FS-500DDR Medical Radiographic X-Ray System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 2, 2016 ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane, Unit 5 MIAMI FL 33155 Re: K152813 Trade/Device Name: FS-500DR Medical Radiographic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 26, 2016 Received: November 8, 2016 Dear Mr. Peng: 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 (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. {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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours. Michael D'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) K152813 Device Name FS-500DDR Medical Radiographic X-Ray System #### Indications for Use (Describe) FS-500DDR Medical Radiographic X-Ray System is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995 ### *DO NOT SEND YOUR COMPEETED 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) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based: The Assigned 510(k) Number is: k152813 ## 1. Submitter Information: #### Sponsor/510(k) Owner: . ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. No. 16 Cuiming Road YAT-SEN Scientific Industrial Park, Tianjin Economic Technological Development Area, Tianjin 301726, China Phone: +86 22 8216 1240 Fax: +86 22 8216 0813 Date: September 26, 2016 #### 510(k) Contact Name: . Mr. Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN Unit 5 Miami, FL 33155 Phone: (305) 609 4701 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com ## 2. Device Name and Classification | Trade Name: | FS-500DDR Medical Radiographic X-Ray System | |----------------------|----------------------------------------------| | Common Name: | Direct Digital Radiographic X-Ray System | | Classification Name: | Stationary X-Ray System, Product code 90 KPR | | Classification: | 21 CFR 892.1680, Class II | | Product code: | KPR | ## 4. Predicate Devices: | Manufacturer Name | GE Medical Systems, Inc. | Orich Medical Equipment<br>(Tianjin) Co., Ltd. | |-----------------------|--------------------------------------------------------|------------------------------------------------| | Regulation Number | K012389 | K120034 | | Trade Name | GE Revolution XR/d Digital Radiographic Imaging System | DF-211H Radiographic X-Ray System | | Common Name | System, X-Ray, Stationary | System, X-Ray, Stationary | | Classification Name | Stationary X-Ray System | Stationary X-Ray System | | Classification Number | 21 CFR 892.1680 | 21 CFR 892.1680 | | Product Code | KPR | KPR | | Date of Clearance | Aug. 10, 2001 | Apr. 17, 2012 | ## 5. Description of Device {4}------------------------------------------------ The FS-500DDR is a Medical Radiographic X-Ray System with digital radiography (DR) technology. It is consisting of a high voltage generator, control console, X-Ray tube assembly, collimator, UC bracket or Rail suspension assembly, solid-state X-Ray flat panel detector, work station and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380Vac, 50Hz/60Hz; fluctuation range for voltage: 10%; the power source capacity: 50kVA, the range of tube voltage is 40-150kV, with current 10-630mA. The time range of exposure is 1ms-10s, the range of mAs is 0.1-630mAs. There are two types of configuration (1001-1002) for FS-500DDR; the difference is for the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the UC arm or Rail suspension assembly. | Component | Model | Manufacturer | |-------------------------------------------------------|---------------|----------------------------------------------| | Digital image<br>acquisition and<br>processing system | FU-800CCS | Orich Medical Equipment (Tianjin)Co., Ltd. | | Medical monitor | RTV-5 | Orich Medical Equipment (Tianjin)Co., Ltd. | | High-voltage generator | HK801-1(50kW) | Orich Medical Equipment (Tianjin)Co., Ltd. | | X-ray tube assembly | DX7254/150 | Orich Medical Equipment (Tianjin)Co., Ltd. | | X-ray tube | E7843 | Toshiba Electron Tubes and Devices Co., Ltd. | | Flat panel detector | FDX4343R | Toshiba Electron Tubes and Devices Co., Ltd. | | UC arm | FSU-I | Orich Medical Equipment (Tianjin)Co., Ltd. | | Mobile radiographic<br>patient table | YDC-I | Orich Medical Equipment (Tianjin)Co., Ltd. | | Beam limiting device | S/DS-2 | Orich Medical Equipment (Tianjin)Co., Ltd. | Table 1-1 Components of FS-500DDR (1001) Table 1-2 Components of FS-500DDR (1002) | Component | Model | Manufacturer | |-------------------------------------------------------|---------------|----------------------------------------------| | Digital image<br>acquisition and<br>processing system | FU-800CCS | Orich Medical Equipment (Tianjin)Co., Ltd. | | Medical monitor | RTV-5 | Orich Medical Equipment (Tianjin)Co., Ltd. | | High-voltage generator | HK801-1(50KW) | Orich Medical Equipment (Tianjin)Co., Ltd. | | X-ray tube assembly | DX7254/150 | Orich Medical Equipment (Tianjin)Co., Ltd. | | X-ray tube | E7843 | Toshiba Electron Tubes and Devices Co., Ltd. | | Flat panel detector | FDX4343R | Toshiba Electron Tubes and Devices Co., Ltd. | | Rail suspension<br>assembly | FSU-III | Orich Medical Equipment (Tianjin)Co., Ltd. | | Elevating photography<br>table | DFY-III | Orich Medical Equipment (Tianjin)Co., Ltd. | {5}------------------------------------------------ | Beam limiting device | S/DS-2 | Orich Medical Equipment (Tianjin)Co., Ltd. | |----------------------|--------|--------------------------------------------| |----------------------|--------|--------------------------------------------| ## 6. Intended Use FS-500DDR Medical Radiographic X-Ray System is designed to be used by a qualified/trained doctor or technician on adult and pediatric for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. ## 7. Comparison of Technological Characteristics The FS-500DDR Medical Diagnostic X-Ray system is similar to the predicate devices: - Has the same intended use and indications for use . - . Utilizes the same operating principle - Incorporates the same basic design ● - Incorporates the same technological characteristics . - Tested to the same electrical and electromagnetic safety standards for medical . electrical equipment - . Manufactured under a quality system The differences between the subject devices and predicate devices: - The subject device utilizes a lower frequency X-ray generator which does not raise . any level of safety concern and affect any effectiveness; the generator frequency does affect the X-ray exposure parameters. - . The subject device utilizes a radiographic table with smaller weight capacity which does not raise any level of safety concern and affect any effectiveness. - . The inherent filtration for the collimator in the subject device is different from the predicate device; this difference does not affect the safety and effectiveness. - . The subject device utilizes a different X-Ray flat panel detector, however, both the bench and clinical test demonstrate that does not raise the level of safety concern and affect any effectiveness. ### 8. Summary Performance Data - EN 60601-1 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance 2006 + AC:2010 - EN 60601-1-2:2007 (Third Edition, 2007), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic - IEC 60601-2-7:1998 Medical electrical equipment -Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators - . IEC 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis - . IEC 60601-2-54:2009 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy - . IEC 60601-1-3:2008 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment + AC2010 {6}------------------------------------------------ - . ISO 10993-5:1999: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity - . ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing - Clinical concurrence study of images pairs to demonstrate the equivalent diagnostic . capability ## 9. Conclusion After analyzing both bench and external laboratory testing data, including electrical safety, mechanical safety and EMC compliance, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate devices.