Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 30, 2019 Medtronic Matthew Lobeck Sr. Regulatory Affairs Specialist 8200 Coral Sea St NE Mounds View, Minnesota 55112 Re: K183547 Trade/Device Name: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 3, 2019 Received: July 5, 2019 Dear Matthew Lobeck: 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. 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 {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183547 Device Name 1. Marinr™ Steerable Intracardiac Electrode Catheter 2. StableMapr™ Steerable Intracardiac Electrode Catheter Indications for Use (Describe) 1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies. 2. The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 5.0 510(k) Summary | Date Summary Prepared: | January 25, 2019 | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Medtronic<br>8200 Coral Sea Street<br>Mail Stop MVS46<br>Mounds View, MN 55112<br>Establishment Registration No. 3001504994 | | Official Correspondent: | Matthew Lobeck<br>Senior Regulatory Affairs Specialist<br>Medtronic<br>8200 Coral Sea Street<br>Mounds View, MN 55112<br>Telephone: 763.514.9515<br>Fax: 763.367.9903<br>Email: matthew.lobeck@medtronic.com | | Device Trade Name: | 1. Marinr™ Steerable Intracardiac Electrode Catheter<br>2. StableMapr™ Steerable Intracardiac Electrode Catheter | | Common Name: | Diagnostic catheter | | Classification Name: | Catheter, Electrode Recording, Or Probe, Electrode<br>Recording | | Classification & Panel:<br>Product Code: | Class II, 21 CFR 870.1220, Cardiovascular<br>DRF | | Predicate Device: | 1. Marinr™ Steerable Intracardiac Electrode Catheter (K951347, K931794)<br>2. StableMapr™ Steerable Intracardiac Electrode Catheter (K981642) | | Device Description: | Medtronic diagnostic catheters are flexible radiopaque<br>catheters constructed of extruded polymer over a stainless-<br>steel braid. The catheters contain platinum-iridium sensing<br>band electrodes and are designed for intracardiac recording<br>or stimulation.<br><br>This premarket notification covers changes impacting<br>Medtronic diagnostic catheters, including labeling updates,<br>packaging design and packaging material changes, and<br>product requirement updates. | | Intended Use: | Medtronic diagnostic catheters are intended for use in<br>diagnostic electrophysiologic procedures. The catheters are<br>designed for recording intracardiac electrograms and<br>temporary pacing associated with electrophysiology studies.<br><br>The intended use is unchanged with the proposed<br>modifications and remains the same as that previously<br>cleared under the respective 510(k)s. | | Indications for Use: | 1. The Medtronic Marinr catheter is intended for use in<br>diagnostic electrophysiologic procedures. The Medtronic<br>Marinr catheter is designed for recording intracardiac<br>electrograms and temporary pacing associated with<br>electrophysiology studies.<br><br>2. The Medtronic StableMapr catheter is intended for use in<br>diagnostic electrophysiologic procedures. These catheters<br>are designed for recording intracardiac electrograms and<br>temporary pacing associated with electrophysiology<br>studies.<br><br>The indications for use are unchanged with the proposed<br>modifications and remains the same as those previously<br>cleared under the respective 510(k)s. | | Comparison of<br>Technological<br>Characteristics: | The following changes are being implemented as part of this<br>premarket notification:<br><br>Labeling Changes:<br>Inclusion of updated storage and transit condition<br>information General symbol updates, formatting and grammatical<br>changes Inclusion of contraindication and adverse event<br>information Various additional changes as part of general labeling<br>improvements Packaging Changes: Increase to shelf carton height Relocation of labeling from shelf carton to product<br>labels | {4}------------------------------------------------ - Change to catheter tray design for securement of . catheter within packaging - Change to a material of the catheter pouch . {5}------------------------------------------------ - . Change to dimensions of the catheter pouch - . Increase to the page count of the IFU and warranty document - Addition of a protective literature bag - . New label stocks for product labels and warranty document - . Addition of a secondary shelf carton label and end cap seal # Product Requirement Changes: This premarket notification includes updates to the following Product Requirement Specifications (PRS): | PRS Attribute | Impacted Products | |----------------------------------------------------|---------------------------------------------------------| | Product Requirements | | | Biocompatibility | All | | Corrosion resistance | All | | Visual - Foreign Material<br>and Defects | All | | Visual - Butt Joint<br>Inspection | All | | Visual - Band Electrodes | All | | Visual - Tip Assembly | All | | Visual - Serial Number | All | | Catheter outer diameter | All | | Electrode Band Spacing | All | | Working Length | All | | Actuation force for linearly<br>activated controls | All | | Tip Springback | All | | Reverse deflection | StableMapr Steerable<br>Intracardiac Electrode Catheter | | Extent & Rate of Tip<br>Deflection | All | | Proximal curve reach | All | | Proximal curve planarity | All | | Lateral deflection control | Marinr Steerable Intracardiac<br>Electrode Catheter | | Tip lateral deflection travel | Marinr Steerable Intracardiac<br>Electrode Catheter | | Distal tip stiffness | All | | Proximal shaft flexibility in<br>37°C | All | | Tip transition kinking | All | {6}------------------------------------------------ | Lateral Stability | StableMapr Steerable<br>Intracardiac Electrode Catheter | |--------------------------------------------------------------|---------------------------------------------------------| | Shaft Torque-ability | All | | Joint - Tip Composite | Marinr Steerable Intracardiac<br>Electrode Catheter | | Joint- Proximal Shaft to<br>Distal Deflectable Tip<br>Tubing | All | | Electrode path AC<br>impedance | Marinr Steerable Intracardiac<br>Electrode Catheter | | Band Electrode Path DC<br>Resistance | All | | Simulated use: catheter<br>pushability | StableMapr Steerable<br>Intracardiac Electrode Catheter | | Simulated use: catheter<br>shaft repeated torqueing | StableMapr Steerable<br>Intracardiac Electrode Catheter | | Handle Control<br>Requirements | All | | Connector Interface<br>Requirements | All | | Packaging Requirements | | | Packaging Configuration | All | | Traceability | All | | Material Sterilization<br>Compatibility | All | | Packaging Performance | Marinr Steerable Intracardiac<br>Electrode Catheter | | Sterile Barrier Integrity | All | | Seal strength | All | | Specified loading<br>configuration | All | | Storage and Shipping<br>Conditions | All | While this premarket notification covers changes to labeling, packaging design and materials, and product requirement specifications, there are no changes to the finished diagnostic catheter designs or materials. The manufacturing processes and inspections related to diagnostic catheter assemblies are also remaining unchanged. Compared to the predicate, the subject device features the: - Same intended use ● - Same indications for use . - Same fundamental scientific technology ● {7}------------------------------------------------ - Same finished catheter design and dimensions ● - . Same user interface - Same materials of construction ● - Same manufacturing and sterilization processes ● The differences between the subject and predicate devices involve labeling, packaging, and product requirements only. The subject device design technology, performance characteristics, materials, shelf life and sterilization process are all unchanged. The proposed changes do not constitute a change in the fundamental scientific technology for the subject devices and do not raise new or different questions of safety and effectiveness. The subject devices do not provide a new therapy, and the intended use and indications for use remain unchanged and identical to the predicates. The modified subject devices described in this 510(k) submission are substantially equivalent to the predicate devices. Performance Data: Performance testing (bench) was completed in support of the proposed modifications. The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements. > To support the proposed product requirement changes in this premarket notification, the following tests were performed on test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years: ### Product Requirement Testing: - Corrosion resistance testing - Visual inspections ● - Electrode band spacing measurement ● - Catheter shaft dimensional measurements ● - Actuation force testing - Tip springback testing - Catheter shaft reach, deflection, and planarity testing ● - Catheter shaft stiffness and flexibility testing ● - Kink resistance testing - Catheter shaft lateral stability testing - Catheter shaft torqueability testing - Catheter tensile testing ● - Electrode path impedance and resistance testing ● {8}------------------------------------------------ - Simulated use testing for pushability and ● torqueability ## Packaging Requirement Testing: - Visual inspections - Sterilization pre-conditioning . - Environmental pre-conditioning - Label legibility testing ● - Label durability testing ● - Bubble leak testing ● ## Conclusion: This premarket notification is limited to labeling, packaging design and materials, and product requirement specifications for Medtronic diagnostic catheters. There are no changes to the intended use, indications for use, performance, or fundamental scientific technology, and the subject devices are considered substantially equivalent to the legally marketed predicate devices.