Medtronic Temporary External Pacemaker 53401

K162054 · Medtronic, Inc. · DTE · Oct 18, 2016 · Cardiovascular

Device Facts

• Record ID: K162054
• Device Name: Medtronic Temporary External Pacemaker 53401
• Applicant: Medtronic, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, 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 Story

Battery-powered, single-chamber external pulse generator (EPG) for temporary antibradycardia pacing. Used in clinical environments by healthcare professionals. Connects to cardiac pacing lead systems to provide demand (synchronous) or asynchronous pacing. Features include high-rate burst pacing for supraventricular tachyarrhythmias. Optional disposable protective cover (Model 53408) prevents accidental control activation. Device provides therapeutic, prophylactic, or diagnostic support for patients with conduction disorders or during cardiac procedures. Clinicians adjust pacing parameters to manage heart rate and rhythm, directly influencing patient hemodynamic stability.

Clinical Evidence

Bench testing only. No clinical data. Testing included performance verification, electromagnetic compatibility (IEC 60601-1-2), safety (IEC 60601-1, IEC 60601-2-31), usability (IEC 60601-1-6, EN 62366, ANSI/AAMI HE75), biocompatibility (ISO 10993-1), and firmware verification (IEC EN 62304).

Technological Characteristics

Battery-powered single-chamber external pulse generator. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-31. Biocompatibility per ISO 10993-1. Includes embedded firmware developed per IEC EN 62304. Usability engineering per EN 62366 and ANSI/AAMI HE75. Packaging tested per ASTM D4169.

Indications for Use

Indicated for patients requiring temporary atrial or ventricular pacing in clinical settings, including those with heart block, sinus bradycardia, Sick Sinus Syndrome, bradycardia with heart failure, arrhythmias, cardiac arrest, or those undergoing cardiac surgery, pacemaker replacement, or invasive procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medtronic Model 5392 Dual Chamber Temporary External Pacemaker (K132924)

Submission Summary (Full Text)

{0}------------------------------------------------

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 18, 2016

Medtronic, Inc. Syed Mohiuddin Principal Regulatory Affairs Specialist 8200 Coral Sea Street Ne Mounds View, Minnesota 55112

Re: K162054

Trade/Device Name: Medtronic Temporary External Pacemaker 53401 Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class II Product Code: DTE Dated: July 22, 2016 Received: July 25, 2016

Dear Syed Mohiuddin:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

M.A. Hillebrenner

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) K162054

Device Name

Medtronic Temporary External Pacemaker 53401

Indications for Use (Describe)

The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes.

Specification 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) | |
|------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size:10pt">☑</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

## Introduction

Medtronic is submitting this Traditional 510(k) to establish substantial equivalence of the Temporary External Pacemaker Model 53401 to its legally marketed predicate device. The Table 3 below lists the administrative information related to this 510(k) submission.

| 510(k) Administrative Information | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------|
| Date Prepared: | 20 July 2016 |
| Submitter: | Medtronic, Inc.<br>Cardiac Rhythm Disease Management<br>8200 Coral Sea Street NE<br>Mounds View, MN 55112 |
| Contact: | Syed Sumran Mohiuddin<br>Principal Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Proprietary Name: | Medtronic Temporary External<br>Pacemaker Model 53401 |
| Common Name: | External pacemaker pulse generator |
| Device Classification | Class II (special controls), 21 CFR<br>870.3600<br>External pacemaker pulse generator |
| Product Code: | DTE |

| | | Table 3: 510(k) Summary |
|--|--|-------------------------|
| | | |

# Substantial Equivalence Statement

The intended use, design, materials and performance of the Medtronic Temporary External Pacemaker Model 53401 is substantially equivalent to the following predicate device:

- Medtronic Model 5392 Dual Chamber Temporary External Pacemaker, initially cleared ● via 510(k) application, reference number K132924 on October 31, 2013.
#### Brief 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

{4}------------------------------------------------

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.

### Indications for Use

The 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The 53401can 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 .

#### Technological Characteristics

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

#### Overview of Testing

Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria to support equivalency to the referenced predicate device. Draft Guidance – Class II Special Controls Guidance Document: External Pacemaker Pulse Generator was followed. All performance testing conducted was nonclinical, and consisted of bench testing and human factors evaluation testing. The testing results indicate that the 53401 SC EPG performs as intended.

The Table 4 below lists the performance standards that were used during testing:

{5}------------------------------------------------

| No. | Standard | Summary/Trace Report |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 1 | IEC 60601-1: 2012 Medical electrical<br>equipment - Part 1: General requirements for<br>safety | |
| 2 | IEC 60601-1-2: 2014 Medical electrical<br>equipment - Part 1-2: General requirements for<br>safety - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests | UL Test Reports, NW EMC Reports, and<br>Product Verification |
| 3 | IEC 60601-2-31: 2011 1995 Particular<br>Requirements for the basic safety and essential<br>performance of external cardiac pacemakers<br>with internal power source | |
| 4 | IEC 60601-1-6:2013 General requirements for<br>basic safety and essential performance –<br>Collateral standard: Usability from the<br>International Electrotechnical Commission | |
| 5 | EN 62366:2014 Medical devices -- Application<br>of usability engineering to medical devices from<br>the International Electrotechnical Commission | Human Factors Evaluation |
| 6 | ISO 10993-1:2013 Biological Evaluation of<br>Medical Devices | Biocompatibility Testing |
| 7 | IEC EN 62304: 2006/AC:2008 Medical device<br>software - Software life-cycle processes | Firmware (Embedded Software)<br>Verification and Validation |
| 8 | ASTM D4169: 2008 Practice for performance<br>testing of shipping containers and systems | Packaging Testing |
| 9 | ANSI/AAMI HE75: 2013 Human factors design<br>process for medical devices from the<br>Association for the Advancement of Medical<br>Instrumentation | Human Factors Evaluation |

#### Table 4: Standards & Testing

# Conclusion

Medtronic demonstrates in this submission that the 53401 SC EPG is substantially equivalent to its predicate device (the Model 5392 Dual Chamber Temporary External Pacemaker) because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent to the predicate device.