(28 days)
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 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
The Model 5392 EPG is a batterv-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.
This document is a 510(k) Premarket Notification from the FDA regarding a Medtronic External Pulse Generator (EPG). It primarily focuses on demonstrating substantial equivalence to a predicate device due to a minor firmware modification. Crucially, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets these criteria.
The 510(k) summary (page 4-5) explicitly states, "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." It also mentions "firmware design verification and system verification" and that "The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues."
However, the document does not disclose:
- The specific acceptance criteria for this firmware change.
- The details of the "firmware design verification and system verification" study. This would typically include performance metrics, sample sizes, ground truth establishment, or any human reader studies.
Therefore, based solely on the provided text, I cannot answer the questions as the required information about specific acceptance criteria and the study proving the device meets them (in the context of detailed performance metrics, test sets, expert involvement, etc.) is not present. The document focuses on the regulatory clearance process rather than the technical details of the verification study itself.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2018
Medtronic Incorporated Brenna Loufek Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K181973
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: July 23, 2018 Received: July 24, 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. 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 (OS) 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 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. Willemen
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) K181973
Device Name
Medtronic Temporary External Pacemaker 5392
Indications for Use (Describe)
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 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
Type of Use (Select one or both, as applicable)
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
| [As required by 21 CFR 807.92] | |
|---|---|
| Date Prepared: | July 02, 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 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) K162550 |
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Device Description
The Model 5392 EPG is a batterv-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.
Indications for Use
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 o
- Atrial and/or ventricular arrhythmias
- Cardiac arrest ●
- o Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
- o 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 (K162550), 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 .
K181973 Page 2 of 3
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- Biological safety
- Packaging materials
- Shelf life ●
The modified Model 5392 EPG and the predicate device differ in the following:
- Modified firmware version number ●
- . Modified labeling
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 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:
- Firmware Verification
- Instructions for Use Verification ●
- System Verification Analysis ●
Conclusion:
The results of the above 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.
| K181973 | |
|---|---|
| Page 3 of 3 | |
| 5392 Dual Chamber EPG Firmware Update | Kxxxxxxx |
| Medtronic | 1-30 |
§ 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.