Straight Arm DDR

K214012 · Konica Minolta Healthcare Americas, Inc. · KPR · Jan 12, 2022 · Radiology

Device Facts

• Record ID: K214012
• Device Name: Straight Arm DDR
• Applicant: Konica Minolta Healthcare Americas, Inc.
• Product Code: KPR · Radiology
• Decision Date: Jan 12, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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).

Device Story

Straight Arm DDR is a stationary digital radiography system for diagnostic imaging. It captures static and sequential (Dynamic Digital Radiography) X-ray images. System components include an X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient table, and digital acquisition station running ULTRA software. Operated by qualified doctors or technicians in clinical settings. The device uses a straight arm configuration for patient positioning (sitting, standing, prone, or supine). The system transforms X-ray inputs into digital images via the acquisition station, which are then reviewed by healthcare providers to support clinical decision-making. Benefits include workflow efficiency and dose management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including image quality testing, product validation, and electrical safety/EMC testing per IEC 60601 standards.

Technological Characteristics

Stationary X-ray system; straight arm configuration. Components: X-ray tube, generator (CPI or Sedecal), collimator (Ralco R225), digital panel detector (AeroDR FPD). Connectivity: DICOM output. Software: ULTRA software. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, NEMA PS 3.1-3.20.

Indications for Use

Indicated for adult and pediatric patients for diagnostic static and serial radiographic exposures of the skull, spine, chest, abdomen, and extremities. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KDR™ AU-DDR System (K193225)

Reference Devices

• Straight arm assembly (K062335)
• ULTRA software (K212291)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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: | [e-mail] |
| 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 |

- 2. 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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- 3. 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<br>Properties | Predicate KDRTM AU-DDR K193225 | Straight Arm DDR | Comparison<br>Results |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications<br>for use | The KDRTM AU-DDR System Advanced U-Arm with Dynamic Digital Radiography<br>and KDRTM AU System Advanced U-Arm<br>with Static Digital Radiography is<br>indicated for use by qualified/trained<br>doctor or technician on both adult and<br>pediatric subjects for taking diagnostic<br>static and serial radiographic exposures<br>of the skull, spinal column, chest,<br>abdomen, extremities, and other body<br>parts. Applications can be performed<br>with the patient sitting, standing, or<br>lying in the prone or supine<br>position (not for mammography). | The Straight Arm DDR is indicated for use<br>by qualified/trained doctor or technician<br>on both adult and pediatric subjects for<br>taking diagnostic static and serial<br>radiographic exposures of the skull,<br>spinal column, chest, abdomen,<br>extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the<br>prone or supine position (not for<br>mammography). | SAME<br>Only the<br>name has<br>changed. |
| Integrated<br>Tube<br>stand/Digital<br>Panel Receptor<br>Configuration | U-Arm | Straight Arm | Equivalent<br>performance,<br>difference is<br>in user<br>preference. |
| Photo | Image: U-Arm X-Ray Machine | Image: Straight Arm X-Ray Machine | These are<br>functionally<br>equivalent |
| Digital X-Ray<br>Detectors | ULTRA and AeroDR FPD | ULTRA and AeroDR FPD | No change |
| Operator<br>console | Windows PC using Windows 10 | SAME | No change. |
| Comparable<br>Properties | Predicate KDR™ AU-DDR K193225 | Straight Arm DDR | Comparison<br>Results |
| Acquisition<br>Software | ULTRA SOFTWARE<br>DICOM OUTPUT | ULTRA SOFTWARE<br>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.

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# 5. Non clinical testing: Testing was performed according to the following standards:

| FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | ES60601-1:2005/(R)2012 and<br>A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012<br>(Consolidated Text) | Medical Electrical Equipment Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601 1:2005, MOD) |
| 19-8 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General<br>Requirements For Basic Safety And Essential<br>Performance Collateral Standard: Electromagnetic<br>Disturbances Requirements And Tests |
| 12-269 | IEC | 60601-1-3 rev 2.1 | Collateral Standard: Radiation protection in<br>diagnostic X-ray equipment. |
| 12-317 | IEC | IEC 60601-2-54, 1.2 2018-06<br>CONSOLIDATED VERSION | Particular requirements for the basic safety and<br>essential performance of X-ray equipment for<br>radiography and radioscopy. |
| 12-300 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in<br>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.

6. 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.