RITHM ID ELECTROPHYSIOLOGY CATHETER

{0}------------------------------------------------ ### K133028 Tab #7 510(k) Summary ....... REF #: M0122013Bd # MAR 0 4 2014 #### Tab # 7 = 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: _K133028_ - 7.1 Date of Submission 09/15/2013 7.2 Sponsor #### Synaptic Medical Limited Building C, 100 Kechuang 6th Street Beijing Economic-Technological Development Area Beijing, 100176, PR China Establishment Registration Number: Not yet registered Contact Person: Mr. Yang, Tiecheng Position: Quality Director Tel: +86-10-51297209-813 Fax: +86-10-51297209-802 Email: tiecheng.yang@synapticmed.com.cn - 7.3 Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net {1}------------------------------------------------ #### Premarket Notification 510(k) Submission Tab #7 510(k) Summary REF #: M0122013Bd 7.4 Identification of Proposed Device Trade Name: Rithm IDTM Electrophysiology Catheter Common Name: Electrophysiology Catheter Regulatory Information: Classification Name: Catheter, Electrode Recording Classification: II; Product Code: DRF; Regulation Number: 21 CFR 870.1220; Review Panel: Cardiovascular; Intended Use Statement: The Rithm ID™ Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. 7.5 Device Description The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves. The catheter has a high-torque shaft with an array of platinum electrodes at the distal tip that can be used for recording. The high-torque shaft allows the plane of the distal curve to be manually rotated to assist in positioning the catheter tip at the desired site. The Rithm IDM Electrophysiology Catheters have to connect with the EP by interface cables, model CI8RS04S, C25S04S, C18RS10S and C25RS10S with different trunk length, leadwire and equipment connector for the different Electrophysiology Catheters. - 7.6 Identification of Predicate Device 510(k) Number: K002976 Product Name: Diagnostic Electrophysiology Catheter Manufacturer: St. Jude Medical,DAIG Division #### 7.7 Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: {2}------------------------------------------------ Premarket Notification 510(k) Submission Tab #7 510(k) Summary - IEC 60601-1:2005 Medical Electrical Equipment-Part 1 General Requirements for basic safety 产 and essential performance; - IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2 General Requirements for basic 公 safety and essential performance - collateral standard: Electromagnetic compatibility -Requirements and tests; - ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro > cytotoxicity; - ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic > toxicity: - ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and A skin sensitization; - ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for > interactions with blood: - ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials; > - ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization > Failure Resistance of Unrestrained Packages; - Bench Test 1: Surface, Dimensions and Shape Keeping of Tip Curve; A - Bench Test 2: Buckling Force, Tip Fatigue, Shaft Fatigue, Torsional Strength, Tensile Strength, A Connector Retention Force; - Bench Test 3: Electrode Isolation, Electrode Conductor Resistance, Insulation Resistance; A - A Bench Test 4: Corrosion Resistance and Radio-detectability; - A Bench Test 5: Freedom from leakage; - Bench Test 6: Shape Keeping of Tip Curve, Electrode Conductor Resistance on Simulation > Test: - > Bench Test 7: Acquiring Clear Intracardiac Electrograms Test; - A Bench Test 8: Stimulating Capability Test. - 7.8 Clinical Test Conclusion No clinical study is included in this submission. - 7.9 Substantially Equivalent (SE) Comparison | ITEM | Proposed Device<br>Rithm ID™ Electrophysiology<br>Catheter | Predicate Device<br>Diagnostic Electrophysiology Catheter<br>K002976 | Remark | |----------------|------------------------------------------------------------|----------------------------------------------------------------------|--------| | Product Code | DRF | DRF | SE | | Regulation No. | 21 CFR 870.1220 | 21 CFR 870.1220 | SE | | Class | Class II | Class II | SE | #### Table 6-1 Comparison of Technology Characteristics {3}------------------------------------------------ ## K133028 Tab #7 510(k) Summary Premarket Notification 510(k) Submission REF #: M0122013Bd_ | Intended Use | The Rithm ID™ Electrophysiology Catheter can<br>be used in the evaluation of a variety of cardiac<br>arrhythmias from endocardial and intravascular<br>sites. | Daig Electrophysiology Catheters can be used<br>in the evaluation of a variety of cardiac<br>arrhythmias form endocardial and intravascular<br>sites. | SE | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----| | Configuration | Cable Connector | Cable Connector | SE | | | Tip Electrode | Tip Electrode | SE | | | Shaft | High-torque shaft | SE | | | Strain reinforcement shrink tubing | Strain reinforcement shrink tubing | SE | | Features | Fixed Curve | Fixed Curve | SE | | | High-torque shaft | High-torque shaft | SE | | | Electrode Spacing | Electrode Spacing | SE | | | Multiple curve and length option | Multiple curve and length option | SE | | How Supplied | EO Sterilized | EO Sterilized | SE | ### 7.10 Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. {4}------------------------------------------------ Public Health Service Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three bars extending from the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002 March 4, 2014 Synaptic Medical Limited c/o Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CH Re: K133028 > Trade/Device Name: Rithm ID Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: January 26, 2014 Received: January 30, 2014 Dear Ms. Hong, 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. {5}------------------------------------------------ Page 2 - Ms. Diana Hong 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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Image /page/5/Picture/7 description: The image shows the name "Linda J. Ricci" in a bold, sans-serif font. The text is surrounded by a decorative border of dashed lines, giving it a framed appearance. The overall design is simple and clear, with the name being the central focus. Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Indications for Use Statement Tab # 6 510(k) Number: K133028 Device Name: Rithm ID™Electrophysiology Catheter Indications for Use: The Rithm IDM Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. Image /page/6/Picture/7 description: The image shows two options, prescription use and over-the-counter use, with the prescription use box checked. The prescription use option is labeled as (Part 21 CFR 801 Subpart D), while the over-the-counter use option is labeled as (21 CFR 801 Subpart C). Below these options, there is a note that says, "PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED." The image also mentions the Concurrence of CDRH, Office of Device Evaluation (ODE). Image /page/6/Picture/8 description: The image contains the name "Linda J. Ric". Below the name is a timestamp. The timestamp reads "2014.03:04:16:01:29+05'00'".