Tempo Temporary Pacing Lead

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 25, 2016 Bio Trace Medical, Inc. Laura Dietch President and CEO 831 Bransten Rd, Suite L San Carlos, California 94070 Re: K160260 Trade/Device Name: Tempo Temporary Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: September 23, 2016 Received: September 26, 2016 Dear Laura Dietch: 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 (QS) 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, M.A. Wilhelm 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) K160260 Device Name Tempo Temporary Pacing Lead #### Indications for Use (Describe) The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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}------------------------------------------------ ## 510(k) SUMMARY for K160260 # General Information: | Date of Summary Preparation: | October 20, 2016 | |--------------------------------------|------------------------------------------------------------------------------| | Name and Address of<br>Manufacturer: | BioTrace Medical, Inc.<br>831 Bransten Road, Suite L<br>San Carlos, CA 94070 | | Contact Person: | Laura N. Dietch<br>President and CEO | | Device Trade Name: | Tempo® Temporary Pacing Lead | | Common Name: | Temporary Lead | | Regulation Number: | 21 CFR 870.3680(a) | | Regulation Name: | Temporary Pacemaker Electrode | | Regulatory Class: | Class II | | Classification Panel: | Cardiovascular | | Product Code: | LDF | {4}------------------------------------------------ Performance Standards: No performance standards currently exist for these devices. However, BioTrace Medical has followed, in part, FDA's Guidance for Industry: Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions (November 1, 2000). Specifically, BioTrace Medical has considered the following sections of the aforementioned guidance document during the design verification and validation testing: Bench Testing - Bond Joint Strength - Fatigue Resistance ● Corrosion Resistance Electrical Safety Testing Biocompatibility Testing GLP Animal Studies Clinical Study Device Description: The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary transvenous intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip. Indications for Use: The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device. Predicate Device: BioTrace Medical cites the following as predicate and reference devices. | Predicate Device | Medtronic Temporary<br>Transvenous Pacing Lead<br>System (Model 6416) | K042190 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Devices | C.R. Bard Temporary Pacing<br>Electrode Catheters | K800298 | | Design/Technological | BioTrace Medical | Predicate Device | | Characteristic | (Subject Device, K160260) | (K042190) | | Indications for Use | The BioTrace Medical<br>Tempo Temporary Pacing<br>Lead is indicated for use in<br>temporary intracardiac<br>pacing for a maximum of<br>seven (7) days and is<br>designed to transmit an<br>electrical signal from an<br>external pulse generator to<br>the heart or from the heart to<br>a monitoring device. | The Medtronic Model 6416<br>Temporary, Transvenous Pacing<br>Lead System features an active<br>fixation, bipolar lead and a soft-<br>tipped lubricated guide catheter.<br>The system is designed for<br>temporary intracardiac pacing<br>and/or EGM recording.<br>The system is disposable, for<br>temporary single patient use, with<br>contemplated implant duration of 7<br>days or less. The lead and<br>accessories are supplied sterile.<br>The lead is introduced<br>transvenously using the guide<br>catheter. Once within the<br>appropriate chamber, the helical tip<br>electrode of the lead is actively<br>fixed into the endocardium. After<br>lead placement the guide catheter is<br>removed by sliding it over the<br>lead's bifurcated connector. | | Lead Type | Temporary, single-use | Temporary, single-use | | Lead Introduction<br>Method | By cutdown or by use of a<br>percutaneous catheter<br>introducer or needle cannula | By cutdown or by use of a<br>percutaneous catheter introducer or<br>needle cannula | | Device Compatibility | Cannula or percutaneous<br>introducer set to<br>accommodate a 6F catheter | Cannula or percutaneous introducer<br>set to accommodate a 6F catheter | | Distal Configuration | Straight with fixation<br>(stabilizers) | Straight with fixation (helix) | | Balloon | Yes | No | | Lead Type | Bipolar | Bipolar | | Fixation | Yes | Yes | | Number of Electrodes | Two (2) | Two (2) | | Single-use only | Yes | Yes | | Non-pyrogenic | Yes | Yes | {5}------------------------------------------------ ### Technological Comparison: For the purpose of demonstrating the substantial equivalence of the Tempo Temporary Pacing Lead in this 510(k), BioTrace Medical has selected the Medtronic Temporary Transvenous Pacing Lead System (Model 6416), #K042190. The Tempo Temporary Pacing Lead was assessed for substantial equivalence relative to the legally marketed predicate device with respect to intended use, indications for use, and technological characteristics as summarized below. {6}------------------------------------------------ Testing Summary: To demonstrate intended device performance, as well as to support the substantial equivalence of the subject Tempo Temporary Pacing Lead to the predicate device, the technological and performance characteristics were evaluated by completion of the following testing: - Design Verification ● - > Bond Joint Strength - > Fatigue Resistance - > Corrosion Resistance - > Simulated Use - > Electrical Resistance - Electrical Safety Testing ● - Packaging Validation - Sterilization Validation - Shelf Life Testing (Accelerated Aging) - Biocompatibility ● - > Cytotoxicity - > Sensitization - > Irritation Reactivity - Systemic Toxicity A - A Subchronic Toxicity - > Genotoxicity - A Implantation - > Hemocompatibility - > Hemolysis - > Complement Activation - > In Vivo Thrombogenicity - > Pyrogenicity - GLP Animal Testing ● - Clinical Study: The Tempo® Study was a prospective, multicenter, non-randomized, single arm study to evaluate the safety and effectiveness of the Tempo® Temporary Pacing Lead in patients requiring temporary cardiac pacing for transcatheter aortic valve replacement, balloon aortic valvuloplasty or electrophysiology (EP) procedures. Twenty five (25) patients were enrolled in two centers. The device was evaluated for safety (freedom from pericardial effusion requiring intervention and/or echocardiographic evidence of tamponade) and technical feasibility (intracardiac {7}------------------------------------------------ delivery and pace capture). Additional evaluations included pace capture thresholds (PCT), success of rapid pacing, and incidence of dislodgement or sustained ventricular arrhythmias (>30 seconds). Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Follow up was to 30 days. The safety endpoint was met in all patients (100%) with no device-related adverse events. The technical feasibility endpoint was met in 23 patients (92%). No patient had a sustained ventricular arrhythmia or lead dislodgement. Average final procedural PCT was 0.7±0.5 mA. Rapid pacing was successful in all cases, with no loss of pace capture. In 5 patients the lead was successfully used postprocedure. This first-in-human study demonstrates that the Tempo Lead is safe and effective for temporary cardiac pacing. The results from these tests and studies demonstrate that the technological and performance characteristics of the subject Tempo Temporary Pacing Lead are adequate for its intended use and ensure the subject device can perform in a manner equivalent to devices currently on the market with the same intended use. Conclusion: The data and information presented within this submission (including in vitro bench, in vivo animal testing and the clinical study) support a determination of substantial equivalence of the Tempo Temporary Pacing Lead to marketed temporary pacing leads.