Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator
This guidance document is being distributed for comment purposes only.
Document issued on: October 17, 2011
You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact Luke Ralston at (301) 796-6362 or via email at firstname.lastname@example.org.
U.S. Department of Health and Human Services
Pacing, Defibrillator and Leads Branch
Additional copies are available from the Internet. You may also send an e-mail request to email@example.com to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number (1769) to identify the guidance you are requesting.
Table of Contents
- Risks to Health
- Device Description
- Software Validation
- Electrical Safety
- Electromagnetic Compatibility
- Performance Testing
Draft Guidance for Industry and Food and Drug Administration Staff
Class II Special Controls Guidance Document: External Pacemaker Pulse Generator
This draft guidance document was developed as a special control guidance to support the reclassificationof the External Pacemaker Pulse Generator into class II (special controls). The device, as proposed, is intended for use 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. This draft guidance will be issued in conjunction with a Federal Register notice announcing the proposal to reclassify this device type. This guidance is issued for comment purposes only. If a final rule to reclassify this device type is not issued, this guidance document will not be issued as a special control.
Following the effective date of a final rule reclassifying the device, any firm submitting a 510(k) for an External Pacemaker Pulse Generator will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the provisions of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of External Pacemaker Pulse Generators. Thus, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug & Cosmetic Act (the Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with an External Pacemaker Pulse Generator identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.
This special controls guidance document identifies the classification regulation and product code for the External Pacemaker Pulse Generator(Please refer to Section 3. Scope). In addition, other sections of this special controls guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these External Pacemaker Pulse Generatorsand lead to a timely 510(k) review. This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87, the guidance, Format for Traditional and Abbreviated 510(k)s1 and the section of CDRH’s Device Advice, Premarket Notification Submission 510(k).2
The scope of this document is limited to the device described below.
- 21 CFR 870.3600 - External Pacemaker Pulse Generator; Product code DTE, to be designated, if a final rule is published.
This generic type of device (and scope of the guidance document) does not include:
- Devices that deliver bi-ventricular pacing, such as those indicated for use to deliver cardiac resynchronization therapy (CRT). CRT devices are regulated as Class III devices that require premarket application (PMA) approval.
- Pacemaker electrode function testers (also known as pacing system analyzers (PSAs). PSAs assess the electrical performance of a lead system during pulse generator implantation or invasive lead-system troubleshooting. PSAs are regulated as Class II devices under 21 CFR 870.3720 with product code DTC.
- Temporary Pacemaker electrode. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. These devices are accessories to the external pacemaker pulse generator and often serve as adaptors between preexisting pacing leads and the external pacemaker pulse generator. Temporary pacemaker electrodes are regulated as Class II devices under 21 CFR 870.3680 with product codes LDF or NHW.
In the table below, FDA has identified the risks to health generally associated with the use of the device addressed in this document. The measures recommended to mitigate these identified risks are described in a particular section of this guidance document, as indicated in the table. We recommend that you also conduct a risk analysis, before submitting your 510(k), to identify any other risks specific to your device and include the results of this analysis in your 510(k). If you elect to use an alternative approach to address a particular risk identified in this document, or have identified risks additional to those in this document, then you should provide sufficient detail to support the approach you have used to address that risk.
|Identified Risk||Recommended Mitigation Measures|
|Electrical Hazards||Section 7, 8, 9|
|Failure to pace||Section 6, 7, 8, 9|
|Improper pacing||Section 6, 8, 9|
|Software failure||Section 6|
You should identify your device, by the regulation and product code described in Section 3 (Scope). In addition, we recommend that your device description contain the following information:
- Device components and theory of operation. You should identify all components, system software, and accessories within the scope of the 510(k), and any collateral devices that can be connected or used with the pulse generator (e.g., ECG monitors, personal computers (PCs), database management software, printers, implantable device programmers).
- Photograph or drawing of the device. You should also provide a photograph or drawing of the device. You should also provide a functional block diagram (including all accessories).
- Functional performance characteristics. You should describe the functional performance characteristics of the device, including computing capability, the display or storage of information, trending capability, data sampling communication (samples per second, bit resolution, interface), telemetry specifications (e.g., FCC frequency bands, transmission system, antenna), number of beds/patients, printer requirements, and system alarms.
- User interface. You should describe the user interface, including whether the device can be programmed and the extent of the device’s programmability.
- Technical specifications. You should summarize the technical specifications (i.e., product specifications, such as the examples below, with ranges and/or accuracy, and any other functional, physical, and environmental specifications of the device), including:
- measurement tolerances;
- operating limitations;
- power source specifications
- all possible pacing modes or settings.
- Patient contacting materials. You should identify the components of the device that are patient contacting. For each component, you should identify the generic material of construction, the supplier, and the unique material identifier.
- Software. You should provide a complete description of software and the appropriate software documentation as described in Section 6 of this guidance.
Comparison to Predicate Device
You must provide information on how your device is similar to and different from the legally marketed predicate device (“predicate device”) in accordance with 21 CFR 807.87(f). We recommend that you provide a side-by-side comparison whenever possible, and that you provide a discussion of the similarities and differences. The discussion should elaborate on the similarities identified in the table of comparison and demonstrate that the differences between your device and the predicate device do not affect safety or effectiveness and do not raise different questions of safety and effectiveness by providing a supporting rationale and/or data.
Please refer to the FDA Software Guidance “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” for a discussion of the software documentation that you should provide in your submission. The Software Guidance outlines the type of documentation to be provided based on the “level of concern” associated with the device. FDA generally considers the software for external pacemaker pulse generators to present a “major” level of concern. If you believe that the software in your device presents either a “minor” or a “moderate” level of concern as defined in the software guidance, you should provide a scientific justification that supports your rationale of the level of concern based on the possible consequences of software failure.
We advise you consider whether you can conform to any recognized software standards and provide statements or declarations of conformity as described in the FDA Guidance, “Use of Standards in Substantial Equivalence Determinations.” Please visit the website to search for the FDA-recognized standards involving medical devices containing software. We have created a supplemental information sheet for each software standard that we have recognized. The supplemental information sheet includes a table that indicates the documentation that you should include in a submission when a declaration of conformity is provided.
If the device includes off-the-shelf software, you should provide the additional information as recommended in the FDA document titled “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices.”
Your documentation regarding software should include the following information:
- Level of Concern. Level of concern refers to an estimate of the severity of injury that a device could permit or inflict on a patient or operator due to device failure. As noted above, we believe that external pacemaker pulse generators present a “major” level of concern because they are life-sustaining devices.
- Software Description. The software description should consist of a thorough discussion of the purpose and function of the software. The description should also include the architecture design charts or diagrams to explain the overall design principles.
For submissions that include modifications to software that was previously used in a device that was cleared to market by FDA, the description should identify the current software version, present a revision level history, and include a list of specific modifications made from the previous software version.
- Software development plan. The software design and development plan identifies the necessary tasks, procedures for anomaly reporting and resolution, necessary resources, and management review requirements, including formal design reviews. It enumerates specific tasks for each development activity and identifies quality factors for each activity. It also defines a system of checks and controls that evaluates output in relation to previously stated design and development requirements.
- Architecture Design Chart/Document. An architecture design chart or document explains how the software is broken into subsystems, the purpose of each subsystem, and how the subsystems interact. The function of each subsystem should be clearly identified (e.g., battery monitoring, ECG acquisition, data storage, etc.) within the context of contributing to overall software or device functionality. Documentation often includes a central diagram with an attached description of each subsystem or module.
- Device hazard analysis. The device hazard analysis identifies new or updated hazards that would result from device failure, malfunction, or misuse. It maps the root cause for each hazard to design and/or testing intended to mitigate the possibility of such events.
- Software Requirements Specification. The software requirements specification provides a baseline for both validation (as defined in 21 CFR 820.3(z) and 820.30(g)) and verification (as defined in 21 820.3(aa) and 820.30(f)). The software validation process is completed with an established software requirements specification.
- Design Requirements Specifications. Documented design specifications map the new software and software specifications to the stated system requirements.
- Traceability matrix. A traceability matrix maps how each Software requirement specification has been validated within both the software level testing and the final device level testing. This is separate from - but can overlap with - the traceability used in the hazard analysis, which identifies design and/or testing intended to mitigate potential hazards.
- Verification and Validation Testing. In instances where software is changed, a validation analysis should be conducted to validate the individual change made as well as to determine the extent and impact of that change on the entire software system. Based on this analysis, an appropriate level of software regression testing should be conducted to show that unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software change.
Regarding electrical safety, we recommend you evaluate your device in accordance with these FDA-recognized standards:
- IEC 60601-2-31, Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source; and
- IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.
You should provide a detailed discussion of the extent to which these standards were used to guide the device design. The discussion should include specific criteria such as:
- protection against electrical and mechanical hazards;
- power supply - supply type, rated voltage, rated current, frequency, etc.;
- protection against excessive radiation and excessive temperature;
- environmental testing;
- accuracy of controls;
- protection from delivering hazardous outputs;
- overall construction; and
- protection from leakage current.
Electromagnetic compatibility (EMC) encompasses both emissions (interference with other electronic devices) and immunity (interference with device performance created by emissions from other electronic devices). We recommend that you evaluate the EMC of your device as discussed below.
EMC testing should demonstrate that the device will not adversely interfere with the performance of other electronic devices (emissions). Testing should include radio frequency (RF) electromagnetic, low frequency magnetic, and conducted emissions.
EMC testing should also demonstrate that the device will perform as expected in the presence of other electrical and electronic devices or other sources of electromagnetic disturbance (EMD) in the intended environment of use (immunity). The device should operate in an acceptable manner (few EMC standards require operation within specification) during and after exposure to various forms of electromagnetic disturbance. Testing should address these conditions:
- electrostatic discharge (ESD)
- radiated RF electromagnetic fields
- electrical fast transients and bursts
- conducted RF electromagnetic energy
- voltage dips, short interruptions, and voltage variations on power supply input lines
- low-frequency magnetic fields; and
- quasi-static electric fields.
We recommend that you test your device according to IEC 60601-1- 2 Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001) to demonstrate the EMC characteristics of your device.
In most cases, you will need to provide complete device-level testing to demonstrate proper operation of all subsystems simultaneously in accordance with the device’s specifications. An exception to this would be a change only made to an accessory - it may be possible to test the accessory alone (instead of device-level testing) if you can confirm that the change does not impact the external pacemaker or the interface between the accessory and the pulse generator. Device-level testing also addresses external factors such as shipping conditions, use environment, and human factors.
Testing recommendations vary based on your device design and the degree of modification from the predicate. Minimum testing recommendations may apply if your device design is very similar to the predicate. The risk analysis and risk management protocol will help to determine necessary tests to be performed for the given device modification. AAMI/IEC 60601-1 can aid in identifying general device requirements and general requirements for testing. In addition, IEC 60601-2-31 can aid in identifying requirements specific to external pacemakers.
Examples of device-level testing include:
- environmental - temperature range for storage, temperature range for operation, humidity, atmospheric pressure, and transportation test;
- functionality of alarms, display screens, and LED indicators;
- power source and run time verification to include backup batteries, if applicable;
- interface to external devices such as printers, monitors, or external data storage;
- device cleaning and disinfection;
- all programmable features - pacing parameters, sensing parameters, lead configurations, AV delay, etc.;
- simulated use and human factors;
- measurement features - pacing threshold, pacing impedance, conduction intervals, etc.; and
- compatibility of patient cables and leads.
FDA Form 3654 should be completed for each standard to which compliance is claimed.
FDA generally expects to rely upon well-designed bench and/or animal testing rather than requiring clinical studies for a new external pulse generator. However, clinical testing may be needed for devices with:
- designs dissimilar from designs previously cleared under a 510(k), such as those incorporating significant new features or pacing parameters;
- new technology, i.e., technology different from that used in legally marketed devices;
- indications for use dissimilar from external pacemakers of the same type; or
- results of bench and/or animal testing that raise questions which warrant resolution with clinical testing.
The 510(k) must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e) and 21 CFR Part 801.3
Directions for Use
Because external pacemakers are prescription use devices, in accordance with 21 CFR 801.109(b)(1), labeling must include the statement “Caution: Federal law restricts this device to sale by or on the order of a physician.”
In addition, section 801.109(d) requires labeling to include adequate information on the use of the device, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects and precautions.
Please address the following specific issues regarding device labeling:
- Separate ECG Monitoring: FDA strongly recommends the instructions for use include a caution statement that, when available, supplemental ECG monitoring of the patient should be considered.
- Connector Terminals: Connector terminals should be clearly, unambiguously marked on the outside of the external pacemaker pulse generator. The markings should identify positive (+) and negative (-) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals.
3 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.