SKR 3000

{0}------------------------------------------------ October 12, 2017 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. 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, New York 10017 Re: K172793 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 14, 2017 Received: September 15, 2017 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172793 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, tomography and angiography applications. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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 | Submitter's Name: | KONICA MINOLTA, INC. | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 1 Sakura-machi,<br>Hino-shi, 191-8511 Japan | | Contact: | Tsutomu Fukui | | Telephone: | +81 42 589 8429 | | Date: | September 14, 2017 | | 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): | K162504 - SKR 3000 (KONICA MINOLTA, INC.)<br>Regulation Name: Stationary x-ray system (21CFR 892.1680),<br>Product Codes: 90-MQB, 90-LLZ | Device Description: The proposed SKR 3000 is modified to consist of new FPD P-71 and P-81 in addition to previously cleared P-61, Console CS-7 and other peripherals. Additionally, a radiography sequence of AeroSync, non tethered operation mode, is modified to incorporate improved usage that allow user to use a FPD without console CS-7. A user can capture the images and store them in FPD memories until when those readout images are transferred to the console CS-7 by a user. 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. Page 1 of 4 {4}------------------------------------------------ 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 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. 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 compatible X-ray system is same as that of previously cleared SKR 3000. 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, tomography and angiography applications. Predicate Comparison Table: | | KONICA MINOLTA | KONICA MINOLTA | |-----------------------|--------------------------|----------------------------| | | SKR 3000 | SKR 3000 | | 510(K) Control Number | Proposed device | K162504 | | 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) | {5}------------------------------------------------ | | KONICA MINOLTA<br>SKR 3000 | KONICA MINOLTA<br>SKR 3000 | |-------------------------------|------------------------------------------------------------|---------------------------------------------| | 510(K) Control Number | Proposed device | K162504 | | Image area size | P-71: 424.8×424.8mm<br>(4,248×4,248 pixels) | P-61: 348.8×425.6mm<br>(3,488×4,256 pixels) | | | P-81: 245.6×296.8mm<br>(2,456×2,968 pixels) | | | Pixel size μ | Same as Predicate device | 100 μm / 200 μm | | A/D conversion | Same as Predicate device | 16 bit (65,536 gradients) | | Mechanical | | | | External dimensions | P-71: 460(W)×460(D)×15(H)mm<br>P-81: 282(W)×333(D)×15(H)mm | P-61: 384(W)×460(D)×15(H)mm | | IPX | Same as Predicate device | IPX6 | | Communication I/F | Same as Predicate device | | | Operator console | Same as Predicate device | | | Compatible X-ray system Spec. | Same as Predicate device | | ## Summary of Technological Characteristics Compared to Predicate Device: The modified SKR 3000 employs additional FPDs of P-71 and P-81 which are overall change in the dimensions of the image receptor with otherwise identical materials of predicate P-61. The system has same scientific technologies as the predicate device (K162504). The indications for use are not modified, and the other summary of comparisons of technological characteristics for both systems is provided below; ## Operational principles and designing: The system including a modified radiography sequence has same operational principles and designing as those of the predicate device. The proposed P-71 / P-81 employ same scintillator and provide same imaging performance as those of the predicate P-61. The same peripheral components provide same function of the component 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. ## 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 {6}------------------------------------------------ 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 concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only. 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. ## Biocompatibility: The all patient contact materials for human body surface are identical to those of predicate device, and are evaluated under ISO 10993-1 and determined as acceptable for this usage. The proposed P-71 / P-81 and the predicate P-61 have achieved same acceptance level for biocompatibility. #### 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 K162504.