ViaCath, AcQRate Dx Steerable Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. October 15, 2021 BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035 Re: K212593 Trade/Device Name: ViaCath Catheter; AcQRate Dx Steerable Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: August 13, 2021 Received: August 16, 2021 Dear Jon Brumbaugh: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212593 Device Name ViaCath Catheter AcQRate Dx Steerable Catheter Indications for Use (Describe) The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 ### VIACATH CATHETERS | | 510(k) NOTIFICATION K212593 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | August 12, 2021 | | Contact: | Jon Brumbaugh<br>Vice President, Regulatory Affairs & New Product Development<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 USA<br>Phone (888) 345-0374<br>Fax (800) 913-6993<br>Email: jon.brumbaugh@biotronik.com | | Manufacturer: | VascoMed GmbH<br>Hertzallee 1<br>79589 Binzen, Germany<br>Phone: +49 (0)7621 16011 0<br>Fax: +49 (0)7621 16011 9191 | | Trade Name: | ViaCath Catheter<br>AcQRate Dx Steerable Catheter | | Generic/Common Name: | Steerable Diagnostic Catheters | | Classification Name: | Electrode recording catheter or electrode recording probe | | Classification & Panel: | Class II / 21 CFR § 870.1220, Cardiovascular | | Product Code: | DRF | | Predicate Device: | StableMapr Steerable Intracardiac Electrode Catheter<br>(K183547, cleared in July 30, 2019) | ### Catheter ### Device Description [807.92(a)(4)] The ViaCath* and the AcQRate Dx Steerable Catheters are temporary, steerable, multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device. The main components of the ViaCath catheter are the distal catheter tip with electrodes, catheter shaft, handle, and connecting cable with pluq, which is a Redel connector. The ViaCath product family includes the ViaCath and the ViaCath NG models. Multiple electrode configurations are available with various numbers of electrodes, electrode shapes and electrode spacing. * Unless otherwise noted, the term "ViaCath" is used throuqhout to represent either ViaCath or AcQRate Dx Steerable Catheter. {4}------------------------------------------------ # Indications for Use [807.92(a)(5)] The indications for use of the catheters are substantially equivalent to that for the predicate. The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies. ### Comparison of Technological Characteristics with the Predicate Devices [807.92(a)(6)] The BIOTRONIK ViaCath Catheters are substantially equivalent to the predicate for this submission, the StableMapr Steerable Intracardiac Electrode Catheter (K183547). These products have the same intended purpose, identical indications for use and have comparable safety and technological features. The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the ViaCath Catheter performance testing. | Comparison of Characteristics between Proposed and Predicate Devices | | | | |----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Subject Device<br>BIOTRONIK<br>ViaCath Catheter<br>(K212593) | Predicate Device<br>StableMapr™<br>Steerable<br>Intracardiac<br>Electrode Catheter<br>(K183547) | Rationale for Substantial<br>Equivalence | | Indications for<br>Use | The catheter is<br>intended for use in<br>diagnostic<br>electrophysiologic<br>procedures in adult<br>patients. These<br>catheters are<br>designed for<br>recording<br>intracardiac<br>electrograms and<br>temporary pacing<br>associated with<br>electrophysiology<br>studies. | The<br>StableMapr™Steerable<br>Intracardiac<br>Electrode Catheters<br>are Intended for use<br>in diagnostic<br>electrophysiologic<br>procedures.<br>Designed for<br>recording intracardiac<br>electrograms and<br>temporary pacing<br>associated with<br>electrophysiology<br>studies. | Substantially equivalent.<br>Minor differences in wording<br>do not raise different<br>questions of safety or<br>effectiveness. | | Electrode<br>material | Platinum/iridium | Platinum/iridium | Identical | | Comparison of Characteristics between Proposed and Predicate Devices | | | | | | Subject Device | Predicate Device | | | Characteristics | BIOTRONIK<br>ViaCath Catheter<br>(K212593) | StableMapr™<br>Steerable<br>Intracardiac<br>Electrode Catheter<br>(K183547) | Rationale for Substantial<br>Equivalence | | Size | Outside diameter: 6F<br>(2mm)<br>Length of tip<br>electrode: 2mm<br>Length of ring<br>electrodes: 1mm<br>Effective length<br>ViaCath NG: 110 cm<br>Effective length<br>ViaCath: 90 cm | Outside diameter: 7F<br>Length of tip<br>electrode: 2mm<br>Effective length: 110<br>cm | Substantially equivalent.<br>Minor differences do not raise<br>different questions of safety<br>or effectiveness. | | Poles<br>(Electrodes) | 4, 5, 10 or 20 poles | 20 poles | Substantially equivalent.<br>Minor differences do not raise<br>different questions of safety<br>or effectiveness. | | Curve Shapes | ViaCath NG: 3 curve<br>shapes<br>ViaCath 20: 1 curve<br>shape | Variable curve shapes | Similar design features.<br>Minor differences do not raise<br>different questions of safety<br>or effectiveness. | | Connector type | ViaCath NG: 4 pin,<br>10 pin<br>ViaCath: 10 pin | 10 pin | Similar design features.<br>Minor differences do not raise<br>different questions of safety<br>or effectiveness. | | Electrode<br>Spacing | ViaCath: 2-8-2 mm<br>ViaCath NG: 2mm,<br>5mm, 2-6-2mm, 2-<br>8-2mm, 2-10-2mm | 2-10-2 mm | Substantially equivalent. The<br>minor difference in electrode<br>spacing does not raise new<br>issues of safety and<br>effectiveness. | | Single Use | Yes | Yes | Identical | | Supplied Sterile | Yes | Yes | Identical | {5}------------------------------------------------ # Performance Data [807.92(b)] All necessary bench testing was conducted on the ViaCath Catheter to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device. {6}------------------------------------------------ # Nonclinical Testing Summary [807.92(b)(1)] The nonclinical bench testing included: - . Design Verification - Dimensional Inspection o - Visual Inspection o - Functional and Compatibility Testing o - Mechanical Testing O - Corrosion Testing o - Design Validation ● - Usability Testing - . Biocompatibility Testing In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ViaCath Catheters meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the ViaCath Catheters do not introduce new issues of safety or effectiveness when compared to the predicate device. | Test performed | Device | Test method summary | Results | |-----------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Dimensional and Visual<br>Inspection | ViaCath | Testing demonstrate that requirements of<br>EN ISO 10555-1 have been met and<br>correspond to the defined specifications. | pass | | Functional and<br>Compatibility Testing | ViaCath | Functional and compatibility testing was<br>performed with FDA approved external<br>generators. The results of the leakage<br>currents testing revealed an outcome below<br>the limits given in the standard IEC 60601-<br>1:2005, COR1:2006, COR2:2007,<br>AMD1:2012. | pass | | Electrical and<br>Mechanical Testing | ViaCath | Testing demonstrates that applicable<br>requirements of EN ISO 10555-1, EN<br>62366-1 and En ISO 60601-1 have been<br>met to ensure that the catheter is safe. | pass | | Shelf life | ViaCath | Confirmation of device functional<br>performance and sterile barrier pouch<br>integrity (seal strength per ASTM F88 and<br>bubble per ASTM F2096) with accelerated<br>aging and simulated distribution per ASTM<br>4169-16. | pass | | Packaging | ViaCath | The methods applied to evaluate the sterile<br>barrier package integrity included transport<br>simulation, preconditioning, seal strength,<br>peel and bubble testing. | pass | {7}------------------------------------------------ | Test performed | Device | Test method summary | Results | |--------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Biocompatibility | ViaCath | The biocompatibility testing demonstrates<br>that the requirements of ISO 10993<br>"Biological evaluation of medical devices -<br>Part 1: "Evaluation and testing within a risk<br>management process" and the 2020 FDA<br>Biocompatibility guidance 2have been met. | pass | | Sterilization Validation | ViaCath | Full Revalidation of Sterilization Process<br>Performance Qualification<br>ISO 11135:2014 Sterilization of health care<br>products - Ethylene oxide: Requirements of<br>development,<br>validation and routine control of a<br>sterilization process for medical devices. | pass | # Clinical Performance Data [807.92(b)(2)] No clinical performance data was submitted or relied upon in support of the substantial equivalence determination. ### Cable ### Device description: BIOTRONIK's MPK-4-R and MPK-10 patient cables are four or ten channel cables to connect electrophysiological diagnostic catheters distributed by BIOTRONIK (e.g. MultiCath, ViaCath) and Acutus Medical (AcQRate Dx Fixed Curve Catheter, AcQRate Dx Steerable Catheter) with electrophysiological examination units and stimulators. ### Intended use: MPK-4-R and MPK-10-R are used to connect BIOTRONIK and Acutus Medical diagnostic catheters to a cardiac stimulator or a lab monitoring system for intracardiac diagnostics as part of an electrophysiological study. MPK-R and diagnostic catheters may only be used by medical personnel qualified to work with lab monitoring systems. Patient cables may not be physically modified, e.g., be shortened. {8}------------------------------------------------ ### Cables Functional and Safety Testing: | Test performed | Device | Test method summary | Results | |-----------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Functional testing:<br>visual inspection,<br>dimensional<br>verification, electrical<br>continuity and<br>resistance, mechanical<br>characteristics | MPK | For validation of the product properties after<br>real time aging of 25 months following tests<br>are performed:<br>a) Visual inspection of the packaging and<br>product<br>b) Functional test of the product<br>c) Electrical measurement | a) Pass<br>b) Pass<br>c) Pass | | Sterilization Validation | MPK | Full Revalidation of Sterilization Process<br>Performance Qualification ISO 11135:2014<br>Sterilization of health care products -<br>Ethylene oxide: Requirements of<br>development,validation and routine control of<br>a sterilization process for medical devices. | Pass | | Reprocessing Validation | MPK | Testing demonstrates that the cable can be<br>reprocessed up to 50 times. | Pass | # Conclusions [807.92(b)(3)] Based on the performance testing and the technological characteristics, it can be concluded that the ViaCath Catheter meets its established performance for its intended use and is substantially equivalent to the predicate device.