Ablacath™ Mapping Catheter

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March 17, 2023 Ablacon, Inc. % Laurie Lewandowski VP Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123 Re: K223666 Trade/Device Name: Ablacath™ Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: MTD Dated: February 16, 2023 Received: February 16, 2023 Dear Laurie Lewandowski: 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. {1}------------------------------------------------ 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 and Part 809); 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. # Aneesh S. Deoras -S Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K223666 Device Name Ablacath™ Mapping Catheter #### Indications for Use (Describe) For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli. 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. 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SUBMITTER INFORMATION Submitter: Ablacon, Inc Frank Rodrigues 4800 Wadsworth Blvd. Ste. 310 Wheat Ridge, CO 80033 USA Email: fr@ablacon.com Primary Contact: Laurie Lewandowski Consultant, Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 Telephone: 612-770-4038 (cell) Email: laurie.lewandowski@ablacon.com DATE PREPARED: December 07, 2022 ### 2. DEVICE INFORMATION Proprietary Name: Regulation Number: Regulation Name: Common/Usual Name: Regulatory Class: Product Code: ## Ablacath™ Mapping Catheter 21 CFR 870.1220 Electrode Recording Catheter or Electrode Recording Probe Catheter, Intracardiac Mapping, High-Density Array Class II MTD ### 3. PREDICATE DEVICE INFORMATION | Proprietary Name: | FIRMap® Catheter | |--------------------|-----------------------------------------------------------| | Regulation Number: | 21 CFR 870.1220 | | Regulation Name: | Electrode Recording Catheter or Electrode Recording Probe | | Common/Usual Name: | Catheter, Intracardiac Mapping, High-Density Array | | Regulatory Class: | Class II | | Product Code: | MTD | | 510K Number: | K163709 | ### 4. DEVICE DESCRIPTION The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver {4}------------------------------------------------ externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes. - . AB-0003-50 is the 50 mm basket size - AB-0003-60 is the 60 mm basket size ● # 5. INDICATION FOR USE For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacon Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli. # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The Ablacath Mapping Catheters have similar technological characteristics as the predicate, Abbott FIRMap Catheter, cleared under K163709. The subject and predicate device both are used for intracardiac electrophysiology mapping and pacing. A comparison of the Ablacath Mapping Catheter and the FIRMap Catheter is in the following table. | Attribute / Device<br>Characteristics | Proposed Device<br>Ablacath™ Mapping Catheter | FIRMap® Catheter<br>K163709<br>Predicate | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intracardiac electrophysiology<br>mapping and pacing | Identical | | Indications for use | For use in cardiac<br>electrophysiology procedures to<br>assist in the diagnosis of<br>arrhythmias that may be difficult<br>to identify using conventional<br>mapping systems alone (i.e., linear<br>mapping catheters). The Ablacath<br>Ablacath™ Mapping Catheter may<br>also be used for delivery of<br>externally generated pacing<br>stimuli. | For use in cardiac electrophysiology<br>procedures to assist in the diagnosis<br>of arrhythmias that may be difficult to<br>identify using conventional mapping<br>systems alone (i.e., linear mapping<br>catheters). The FIRMap Catheter may<br>also be used for delivery of externally<br>generated pacing stimuli. | | Users | Electrophysiologists | Identical | | Device Components | Basket | Identical | Ablacon Inc., Ablacath™ Mapping Catheter K223666 {5}------------------------------------------------ | Attribute / Device<br>Characteristics | Proposed Device<br>Ablacath™ Mapping Catheter | FIRMap® Catheter<br>K163709<br>Predicate | |---------------------------------------|-----------------------------------------------|------------------------------------------| | | Shaft<br>Handle<br>Introducer Tool | | | Basket Dimensions | 50 mm<br>60 mm | 50 mm<br>60 mm<br>70 mm | | Catheter Shaft<br>Diameter | 2.8 mm | Identical | | Length | $128\pm 1$ cm | Identical | | Effective Length | 113 cm | Identical | | Recommended Guide<br>Sheath Size | 8.5F | Identical | | Number of Splines | 8 (expanding) | Identical | | Strut Material | Nitinol | Identical | | Spine Tube Material | Pebax | Identical | | Catheter Tubing | Pebax | Identical | | Number of Electrodes | 64 | Identical | | Electrode Material | Gold Plated Copper | Identical | | Electrode<br>Configuration | Unipolar or Bipolar | Identical | | Electrical Rating | Maximum = ±30 V, 25 mA | Typical = ±27 V, 25 mA | | Dielectric Strength | 500 VDC | 500 VDC | | Sterility | EO sterilized | Identical | | SAL | 1x10-6 | Identical | | Biocompatible | Yes | Identical | The Ablacath Mapping Catheter has the same intended use and indications for use as the predicate. The technological characteristics are similar to the predicate. The difference electrical rating reflects the actual testing performed on the subject device. The Ablacath Mapping Catheter is substantially equivalent to the predicate device. ## 7. PERFORMANCE DATA ### Bench Testing All testing was performed pre and post aging (per ASTM F1980:2016), except for radiopacity and electrical safety testing, that were performed at T=0. - . Visual / Dimensional {6}------------------------------------------------ - Mechanical Integrity-flexibility, kink, spline radial strength, basket vertical compression Flexibility - Torque Resistance / Strength ● - Track Force/Withdrawal Cycling and Withdrawal Force ● - Radiopacity per ASTM F640 ● - Corrosion per ISO 10555-1 - Fluid Leak - Mating / Uncoupling Force - . Tensile Testing per ISO 10555-1 - Continuity / resistance / pin short, spline orientation, and connector alignment ● - Electrical Safety Testing per ISO 60601-1 ● Packaging - Distribution per ASTM D4169:2016 ● - Environmental Conditioning per ISTA 3A:2011 - Aging per ASTM F1980:2016 - Packaging per ISO 11607-1:2006 - Visual per ASTM F1886-16/F1886M-16 o - Bubble Leak per ASTM F2096-11:2019 o - Seal Strength per ASTM F88/F88M-15 O All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness. ### Summary of Pre-clinical Studies Preclinical animal studies were performed to confirm validation and usability requirements using a swine model under simulated use conditions. The studies complied with the guidelines for nonclinical laboratory studies as described in CFR 21 Part 58. - . GLP Validation Testing The purpose of the study was to ensure that Ablacath Mapping Catheter conformed to the intended user needs and indication for use through the evaluation of each performance requirement and met acute safety attributes as evaluated by physician end-users. The Ablacath Mapping Catheter met all study endpoints; performance and acute safety requirements and was found to be clinically acceptable by all evaluators with the performance equivalent to the predicate device. - . GLP Usability Testing The purpose of the study was to obtain performance data through observation of the end-users under simulated end-use environment. No User Errors or Close Calls were observed in any of the physician end-users in the conduct of the usability validation study. {7}------------------------------------------------ Biocompatibility Biocompatibility testing was performed in accordance with: - . ISO 10993-1:2018 for a limited (<24 hour), externally communicating, circulating blood contacting device - Chemical Characterization per ISO 10993-18:2020 ● - Cytotoxicity: MEM Extraction Cytotoxicity Assay per ISO 10993-5:2009 - Sensitization: Guinea Pig Maximization Test per ISO 10993-10:2010 ● - Irritation: Intracutaneous Reactivity Test. per ISO10993-10:2010 ● - . Toxicity: Acute Systemic Toxicity per ISO 10993-11:2017 - Toxicity: Materials Medicated Rabbit Pyrogen Test ISO 10993-11:2017 - . Hemocompatibility: Hemolysis Direct and Indirect per ISO 10993-4: 2017 - . Hemocompatibility: C3a and SC5b-9 Complement Activation ISO 10993-4: 2017 - . Hemocompatibility: In Vivo Thromboresistance ISO 10993-4: 2017 All devices met their endpoints. ## Sterilization: Sterilization (ethylene oxide) and packaging of the Ablacath Mapping Catheter were validated using the following standards: - ANSI/AAMI/ISO 11135-1:2014 Sterilization of health-care products -. ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices Testing demonstrated that all endpoints were met. ## 8. CONCLUSION The Ablacath Mapping Catheter is substantially equivalent in terms of the intended use, indications for use, technological characteristic, performance testing and comparison to the cited predicate, and does not present any new questions of safety and effectiveness.