(30 days)
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).
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
The provided document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the way typically found in a clinical performance study for an AI/ML medical device. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and indications for use.
Therefore, many of your specific questions cannot be answered from this content.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the "OTC DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images." The "reported device performance" is essentially that it functions similarly to the predicate device and meets relevant safety and electromagnetic compatibility (EMC) standards.
| Acceptance Criteria Category | Reported Device Performance (as stated in the submission) |
|---|---|
| Indications for Use Equivalence | "SAME Only the name has changed." (Compared to predicate) |
| Functional Equivalence | "The OTC DDR performs the same functions as the predicate..." |
| Technological Equivalence | Uses same imaging components (ULTRA and AeroDR FPD Digital X-Ray Detectors, ULTRA SOFTWARE, Sedecal Generator, Ralco Collimator, AC Line Power Source). The main difference is the tube stand configuration (Overhead Tube Crane vs. Straight Arm). |
| Safety and EMC Standards Compliance | "We performed IEC60601-1 Safety and IEC60601-1-2 EMC testing with satisfactory results." Also complied with IEC 60601-1-3 rev 2.1, IEC 60601-2-54, and NEMA PS 3.1 - 3.20 (DICOM). |
| Image Quality / Product Validation | "Image Quality Testing and Product Validation." "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a performance study on a test set of medical cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert ground truth was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. No MRMC study was conducted or reported. The device is an X-ray system, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an X-ray imaging system, not a standalone AI algorithm. It's a device that produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is primarily based on meeting engineering and safety standards, as well as functional equivalence to the cleared predicate device.
8. The sample size for the training set
Not applicable. This submission doesn't describe an AI training process or dataset.
9. How the ground truth for the training set was established
Not applicable.
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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
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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
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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) |
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510(k) Summary K221853
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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 |
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- 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).
| ComparableProperties | Predicate Straight Arm DDR K214012 | OTC DDR | ComparisonResults |
|---|---|---|---|
| Indications foruse | The Straight Arm DDR is indicated foruse by qualified/trained doctor ortechnician on both adult and pediatricsubjects for taking diagnostic staticand serial radiographic exposures ofthe skull, spinal column, chest,abdomen, extremities, and other bodyparts. Applications can be performedwith the patient sitting, standing, orlying in the prone or supine position(not for mammography). | The OTC DDR is indicated for use byqualified/trained doctor or technician onboth 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. |
| Tubestand/DigitalPanel ReceptorConfiguration | Straight Arm | Overhead tube crane, receptor panel intable and/or wall stand. | Equivalentperformance,difference isin userpreference. |
4. Technological characteristics: Comparison Table presented below.
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| ComparableProperties | Predicate Straight Arm DDR K214012 | OTC DDR | ComparisonResults |
|---|---|---|---|
| Photo | Image: Predicate Straight Arm DDR K214012 | Image: OTC DDR | These arefunctionallyequivalent.The OTCoffers moreflexibility inpatientpositioning. |
| Digital X-RayDetectors | ULTRA and AeroDR FPD | ULTRA and AeroDR FPD | No change |
| Operatorconsole | Windows PC using Windows 10 | SAME | No change. |
| AcquisitionSoftware | ULTRA SOFTWAREDICOM OUTPUT | ULTRA SOFTWAREDICOM 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:
| 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. |
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| FDARecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber And Date | Title Of Standard |
|---|---|---|---|
| 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.
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.
§ 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.