MasterX 800 Series

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September 1, 2023 Medicatech USA % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K230918 Trade/Device Name: MasterX 800 Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 7, 2023 Received: August 7, 2023 Dear Daniel Kamm: 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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Lu Jiang Lu Jiang, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K230918 Device Name MasterX 800 Series Indications for Use (Describe) The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography. Type of Use (Select one or both, as applicable) | <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:16px">☐</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, 510(k) Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: August 25, 2023 #### 1. Identification of the Device: Trade/Device Names: MasterX 800 Series Regulation Number: 21CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade - 2. Equivalent legally marketed device: K130377 Trade/Device Name: KrystalRad "New Series" Radiographic Portable Retrofit Manufacturer: MedicaTech USA Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade - 3. Reference Devices: Uses software cleared in our 510(k) number K190601, but updated. Uses one of the following previously cleared digital receptor panels, supplied unmodified: | InnoCare Model Name Yushan Series | 510(K)<br>numbers | Product code/regulation | |------------------------------------------------------------------|-------------------|-------------------------| | Yushan V14C/ Yushan V14G/ Yushan V17C/ Yushan V17G/ Yushan V17Ge | K201528 | MQB/21CFR892.1680 | | Yushan F14C/ Yushan F14G | K210988 | MQB/21CFR892.1680 | | Yushan V17Ce | K220510 | MQB/21CFR892.1680 | - 4. Indications for Use The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography. - 5. Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems. {4}------------------------------------------------ The purchaser may select their digital panel from this list: | InnoCare Model<br>Name Yushan<br>Series | MedicatechUSA<br>Model Name<br>Masterx80XX | 510(K)<br>number | Size and Description | |-----------------------------------------|--------------------------------------------|------------------|-----------------------------------------------------------| | Yushan V14C | MasterX80IC | K201528 | 14X17 Csi Wireless Panel (Can work as Tethered) | | Yushan V14G | MasterX801G | K201528 | 14X17 GOS Wireless Panel (Can work as Tethered) | | Yushan F14C | MasterX802C | K210988 | 17X17 Csi Wireless Panel (can work as Tethered) | | Yushan F14G | MasterX802G | K210988 | 17X17 GOS Wireless Panel (can work as Tethered ) | | Yushan V17C | MasterX803C | K201528 | Glassless 14X17 Csi Wireless Panel (Can work as Tethered) | | Yushan V17G | MasterX803G | K201528 | Glassless 14X17 GOS Wireless Panel (Can work as Tethered) | | Yushan V17Ce | MasterX804Ce | K220510 | 17X17 Csi Fixed Tethered Panel | | Yushan V17Ge | MasterX804Ge | K201528 | 17X17 GOS Fixed Tethered Panel | As compared to our predicate system, the digital panels are more recently cleared by FDA. The image acquisition software is our Voyance software most recently cleared in K190601. The digital panels all comply with the voluntary IEC 60601-1 and IEC 60601-1-2. - 6. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels (except for the Toshiba unit) and software. #### 7. Substantial Equivalence Chart: | Item | K130377 KystalRad "New Series"<br>Radiographic Portable Retrofit | MasterX 800 Series | Comment | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Indications<br>for Use: | Intended for use by a qualified/trained<br>doctor or technologist. As part of a<br>radiographic system, the KrystalRad<br>"New Series" is intended td acquire<br>digital radiographic images. It is<br>suitable for all routine radiography<br>exams, including specialist areas like<br>intensive care or trauma work,<br>excluding fluoroscopy, angiography and<br>mammography. | The MasterX 800 Series is intended for use<br>by a qualified/trained doctor or<br>technologist. As part of a radiographic<br>system, the MasterX 800 Series is intended<br>to acquire digital radiographic images on<br>adult and pediatric patients. It is suitable for<br>all routine radiography exams, including<br>specialist areas like intensive care or trauma<br>work, excluding fluoroscopy, angiography<br>and mammography. | Patient<br>population<br>added. | | Configur-<br>ation of<br>Digital Panels | Battery or AC operated wireless IEEE<br>ac/a/g/n or Wired Ethernet (depending<br>on the model chosen) | Battery or AC operated wireless IEEE ac /<br>a/g/n or Wired Ethernet (depending on the<br>model chosen) | Exactly the<br>same. | | Power<br>Source | AC Line or Rechargeable Battery<br>Battery life up to 8 hours | AC Line or Rechargeable Battery<br>Battery life up to 8 hours<br>Some models use AC Line only. See chart<br>above. | SAME | | Item | K130377 KystalRad "New Series"<br>Radiographic Portable Retrofit | MasterX 800 Series | Comment | | Digital Panel<br>Models | Vieworks Vivix-S K122866 or<br>Vivix-S Wireless K122865 | 8 new models from InnoCare, see list in<br>paragraph 5, above. | Newer<br>models | | Panel<br>Performance | DQE @ 1lp/mm : 50 %<br>MTF @ 1lp/mm : 60 % | DQE at 1 lp/mm, 50%<br>MTF @ 1 lp/mm, 63% | Similar | | Interface | Tethered or Wireless | Tethered or Wireless (See table above) | SAME | | Photo<br>(example) | Image: Two radiographic panels, one with a cable attached. | Image: Two radiographic panels. | Similar<br>appear-<br>ance. | | Panel sizes | 14" x 17" or 17" x 17" | SAME sizes are available. | SAME | | X-ray<br>Conversion<br>Layer | Cesium lodide (Csl) with Amorphous<br>Silicon (a-Si) Photodiode | Csi OR GOS (GOS is lower cost but has nearly<br>comparable peformance) | SAME | | Active Areas | Wired panel pixels:<br>2,560 x 3,072, or 3,072 x 3,072<br>or Wireless panel pixels<br>2560 x 3072 | MasterX80IC/G: 2500 x 3052<br>MasterX802C/G: 2500 x 3052<br>MasterX803C/G: 3072 x 3072<br>MasterX804Ce/Ge: 3072 x 3072 (wired<br>only) | Nearly<br>identical | | Pixel pitch | 140 μm | 140 μm | SAME | | A/D<br>Conversion | 14 Bits | All the new panels have 16 bit conversion | Better | | Image<br>acquisition<br>software | Voyance | Voyance | SAME | | DICOM | DICOM 3 | DICOM 3 | SAME | {5}------------------------------------------------ - Summary of non-clinical testing: We performed software validation and risk management for the 8. updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Our labeling reflects the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device {6}------------------------------------------------ - Summary of clinical testing: Not required. 9. - 10. Conclusion: After analyzing software integration validation, safety testing data, and test MasterX 800 Series images, it is the conclusion of Medicatech USA that the MasterX 800 Series system is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.