(30 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and existing software.
No
The device is described as taking diagnostic radiographic exposures, indicating it is used for imaging and diagnosis, not for treating a disease or condition.
Yes
The device is an "OTC DDR" (Overhead Tube Crane Digital Radiography) system used for "taking diagnostic static and serial radiographic exposures." The "Intended Use / Indications for Use" explicitly states its purpose is for diagnostic imaging.
No
The device description explicitly lists multiple hardware components (X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and digital x-ray acquisition station) and the submission is for a modification to a hardware component (tube stand to overhead tube crane). While software is mentioned, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a digital radiography system that takes X-ray images of various body parts. It is used for diagnostic imaging, not for testing biological samples.
- Intended Use: The intended use is for taking radiographic exposures of the skull, spinal column, extremities, and other body parts. This is a direct imaging function, not an in vitro test.
- Components: The components listed (X-ray tube, positioner, generator, etc.) are all typical of an X-ray imaging system, not an IVD.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OTC 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
KPR, MQB
Device Description
This submission is for a MODIFICATION to our predicate device. Instead of supplying a straight arm tube stand we be supplying an overhead tube crane. The imaging components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The OTC 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-rav generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The ULTRA software was most recently cleared in K214012 and has not been changed from the cleared version
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
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
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
Not Found
Predicate Device(s)
Reference Device(s)
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
July 27, 2022
Image /page/0/Picture/1 description: The image shows the logo for 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.
Konica Minolta Healthcare Americas, Inc % Jan Maniscalco Director of QA/RA 2217 US Highway 70 East GARNER NC 27529
Re: K221853
Trade/Device Name: OTC DDR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: June 24, 2022 Received: June 27, 2022
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. 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 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
1
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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K221853
Device Name OTC DDR
Indications for Use (Describe)
The OTC 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K221853
Image /page/3/Picture/1 description: The image shows a blue circle with several horizontal white lines across the middle. The circle has a gradient effect, with the top being lighter and the bottom being darker. The white lines are evenly spaced and appear to be slightly curved, following the contour of the circle. The overall design is simple and modern.
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 OTC 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: | July 19, 2022 |
| Identification: | |
| Classification Name: | OTC DDR |
| Classification Panel: | Stationary X-Ray System |
| Classification Regulation: | Radiology |
| Device Class: | 21 CFR §892.1680 |
| Product Code: | Class II |
| KPR, MQB | |
| Substantially equivalent device: | |
| Trade Name: | Straight Arm DDR System |
| Manufacturer: | Konica Minolta Healthcare Americas, Inc |
| 510(k) #: | K214012 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
| Reference device: | The Overhead Tube Crane, Table, and Wall Stand components were previously cleared in: |
| Trade Name: | Radiographic System Challenge X |
| Manufacturer: | Sedecal SA |
| 510(k) #: | K202293 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
4
- Device description: This submission is for a MODIFICATION to our predicate device. Instead of 2. supplying a straight arm tube stand we be supplying an overhead tube crane. The imaging components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The OTC 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-rav generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The ULTRA software was most recently cleared in K214012 and has not been changed from the cleared version
- Indications for Use: The OTC DDR is indicated for use by qualified/trained doctor or technician on both 3. 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 Straight Arm DDR K214012 | OTC DDR | Comparison
Results |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 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). | The OTC 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. |
| Tube
stand/Digital
Panel Receptor
Configuration | Straight Arm | Overhead tube crane, receptor panel in
table and/or wall stand. | Equivalent
performance,
difference is
in user
preference. |
4. Technological characteristics: Comparison Table presented below.
5
| Comparable
Properties | Predicate Straight Arm DDR K214012 | OTC DDR | Comparison
Results |
|----------------------------|-------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Photo | Image: Predicate Straight Arm DDR K214012 | Image: OTC DDR | These are
functionally
equivalent.
The OTC
offers more
flexibility in
patient
positioning. |
| Digital X-Ray
Detectors | ULTRA and AeroDR FPD | ULTRA and AeroDR FPD | No change |
| Operator
console | Windows PC using Windows 10 | SAME | No change. |
| Acquisition
Software | ULTRA SOFTWARE
DICOM OUTPUT | ULTRA SOFTWARE
DICOM OUTPUT | No change. |
| Generator | Sedecal | 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 |
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. |
6
| FDA
Recognition
Number | Standard
Developing
Organization | Standard Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------|
| 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.
7. Substantial Equivalence Discussion.
The OTC DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Straight Arm DDR and OTC 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 OTC 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.