(21 days)
No
The summary describes a modification to a digital radiography system, primarily changing the physical arm from U-shaped to straight. It explicitly states the software remains unchanged from a previously cleared version and there are no mentions of AI, ML, or related concepts like training/test sets.
No.
The device is indicated for diagnostic imaging purposes, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "for taking diagnostic static and serial radiographic exposures."
No
The device description explicitly lists multiple hardware components including an X-ray tube, positioner, generator, and a physical "Straight arm" assembly, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Straight Arm DDR is an X-ray system used for taking radiographic images of the body. It directly interacts with the patient to produce images, rather than analyzing samples taken from the patient.
- Intended Use: The intended use clearly states it's for "taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts." This is a diagnostic imaging function, not an in vitro diagnostic function.
- Device Description: The components listed (X-ray tube, positioner, generator, etc.) are all typical components of an X-ray imaging system.
Therefore, based on the provided information, the Straight Arm DDR is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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).
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic exposures
Anatomical Site
skull, spinal column, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor 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 according to the following standards:
- IEC ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - 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
- IEC 60601-1-3 rev 2.1 - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC IEC 60601-2-54, 1.2 2018-06 CONSOLIDATED VERSION - Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
- 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 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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
January 12, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & 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.
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.
1
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
2
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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3
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.
4
-
- 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).
| Comparable
Properties | Predicate KDRTM AU-DDR K193225 | Straight Arm DDR | Comparison
Results |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications
for use | The KDRTM AU-DDR System Advanced U-Arm with Dynamic Digital Radiography
and KDRTM AU System Advanced U-Arm
with Static Digital Radiography 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). | 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). | SAME
Only the
name has
changed. |
| Integrated
Tube
stand/Digital
Panel Receptor
Configuration | U-Arm | Straight Arm | Equivalent
performance,
difference is
in user
preference. |
| Photo | Image: U-Arm X-Ray Machine | Image: Straight Arm X-Ray Machine | These are
functionally
equivalent |
| Digital X-Ray
Detectors | ULTRA and AeroDR FPD | ULTRA and AeroDR FPD | No change |
| Operator
console | Windows PC using Windows 10 | SAME | No change. |
| Comparable
Properties | Predicate KDR™ AU-DDR K193225 | Straight Arm DDR | Comparison
Results |
| Acquisition
Software | ULTRA SOFTWARE
DICOM OUTPUT | ULTRA SOFTWARE
DICOM 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.
5
5. Non clinical testing: Testing was performed according to the following standards:
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) | Medical Electrical Equipment Part 1: General
Requirements For Basic Safety And Essential
Performance (IEC 60601 1:2005, MOD) |
| 19-8 | 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 |
| 12-269 | IEC | 60601-1-3 rev 2.1 | Collateral Standard: Radiation protection in
diagnostic X-ray equipment. |
| 12-317 | IEC | IEC 60601-2-54, 1.2 2018-06
CONSOLIDATED VERSION | Particular requirements for the basic safety and
essential performance of X-ray equipment for
radiography and radioscopy. |
| 12-300 | 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 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.
6
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.