(15 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on hardware components and standard software for controlling x-ray generators.
No
The device is described as an upgrade kit for a digital x-ray system intended for taking diagnostic x-rays, which aligns with diagnostic imaging rather than therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Intended for use... for taking diagnostic x-rays."
No
The device description explicitly states that the upgrade kit includes both software and digital radiography panels, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a "digital x-ray system upgrade kit" used for "taking diagnostic x-rays." This is an imaging modality that works externally to the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "taking diagnostic x-rays," which aligns with imaging, not in vitro testing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOB, LLZ
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical testing: Testing was performed in previous submssions according to the following standards: IEC 60601-1:2005/(R)2012 And A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601 1:2005, MOD); IEC 60601-1-2:2014 Medical Electrical Equipment Part 12: General Requirements For Basic Safety And Essential Performance Collateral Standard: Electromagnetic Disturbances Requirements And Tests; 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K192400, K193017, K171137, K162552, K162555
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 % 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
1
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
2
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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3
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
-
- 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:
- 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.
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
4
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.
-
- 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
Properties | AcuityPDR K200726 | Accuvue+, K201058 | Comparison
Results |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 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. | Intended for use by a
qualified/trained physician or
technician on both adult and
pediatric subjects for taking
diagnostic x-rays. Not for
mammography. | Identical |
| X-ray tube | TOSHIBA ELECTRON
TUBES & DEVICES
CO., LTD D-125SB 100kV, 40mA | Depends on Tube Head/Stand
Chosen. | Equivalent
Functionality |
| Collimator | Built in | Depends on Tube Head/Stand
Chosen. | Equivalent
Functionality |
| X-ray Generator | One model, up to 100 kVp | Supplied by User: CPI or
Sedecal | Equivalent
Functionality |
| Software
Control of
Technique
Factor | Not available | Possible for certain CPI or
Sedecal Generators (Validated
previously). See below. | Better
functionality |
| Digital X-Ray
Detectors | 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 |
| Operator
console | Windows PC using Windows 10-IoT | SAME | SAME |
| Acquisition
Software | Customer Selects:
AccuVueMED (K152172)
AccuVue (K141440) or
AccuVue+ (K130883) | AccuVue+ (only) | Equivalent
Functionality
Only cleared
software is
supplied. |
| Power Source | AC Line or rechargeable batteries | AC Line only. | SAME. |
| Standards | Same as below | See below | SAME |
4. Technological characteristics: Comparison Table
5
- Non clinical testing: Testing was performed in previous submssions according to the following standards:
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | 60601-1:2005/(R)2012
And A1:2012 | Medical Electrical Equipment Part 1: General Requirements For
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
Basic 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.