EasyMap MAP Catheter

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 18, 2016 MedFact Engineering GmbH % Melissa Walker President & Cto Graematter, Inc 1324 Clarkson Clayton Ctr. #332 Ballwin, Missouri 63011 Re: K151139 Trade/Device Name: EasyMap MAP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: September 11, 2016 Received: September 13, 2016 Dear Melissa Walker: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K151139 Device Name EasyMap MAP Catheter Indications for Use (Describe) EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | <span style="white-space: nowrap;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="white-space: nowrap;"> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ # Appendix 1: 510(k) Summary per 21CFR §807.92 | Submitter's<br>information | Jörg Reinhardt<br>MedFact Engineering GmbH<br>Hammerstrasse 3<br>D-79540 Löerrach/ Germany | Contact: Melissa Walker<br>Graematter, Inc.<br>1324 Clarkson Clayton Ctr #332<br>Ballwin, MO 63011<br>Phone: 636-405-7498<br>Date: 04/20/2015 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Device/<br>classification<br>name | Classification information for the EasyMap MAP Catheter follows:<br>• 21 CFR 870.1220<br>• Product Code DRF<br>• Classification/Common name: Electrode recording catheter or electrode recording probe | | | | The marketed device(s) to which substantial equivalence is claimed:<br>• Franz Steerable Combination Catheter 510(k)<br>• K903880 cleared October 12, 1990. | | | Device<br>description | EasyMap MAP is a single-use disposable quadropolar catheter for recording<br>monophasic action potentials and for intracardial pacing. Integrated in the<br>catheter tip are a Silver-Chloride Electrode (AgCI), a Silver Electrode (Ag)<br>and two orthogonally placed Silver Electrodes (Ag). These electrodes enable<br>mapping of cardiac electrochemical potentials. | | | | The catheter tip can be deflected in a single direction up to 270 degrees. | | | Indications for<br>use | EasyMap MAP catheters are indicated for simultaneously pacing and<br>recording monophasic Action-Potentials (MAPs) from the endocardial surface<br>of the human heart. | | | | Continued on next page | | {4}------------------------------------------------ ## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued Comparison matrix of basic key characteristics The table below lists the main characteristics of the proposed EasyMap MAP Catheter compared to the Predicate Franz MAP Catheter. The Franz MAP Catheter was chosen as the predicate device because the intended use is identical to the EasyMap MAP Catheter in that both are designed to detect and record electrical potentials from the endocardial surfaces of the heart and to deliver externally generated pacing stimuli. | Device Characteristic | Franz Steerable<br>Combination Catheter<br>Predicate Device<br>K903880 | Proposed New Device:<br>EasyMap MAP<br>Catheter | |-------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------| | Physiologic purpose | Aid physician in<br>management of<br>arrhythmias | same | | Intended for use by | Cardiac EP or<br>cardiovascular surgeons | same | | Primary function | MAP recording and<br>temporary cardiac pacing | same | | Insertion method | Percutaneous through a<br>large vein by Seldinger<br>technique | same | | Electrode material | MAP: AG/AgCl<br>Pacing: Platinum | same | | No. of electrodes | 4-8 electrodes<br>2 MAP<br>2-6 Pacing | 4 electrodes<br>2 MAP<br>2 Pacing | | Electrode spacing - | MAP electrodes<br>4.5 mm edge to edge | MAP electrodes<br>4.5 mm edge to edge | | Image: Diagram of pacing and MAP recording electrodes | Pacing electrodes<br>3.6 mm (center to center),<br>1.6 mm (edge to edge) | Pacing electrodes<br>3.6 mm (center to center)<br>1.6 mm (edge to edge) | | Sterile | Yes | same | | Method of sterilization | EO gas | same | | Single use | Yes | same | | Catheter body material | Pebax | Pebax | | Catheter diameter | 5, 6, 7 F | 7F | | catheter length | 80-150 cm | 110 cm | | Tip deflection angle/<br>range | 270° in two directions | Unidirectional up to 270° | Continued on next page {5}------------------------------------------------ ## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued #### Test summary The table below lists the applied standards and test results for the EasyMap MAP Catheter. | Test | Applied Standard | Result | |---------------------------------------------------------------------------------------------------------------|----------------------|-------------| | Corrosion Test | ISO 10555 | Passed Test | | Dimension Tests | Internal Test Method | Passed Test | | Electrical Tests<br>- Continuity<br>- Short Circuit<br>- Isolation/Leakage Test<br>- High Voltage Test (1 kV) | EN 60601 | Passed Test | | Mechanical Test<br>- Mechanical Strength after moisture storage | ISO 10555 | Passed Test | | - Steerability | Internal Test Method | | | - Fixation Push / Pull Control | Internal Test Method | | | Compatibility with existing products<br>- Bending<br>- Dimensions | Internal Test Method | Passed Test | | Biocompatibility | ISO 10993 | Passed Test | | Shelf Life Test | Internal Test Method | Passed Test | | Packaging Validation | ISO 11607-1 | Passed Test | | Sterilization Validation | EN 550; ISO11135 | Passed Test | | X-Ray Test / Visibility | Internal Test Method | Passed Test | Note: Tests are to be performed on sterilized products after storage and moisture (0.9% NaCl water bath 37 °C, 24 h) Thermal Shock Test and bending performance test. Performance Based upon the documentation presented in this 510(k) it has been data demonstrated that the EasyMap MAP Catheter is safe and effective for its intended use.