The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.

The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.

Device Description

The digital radiography SKR 3000 performs X-ray imaging of the human body using an Xray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.

This device is not intended for use in mammography
This device is also used for carrying out exposures on children.

The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. The CS-7 is a software with Moderate level of concern. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation correction - (Intelligent-Grid). The Intelligent-Grid is cleared in K151465. The CS-7 modifications have been made for a wireless serial radiography.

The SKR 3000 is distributed under a commercial name AeroDR 3.

This submission is to introduce a wireless serial radiography into the SKR 3000 system. The wireless serial radiography function of P-65 / P-75 used with Phoenix was cleared under K221803. These detectors are wireless and their serial radiography functions are not being controlled by the x-ray generator. Hence no detector integration testing is necessary.

AI/ML Overview

The provided text is a 510(k) Summary for the Konica Minolta SKR 3000 device, which is a digital radiography system. This document focuses on demonstrating substantial equivalence to a predicate device (K213908), rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert involvement, or statistical analysis.

The document states that the changes made to the SKR 3000 (specifically the addition of wireless serial radiography for P-65 and P-75 detectors) did not require clinical studies. Therefore, the information requested about a study demonstrating the device meets acceptance criteria regarding clinical performance is not available in this filing. The "Performance Data" section primarily addresses compliance with electrical safety and EMC standards.

However, based on the information provided, here's what can be extracted and inferred regarding "acceptance criteria" in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study specific to this submission's modifications is presented, the "acceptance criteria" here relate to general regulatory and technical compliance rather than clinical performance metrics (e.g., sensitivity, specificity for a particular pathology). The "reported device performance" is essentially a statement of compliance.

Acceptance Criteria Category	Reported Device Performance
Safety and Effectiveness	"The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K213908)."
Performance to Specifications	"Performance tests demonstrate that the SKR 3000 performs according to specifications and functions as intended."
Compliance with Standards	"The SKR 3000 is designed to comply with the following standard; AAMI/ANSI ES 60601-1 (Ed.3.1) and IEC 60601-1-2 (Ed.4.0)." (General electrical safety and electromagnetic compatibility standards are met.)
Risk Analysis	"The verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the subject device modifications."
Functional Equivalence (Wireless Radiography)	The submission implies that the newly added wireless serial radiography functions (P-65 / P-75) are functionally equivalent to the wired serial radiography functions of the predicate device, especially since "no detector integration testing is necessary" because "their serial radiography functions are not being controlled by the x-ray generator."

Note: This table reflects the nature of a 510(k) submission focused on substantial equivalence rather than a clinical performance study.

Here's the breakdown for the other requested information, based on the limitations of the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document states that "The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the subject device modifications." This indicates that no clinical "test set" with patient data was used for this specific submission. The performance assessment was based on non-clinical testing (e.g., engineering verification, validation testing to internal specifications and regulatory standards).

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. As no clinical study or test set with patient data was conducted or analyzed, there were no experts establishing ground truth for performance metrics like diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

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. This submission is for a digital radiography system, not an AI-powered diagnostic aide. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an imaging system, not an algorithm for standalone diagnosis. The "performance tests" mentioned are related to the hardware and software functionality of the imaging system itself (e.g., image quality specifications, electrical safety, EMC), not an algorithm's diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the purpose of this 510(k) filing for device modifications, the "ground truth" for performance was implicitly defined by the compliance with engineering specifications, safety standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2), and the functional equivalence to the predicate device. No clinical ground truth (e.g., pathology, outcomes) was established for this submission.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the sense of patient data for learning.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML algorithm.

Summary

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November 17, 2022

Image /page/0/Picture/1 description: The image shows the logo of 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 consists of 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, Inc. % Jan Maniscalco Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike WAYNE NJ 07470

Re: K223267

Trade/Device Name: SKR 3000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: October 24, 2022 Received: October 24, 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 medical devices and radiation-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,

Zhkke

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) K223267

Device Name SKR 3000

Indications for Use (Describe)

The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.

The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.

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 K223267

Company:	KONICA MINOLTA, INC.
	1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan
Contact:	Tsutomu FukuiSenior Manager of Regulatory & QMS DivisionQuality Assurance OperationsHealthcare Business HeadquartersTelephone: +81 42 589 8429Email: tsutomu.fukui1@konicaminolta.com
Date Prepared:	November 04, 2022
Device Name:	SKR 3000
Common Name:	Digital Radiography
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary x-ray system
Regulatory Class:	Class II
Product Code(s):	MQB, LLZ
Predicate Device:	K213908 - SKR 3000 (KONICA MINOLTA, INC.)
	Regulation Number: 21 CFR 892.1680
	Regulation Name: Stationary x-ray system
	Regulatory Class: Class II
	Product Codes: MQB, LLZ
Reference Device:	K221803 - PHOENIX/AeroDR TX m01 andPHOENIX/mKDR Xpress (SEDECAL SA)
	Regulation Number: 21 CFR 892.1720
	Regulation Name: Mobile x-ray system
	Regulatory Class: Class II
	Product Codes: IZI, MQB

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Device Description

This device is not intended for use in mammography
This device is also used for carrying out exposures on children.

The SKR 3000 is distributed under a commercial name AeroDR 3.

Indications for Use

This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures.

This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

Comparison Table

The comparison to the predicate device was summarized in the table blow.

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	Subject Device	Predicate Device
Device Name	SKR 3000	SKR 3000
510(K) Number	K223267	K213908
Indications for Use	This device is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended to replace areplace radiographic film/screensystem in general-purpose diagnosticprocedures.This device is not indicated for use inmammography, fluoroscopy, andangiography applications.	This device is indicated for use ingenerating radiographic images ofhuman anatomy. It is intended to replace areplace radiographic film/screensystem in general-purpose diagnosticprocedures.This device is not indicated for use inmammography, fluoroscopy, andangiography applications.
DR Detector	P-61 (14" x 17")P-71 (17" x 17")P-81 (10" x 12")P-65 (14" x 17")P-75 (17" x 17")P-82 (14" x 17")P-85 (14" x 17")P-95 (17" x 17")	P-61 (14" x 17")P-71 (17" x 17")P-81 (10" x 12")P-65 (14" x 17")P-75 (17" x 17")P-82 (14" x 17")P-85 (14" x 17")P-95 (17" x 17")
Serial Radiography	Wired (P-61, P-71, P-65, P-75)Wireless (P-65, P-75)	Wired (P-61, P-71, P-65, P-75)
Components orAccessories	AeroDR Interface Units, DetectorInterface Units, Power Supply Unit,Generator Interface Units, GIU SZ,Battery Charger, etc.	AeroDR Interface Units, DetectorInterface Units, Power Supply Unit,Generator Interface Units, BatteryCharger, etc.
Operator Console	CS-7	CS-7
Image Processing	Auto-gradation processFrequency processing (F process)Equalization processing (E process)Hybrid processing (HF, HE, HS)REALISM processing (RF, RE, RS)Intelligent-GridAutomatic exposure field recognitionprocess	Auto-gradation processFrequency processing (F process)Equalization processing (E process)Hybrid processing (HF, HE, HS)REALISM processing (RF, RE, RS)Intelligent-GridAutomatic exposure field recognitionprocess

Performance Data

The SKR 3000 is designed to comply with the following standard; AAMI/ANSI ES 60601-1 (Ed.3.1) and IEC 60601-1-2 (Ed.4.0). The verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The results of risk

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management did not require clinical studies to demonstrate the substantial equivalency of the subject device modifications.

Conclusion

The SKR 3000 has the same intended use and indications for use, technological characteristics, and principal operations. The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K213908). Performance tests demonstrate that the SKR 3000 performs according to specifications and functions as intended. It is concluded that the subject device is to be as safe and effective as the predicate and substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.