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) K201058

Device Name Accuvue+

Indications for Use (Describe)

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K201058

Image /page/3/Picture/1 description: The image shows the logo for RadmediX. The logo features a large, stylized letter "R" in blue, with the word "admedi" in smaller letters next to it. Behind the blue "R" and "admedi" is a larger, faded gray "RX". The logo is clean and modern, with a focus on the company's name.

RadmediX. LLC 2510 Lance Rd. Dayton, OH 45409 Tel 844 723 6334 Registration Number: 3009134655

1. Administrative Information

Reason for Submission: 510(k) Notification for Accuvue+

Submitter:

Submission contact person: Gabriel Issa, Director of Equipment Contact telephone: 844 723 6334 Contact e-mail: gabe@radmedix.com May 4, 2020 Date prepared: ldentification: Accuvue+ Stationary X-Ray System Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ

Substantially equivalent device: Trade Name: Manufacturer: RadmediX 510(k) #: K200726 Classification Name: Moble X-Ray System Classification Panel: Radiology 21 CFR §892.1720 Classification Regulation: Device Class: Class II Product Code: IZL, MQB, LLZ

1. Device description: Accuvue+ components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one (or more) of the following digital x-ray receptor panels: DRTech 4343A, (K192400); DRTech 4343W, (K193017); AcuityDR (K171137); AcuityDR 1417 (K162552 EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). We wish to offer for sale a subset of our recently cleared submission K200726. This in essence would be an upgrade kit. The indications for use remains unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the generator/tubestand combination.
  Each system consists of the following items:

Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITY + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt

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We supply:

Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. All panels offered for sale with this system have received clearance in K200726.

Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K200726.

1. Indications for Use: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

ComparableProperties	AcuityPDR K200726	Accuvue+, K201058	ComparisonResults
Indications foruse	Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography.	Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography.	Identical
X-ray tube	TOSHIBA ELECTRONTUBES & DEVICESCO., LTD D-125SB 100kV, 40mA	Depends on Tube Head/StandChosen.	EquivalentFunctionality
Collimator	Built in	Depends on Tube Head/StandChosen.	EquivalentFunctionality
X-ray Generator	One model, up to 100 kVp	Supplied by User: CPI orSedecal	EquivalentFunctionality
SoftwareControl ofTechniqueFactor	Not available	Possible for certain CPI orSedecal Generators (Validatedpreviously). See below.	Betterfunctionality
Digital X-RayDetectors	DRTech 4343A, (K192400);DRTech 4343W, (K193017); AcuityDR(K171137);AcuityDR 1417 (K162552);AcuityDR 1717 (K162555)	DRTech 4343A, (K192400);DRTech 4343W, (K193017);AcuityDR (K171137);AcuityDR 1417 (K162552);AcuityDR 1717 (K162555)	SAME
Operatorconsole	Windows PC using Windows 10-IoT	SAME	SAME
AcquisitionSoftware	Customer Selects:AccuVueMED (K152172)AccuVue (K141440) orAccuVue+ (K130883)	AccuVue+ (only)	EquivalentFunctionalityOnly clearedsoftware issupplied.
Power Source	AC Line or rechargeable batteries	AC Line only.	SAME.
Standards	Same as below	See below	SAME

4. Technological characteristics: Comparison Table

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Non clinical testing: Testing was performed in previous submssions according to the following standards:

FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber And Date	Title Of Standard
19-4	IEC	60601-1:2005/(R)2012And A1:2012	Medical Electrical Equipment Part 1: General Requirements ForBasic Safety And Essential Performance (IEC 60601 1:2005, MOD)
19-1	IEC	60601-1-2:2014	Medical Electrical Equipment Part 12: General Requirements ForBasic Safety And Essential Performance Collateral Standard:Electromagnetic Disturbances Requirements And Tests
12-238	NEMA	PS 3.1 - 3.20 (2011)	NEMA Digital Imaging and Communications in Medicine (DICOM)Set

The digital panel software employed was used unmodified from clearances obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators. Compatible CPI generators: CMP 200 Series. Compatible Sedecal generators: SFHR and SHF Series.

Since multiple configurations are available (generator and panel models), our service engineers fully test each new system upon installation at the customer site. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. The User Manual has been updated to add pediatric and cybersecurity considerations. Each system is tested for proper integration prior to the customer. All proposed compatible generators carry NRTL listing labels, having been tested for safety, Validation of proper generator technique control has been supplied.

Clinical testing. Not required for a determination of substantial equivalence.

7. Substantial Equivalence Discussion.

When combined with a compatible generator/Tubestand combination the Accuvue+ performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Visaris and the RadmediX systems are substantially equivalent to each other.

8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of RadmediX LLC that the Accuvue+ is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.