AcuityPDR

K200726 · Radmedix, LLC · IZL · Apr 13, 2020 · Radiology

Device Facts

• Record ID: K200726
• Device Name: AcuityPDR
• Applicant: Radmedix, LLC
• Product Code: IZL · Radiology
• Decision Date: Apr 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

AcuityPDR is a mobile x-ray system; integrates generator/collimator, digital radiography (DR) panels, and acquisition software. System inputs: x-ray radiation; outputs: diagnostic digital images. Used in clinical settings by physicians or technicians. Operation: user selects exposure parameters (kV, mAs) via console; generator produces x-rays; DR panel captures signal; acquisition software processes and displays images. Benefits: portable diagnostic imaging for various patient populations. System components are sourced from various manufacturers; integrated and tested by RadmediX. Healthcare providers use images for diagnostic decision-making. Battery-powered generator allows mobile use; supports 200 exposures per charge.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54 standards, and verification of system integration.

Technological Characteristics

Mobile x-ray system; Toshiba D-125SB x-ray tube; 2 kW generator; rechargeable lithium-ion battery. Digital radiography panels (DRTech/AcuityDR series). Acquisition software (AccuVue series). Connectivity: DICOM (NEMA PS 3.1-3.20). Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 21 CFR 1020. System integration tested per internal SOPs.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic x-ray imaging. Contraindicated for mammography.

Regulatory Classification

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.

Predicate Devices

• CMDR 2CW (K191451)

Reference Devices

• DRTech 4343A (K192400)
• DRTech 4343W (K193017)
• AcuityDR (K171137)
• AcuityDR 1417 (K162552)
• AcuityDR 1717 (K162555)
• Accuvue+ (K130883)
• AccuVueMED (K152172)
• AccuVue (K141440)
• CareView 1500Cw (K150929)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

April 13, 2020

### Re: K200726

Trade/Device Name: AcuityPDR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB, LLZ Dated: March 17, 2020 Received: March 20, 2020

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 ([e-mail]) or phone [phone] 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) K200726

Device Name AcuityPDR

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.

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

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 K200726

Image /page/3/Picture/1 description: The image shows a logo with the text "RadmediX". The letters "R" and "X" are in blue, while the letters "R", "m", "e", "d", and "i" are in gray. The logo is likely for a company or organization with the name RadmediX.

RadmediX, LLC 2510 Lance Rd. Dayton, OH 45409 Tel [phone] Registration Number: 3009134655

### 1. Administrative Information

Reason for Submission: 510(k) Notification for RadmediX AcuityPDR

| Submitter: | Submission contact person: | Gabriel Issa, Director of Equipment |
|----------------------------------|----------------------------|-------------------------------------|
| | Contact telephone: | 844 723 6334 |
| | Contact e-mail: | [e-mail] |
| | Date prepared: | April 9, 2020 |
| Identification: | Classification Name: | AcuityPDR |
| | Classification Name: | Mobile X-Ray System |
| | Classification Panel: | Radiology |
| | Classification Regulation: | 21 CFR §892.1720 |
| | Device Class: | Class II |
| | Product Code: | IZL, MQB, LLZ |
| Substantially equivalent device: | Trade Name: | CMDR 2CW |
| | Manufacturer: | MinXray |
| | 510(k) #: | K191451 |
| | Classification Name: | Mobile X-Ray System |
| | Classification Panel: | Radiology |
| | Classification Regulation: | 21 CFR §892.1720 |
| | Device Class: | Class II |
| | Product Code: | IZL, MQB, LLZ |

- 2. Device description: RadmediX AcuityPDR combines components into a complete mobile x-ray system, including software, a generator/collimator combination, and digital radiography panels. Radmedix combines components from various manufacturers into a complete mobile x-ray system. 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 3643, EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). In addition, the customer selects one of three software packages: Accuvue+ (K130883), AccuVueMED, (K152172) or AccuVue (K141440). The generator can be battery operated. A single battery charge produces 200 Exposures at max KV and MAS settings. The battery charger is UL Listed and the internal lithium ion battery is overcharge and overcurrent protected. A typical acquisition computer would be a Lenovo P53S or a Dell Precision 3541.

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- 3. 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.

| Comparable<br>Properties | CMDR 2CW, made by MinXray<br>510(k) #: K191451 | AcuityPDR | Comparison<br>Results |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Indications<br>for use | Intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography. | Intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography. | Identical |
| X-ray tube | Toshiba D-124S | TOSHIBA D-125SB 100kV, 40mA | Equivalent<br>Functionality |
| Peak<br>generator<br>output | 2 kW | 2 kW | SAME |
| Tube current<br>range | 30 mA±20% at 60kV mA<br>25 mA±20% at 80kV mA<br>20 mA±20% at 100kV | 40-60kV: 25mA.<br>61-100kV: 20mA. | Comparable<br>ranges. |
| Tube voltage<br>adjustable<br>range | 40-100 kV, 2kV steps | 40-100kV, step value 1kV. | More flexible<br>kV<br>adjustment |
| mAs range | 2.0-150 (steps not specified) | 0.4mAs ~ 50mAs, with the range of:<br>0.40, 0.50, 0.63, 0.80, 1.00, 1.25, 1.6,<br>2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8, 10, 12.5, 16,<br>20, 25, 32, 40, 50. | Comparable<br>adjustability |
| Collimator | Built in | Built in | Equivalent<br>Functionality |
| X-ray<br>Generator | Three models, from 100 to 120 kVp<br>maximum | One model, up to 100 kVp | Equivalent<br>Functionality |
| Digital X-Ray<br>Detectors | K150929 CareView 1500Cw X-ray Flat<br>Panel Detector manufactured by<br>CareRay | DRTech 4343A, (K192400);<br>DRTech 4343W, (K193017);<br>AcuityDR (K171137);<br>AcuityDR 1417 (K162552);<br>AcuityDR 1717 (K162555) | Equivalent<br>Functionality |
| Operator<br>console | Touch Control or Touch Screen | SAME | Similar<br>Functionality |
| Comparable<br>Properties | CMDR 2CW, made by MinXray<br>510(k) #: K191451 | AcuityPDR | Comparison<br>Results |
| Acquisition<br>Software | dicomPACS® DX-R K141440 | Customer Selects:<br>AccuVueMED (K152172)<br>AccuVue (K141440) or<br>AccuVue+ (K130883) | Equivalent<br>Functionality<br>Only cleared<br>software is<br>supplied. |
| Photos | Image: CMDR 2CW | Image: AcuityPDR | Similar form<br>factors |
| Power Source | AC LINE, single or three phase<br>depending on the generator | AC Line or rechargeable batteries<br>(Generator only) | SAME. |
| Standards | 60601-1:2005; 60601-1-2:2014<br>21CFR1020 | SAME<br>Generators are TUV Tested<br>AC Line Power Supply is UL Listed<br>See list below. | SAME |

## 4. Technological characteristics: Comparison Table

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5. Non clinical testing: Testing was performed successfully according to the following standards:

| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | 60601-1:2005/(R)2012<br>And A1:2012 | Medical Electrical Equipment Part 1: General Requirements For<br>Basic Safety And Essential Performance (IEC 60601 1:2005, MOD) |
| 19-1 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General Requirements For<br>Basic Safety And Essential Performance Collateral Standard:<br>Electromagnetic Disturbances Requirements And Tests |

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| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12-269 | IEC | 60601-1-3 Edition 2.1<br>2013-04 | Medical electrical equipment - Part 1-3: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Radiation protection in diagnostic X-ray equipment |
| 12-296 | IEC | 60601-2-54 -<br>2009+AMD1 :<br>2015+AMD2:2018 | Particular Requirements For The Basic Safety And Essential<br>Performance Of X-Ray Equipment for Radiography and<br>Radioscopy |
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in Medicine (DICOM)<br>Set |
| N/A | FDA | 21CFR1020 | Electronic Products; Performance Standard for Diagnostic X-Ray<br>Systems and Their Major Components |

All of the components subject to the CDRH performance standard are certified to comply with the standard by their respective manufacturers. We do not supply any non-certified components. Applicable components carry a certification label (UL, ETL, etc.). The digital panel software employed was used unmodified from clearances obtained from FDA. Since multiple configurations are available, 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 Druq Administration Stoff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. The generator User Manual has been updated to add Pediatric Considerations. Each system is tested for proper integration prior to shipment to the customer.

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

# 7. Substantial Equivalence Discussion.

The RadmediX AcuityPDR performs the same functions 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 RadmediX AcuityPDR 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.