(58 days)
The SKR 4000 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 4000 is not indicated for use in mammography, fluoroscopy and angiography applications.
The SKR 4000 consists of the DR Detector (P-41), Battery, Battery Charger, AC Adapter, AC Power Cable and DC Power Cable It is intended for use replacing a radiographic film/screen system in general-purpose diagnostic procedures of human anatomy.
The SKR 4000 performs radiography imaging of the human body using an X-ray FPD that outputs a digital signal, which is then input into an image processing device.
The SKR 4000 can communicate with the image processing device through the Wireless LAN (IEEE802.11a/b/g/n/ac and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The provided document is a 510(k) summary for the Konica Minolta SKR 4000, a stationary x-ray system. This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and performance data for a new AI algorithm or standalone device.
Therefore, much of the requested information regarding acceptance criteria, study design, ground truth establishment, expert adjudication, MRMC studies, or training/test set sample sizes for an AI-driven device is NOT available in this document. The SKR 4000 is a digital radiography hardware system, not an AI-powered diagnostic tool.
The document states: "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 4000 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."
This means that the "acceptance criteria" referred to are likely technical performance specifications for the imaging hardware itself, and the "study" was primarily engineering verification and validation against those technical specifications, rather than a clinical study evaluating diagnostic accuracy with a human-in-the-loop or standalone AI.
However, based on the provided text, I can extract and infer some limited information:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Comparison Table" which lists specifications for the subject device (SKR 4000) and its predicate devices. These effectively act as the "acceptance criteria" in terms of mirroring or improving upon the predicate's performance for a hardware device.
| Characteristic | Acceptance Criteria (based on Predicate 1 or 2) | Reported Device Performance (SKR 4000) |
|---|---|---|
| Detection method | Indirect conversion method (PD1, PD2) | Same as PDs (Indirect conversion method) |
| Scintillator | Csl (Cesium Iodide) (PD1, PD2) | Same as PDs (Csl) |
| Image area size | PD1: 343.2mm x 420mm; PD2: 348.95x425.25mm | 345.6 x 420.0 mm |
| Pixel size | PD1: 150 µm; PD2: 100/200/400 µm | Same as PD1 (150 µm) |
| A/D conversion | PD1: 14 bit; PD2: 16 bit | Same as PD2 (16 bit) |
| MTF (1.0 cycle/mm) | PD1: 0.83 @ 0.5 (1/mm) (Better); PD2: >0.53 | More than 0.60 |
| DQE (1.0 cycle/mm) | PD1: 0.55 @ 0.5 (1/mm) (Better); PD2: >49%@1mR, >39%@0.1mR | More than 30%@0.3mR |
| Electrical Power Source | AC Line and/or Removable Battery (PD1) | Same as PD1 |
| Battery type | Lithium Ion Battery (PD1) | Same as PD1 |
| External dimensions | PD1: 384(W)x460(D)x15.2(H)mm; PD2: 384(W)x460(D)x15(H)mm | 384(W)x460(D)x15(H)mm |
| Weight | PD1: 3.82 kg (with battery); PD2: 2.6 kg | 3.6kg (with battery) |
| IPX | PD1: IPX0; PD2: IPX6 | IPX1 |
| Communication | Wireless/Wired (PD1, PD2) | Wireless |
Note: The "acceptance criteria" columns above are derived from the specifications of the predicate devices. The SKR 4000's reported performance is compared against these to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified for a clinical test set. The performance evaluation was based on technical specifications and engineering verification, not a clinical study on a patient sample set involving diagnostic outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of diagnostic interpretation by experts is not relevant for this type of hardware performance evaluation.
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:
- No. This device is a digital radiography system, not an AI assistance tool. The document explicitly states: "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."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for a clinical ground truth. The "ground truth" for this device would be established by validated measurement equipment and scientific standards for assessing the physical performance characteristics (e.g., MTF, DQE, pixel size, etc.) of an x-ray detector.
8. The sample size for the training set:
- Not applicable. This relates to machine learning models, which are not part of this device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is for a medical device (a digital radiography system) that is hardware-based. The "acceptance criteria" and "study" refer to engineering and technical performance validations against established standards and predicate device specifications, not to clinical studies involving human diagnostic performance or AI algorithms.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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, Inc. % Mr. Russell D. Munves Official Correspondent Storch Amini PC 140 East 45th Street 25th Floor NEW YORK NY 10017
Re: K191645
Trade/Device Name: SKR 4000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 17, 2019 Received: June 19, 2019
Dear Mr. 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 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
August 16, 2019
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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,
For
Thalia T. Mills, Ph.D. Director 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)
Device Name SKR 4000
Indications for Use (Describe)
The SKR 4000 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 4000 is not indicated for use in mammography, 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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Image /page/3/Picture/1 description: The image contains the logo for Konica Minolta. The logo features a blue globe-like shape with several horizontal white lines running across it. Below the globe, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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: | July 26, 2019 | ||
| Trade Name: | SKR 4000 | ||
| Model No: | P-41 | ||
| Common Name: | Digital Radiography | ||
| Regulation Name / Number: | Stationary x-ray system / 21 CFR 892.1680 | ||
| Regulatory Class: | Class II | ||
| Product Code(s): | 90-MQB | ||
| Predicate Device(s): | K160810 - ViZionDR + Wireless (Viztek LLC)Regulation Name: Stationary x-ray systemRegulation Number: 21CFR 892.1680Product Codes: 90-MQBK182688 - SKR 3000 (KONICA MINOLTA, INC.)Regulation Name: Stationary x-ray systemRegulation Name: 21CFR 892.1680Product Codes: 90-MQB, 90-LLZ | ||
| Device Description: | The SKR 4000 consists of the DR Detector (P-41), Battery, BatteryCharger, AC Adapter, AC Power Cable and DC Power Cable It is |
intended for use replacing a radiographic film/screen system in
general-purpose diagnostic procedures of human anatomy.
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Image /page/4/Picture/1 description: The image features the Konica Minolta logo. The logo consists of a blue sphere with several horizontal white lines across the upper portion, creating a stylized and modern design. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font, with "KONICA" stacked above "MINOLTA".
The SKR 4000 performs radiography imaging of the human body using an X-ray FPD that outputs a digital signal, which is then input into an image processing device.
The SKR 4000 can communicate with the image processing device through the Wireless LAN (IEEE802.11a/b/g/n/ac and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The SKR 4000 is designed to comply with the following standards; AAMI/ANSI ES 60601-1 "Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-1-2 "Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests", and ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Indications for Use:
The SKR 4000 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 4000 is not indicated for use in mammography, fluoroscopy and angiography applications.
Comparison Table:
| Subject Device | Predicate Device 1 (PD1) | Predicate Device 2 (PD2) | |
|---|---|---|---|
| SKR 4000 | ViZionDR + Wireless | SKR 3000 | |
| 510(K) Number | This Submission | K160810 | K182688 |
| Indications forUse | The SKR 4000 is indicatedfor use in generatingradiographic images ofhuman anatomy. It isintended to replaceradiographic film/screensystem in general-purposediagnostic procedures.The SKR 4000 is notindicated for use in | Intended for digital imagecapture use in generalradiographic examinations,wherever conventionalscreen-film systems may beused, excludingfluoroscopy, angiographyand mammography. ViZionDR + Wireless allowsimaging of skull, chest, | The SKR 3000 is indicatedfor use in generatingradiographic images ofhuman anatomy. It isintended to replaceradiographic film/screensystem in general-purposediagnostic procedures.The SKR 3000 is notindicated for use in |
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Image /page/5/Picture/1 description: The image contains the Konica Minolta logo. The logo features a blue globe-like shape at the top with several horizontal white lines across it. Below the globe is the text "KONICA MINOLTA" in a bold, sans-serif font.
| Subject Device | Predicate Device 1 (PD1) | Predicate Device 2 (PD2) | |
|---|---|---|---|
| 510(K) Number | SKR 4000This Submission | ViZionDR + WirelessK160810 | SKR 3000K182688 |
| mammography,fluoroscopy, andangiography applications. | shoulders, spine, abdomen,pelvis, and extremities. | mammography,fluoroscopy andangiography applications. | |
| Specification | |||
| Detection method | Same as PDs | Indirect conversion method | Indirect conversion method |
| Scintillator | Same as PDs | Csl (Cesium Iodide) | Csl (Cesium Iodide) |
| Image area size | $345.6\times420.0$ mm(2,304 x 2,800 pixels) | 343.2mm x 420mm(2,288 x 2,784 pixels) | $348.95\times425.25$ mm(3,488 x 4,256pixels) |
| Pixel size | Same as PD1 | 150 μm | 100 μm / 200 μm / 400 μm |
| A/D conversion | Same as PD2 | 14 bit | 16 bit |
| MTF (1.0 cycle/mm) | More than 0.60 | 0.83 at 0.5 (1/mm) (Better) | More than 0.53 |
| DQE (1.0 cycle/mm) | More than 30%@0.3mR | 0.55 at 0.5 (1/mm) (Better) | More than 49% @ 1mRMore than 39% @ 0.1mR |
| Electrical | |||
| Power source | Same as PD1 | AC Line and/or RemovableBattery | AC Line and/or Built-inBattery |
| Battery type | Same as PD1 | Lithium Ion Battery | Lithium Ion Capacitor |
| Mechanical | |||
| Externaldimensions | 384(W)×460(D)×15(H)mm | 384(W)×460(D)×15.2(H)mm | 384(W)×460(D)×15(H)mm |
| Weight | 3.6kg (with battery) | 3.82 kg (with battery) | 2.6 kg |
| IPX | IPX1 | IPX0 | IPX6 |
| Communication | Wireless | Wireless/Wired | Wireless/Wired |
Summary of Technological Characteristics Compared to Predicate Devices:
The SKR 4000 employs the same fundamental scientific technologies as the PDs (K160810 and K182688). The indications for use is identical to the PD1 (K182688), and the other summary of comparisons of technological characteristics for both systems is provided below;
Operational principles and designing:
The SKR 4000 has same scientific technologies and operational principal as the predicate devices (K160810 and K182688). All the verification activities required by the specification and the risk analysis for the SKR 4000 were performed and the results demonstrated that the predetermined acceptance criteria were met.
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Image /page/6/Picture/1 description: The image contains the logo for Konica Minolta. The logo features a blue sphere at the top with several horizontal white lines running across it. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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 4000 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 4000 has been conducted in accordance with ISO 14971 "Medical devices -- Application of risk management to medical devices". The risks associated with all the identified hazards were reduced to acceptable level by the risk control measures as shown in risk assessment record.
Biocompatibility:
The all patient contact materials for human body surface are evaluated under ISO 10993 "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process" and determined as acceptable for this usage. The proposed P-41 and the predicate devices achieve the same acceptance level for biocompatibility.
Relevant FDA Guidance
The SKR 4000 was developed in accordance with the following FDA guidance:
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (September 2016)
- Radio Frequency Wireless Technology in Medical Devices (August 2013) ●
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices (September 2018)
- Refused to Accept Policy for 510(k)s (February 2019)
- Format for Traditional and Abbreviated 510(k)s (August 2005)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)
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Image /page/7/Picture/1 description: The image shows the Konica Minolta logo. The logo consists of a blue sphere with several horizontal white lines across the middle. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
Conclusion:
The SKR 4000 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 devices. Performance tests demonstrate that the SKR 4000 performs according to specifications and functions as intended. Therefore, the SKR 4000 is substantially equivalent to its predicate devices (K160810 and K182688).
N/A