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 modified SKR 3000 employs additional peripheral units, the Detector Interface Unit 2 (DIU2) and the Generator Interface Units 3 (GIU3), to incorporate serial radiography operation that is an additional radiography acquisition sequence.

The system is intended for use replacing a radiographic film/screen system in general-purpose diagnostic procedures of human anatomy. The system can be used in conjunction with current cleared AeroDR FPDs. The P-61, P-71, P-81 and the other compatible FPDs availably used in SKR 3000 are lightweight, mobile FPD and they are formed in compatible size with the cassette of ISO standard size. The FPDs availably used for the serial radiography are P-61 and P-71.

The SKR 3000 performs radiography imaging of the human body using an X-ray planar detector (FPD) that outputs a digital signal, which is then input into an image processing device. The serial radiography is a function of multi-frame radiography simply repeating single still radiography multiple times. The acquired image is transmitted to a filing system, printer, and image display device as diagnostic image after applying image processing to the raw data of image by the image processing device, Console CS-7.

AI/ML Overview

This document describes the SKR 3000 device, specifically modified with additional peripheral units (Detector Interface Unit 2 (DIU2) and Generator Interface Units 3 (GIU3)) to incorporate a serial radiography operation. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K172793).

Since the primary claim is substantial equivalence based on technological characteristics and performance tests, not a new clinical claim or improvement over human readers, much of the requested information regarding AI performance and comparative studies with human readers is not applicable or provided in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical performance metrics. Instead, it states that:

"All of the verification activities required by the specification and the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met."
"The performance tests according to the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and the other 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 acceptance criteria are implicitly tied to compliance with relevant standards and the risk analysis. Performance is reported as meeting these predetermined criteria.

Acceptance Criteria Category	Reported Device Performance
Operational Principles	Same scientific technologies and operational principal as predicate device (K172793). Additional peripheral components (DIU2, GIU3) employ equivalent function and comply with same EMC and electrical safety standards. Modified serial radiography operation does not raise new safety or effectiveness issues.
Verification Activities	Performed according to specifications and risk analysis; predetermined acceptance criteria met.
Performance Tests	Performed according to "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and other verification/validation, including risk analysis items; predetermined acceptance criteria met.
Safety	Conforms with AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2, and ISO 10993-1. Risks, including serial radiography, reduced to acceptable levels per ISO 14971.
Biocompatibility	No material change in patient contact materials.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of image analysis performance as typically seen with AI devices. The assessment relies on engineering and performance tests of the device's hardware and software functionalities for image acquisition and processing.

No specific sample size of images or patients is provided for a "test set" in the context of diagnostic accuracy.
The provenance of data (e.g., country of origin, retrospective/prospective) is not mentioned because the evaluation is based on technical verification and validation, rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device's performance demonstration appears to be defined by technical specifications, compliance with standards, and risk analysis, rather than expert consensus on diagnostic interpretations of images.

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

Not applicable, as no external expert adjudication of images is described.

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 device is a digital radiography system, not an AI-powered image analysis tool intended to assist human readers or improve their performance. The submission focuses on the safety and effectiveness of the imaging system itself.

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

Not applicable. The SKR 3000 is an X-ray imaging system, not a standalone algorithm.

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

The "ground truth" for the device's performance is established through:

Technical Specifications: The device's ability to produce radiographic images of human anatomy according to defined parameters (e.g., pixel size, A/D conversion, frame rate for serial radiography).
Compliance with Standards: Meeting established engineering and safety standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2, ISO 10993-1).
Risk Analysis: Demonstrating that identified risks, including those related to the new serial radiography function, are reduced to acceptable levels.
Comparison to Predicate Device: The modified device maintains similar technological characteristics and operational principles to its legally marketed predicate, which implicitly serves as a benchmark for "ground truth" regarding general-purpose diagnostic imaging.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

Not applicable, as there is no training set for this device.

Summary

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December 18, 2018

Konica Minolta, Inc. % Russell D. Munves U.S. Agent STORCH AMINI PC 140 East 45th Street, 25th Floor NEW YORK, NY 10017

Re: K182688

Trade/Device Name: SKR 3000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MOB, LLZ Dated: September 25, 2018 Received: September 26, 2018

Dear Russell Munves:

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

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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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.

Hol 2. mils

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182688

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

Submitter's Name:	KONICA MINOLTA, INC.
Address:	1 Sakura-machi,Hino-shi, 191-8511 Japan
Contact:	Tsutomu Fukui
Telephone:	+81 42 589 8429
Date:	November 26, 2018
Trade Name:	SKR 3000
Model No:	P-61, P-71, P-81
Common Name:	Digital Radiography
Regulation Name / Number:	Stationary x-ray system / 21 CFR 892.1680
Regulatory Class:	Class II
Product Code(s):	90-MQB, 90-LLZ
Predicate Device(s):	K172793 - SKR 3000 (KONICA MINOLTA, INC.)Regulation Name: Stationary x-ray system (21CFR 892.1680),Product Codes: 90-MQB, 90-LLZ
Device Description:	The modified SKR 3000 employs additional peripheral units, the DetectorInterface Unit 2 (DIU2) and the Generator Interface Units 3 (GIU3), toincorporate serial radiography operation that is an additional radiographyacquisition sequence.The system is intended for use replacing a radiographic film/screensystem in general-purpose diagnostic procedures of human anatomy.The system can be used in conjunction with current cleared AeroDR FPDs.The P-61, P-71, P-81 and the other compatible FPDs availably used in SKR3000 are lightweight, mobile FPD and they are formed in compatible sizewith the cassette of ISO standard size. The FPDs availably used for theserial radiography are P-61 and P-71.

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The radiography sequences to be synchronized with a trigger timing of Xray irradiation are the same as the way of predicate device that requires the SRM / S-SRM connection between the SKR 3000 and X-ray generator. The AeroSync allows to use a FPD without a wired connection of SRM / S-SRM, the FPD itself begins to acquire an image when it detects X-ray irradiation in this mode. The AeroSync is not available for the serial radiography.

Applicable FPD	P-61, P-71
Max. frame rate	15 fps
Max. acquisition time	20 seconds
Max. number of acquisition	300 frames
Max. per-frame exposure time	"frame-interval-time" – "frame readout time (constant)" milliseconds
Pixel size (binning)	400 μm (4 X 4)

Serial Radiography

The basic operation of serial radiography is the same as conventional still radiography, but using a pulsed x-ray generator. The patient information and orders of examination are set, the conditions of X-ray irradiation are set through the console of the X-ray generator, then exposure is executed. By pressing and holding the exposure button, sequential frames are acquired in accordance with user selected parameters. The adjustment of image processing parameters and reviewing sequential images are available by the user before the image data is output to the host. The SKR 3000 does not permit "live imaging" unlike a fluoroscopic device.

There are restrictions on operation such as not being able to apply some image processing functions, besides being unable to use the high image quality monitor that can be used for conventional still radiography, it is necessary to confirm with the operation manual before use.

The compatible X-ray system is same as that of previously cleared SKR 3000. Additionally, the X-ray devices used for the serial radiography need to be capable for generating pulsed x-ray output and must be compatible to connect with UEC2 board of GIU3 unit.

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The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.

The SKR 3000 is designed to comply with the following standards; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2, and ISO 10993-1.

Indications for Use:

The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures. The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.

Predicate Comparison Table:

	KONICA MINOLTA	KONICA MINOLTA
	SKR 3000	SKR 3000
510(K) Control Number	Proposed device	K172793
Indications for Use	Same as Predicate device
Specification
Detection method	Same as Predicate device	Indirect conversion method
Scintillator	Same as Predicate device	Csl (Cesium Iodide)
Image area size	Same as Predicate device	P-61: 348.8×425.6mm(3,488×4,256 pixels)
		P-71: 424.8×424.8mm(4,248×4,248 pixels)
		P-81: 245.6×296.8mm(2,456×2,968 pixels)
Pixel size	100 μm / 200 μm / 400 μm	100 μm / 200 μm
A/D conversion	Same as Predicate device	16 bit (65,536 gradients)
Mechanical
External dimensions	Same as Predicate device	P-61: 384(W)×460(D)×15(H)mmP-71: 460(W)×460(D)×15(H)mmP-81: 282(W)×333(D)×15(H)mm
IPX	Same as Predicate device	IPX6
Communication I/F	Same as Predicate device
Operator console	OTS Desktop PC and Laptop PC,the higher specification is requiredfor serial radiography.	OTS Desk Top PC and Laptop PC

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	KONICA MINOLTA	KONICA MINOLTA
	SKR 3000	SKR 3000
510(K) Control Number	Proposed device	K172793
Compatible X-ray System Spec.	The SKR 3000 can be connectedwith X-ray devices beingcompatible with XIF, XGIF, UEC orUEC2 board along with certainelectronic requirement such asspecific signal controls forhardware and software.The X-ray device used for serialradiography needs to be capablefor generating pulsed x-ray outputand must be compatible toconnect with UEC2 board.	The SKR 3000 can be connectedwith X-ray devices beingcompatible with XIF, XGIF or UECboard along with certain electronicrequirement such as specific signalcontrols for hardware andsoftware.

Summary of Technological Characteristics

Compared to Predicate Device:

The discussion of substantial equivalence based on comparisons of indication for use, technologies, and performance characteristics for both systems are provided as follows;

Operational principles and designing:

The system has same scientific technologies and operational principal as the predicate device (K172793). The additional peripheral components, DIU2 and GIU3, employs equivalent function of the similar components of the predicate device, and complies with same EMC and electrical safety standards. The proposed device is essentially the same as previously cleared predicate device from technology view point. The serial radiography, a modified radiography sequence, is evaluated and concluded that it does not raise any new issues of safety and effectiveness through design activities. All of the verification activities required by the specification and the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met.

Performance test:

The performance tests according to the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and the other verification and validation including the items required by the risk analysis for the SKR

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3000 were performed and the results demonstrated that the predetermined acceptance criteria were met.

The concurrence study is not necessary because the proposed modifications are categorized as the type of unnecessary to provide additional clinical data in accordance with the SSXI guidance. Besides, the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device.

Safety:

The system is in conformance with the standards described above, which are same standards to those of predicate device.

The Risk Analysis for the SKR 3000 has been conducted in accordance with the SOP conforming to ISO 14971. The risks associated with all the identified hazards including serial radiography were reduced to acceptable level by the risk control measures as shown in Risk Assessment Record.

Biocompatibility:

There is no material change in patient contact materials for human body surface at all.

Conclusion:

The clinical study as a performance testing is not required to support substantial equivalence for the proposed device. In addition, as discussed in the above technological comparison, the technological characteristics of the SKR 3000 are deemed to be substantially equivalent to the predicate device that have already been cleared for USA distribution with 510(k) premarket notification number K172793.

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.