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 document is a 510(k) premarket notification for the Medtronic Model 5392 External Pulse Generator (EPG). This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study of a novel device's performance against specific acceptance criteria for a new clinical application.

Therefore, the requested information about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/human comparative effectiveness study, ground truth establishment, and training/test set details, is not fully applicable or directly provided in this document. This submission is for a minor modification to an already cleared device.

However, I can extract the relevant information from the document regarding the modifications and the qualification that addresses those changes.

Here's an analysis based on the provided text, addressing what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for the entire device or specific performance metrics in a clinical sense. Instead, it refers to acceptance criteria for the qualification of manufacturing process changes.

Acceptance Criteria (for manufacturing process changes)	Reported Device Performance (regarding process changes)
Specified acceptance criteria for manufacturing process qualification	Results met the specified acceptance criteria.
Did not raise new safety or performance issues.	No new safety or performance issues were raised.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document states "devices manufactured with the updated cables and new routing" were evaluated. This likely refers to a manufacturing batch or a specific number of units undergoing testing related to the physical changes.
Data Provenance: Not explicitly stated, but implicitly derived from an internal manufacturing qualification process by Medtronic, Inc. This would be considered retrospective in the sense that it's an internal validation of manufacturing changes, not new clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" here is compliance with manufacturing specifications and ensuring the physical changes do not introduce new safety or performance issues. This would typically be assessed by engineering and quality assurance personnel against established internal standards, rather than clinical experts establishing a medical "ground truth."

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified. The evaluation involved "qualification of the manufacturing process," which implies adherence to predefined manufacturing and quality control standards, rather than a subjective adjudication process by multiple individuals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic imaging devices or AI algorithms used in clinical decision-making, often comparing human performance with and without AI assistance. The Medtronic Model 5392 EPG is a temporary pacemaker, and this submission is for a minor modification to its manufacturing.

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

Standalone Performance Study: No. This device is not an AI algorithm. Its performance is inherent to its electromechanical function as a pacemaker, not a software algorithm providing independent analysis.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" related to this submission is primarily adherence to engineering specifications, manufacturing quality standards, and safety requirements for the physical changes (cable routing and length). It's about ensuring the modified device functions as intended and meets established design and quality parameters, not a clinical ground truth like pathology or patient outcomes.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a training set.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set Establishment: Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of the K162550 Submission:

This 510(k) submission is for minor modifications to the Medtronic Model 5392 External Pulse Generator (EPG). The modifications are specifically related to the "routing and length of three internal cables." The purpose of the submission is to demonstrate that these minor changes do not alter the device's fundamental safety or effectiveness and that it remains substantially equivalent to the previously cleared version (K150246).

The "study" referenced is a qualification of the manufacturing process, which included "new fixtures." The key finding is that this qualification "met the specified acceptance criteria and did not raise new safety or performance issues," leading to the conclusion of substantial equivalence. This is a common type of submission for non-significant device changes and not a clinical performance study.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2016

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

Re: K162550

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 II Product Code: DTE Dated: September 12, 2016 Received: September 13, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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,

M.A. Hillebrand

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162550

Device Name

Medtronic Model 5392 External Pulse Generator (EPG)

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 (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared:	October 11, 2016
Submitter:	Medtronic, Inc.Medtronic Cardiac Rhythm Heart Failure8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208
Contact Person:	Brenna LoufekAssociate Regulatory 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 5392 External Pulse Generator (EPG)
Common Name:	External pacemaker pulse generator
Regulation Number:	21 CFR 870.3600
Product Code:	DTE
Classification:	Class II (As per Final Order published 18-APR-2016 by FDA docketnumber 2011-N-0650)
Classification Panel:	Cardiovascular
Special Controls:	Not applicable
Predicate Devices:	Medtronic Model 5392 External Pulse Generator (EPG) K150246

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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
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 .

Technological Characteristics

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

Technological Characteristics

When compared to the predicate device (K150246), the modified Medtronic Model 5392 External Pulse Generator presented in this submission has the same:

Intended use/indications for use ●
Operating principle
. Design features

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Device functionality ●
Biological safety
Packaging materials ●
Shelf life

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

Modified routing and length of three internal cables ●

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated with devices manufactured with the updated cables and new routing. The data from the newly qualified process shows that the devices could be manufactured with minor enhancements to the design specifications to mitigate internal pinching of the Patient Cable, Battery Cable, and LCD Cable.

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:

Qualification of the manufacturing process, including new fixtures ●

Conclusion:

The results of the above qualification 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Device Name

Indications for Use (Describe)

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510(k) Summary

General Information

Device Description

Indications for Use

Technological Characteristics

Technological Characteristics

Substantial Equivalence and Summary of Studies:

Conclusion:

§ 870.3600 External pacemaker pulse generator.

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