(112 days)
The purpose of AcuityUDR 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 both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 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 of device may include signal analysis and display equipment supports, comports, component parts, and accessories.
The provided text is a 510(k) summary for the RadmediX AcuityUDR, which is a stationary X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.
Here's what can be extracted based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for image quality or clinical performance. Instead, it refers to compliance with recognized standards and successful non-clinical testing.
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Inferred/General) |
|---|---|
| Compliance with IEC 60601-1:2005 + A1:2012 + A2:2020 (Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance) | Successfully performed |
| Compliance with IEC 60601-1-2:2014 (Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance Collateral Standard: Electromagnetic Disturbances Requirements And Tests) | Successfully performed |
| Compliance with CDRH performance standards for X-ray components | All components subject to CDRH performance standard are certified to comply. |
| Production of high-quality, high-contrast, and clinically acceptable DICOM images for various body structures | All images were of high quality and contrast and clinically acceptable. |
| Proper functioning of new configurations after digital image integration and total system validation protocol | Each new configuration undergoes these protocols prior to shipment to ensure it works as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The non-clinical testing involved acquiring DICOM images "from all major body structures." This implies a set of images, but a specific number is not provided.
- Data Provenance: Not explicitly stated. It describes "field tested a complete system" with images acquired from various body structures. This suggests either phantom studies or possibly human subject studies, but the nature (retrospective/prospective, country of origin) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text. The document states that the acquired images were "clinically acceptable," but it does not specify who made this determination, how many experts were involved, or their qualifications.
4. Adjudication method for the test set:
This information is not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device is a stationary X-ray system, not an AI-powered diagnostic tool. The document states, "Clinical testing: Not required for a determination of substantial equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a hardware X-ray system with accompanying image acquisition software, not a standalone AI algorithm for interpretation. The software "communicates with the digital x-ray detector and allows acquisition and processing of x-ray images."
7. The type of ground truth used:
The text states that the non-clinical testing involved acquiring images that were "of high quality and contrast and clinically acceptable." This implies expert consensus or visual assessment of image quality was used as a form of ground truth, but the specifics of how this was established are not detailed. There is no mention of pathology or outcomes data being used for this device's non-clinical testing.
8. The sample size for the training set:
The concept of a "training set" is not applicable as the device is a hardware X-ray system with image acquisition software, not a machine learning or AI-based diagnostic algorithm that requires a training set. The software is "previously cleared" and "used unmodified."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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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 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.
October 25, 2023
Radmedix LLC % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct NAPLES, FL 34114
Re: K231995
Trade/Device Name: AcuityUDR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: September 24, 2023 Received: September 25, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality
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Indications for Use
510(k) Number (if known) K231995
Device Name AcuityUDR
Indications for Use (Describe)
The purpose of AcuityUDR 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 both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K231995
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 smaller font size and in black. The "R" and "X" are also in a larger font size than the "admedi". The logo has a professional and modern look.
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 RadmediX AcuityUDR, 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: | September 24, 2023 |
ldentificatio
| Identification: | |
|---|---|
| Trade/Device Name: | AcuityUDR |
| Regulation Number: | 21 CFR 892.1680 |
| Regulation Name: | Stationary x-ray system |
| Regulatory Class: | Class II |
| Product Code: | KPR, MQB |
Substantially equivalent device:
Manufacturer: Trade/Device Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:
RadmediX LLC Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard 21 CFR 892.1680 Stationary x-ray system Class II KPR, MQB
Reference devices:
| (1) K201043 | |
|---|---|
| Manufacturer: | iRay Technology Taicang Ltd. |
| Trade/Device Name: | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI) |
| Regulation Number: | 21 CFR 892.1680 |
| Regulation Name: | Stationary x-ray system |
| Regulatory Class: | Class II |
| Product Code: | MQB |
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| (2) K210919 | |
|---|---|
| Manufacturer: | RadmediX LLC |
| Trade/Device Name: | AcuityDRe |
| Regulation Number | 21 CFR 892.1680 |
| Product Code | MQB |
| Subsequent Product Code | LLZ |
2. Device description: 21 CFR 807 92 (a) (4)
RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software.. 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 of device may include signal analysis and display equipment supports, comports, component parts, and accessories.
The major component combining these into a complete solution is the tube stand is UL Listed, file number E309191. 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, step stools, 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.
Image /page/4/Figure/4 description: The image shows a white X-ray machine. The machine has a digital display screen with a user interface. There are two knobs below the screen. The machine has a long, flexible tube that connects the X-ray source to the detector. The detector is located at the bottom of the machine and has a red button.
Radmedix AcuityUDR
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Radmedix provides a previously cleared digital x-ray detector. The panel enclosure can support other similarly sized detectors.
The previously cleared software supplied with the system is AccuVue (K210919). 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.
Available Generators (Unchanged from Predicate)
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 (Unchanged from Predicate)
CML-150-0001-C, 150kVp Certified Manual Collimator or CML-125-0001-C, 125kVp Collimare, LLC Certified Manual Collimator
X-Ray Tube Housing: Canon (Unchanged from Predicate)
The purchaser selects one of these: Canon E7239FX tube Canon E7242FX tube Canon E7252FX tube
3. Indications for Use: 21 CFR 807 92 (a) (5)
The purpose of AcuityUDR is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.
4. Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table
| ComparableProperties | Acuity (Three models) AcuitySDRStandard; AcuitySDR Plus; AcuityFDRStandard K193360 | AcuityUDR | Comparison Results |
|---|---|---|---|
| Indicationsfor use | The purpose of Acuity is to acquire,store, communicate, display andprocess medical X-ray images. Theseradiographic systems are intendedfor use by a qualified/trainedphysician or technician on both adultand pediatric subjects for takingdiagnostic x-rays. Not formammography, angiography,interventional, or fluoroscopy use. | The purpose of AcuityUDR is toacquire, store, communicate, displayand process medical X-ray images.These radiographic systems areintended for use by a qualified/trainedphysician or technician on both adultand pediatric subjects for takingdiagnostic x-rays. Not formammography, angiography,interventional, or fluoroscopy use. | Identical |
| Wall stand | Motorized vertical movable wallstand, tiltable tray. | Motorized vertical movable wall stand,tiltable tray. | SAME |
| ComparableProperties | Acuity (Three models) AcuitySDRStandard; AcuitySDR Plus; AcuityFDRStandard K193360 | AcuityUDR | Comparison Results |
| X-ray tube | 150 kVp 0.6/1.2mm focal spots.Canon | SAME | SAME |
| Collimator | Collimaire collimators, all CFRCertified (510(k) exempt) | SAME | SAME |
| X-rayGenerator | Various Models available: (All HF, AllCFR Certified):Summit models from 40 to 50 kWCPI generators up to 80 kW areavailable optionally. (510(k) exempt) | Various Models available: (All HF, AllCFR Certified):Summit models from 40 to 50 kWCPI generators up to 80 kW areavailable optionally. (510(k) exempt) | SAME |
| Wirelessdetector | Enclosure allows for 14" x 17" or 17"x 17" fixed and removable FDAcleared detectors and software. | Includes a 17" x 17" FDA clearedwireless detector, K201043. | EquivalentFunctionality |
| Conventionalfilm/screensystems orCR cassettes | Comes with FDA cleared digital x-raypanels. Conventional film and CRcassettes can still be used | SAME | SAME |
| Operatorconsole | GUI-based | GUI-based | SAME |
| AcquisitionSoftware | Customer Selects:AccuVueMED (K152172)AccuVue (K141440) | Accuvue software, most recentlycleared in K210919. | EquivalentFunctionality Onlyclearedsoftware issupplied. |
| Photos | Image: Radmedix AcuitySDR | Image: Radmedix AcurityUDR | Similarityis obvious. |
| PowerSource | AC LINE, single or three phasedepending on the generator | SAME | SAME. |
| ComparableProperties | Acuity (Three models) AcuitySDRStandard; AcuitySDR Plus; AcuityFDRStandard K193360 | AcuityUDR | Comparison Results |
| Standards | 60601-1:2005; 60601-1-2:201460601-2-54 Edition 1.0; PS 3.1 - 3.20(2011) 21CFR1020 | Updated standards | SAME |
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5. Non clinical testing
Testing on the changed component (the tube stand) was performed successfully according to the following standards:
| FDARecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber And Date | Title Of Standard |
|---|---|---|---|
| 19-49 | IEC | IEC 60601-1:2005 +A1:2012 + A2:2020 | Medical Electrical Equipment Part 1: General Requirements ForBasic Safety And Essential Performance |
| 19-8 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General Requirements ForBasic Safety And Essential Performance Collateral Standard:Electromagnetic Disturbances Requirements And Tests |
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. 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 were previously 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 AcuityUDR system equipped with the following components: Stand, (SYFM), a Canon E7242FXX tube head, a Collimaire CML-125, a Summit L550-31 generator, and an iRay Technology Taicang Ltd. digital receptor panel. Each new configuration undergoes a digital image integration protocol and a total system validation protocol prior to shipment 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 AcuityUDR performs the same functions using the same technological methods to produce diagnostic x-ray images as the predicate. In all material aspects, the two 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.
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8. Substantial Equivalence Conclusion:
After analyzing standards test results, risk analysis, and image evaluation (performed on every system after assembly and prior to shipment), it is the conclusion of RadmediX LLC that the RadmediX AcuityUDR System 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.
§ 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.