Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

{0}------------------------------------------------ January 2, 2020 Image /page/0/Picture/1 description: The image shows 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, and then the word "ADMINISTRATION" in a smaller font size below. Radmedix LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114 ### Re: K193360 Trade/Device Name: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 2, 2019 Received: December 4, 2019 ### 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 avare 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 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-reporting {1}------------------------------------------------ combination-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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193360 #### Device Name Acuity: AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard Indications for Use (Describe) The purpose of Acuity is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | <span style="display:inline-block; width:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; width:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary K193360 Image /page/3/Picture/1 description: The image shows a logo with the text "RadmediX". The "R" and "X" are in blue, while the "admedi" is in a lighter gray color. The letters are overlapping each other, creating a layered effect. The logo appears to be for a company or organization named RadmediX. # RadmediX, LLC 2510 Lance Rd. Dayton, OH 45409 Tel 844 723 6334 Registration Number: 3009134655 Radmedix Acuity (AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard) #### 1. Administrative Information # Reason for Submission: 510(k) Notification for RadmediX AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard), new combination of Exempt and Cleared devices | Submitter: | | |----------------------------------|----------------------------------------------------------| | Submission contact person: | Gabriel Issa, Director of Equipment | | Contact telephone: | 844 723 6334 | | Contact e-mail: | gabe@radmedix.com | | Date prepared: | December 17, 2019 | | Identification: | | | Classification Name: | AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR, Secondary: MQB | | Substantially equivalent device: | | | Trade Name: | Visaris Vision® (Vision C, Vision U. Vision V, Vision X) | | Manufacturer: | Visaris DOO. | | 510(k) #: | K160620 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR, Secondary: MQB | # 2. Device description: 21 CFR 807 92 (a) (4) RadmediX Acuity combines components into a complete stationary x-ray system, including software, tube stands, tube heads, collimators, generators, tables, and digital radiography panels. 21CFR §892.1680 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 {4}------------------------------------------------ of device may include signal analysis and display equipment supports, comports, component parts, and accessories. Radmedix combines components from various manufacturers into a complete stationary x-ray system. The major component combining these into a complete solution is the tube stands are made to carry the weight of the tube head, collimator, and digital X-ray panels. These tube stands may also have supporting devices such as wall stands, tables, stitching stands, and chairs. These supporting devices allow for imaging in standing, sitting, and laying positions. The Radmedix Acuity tube stands with supporting devices make a stationary x-ray system allowing for ease of use for the technologist and provides rapid patient care. Similar to the predicate our stationary x-ray system employs a tube stand that is a generic type of device and can use various brands of tube heads, collimators, generators, and digital radiography panels all meeting the cited performance standard. | AcuitySDR<br>Standard; | Straight Arm System Stand:<br>"SYFM SU-2000" | Image: Straight Arm System Stand | |------------------------|---------------------------------------------------------------|---------------------------------------------------| | AcuitySDR<br>Plus; | Straight Arm System Stand with<br>Touchscreen "SYFM SU-2100", | Image: Straight Arm System Stand with Touchscreen | Radmedix Acuity models: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the AcuityFDR Standard Floor Mounted System "SST-4000". The system includes a floor-mounted stand with a detector and a table. The table is designed to support patients during X-ray imaging. Radmedix provides previously cleared digital x-ray detectors. The panel enclosures in our systems are designed around the EVS 3643, EVS 3643G panel cleared under (K151942), and the EVS 4343G panel cleared under (K142475). Those digital x-ray panels are 14″ x 17″ standard cassette sized digital x-ray detectors. The panel enclosure can support other similarly sized detectors. The previously cleared software supplied with the system is AccuVueMED (Relabeled version of K152172). This medical software communicates with the digital x-ray detector and allows acquisition and processing of x-ray images. This software complies with DICOM standards and can transmit and receive data with a PACS system. The software is configurable to acquire images from various digital radiography panels. The other previously cleared software optionally available package is AccuVue, (Relabeled version of K141440.) The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors. | DRTECH<br>CORPORATION | EVS 3643, EVS 3643G | K162552 | |-----------------------|------------------------------------------------------------------------|---------| | DRTECH<br>CORPORATION | EVS 3643 | K151942 | | DRTECH<br>CORPORATION | EVS 4343 | K142475 | | DRTECH<br>CORPORATION | EVS 4343, EVS 4343G | K162555 | | DRTECH<br>CORPORATION | EVS 2430W, EVS 2430GW | K171137 | | DRTECH<br>CORPORATION | EVS 4343W, EVS4343WG, EVS 3643W, EVS 3643WG, EVS<br>4343WP, EVS 3643WP | K193017 | The default software AccuVueMED (K152172) is the software normally paired with the default digital panels from DRTECH CORPORATION. Here is a compatibility table: {6}------------------------------------------------ For other optionally available panels the customer would receive the AccuVue software, a relabeled version of K141440. See the table below. | Optionally available panels | | | |-----------------------------|-------------------------|---------| | LG Electronics | 17HK700G-W | K180332 | | LG Electronics | 14HK701G-W | K182348 | | LG Electronics | 17HK701G-W | K183286 | | IRay | Mars1717XF-CSI Wireless | K183713 | | IRay | Mars1717XF-GSI Wireless | K183422 | | IRay | Mars1417XF-GSI Wireless | K182550 | | IRay | Mars1417XF-CSI Wireless | K182551 | | IRay | Mars1417V-PSI Wireless | K161730 | ### Available Generators Summit Models L300, L500, L550, 00210, 02968, 03900, 03901 (40 or 50 kW) or CPI Model CMP 200 DR (40, 50, 65, or 80 kW) #### Collimators Collimare, LLC CML-150-0001-C, 150kVp Certified Manual Collimator or CML-125-0001-C, 125kVp Certified Manual Collimator #### X-Ray Tube Housing: Toshiba The purchaser selects one of these: Toshiba E7239FX tube Toshiba E7242FX tube Toshiba E7252FX tube #### 3. Indications for Use: 21 CFR 807 92 (a) (5) The purpose of Acuity is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use. {7}------------------------------------------------ # 4. Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table | Comparable<br>Properties | Predicate Device: K160620 Visaris<br>Vision® (Vision C, Vision U, Vision V,<br>Vision X) | Acuity (Three models) AcuitySDR<br>Standard; AcuitySDR Plus;<br>AcuityFDR Standard | Comparison<br>Results | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Indications<br>for use | The purpose of Visaris Vision® is to<br>acquire, store, communicate, display<br>and process medical X-ray images.<br>These radiographic systems are<br>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, angiography,<br>interventional, or fluoroscopy use. | The purpose of Acuity is to acquire,<br>store, communicate, display and<br>process medical X-ray images.<br>These radiographic systems are<br>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, angiography,<br>interventional, or fluoroscopy use. | Identical | | Wall stand | Motorized vertical movable wall<br>stand, tiltable tray. | SAME | Equivalent<br>Functionality | | Table | Free-floating and height-adjustable,<br>maximum patient weight 660 lbs.,<br>working table height 20-5/16 inch to<br>37-5/8 inch. | SAME. | Equivalent<br>Functionality | | X-ray tube | 150 kVp 0.6/1.2mm focal spots.<br>Toshiba | SAME | Equivalent<br>Functionality | | Collimator | Ralco Claymount, X-Alliance, or (All<br>CFR Certified) (510(k) exempt) | Collimaire collimators, all CFR<br>Certified (510(k) exempt) | Equivalent<br>Functionality | | X-ray<br>Generator | Various Models available: (All HF)<br>Claymount, (up to 63 kW)<br>CPI, (32kW to 100kW)<br>EMD, (45 kW, to 80 kW)<br>POSKOM (32 kW to 50 kW)<br>Sedecal (40, 50, 65, or 80 kW)<br>(All CFR Certified) | Various Models available: (All HF)<br>(All CFR Certified):<br>Summit models from 40 to 50 kW<br>CPI generators up to 80 kW are<br>available optionally. (510(k)<br>exempt) | Equivalent<br>Functionality | | Wireless<br>detector | 14" x 17" Uses FDA cleared detector<br>and software. Pixium 3543 EZ C<br>(Other previously cleared models<br>available, see table above) | Optional enclosure allows for 14" x<br>17" fixed and removable FDA<br>cleared detectors and software. | Equivalent<br>Functionality | | Fixed<br>detector | 17"x17". Uses FDA cleared detector<br>and software. Pixium 4343RC (Other<br>previously cleared models available) | 17"x17". Uses FDA cleared<br>detector and software. | Equivalent<br>Functionality | | Conventional<br>film/screen<br>systems or CR<br>cassettes | Comes with FDA cleared digital x-ray<br>panels.<br>Conventional film and CR<br>cassettes can still be used. . | SAME | Similar<br>Functionality | | Comparable<br>Properties | Predicate Device: K160620 Visaris<br>Vision ® (Vision C, Vision U, Vision V,<br>Vision X) | Acuity (Three models) AcuitySDR<br>Standard; AcuitySDR Plus;<br>AcuityFDR Standard | Comparison<br>Results | | Operator<br>console | GUI-based | SAME | Similar<br>Functionality | | Acquisition<br>Software | Visaris Avanse, K150725, | Customer Selects:<br>AccuVueMED (K152172)<br>AccuVue (K141440) | Equivalent<br>Functionality<br>Only cleared<br>software is<br>supplied. | | Photos | Visaris Vision X | Radmedix AcuitySDR | Similarity is<br>obvious. | | Power Source | AC LINE, single or three phase<br>depending on the generator | SAME | SAME. | | Standards | 60601-1:2005; 60601-1-2:2014<br>60601-2-54 Edition 1.0; PS 3.1 - 3.20<br>(2011) 21CFR1020 | SAME<br>Generators are UL Listed | SAME | {8}------------------------------------------------ # 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 | |------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 19-5 | IEC | 60601-1:2005 | 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 | | 12-274 | IEC | 60601-2-54 Edition 1.0 | Medical Electrical Equipment Part 2-54: Particular Requirements<br>For The Basic Safety And Essential Performance Of X- Ray<br>Equipment For Radiography And Radioscopy [Including: Technical<br>Corrigendum 1 (2010), Technical Corrigendum 2 (2011)] | | 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. All X-ray components (generators, tubes, collimators, and applicable accessories) carry an NRTL certification label (UL, ETL, etc.). The software employed was used unmodified from clearances obtained from FDA. Since {9}------------------------------------------------ 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 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. Generator User Manuals have been updated to add Pediatric Considerations. We also constructed and field tested a complete system and acquired DICOM images from all major body structures, including abdomen, ankle, calcaneus, c-spine ap and c-spine lateral, elbow, foot, knee, hand, lspine ap and I-spine lateral, shoulder, chest, and skull. All images were of high quality and contrast and clinically acceptable. This testing was performed on an AcuitySDR system equipped with the following components: Stand, SYFM SU2100, a Toshiba E7242FXX tube head, a Collimaire CML-125, a Summit L550-31 generator, and a DRTech EVS 4343G digital receptor panel. Each new configuration undergoes a digital image integration protocol and a total system validation protocol prior to make sure that the configuration works as intended. # 6. Clinical testing Not required for a determination of substantial equivalence. # 7. Substantial Equivalence Discussion. The RadmediX Acuity 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. The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors. # 8. Substantial Equivalence Conclusion: After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of RadmediX LLC that the RadmediX Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.