8ch Foot Ankle Coil

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 28, 2016 Shenzhen RF Tech Co., Ltd. % Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Road Baiyun District, Guangzhou, Guangdong 510420 CHINA Re: K151653 Trade/Device Name: 8ch Foot Ankle Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 8, 2015 Received: July 10, 2015 Dear Mike Gu: This letter corrects our substantially equivalent letter of August 7, 2015. 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 {1}------------------------------------------------ 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. 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/ResourcesforYou/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, Robert Ochs 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K151653 Device Name 8ch Foot Ankle Coil Indications for Use (Describe) 8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with the SIGNA Pioneer only. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen. 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "RFT" in a bold, sans-serif font, with a small orange diamond in place of the crossbar of the "T". The logo is enclosed in an oval shape. Below the logo, the text "510(k) Summary" is written in a bold, sans-serif font. | In accordance with 21 CFR 807.92 the following summary of information is provided: | | |------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | I. SUBMITTER | | | | Shenzhen RF Tech Co.,Ltd. | | | 2-F,Bld4,Juhui Industrial Park, Tianliao, Guangming, Shenzhen, 518132 China | | | Phone: (+86) 755-2664 1989 | | | Fax: (+86)755-2664 2989 | | Primary Contact Person: | Mike Gu | | | Regulatory Affairs Manager | | | OSMUNDA Medical Device Consulting Co., Ltd | | | Tel: (+86) 20-6232 1333 | | | Fax: (+86) 20-8633 0253 | | Secondary Contact Person: | Mr.Ke Xi | | | CEO | | | Shenzhen RF Tech Co.,Ltd | | Date Prepared: | May 08, 2015 | | II. DEVICE | | | Name of Device: | 8ch Foot Ankle Coil | | Common/Usual Name: | Coil, Magnetic Resonance, Specialty | | Classification Names: | Magnetic resonance diagnostic device (21 CFR 892.1000) | | Regulation Class: | II | | Product Code: | MOS | | Model: | RFT Model Number: 10-F21457<br>GE Part Number: 5567773-2 | | III. PREDICATE DEVICE | This device is manufactured by RFT and distributed by GE Medical Systems, LLC. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters "RFT" in bold, dark blue font. A small orange diamond is placed between the letters. The letters and diamond are encircled by a dark blue oval. The logo appears to be for a company or organization with the initials RFT. Traditional 510(k) Submission_ 8ch Foot Ankle Coil Primary predicate device: MRI'S FAC-127 Foot and Ankle Coils, K050514; This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques. The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory. The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table. The associated accessories include: - -1 cable - 1 baseplate, - - -1 ankle pad, - -1 foot pad, - 1 ramp pad, - - 1 knee pad support, - - 1 strap. - #### V. INDICATIONS FOR USE 8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with the SIGNA Pioneer only. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen. The Indications for Use statement for the 8ch Foot Ankle Coil is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both Indications for Use statements indicate that the device is intended to be used in conjunction with a 3T MR system to produce images of the knee and foot, and that the images can be interpreted by a trained physician. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for RFT, which is a company or organization. The logo consists of the letters "RFT" in a bold, blue font, with a small orange diamond in place of the dot over the "I". The letters are enclosed in a blue oval shape, which serves as a border for the logo. The logo has a clean and professional design. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The 8ch Foot Ankle Coil employs the same technology as its predicate device K050514. At a high level, the subject and predicate are based on the following same technological elements: - . Receive phased array RF coils; - Compatible with 3T MR systems ; - . Active PIN diode switching blocking circuitry. Passive blocking circuitry; - 8 channels; - Lexan 940 polycarbonate housing material. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility testing: The biocompatibility evaluation for the 8ch Foot Ankle Coil was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: - Cytotoxicity - Sensitization - Irritation Under the conditions of the study, the result of biocompatibility testing demonstrated that the 8ch Foot Ankle Coil is not a sensitizer or an irritant, and is non-cytotoxic. ## Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the 8ch Foot Ankle Coil. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for RFT bench testing. The logo is an oval shape with the letters "RFT" in bold, blue font. There is a small orange diamond in the middle of the "F". Below the logo, the words "Bench testing:" are written in black font. Traditional 510(k) Submission_ 8ch Foot Ankle Coil The following Bench tests were conducted, submitted, referenced or relied on to demonstrate the 8ch Foot Ankle Coil are safe and effective, the proposed device's performance meets the requirements of pre-defined acceptance criteria and intended use: - . Blocking Network analysis - This test determines the effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize Bl distortion. - Surface temperature test - normal condition. - Surface temperature test - unplugged condition. - elements signal check; - . max B1; # Clinical tests Analyses in sagittal, coronal, and axial planes were run on the 8ch Foot Ankle Coil to show that anatomies of the submitted and predicate coils have substantial equivalence. #### VIII. CONCLUSIONS The non-clinical data and the clinical data support the device. The device should perform as intended in the specified use conditions. Shenzhen RF Tech Co., Ltd. considers the 8ch Foot Ankle Coil does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.