The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

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

Complete heart block
Sinus bradycardia
Sick sinus syndrome
Bradycardia with congestive heart failure
Atrial and/or ventricular arrhythmias
Cardiac arrest
Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
Support during permanent pacemaker replacement
Cardiac complications during invasive or surgical procedures
Support following cardiac surgery
Acute myocardial infarction complicated by heart block
Atrial tachyarrhythmias that require high-rate burst pacing for treatment

Device Description

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

AI/ML Overview

The provided text describes documentation related to the FDA 510(k) clearance for the Medtronic Model 5392 External Pulse Generator (EPG). This document is a premarket notification for a medical device and therefore does not contain information about AI/ML device performance or clinical studies of AI-assisted human readers.

The clearance is for a change in the material of the patient connector in an existing device (predicate device K181973), not a new AI-powered device. Therefore, the questions related to AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable.

However, based on the information provided, here is what can be inferred about the device and its testing, though it does not involve AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The data from this testing showed that the devices could be manufactured with the modified patient connector material and continue to meet the current 5392 design specifications." and "The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues."

While specific numerical acceptance criteria and performance metrics are not detailed in this summary, the general acceptance criterion was that the modified device continued to meet the existing design specifications of the predicate Medtronic Model 5392 EPG.

Acceptance Criteria (General)	Reported Device Performance
Device continues to meet current design specifications	Modified device met specified acceptance criteria; no new safety/performance issues
Device maintains safe and effective use	Demonstrated safe and effective use with modified connector material

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: The studies performed were "bench tests." This indicates the testing was conducted in a laboratory setting, not with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the testing involved bench tests to verify engineering specifications, not clinical outcomes requiring expert interpretation of ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI/ML device, and no human-in-the-loop studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware device (external pulse generator) and does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the bench tests would be the established engineering and performance specifications for the predicate device. Compliance with these specifications was verified.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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April 30, 2019

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

Re: K190825

Trade/Device Name: Medtronic Model 5392 External Pulse Generator (EPG) Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III Product Code: DTE Dated: March 29, 2019 Received: April 1, 2019

Dear Alexandra Theisen:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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.

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) K190825

Device Name Medtronic Temporary External Pacemaker 5392

Indications for Use (Describe)

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

· Complete heart block
· Sinus bradycardia
· Sick sinus syndrome
· Bradycardia with congestive heart failure
· Atrial and/or ventricular arrhythmias
· Cardiac arrest
Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
· Support during permanent pacemaker replacement
· Cardiac complications during invasive or surgical procedures
· Support following cardiac surgery
· Acute myocardial infarction complicated by heart block
· Atrial tachyarrhythmias that require high-rate burst pacing for treatment

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

General Information

[As required by 21 CFR 807.92]

Date Prepared:	March 29, 2019
Submitter:	Medtronic, Inc.Medtronic Cardiac Rhythm Heart Failure8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208
Contact Person:	Alexandra TheisenRegulatory Affairs SpecialistMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.6758Fax: 651.367.0603Email: alexandra.r.theisen@medtronic.com
Alternate Contact:	Rachel LibiSenior Regulatory Affairs ManagerMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.1668Fax: 651.367.0603Email: rachel.libi@medtronic.com

Trade Name:	Medtronic Model 5392 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 5392 External Pulse Generator (EPG) K18197-

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Device Description

Indications for Use

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

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

Technological Characteristics

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

When compared to the predicate device (K181973), the modified Medtronic Model 5392 External Pulse Generator presented in this submission has the same:

Intended use/indications for use ●
Operating principle
Design features ●
Device functionality
Biological safety ●
Packaging materials ●
o Shelf life

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The modified Model 5392 EPG and the predicate device differ in the following:

Modified patient connector material ●

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of safe and effective use. The data from this testing showed that the devices could be manufactured with the modified patient connector material and continue to meet the current 5392 design specifications.

The modified Medtronic Model 5392 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:

Regression bench testing

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 5392 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.