GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 10, 2014 GEMSS Medical Systems Co., Ltd. % Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071 Re: K132289 Trade/Device Name: Spinel 3G Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, OXO Dated: May 22, 2014 Received: May 23, 2014 Dear Mr. Knauss: This letter corrects our substantially equivalent letter of June 16, 2014. 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. Sm. 7) for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K132289 Device Name Spinel 3G Indications for Use (Describe) The SPINEL 3G, Surgical Mobile Fluoroscopic X-ray system, is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not interventional guided procedure & mammographic applications. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Robert A. Ochs {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: May 22, 2014 ### 1. Company and correspondent making the submission: - > Company Name: GEMSS MEDICAL SYSTEMS Co., LTD. - > Address : 61,Dunchon-daero 541(obaeksasibil), Jungwon-gu, Seongnam-si, yeonggi-do, Korea - > Telephone : +82-31-764-7321~3 - ► Fax: +82-31-764-7324 - > Contact: Mr. Sangwoo Lee - > Internet: http://www.gemss-medical.com ### 2. General information for predicate & proposed device | | Predicate device | Proposed device | |---------------------------|-----------------------------------------------|-----------------------------------------------| | Manufacturer | United Radiology Systems, Inc. | GEMSS MEDICAL SYSTEMS Co., LTD. | | 510(k) number | K032761<br>(Decision Date - May. 14. 2004) | K132289 | | Common Name | Surgical Mobile Fluoroscopic X-ray<br>System | Surgical Mobile Fluoroscopic X-ray<br>System | | Trade/proprietary<br>name | KMC-950 | SPINEL 3G | | Classification rule | 21CFR 892.1650 | 21CFR 892.1650 | | Classification Name | Image Intensified Fluroscopic X-ray<br>System | Image Intensified Fluroscopic X-ray<br>System | | Product code | JAA & OXO & OWB | JAA & OXO | ### 3. Description: ### 3.1 General: The Image Intensified Fluroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended for interventional quided procedure & mammographic applications. ### 3.2 Product features: The SPINEL 3G is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. {4}------------------------------------------------ The SPINEL 3G has following features. The high voltage generation circuit uses the method of inverter with a high power of 12kVA, to ensure that stable X-Ray with small amount of ripples are obtained. The X-Ray tube system uses the X-Ray tube with rotating anode, thus enabling to obtain high-quality images necessary for the longtime operation or diagnosis. Control panel adopting TACT key, B/W LCD and touch screen for excellent controllability, Soft but solid motions of the large size C-Arm, which has a 768mm radius, gives facility to perform an operation.(Depth:692mm) For fluoroscopy, the collimator is used to reduce an unnecessary irradiation of X-Ray. Using the built-in SNAP SHOT mode, the image quality is improved further, and it has built-in DIS (Digital Interface System). The SPINEL 3G has PACS connectivity with DICOM 3.0. Thermal sensor prevents the tube from overheating. If the tube is overheated, thermal sensor attached to the exterior of it warns the system and 'Tube Limit' sign will be displayed on the touch screen. Then the machine can work again by the time the tube gets cooled. ### 4. Intended use SPINEL 3G is intended to be used as a universal diagnostic imaging system and fluoroscopic studies. Using an Image intensifier and CCD camera, it can perform a range of applications including general fluoroscopy, diagnostic fluoroscopy. SPINEL 3G, Mobile Fluoroscopy System is designed to provide fluoroscopic of the patient during diagnostic, surqical procedures. Examples of clinical application may include horologic, orthopedic, neurologic, critical care and emergency room procedures. ### 5. Indications for use The SPINEL 3G, Surgical Mobile Fluoroscopic X-ray system, is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional quided procedure & mammographic applications. ### 6. Comparison with predicate device: | | | Predicate device | Proposed device | |----------------------|----------------------------------------|------------------------------------|-------------------------------------------------------------------------| | Model name | | KMC-950 | SPINEL 3G | | 510(k) number | | K032761 | K132289 | | 510(k) owner | | United Radiology<br>Systems, Inc. | GEMSS Medical Systems<br>Co., Ltd. | | X-ray Tube | Model name | Varian:RAD-99 | Toshiba:E7833X,<br>Varian:RAD-99 | | | Manufacturer | Varian | Toshiba/Varian | | | Anode Type | Rotating | Rotating | | | Heat Capacity | 300,000 HU | 300,000HU | | | | Predicate device | Proposed device | | | Anode heat cooling | 15kHU/min | 15kHU/min | | | Focal Size | 0.3 mm / 0.6 mm | 0.3 mm / 0.6 mm | | | Model name | HTC-120 | HTC-120 | | | Manufacturer | POSKOM | POSKOM | | X-ray Generator | X-ray Generator Type | High frequency / inverter<br>type | High frequency / inverter<br>type | | | Power Output | 12.0 kVA | 12.0 kVA | | Fluoroscopic | kV range | 40 to 125 kV | 40 to 120 kV | | Mode | | See below different<br>discussion | See below different<br>discussion | | | mA range | 0.5 to 5 mA | 0.2 to 10 mA | | | | See below different<br>discussion | See below different<br>discussion | | | Pulse Fluoro | Yes | Yes | | | ABS function | Yes | Yes | | | Snap Shot | 8.0 mA shot available | 8.0 mA shot available | | | Boost Shot | 20.0 mA sot available | 20.0 mA shot available | | Image<br>Intensifier | Model name | Thales:TH9428HP2 | Toshiba:E5830SD-P4A,<br>Thales:TH9438QX | | | Manufacturer | Thales | Toshiba/Thales | | | Size | 9" | 9" | | | Magnification | 9" / 6" / 4.5" | 9" / 6" / 4.5" | | | Model name | RS-138EDR | LUNA-1K | | Camera | Manufacturer | RAYSIS | GEMSS Medical Systems<br>Co., Ltd. | | | Type | 1/2" CCD | 1/2" CCD | | | active pixel | 512X512 | 1024X1024 | | C-arm | Manufacturer | COMED Medical Systems<br>Co., Ltd. | GEMSS Medical Systems<br>Co., Ltd. | | | SID | 950 mm | 1000 mm | | | Range of C-arm Rail<br>Rotation | 115° (90° / 25°) | 135° (90° / 45°) | | | Range of the Liner FR-<br>arm Movement | 200 mm | 200 mm | | | Range of the Linear T-<br>arm Movement | 500 mm | 500 mm | | | Range of Swing-arm<br>Rotation | ± 12.5° | ± 12.5° | | | Range of Stay-arm<br>Rotation | 360° | ± 225° | | Image | Storage Capacity | Digital | HDD 500G | | Processing | Image Matrix size | 5,000 Images | store more than 35,000<br>pictures<br>(1 image is approximately<br>2MB) | | | Monitor Size | 17" | 19" | | | | Predicate device | Proposed device | | Collimator | Model name | KMC-950CM | KMC-950CMR1 | | | Manufacturer | COMED Medical Systems<br>Co., Ltd. | GEMSS Medical Systems<br>Co., Ltd. | | | Collimator | Motor control / rotation | Motor control / rotation | | | Power Requirements | DC 24V | DC 24V | {5}------------------------------------------------ {6}------------------------------------------------ GEMSS MEDICAL SYSTEMS CO., LTD., believes that the SPINEL 3G is substantially equivalent to the KMC-950 of United Radiology Systems, Inc. The SPINEL 3Gdescribed in this 510(k) has the similar intended use and similar technical and construction characteristics as the KMC-950 of United Radiology Systems, Inc. ### 7. Safety, EMC and Performance Data: Electrical, mechanical, environmental safety and performance testing according to FDA recognized standards were performed. All test results were satisfactory. Applied standards are as follows: - > IEC60601-1:2005 - > IEC60601-1-2:2007 - > IEC60601-1-3:2008 - > IEC60601-2-28:2010 - > IEC60601-2-54:2009 - > NEMA PS 3.1-3.20 - > ISO14971:2012 And, EPRC requlation was satisfactory. - ▷ 21CFR1020.32 In addition, FDA guidance was satisfactorily considered. - > Guidance for the Submissions of 510(k)s for Solid State X-ray Imaging Devices ### 8. Conclusions: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification GEMSS MEDICAL SYSTEMS CO., LTD. concludes that the SPINEL 3G is safe and effective and substantially equivalent to predicate devices as described herein.