AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

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July 1, 2020 Atrility Medical, LLC % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589 Re: K200674 Trade/Device Name: AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 15, 2020 Received: May 15, 2020 Dear Gary Syring: 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. 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Hetal Odobasic 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) K200674 Device Name AtriAmp Indications for Use (Describe) The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and modern. #### 510(k) Summary This 510(k) summary was prepared to provide an understanding of the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92. | Submitters Name: | Atrility Medical, LLC<br>313 Price Place, Suite #13<br>Madison, WI 53705 | |------------------------|-----------------------------------------------------------------------------------------------------------------------| | Contact Person: | Matthew Knoespel, Regulatory Engineer<br>Atrility Medical, LLC | | Contact Phone: | Phone: 920-619-8737 | | Date Summary Prepared: | June 22, 2020 | | Device Trade Name: | AtriAmp | | Common Name: | Passive interface cable to external pacemaker, epicardial pacing lead wire and<br>cardiac monitor | | Classification Name: | 21 CFR 870.290 Patient transducer and electrode cable (including connector)<br>Product Code: DSA, Class II | | Predicate Devices: | K080621, Fastlock Pacing Wire Extension (Primary Predicate)<br>K070926, Electrode/Extension Cables, Model series ATAR | #### Device Description The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device. #### Intended Use of the Device The AtriAmp is a single-use device that is intended to connect an electrode/lead from a patient to a Type CF, defibrillation-proof ECG Monitor and/or an external pacemaker. #### Summary of Technological Characteristics The following table provides a side-by-side comparison of the predicate devices applied to support this pre-market notification. | Technical Characteristics Comparison | | | | | |--------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------| | Feature | AtriAmp and<br>Accessories<br>Under Review | Fastlock Pacing<br>Wire Extension<br>Cable<br>(Primary Predicate:<br>K080621) | Electrode/Extension<br>Cables, Model series<br>ATAR<br>Predicate: K070926 | Equivalence<br>Comments | | Product Code,<br>Classification | DSA,<br>21 CFR 870.2900,<br>Class II | DSA,<br>21 CFR 870.2900,<br>Class II | IKD,<br>21 CFR 890.1175<br>Class II | Identical to primary<br>predicate. | {4}------------------------------------------------ | Technical Characteristics Comparison | | | | | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | AtriAmp and<br>Accessories<br>Under Review | Fastlock Pacing<br>Wire Extension<br>Cable<br>(Primary Predicate:<br>K080621) | Electrode/Extension<br>Cables, Model series<br>ATAR<br>Predicate: K070926 | Equivalence<br>Comments | | Indications for<br>Use | The AtriAmp supports<br>pacing by acting as an<br>extension cable between<br>an external pacemaker<br>and cardiac pacing<br>leads. The AtriAmp also<br>supports monitoring of<br>intra-cardiac signals by<br>transmitting signals to<br>one of the unipolar<br>precordial chest leads<br>(leads V1-V6) of a Type<br>CF, defibrillation-<br>proof ECG monitor. | Fastlock pacing wire<br>extension cable with<br>connectors is indicated<br>for use as an electrical<br>extension cable used to<br>transmit signal from, or<br>power or excitation<br>signal to patient-<br>connected electrodes. | Electrode/extension<br>cable is intended to<br>connect an<br>electrode/lead from a<br>patient or another<br>cable to a diagnostic<br>machine or an<br>external pacemaker. | Equivalent<br>The same as the<br>predicate devices, the<br>AtriAmp interfaces<br>between an external<br>pacemaker and patient<br>applied intra-cardiac<br>pacing lead wires.<br>Equivalent to the<br>secondary predicate, the<br>AtriAmp interfaces the<br>signal from the<br>epicardial lead wires to<br>a, defibrillation-proof<br>ECG Monitor, one of<br>the leads (V1 to V6) of<br>an ECG monitor. | | Duration of<br>use | Anticipated to be less<br>than 14 days | < 7 Days | < 7 Days | Similar | | Single use,<br>disposable | Yes | Yes | Yes | Same | | Provided sterile | Yes | Yes | Yes | Same | | Sterilization<br>method | e-beam | ethylene oxide | ethylene oxide | Similar | | Sterility<br>Assurance Level<br>(SAL) | $ ≤ 10^{-6} $ | Unknown | Unknown | Acceptable for the<br>intended use | | Sterile barrier<br>package | Flexible Double Pouch | Tyvek Flexible Barrier | Tyvek Flexible Barrier | Similar | | Biocompatibility<br>evaluation | Cytotoxicity, Irritation,<br>Sensitization | Unknown | Unknown | Similar | # Non-clinical Performance Tests To establish the technical equivalency of the AtriAmp with accessories, evaluations were conducted to confirm compliance with performance requirements, including: | Test | Test Method Summary | Result | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | ANSI/AAMI<br>EC53:2013<br>compliance | The AtriAmp complies with applicable requirements of EC53:2013<br>and performs the same as the predicate for Subclause 5.3.2 Cable<br>and leadwire noise. | Pass | | ANSI/AAMI ES<br>60601-1 and IEC<br>60601-2-31<br>compliance | The AtriAmp with accessory external pacemaker interface cables<br>complies with applicable requirements of ANSI/AAMI ES60601-<br>1:2005 & A1:2012 and IEC 60601-2-31:2011. | Pass | {5}------------------------------------------------ | Test | Test Method Summary | Result | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | ES60601-1<br>Subclause 8.5.2.3 | In support of 21 CFR Part 898 compliance, the AtriAmp complies<br>with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables. | Pass | | Sterility | Sterilization of the subject device was validated according to ISO<br>11137-1:2006(R)2015 & A1:2013 & A2:2018, demonstrating the<br>device is provided with a minimum sterility assumed level (SAL) of<br>$10^{-6}$ . | Pass | | Sterile barrier<br>integrity | The sterile barrier package is a flexible pouch. The methods applied<br>to evaluate the sterile barrier package integrity included post<br>terminal sterilization simulated distribution, seal peel and bubble<br>emission testing. | Pass | | Biocompatibility | The ISO 10993-5:2009 and ISO 10993-10:2020 test methods were<br>applied, with passing results: for Cytotoxicity, Sensitization,<br>Irritation. | Pass | | Shelf life<br>two (2) years | Confirmation of device functional performance and sterile barrier<br>pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM<br>F2096) with accelerated aging and simulated distribution per ASTM<br>4169-16 and bubble leak (ASTM F2096). | Pass | | Duration of use | Operation use was evaluated to verify use for up to 14 days. | Pass | Clinical data are not needed. ## Conclusion The AtriAmp with accessories meet performance requirements equivalent to the predicate device. The intended use and technology of the AtriAmp with accessories is the same as the predicate device.