(21 days)
The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).
This submission is for a MODIFICATION to our predicate device. Instead of supplying a "U-shaped" arm we will be supplying a "Straight" arm. The other components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The Straight Arm DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The straight arm assembly was originally cleared in K062335. The ULTRA software was most recently cleared in K212291 and has not been changed from the cleared version.
The provided text describes a 510(k) premarket notification for a medical device called "Straight Arm DDR." This is a modification to an existing predicate device (KDR™ AU-DDR System) where the only change is the physical arm configuration from a "U-shaped" arm to a "Straight" arm. The software (ULTRA) and other core components remain unchanged.
Given this context, the acceptance criteria and study described will focus on demonstrating that this mechanical modification does not negatively impact the safety and effectiveness of the device as an X-ray system. This is not a submission for an AI/ML medical device, so the detailed criteria typically associated with AI/ML algorithm performance (e.g., sensitivity, specificity, MRMC studies) are not applicable here.
Here's an interpretation based on the provided information, focusing on the demonstrated substantial equivalence for a modified X-ray system:
Acceptance Criteria and Device Performance for Straight Arm DDR (K214012)
For this type of device modification (physical change to an existing X-ray system), the acceptance criteria primarily revolve around demonstrating that the modified device remains safe, effective, and performs equivalently to the predicate device, especially in terms of image quality and adherence to relevant safety and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments/Proof |
|---|---|---|---|
| Safety & Essential Performance | Adherence to IEC 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance) | "IEC60601-1 Safety...testing with satisfactory results." | Non-clinical testing results. |
| Electromagnetic Compatibility (EMC) | Adherence to IEC 60601-1-2:2014 (Medical Electrical Equipment - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests) | "IEC60601-1-2 EMC testing with satisfactory results." | Non-clinical testing results. |
| Radiation Protection | Adherence to IEC 60601-1-3 rev 2.1 (Collateral Standard: Radiation protection in diagnostic X-ray equipment) | Testing performed according to the standard. | Assumed satisfactory results as no issues were reported. |
| Particular Safety/Performance for X-ray Equipment | Adherence to IEC 60601-2-54, 1.2 2018-06 (Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy) | Testing performed according to the standard. | Assumed satisfactory results as no issues were reported. |
| Image Quality | Maintain comparable image quality to the predicate device. | "Image Quality Testing... performed." "The Straight Arm DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images." | Non-clinical testing results, though specific metrics are not provided in this summary. The inference is that image quality was maintained as it shares the same digital panel software and overall imaging chain. |
| Product Validation & Functional Testing | Full functional testing of the assembled system. Proper integration of components (generators, panels). | "Product validation consisted of assembling and fully functionally testing the entire system." "Each system is tested for proper integration prior to shipment to the customer." "service engineers fully test each new system upon installation at the customer site." | Post-assembly and installation testing. |
| Software Functionality | ULTRA software functions as previously cleared (K212291) and remains unmodified. | "The ULTRA software was most recently cleared in K212291 and has not been changed from the cleared version." "The digital panel software employed was used unmodified from the predicate. The software has been previously validated as a control for Sedecal diagnostic x-ray generators." | Validation by prior clearance; no changes made. |
| DICOM Compatibility | Adherence to NEMA PS 3.1 - 3.20 (2011) (NEMA Digital Imaging and Communications in Medicine (DICOM) Set) | "DICOM OUTPUT" is identical to predicate. | No change from predicate; adherence through non-clinical testing. |
| Clinical Indications for Use | Same as predicate device. | "SAME Only the name has changed." (for Indications for Use) | Direct comparison table confirms identical indications. |
| Technological Characteristics | Substantially equivalent to predicate device. | All comparable properties (Digital X-Ray Detectors, Operator console, Acquisition Software, Generator, Collimator, Power Source) are "No change" or "SAME" compared to predicate. The arm configuration is "Equivalent performance, difference is in user preference." | Comparison table. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Nature: This submission primarily relies on non-clinical engineering and performance testing of the device components and the integrated system, rather than a clinical "test set" of patient data like an AI/ML algorithm would use.
- Sample Size: Not applicable in the sense of patient data. The "sample" is the physical device itself, prototypes, or test configurations.
- Data Provenance: Not applicable as it's not a data-driven AI/ML study. The testing is conducted on the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Ground Truth Establishment: Not applicable for establishing "ground truth" in the diagnostic sense (e.g., disease presence). The "ground truth" here is adherence to engineering standards and functional performance.
- Expert Oversight: The testing described would be supervised by qualified design, quality, and regulatory engineers within Konica Minolta Healthcare Americas, Inc., and assessed by regulatory bodies like the FDA. Their qualifications would be in medical device engineering, quality assurance, regulatory affairs, and X-ray system design/functionality.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical images. Performance is measured against engineering specifications and regulatory standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC study was not done.
- Reason: This submission is for a physical modification of an X-ray system, not an AI/ML algorithm intended to assist human readers in diagnosis. Clinical performance was deemed "Not required for a determination of substantial equivalence" because the core imaging technology and software remained unchanged from the previously cleared predicate, and the physical modification ("Straight Arm" vs "U-Arm") was considered to have equivalent performance for image acquisition.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. This is a medical imaging hardware system with integrated control software, not an AI/ML algorithm whose performance would be assessed in isolation. The software component ("ULTRA") was previously cleared and is used unmodified.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is primarily engineering specifications, international performance standards (e.g., IEC standards), and functional requirements for X-ray systems.
- For safety and performance, the ground truth is defined by the passing criteria of the listed IEC standards (e.g., "satisfactory results" for IEC60601-1 and IEC60601-1-2).
- For image quality, the ground truth would be comparison to the expected output from the predicate device and the quality deemed acceptable for diagnostic imaging.
- For functionality, the ground truth is the successful operation of all components and the system as a whole.
8. The Sample Size for the Training Set
- Training Set: Not applicable. This is not an AI/ML device that requires a training set of data. The "training" for this device's development comes from established engineering principles and past validated designs.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. See point 8.
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January 12, 2022
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Konica Minolta Healthcare Americas, Inc % Jan Maniscalco Director of QA/RA 2217 US Highway 70 East GARNER NC 27529
Re: K214012
Trade/Device Name: Straight Arm DDR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 21, 2021 Received: December 22, 2021
Dear Jan Maniscalco:
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. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K214012
Device Name Straight Arm DDR
Indications for Use (Describe)
The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).
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 K214012
Image /page/3/Picture/1 description: The image shows the Konica Minolta logo. The logo features a blue sphere with several horizontal white lines running across the center. The sphere appears to be a gradient of blue, with lighter shades at the top and darker shades at the bottom, giving it a three-dimensional appearance.
KONICA MINOLTA
Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 East Garner, NC 27529 1-800-366-5343
1. Administrative Information
Reason for Submission: 510(k) Notification for Straight Arm DDR, a modified device.
| Submitter: | |
|---|---|
| Submission contact person: | Jan Maniscalco, Executive Vice President of QA/RA |
| Contact telephone: | 973.633.1500 |
| Contact e-mail: | jan.maniscalco@konicaminolta.com |
| Date prepared: | January 4, 2022 |
| Identification: | Straight Arm DDR |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
| Substantially equivalent device: | |
| Trade Name: | KDR™ AU-DDR System |
| Manufacturer: | Konica Minolta Healthcare Americas, Inc |
| 510(k) #: | K193225 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
-
- Device description: This submission is for a MODIFICATION to our predicate device. Instead of supplying a "U-shaped" arm we will be supplying a "Straight" arm. The other components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The Straight Arm DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The straight arm assembly was originally cleared in K062335. The ULTRA software was most recently cleared in K212291 and has not been changed from the cleared version.
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-
- Indications for Use: The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).
| ComparableProperties | Predicate KDRTM AU-DDR K193225 | Straight Arm DDR | ComparisonResults |
|---|---|---|---|
| Indicationsfor use | The KDRTM AU-DDR System Advanced U-Arm with Dynamic Digital Radiographyand KDRTM AU System Advanced U-Armwith Static Digital Radiography isindicated for use by qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticstatic and serial radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and other bodyparts. Applications can be performedwith the patient sitting, standing, orlying in the prone or supineposition (not for mammography). | The Straight Arm DDR is indicated for useby qualified/trained doctor or technicianon both adult and pediatric subjects fortaking diagnostic static and serialradiographic exposures of the skull,spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position (not formammography). | SAMEOnly thename haschanged. |
| IntegratedTubestand/DigitalPanel ReceptorConfiguration | U-Arm | Straight Arm | Equivalentperformance,difference isin userpreference. |
| Photo | Image: U-Arm X-Ray Machine | Image: Straight Arm X-Ray Machine | These arefunctionallyequivalent |
| Digital X-RayDetectors | ULTRA and AeroDR FPD | ULTRA and AeroDR FPD | No change |
| Operatorconsole | Windows PC using Windows 10 | SAME | No change. |
| ComparableProperties | Predicate KDR™ AU-DDR K193225 | Straight Arm DDR | ComparisonResults |
| AcquisitionSoftware | ULTRA SOFTWAREDICOM OUTPUT | ULTRA SOFTWAREDICOM OUTPUT | No change. |
| Generator | CPI or Sedecal | CPI or Sedecal | No change |
| Collimator | Ralco R225/R225 DHHS | Ralco R225/R225 DHHS | No change |
| Power Source | AC Line | AC Line | No change |
| Standards | Same as below | See below | No change |
4. Technological characteristics: Comparison Table presented below.
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5. Non clinical testing: Testing was performed according to the following standards:
| FDARecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber And Date | Title Of Standard |
|---|---|---|---|
| 19-4 | IEC | ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) | Medical Electrical Equipment Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601 1:2005, MOD) |
| 19-8 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: GeneralRequirements For Basic Safety And EssentialPerformance Collateral Standard: ElectromagneticDisturbances Requirements And Tests |
| 12-269 | IEC | 60601-1-3 rev 2.1 | Collateral Standard: Radiation protection indiagnostic X-ray equipment. |
| 12-317 | IEC | IEC 60601-2-54, 1.2 2018-06CONSOLIDATED VERSION | Particular requirements for the basic safety andessential performance of X-ray equipment forradiography and radioscopy. |
| 12-300 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications inMedicine (DICOM) Set |
The digital panel software employed was used unmodified from the predicate. The software has been previously validated as a control for Sedecal diagnostic x-ray generators.
The following testing was performed:
Image Quality Testing and Product Validation.
Product validation consisted of assembling and fully functionally testing the entire system.
The proposed compatible generator carries NRTL (UL) 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 shipment 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.
We performed IEC60601-1 Safety and IEC60601-1-2 EMC testing with satisfactory results.
- Clinical testing. Not required for a determination of substantial equivalence.
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7. Substantial Equivalence Discussion.
The Straight Arm DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the KDR™ AU-DDR and the Straight Arm DDR 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 Konica Minolta that the Straight Arm DDR 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.