The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes.

Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:

Complete heart block
Sinus bradycardia
Sick Sinus Syndrome
Bradycardia with congestive heart failure
Atrial and/or ventricular arrhythmias
Cardiac arrest
Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
Support during permanent pacemaker replacement
Cardiac complications during invasive or surgical procedures
Temporary support of a patient following cardiac surgery
Acute myocardial infarction complicated by heart block
High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

Device Description

The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.

AI/ML Overview

The Medtronic Model 53401 External Pulse Generator (EPG) (K180873) is found to be substantially equivalent to its predicate device (K162054) based on verification testing that met specified acceptance criteria.

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Firmware Verification: Ensure the updated firmware (Version 1.03) operates as intended.	Data from the newly verified firmware (Version 1.03) showed that the devices could be manufactured with this new version to mitigate rebooting of the device caused by interrupts in the firmware system.
System Verification: Confirm overall system functionality and safety with the updated firmware.	The results of system verification testing met the specified acceptance criteria and did not raise new safety or performance issues.
Maintain Substantial Equivalence in intended use/indications, operating principle, design, functionality, biological safety, packaging, and shelf life compared to the predicate device.	The modified device has the same intended use/indications for use, operating principle, design features, device functionality, biological safety, packaging materials, and shelf life as the predicate.

Sample size used for the test set and the data provenance: Not applicable. The submission focuses on firmware and system verification rather than performance with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved engineering verification of firmware and system, not expert-based ground truth establishment for clinical outcomes.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This was not an MRMC study for AI assistance; it was a verification study for a hardware/firmware update to an existing medical device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The study focused on the standalone performance of the updated firmware and the overall system according to engineering specifications. While not explicitly framed as "algorithm only," it evaluates the device's functional performance in isolation of a human operator, outside of standard operating parameters.
The type of ground truth used: The ground truth for this verification study was based on engineering specifications and expected functional behavior of the device and its firmware. The objective was to confirm that the updated firmware addressed a known issue (rebooting due to interrupts) and that the system continued to function according to its established design requirements.
The sample size for the training set: Not applicable. This was a verification study of a firmware update for an existing device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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April 19, 2018

Medtronic, Inc. Brenna Loufek Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K180873

Trade/Device Name: Medtronic Model 53401 External Pulse Generator (EPG) Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class II Product Code: DTE Dated: April 2, 2018 Received: April 3, 2018

Dear Brenna Loufek:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Willenmen

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180873

Device Name Medtronic Model 53401 External Pulse Generator (EPG)

Indications for Use (Describe)

Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:

Complete heart block .
Sinus bradycardia .
Sick Sinus Syndrome .
Bradycardia with congestive heart failure .
Atrial and/or ventricular arrhythmias .
Cardiac arrest
Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
Support during permanent pacemaker replacement
Cardiac complications during invasive or surgical procedures
Temporary support of a patient following cardiac surgery
Acute myocardial infarction complicated by heart block
High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared:	March 16, 2018
Submitter:	Medtronic, Inc.Medtronic Cardiac Rhythm Heart Failure8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208
Contact Person:	Brenna LoufekRegulatory Affairs SpecialistMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.7829Fax: 651.367.0603Email: brenna.loufek@medtronic.com
Alternate Contact:	Rachel LibiSenior Regulatory Affairs ManagerMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.1668Fax: 651.367.0603Email: rachel.libi@medtronic.com

General Information

Trade Name:	Medtronic Model 53401 External Pulse Generator (EPG)
Common Name:	External pacemaker pulse generator
Regulation Number:	21 CFR 870.3600
Product Code:	DTE
Classification:	Class II
Classification Panel:	Cardiovascular
Special Controls:	Not applicable
Predicate Devices:	Medtronic Model 53401 External Pulse Generator (EPG) K162054

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Device Description

Indications for Use

Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:

Complete heart block
o Sinus bradycardia
Sick Sinus Syndrome ●
Bradycardia with congestive heart failure ●
Atrial and/or ventricular arrhythmias
Cardiac arrest
Temporary support, management, and evaluation of a patient prior to permanent ● pacemaker implantation
Support during permanent pacemaker replacement
Cardiac complications during invasive or surgical procedures
Temporary support of a patient following cardiac surgery
Acute myocardial infarction complicated by heart block ●
o High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

Technological Characteristics

Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.

When compared to the predicate device (K162054), the modified Medtronic Model 53401 External Pulse Generator presented in this submission has the same:

Intended use/indications for use
Operating principle ●
Design features
Device functionality

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Biological safety
Packaging materials
Shelf life ●

The modified Model 53401 EPG and the predicate device differ in the following:

The modified 53401 EPG has updated firmware, Firmware Version 1.03

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated with firmware design verification and system verification. The data from the newly verified firmware show that the devices could be manufactured with a new firmware version to mitigate rebooting of the device caused by interrupts in the firmware system.

The modified Medtronic Model 53401 External Pulse Generator is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design and materials have been verified through the following:

Firmware Verification ●
System Verification

Conclusion:

The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Medtronic Model 53401 External Pulse Generator described in this submission result in a device that is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.3600 External pacemaker pulse generator.

(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.