AcuityDRe

K210919 · Radmedix, LLC · MQB · Apr 30, 2021 · Radiology

Device Facts

• Record ID: K210919
• Device Name: AcuityDRe
• Applicant: Radmedix, LLC
• Product Code: MQB · Radiology
• Decision Date: Apr 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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

AcuityDRe is a digital x-ray system upgrade kit comprising digital radiography panels and software; designed to integrate with user-supplied diagnostic x-ray generators, tubeheads, and mounts. The system captures x-ray signals via digital receptor panels (wireless or tethered); processes data through an acquisition workstation (Windows 10-IoT PC); and produces diagnostic images for clinical review. Operated by physicians or technicians in clinical settings. The system facilitates diagnostic imaging; output images assist clinicians in diagnostic decision-making. Benefits include digital image acquisition and integration with existing x-ray infrastructure.

Clinical Evidence

No clinical trials were required. Bench testing included performance evaluation of digital receptor panels (DQE and MTF metrics) and safety testing per IEC 60601-1 and IEC 60601-1-2. Clinical image evaluation was performed by a board-certified radiologist to confirm image quality; images were rated as excellent.

Technological Characteristics

Digital x-ray upgrade kit including wireless/tethered receptor panels and acquisition software. Panels utilize solid-state technology. Connectivity via standard Wi-Fi (FCC-approved components) or tethered connection. Operates on Windows 10-IoT PC. Complies with IEC 60601-1, IEC 60601-1-2, and DICOM standards. Software provides control for specific CPI and Sedecal x-ray generators.

Indications for Use

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

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Accuvue+ (K201058)

Reference Devices

• DRTech 4343A (K192400)
• DRTech 4343W (K193017)
• AcuityDR (K171137)
• AcuityDR 1417 (K162552)
• AcuityDR 1717 (K162555)

Submission Summary (Full Text)

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April 30, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Radmedix LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 45409

### Re: K210919

Trade/Device Name: AcuityDRe Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: March 26, 2021 Received: March 29, 2021

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) K210919

Device Name AcuityDRe

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) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary K210919

Image /page/3/Picture/1 description: The image shows the logo for RadmediX. The logo features a large, stylized "R" in blue, with the word "admedi" in a smaller font size next to it. Behind the blue "R" and "admedi" is a faded gray "RX". The "X" in "RadmediX" is also in blue.

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

### 1. Administrative Information

Reason for Submission: 510(k) Notification for AcuityDRe

| Submitter: | |
|----------------------------|-------------------------------------|
| Submission contact person: | Gabriel Issa, Director of Equipment |
| Contact telephone: | 844 723 6334 |
| Contact e-mail: | [e-mail] |
| Date prepared: | April 28, 2021 |

Identification: AcuityDRe (Three models: AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t) Classification Name: Stationary X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ Substantially equivalent device: Trade Name: Accuvue+ Manufacturer: RadmediX 510(k) #: K201058 Classification Name: Stationary x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: MQB, LLZ

- 2. Device description: AcuityDRe components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDRe 1417w, AcuityDRe 1717w, AcuityDRe 1717t. The "w" indicates wireless wi-fi while the "t" indicates tethered. 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 We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. 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 K201058.

- 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.

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## 4. Technological characteristics: Comparison Table

| Comparable<br>Properties | Accuvue+, K201058 | AcuityDRe | Comparison<br>Results |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Indications for<br>use | Intended for use by a qualified/trained<br>physician or technician on both adult<br>and pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography. | Intended for use by a qualified/trained<br>physician or technician on both adult<br>and pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography. | SAME |
| X-ray Generator | Supplied by User: CPI or Sedecal | Supplied by User: CPI or Sedecal | SAME |
| Software Control<br>of Technique<br>Factor | Possible for certain CPI or Sedecal<br>Generators (Validated previously). See<br>below.l | Possible for certain CPI or Sedecal<br>Generators (Validated previously). See<br>below. | SAME |
| Digital X-Ray<br>Detectors | DRTech 4343A, (K192400);<br>DRTech 4343W, (K193017);<br>AcuityDR (K171137);<br>AcuityDR 1417 (K162552);<br>AcuityDR 1717 (K162555) | AcuityDRe 1417w,<br>AcuityDRe 1717w,<br>AcuityDRe 1717t | SAME |
| Panel<br>Performance | AcuityDR 1417 (K162552);DQE 34.6 %<br>at 1 lp/mm MTF 34 % at 2 lp/mm<br><br>AcuityDR 1717 (K162555) DQE 23.6 % at<br>1 lp/mm MTF 34 % at 2.0 lp/mm | AcuityDRe 1417w: DQE @ 1.0 lp/mm:<br>35%; MTF @ 2.0 lp/mm: 31%<br><br>AcuityDRe 1717w/1717t: DQE @ 1.0<br>lp/mm: 42%; MTF @ 2.0 lp/mm: 38% | Almost<br>IDENTICAL |
| Panel Sizes | AcuityDR 1417 140µm<br>AcuityDR 1717 140μm | AcuityDRe 1417w 148 µm<br>AcuityDRe 1717w 140 µm<br>AcuityDRe 1717t 140 µm | Almost<br>IDENTICAL |
| Operator<br>console | Windows PC using Windows 10-IoT | SAME | SAME |
| Acquisition<br>Software | Customer Selects:<br>AccuVue<br>AccuVue+ | SAME | SAME. |
| Power Source | AC Line or rechargeable batteries<br>(wireless models) | AC Line or rechargeable batteries<br>(wireless models) | SAME. |
| Standards | Same as below | See below | SAME |

## 5. Non clinical testing: Testing was performed 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 |
| 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in Medicine (DICOM)<br>Set |

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The digital panel software employed was used unmodified 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.

In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Manaqement 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.

In recognition of FDA pediatric concerns, we reviewed the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and created labeling to comply with this guidance.

In recognition of FDA's concerns about wireless performance we reviewed the FDA guidance: Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff. Both the predicate and subject devices use the same wireless technology, standard Wi-Fi using FCC approved off the shelf components.

Since the three new digital receptor panels have not had previous FDA clearance, testing was performed according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff. Clinical image evaluation was performed on the proposed new panels by a Board Certified Radiologist. The images were found to be of excellent quality. Performance characteristics are as follows:

DQE @ 1.0 lp/mm: 0.35; MTF @ 2.0 lp/mm: 0.31 AcuityDRe 1417w:

AcuityDRe 1717w: DQE @ 1.0 lp/mm: 0.42; MTF @ 2.0 lp/mm: 0.38

AcuityDRe 1717t: DQE @ 1.0 lp/mm: 0.42; MTF @ 2.0 lp/mm: 0.38

All proposed compatible generators carry NRTL listing labels, having been tested for safety. Validation of proper generator technique control had been previously performed.

Each system is tested for proper integration prior to the customer. Since multiple configurations are available (generator and panel models), our service engineers fully test each new system upon installation at the customer site

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

### 7. Substantial Equivalence Discussion.

When combined with a compatible generator/Tubestand combination the AcuityDRe performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Accuvue+ and the AcuityDRe 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 AcuityDRe series of upgrade kits are 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.