CIRCULATORY SYSTEM DEVICES PANEL Thursday, July 29, 2004 Philips Medical System Heartstart Home OTC...

CIRCULATORY SYSTEMCIRCULATORY SYSTEMDEVICES PANELDEVICES PANEL

Thursday, July 29, 2004Thursday, July 29, 2004

Philips Medical System

Heartstart Home OTC Defibrillator

510(k) K040904

Lead FDA Reviewer

Oscar H. Tovar MD

Oscar H Tovar CDRH / FDA/ DHHS 3

Introduction

●Regulatory Context - 510(k)

●Regulatory History of the Heartstart Home Defibrillator

●Review Summaries

●Panel Questions


FDA Review TeamFDA Review Team

Lead / Clinical Reviewer Oscar Tovar M.D.

Clinical Reviewer Lesley Ewing M.D.

Human Factors Michael Mendelson D.D.S., M.S. Biomed. Eng

Peter Carstensen B.S.

Statistics Gary Kamer M.S.

Risk Analysis Victor Krauthamer Ph.D.

Post-Market Beverly Galluresi R.N.


Purpose of the SubmissionPurpose of the Submission

The purpose of this submission is to remove the prescription requirement from the Philips HeartStart Home Defibrillator Rx labeling.

The HeartStart Home Defibrillator was previously cleared under K020715 in November 2002.


Regulatory History of the Regulatory History of the Heartstart Home OTC DefibrillatorHeartstart Home OTC Defibrillator

●September 1996. FDA clears ForeRunner AED with prescription caution (K953635).

●May 2001. FDA clears FR2 defibrillator with attenuated defibrillation pads for pediatric use (K003819).

●November 2002. FDA clears HeartStart Home Defibrillator, designed for home use (K020715).

●April 2004. Philips submits 510(k) proposing removal of prescription caution from labeling.


Regulatory ContextRegulatory Context

●Definition of prescription device

●Focus of FDA review

●510(k) substantial equivalence


Prescription DevicePrescription Device

Code of Federal Regulations - Sec. 801.109

Prescription devices.

A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which ``adequate directions for use`` cannot be prepared…


Removal of Prescription LabelingRemoval of Prescription Labeling

● Regulations do not describe requirements for removing prescription language

●Definition of “prescription device” suggests two elements must be met:

• Device safe to use without supervision of practitioner; and

• Adequate directions for use can be created


Review Focus

FDA’s review, therefore, has focused primarily on the device labeling and human factors evaluation.


Device DescriptionDevice Description

Philips Medical Systems states that the HeartStart Home OTC Defibrillator and its accessories included in this 510(k) are the same as the HeartStart Home Rx Defibrillator, including:

●Waveform therapy;

●Design;

●Functionality;

●Technology;

●Software;


Device DescriptionDevice Description

● Manufacturing process;

● Acceptance criteria for bench tests;

● Packaging (modifications to the text of the written materials)

● Target population (adults and children)


Indications for UseIndications for Use

The HeartStart Home Defibrillator is intended to be used to treat someone who the rescuer thinks may be a victim of sudden cardiac arrest. A person in sudden cardiac arrest:

• does not respond when shaken, and

• is not breathing normally.

If in doubt, apply the pads.


Indications for Use - continued

For children 8 years or older, or who weigh 55 pounds or more, use the defibrillator with the adult pads that come with it. For younger children or those who weigh less than 55 pounds, the special infant/child pads should be used, if available.

Review Summaries

Lead Reviewer


Duration of VF and SurvivalDuration of VF and Survival

●Cardiac function during ventricular fibrillation (VF) deteriorates rapidly with time.

●This deterioration in function is associated with a rapid decrease in survival of sudden cardiac arrest produced by VF.

●Rapid access to a defibrillator addresses this problem and in some instances might be sufficient.


Treatment of Ventricular FibrillationTreatment of Ventricular Fibrillation

A recent report* proposed that:● if the duration of VF is less than 4 minutes

(electrical phase), a defibrillation shock could be sufficient to convert VF to a normal sinus rhythm.

●Between 4 and 10 minutes (circulatory phase), CPR should precede defibrillation.

●Beyond 10 minutes of VF (metabolic phase) other additional measures like controlled reperfusion, cooling, etc., are required

* Weisfeldt and Becker, JAMA, 2002


Access to AEDsAccess to AEDs

Around 80% of SCA occur in homes; the greater experience with AEDs is in public places like the PAD1 trial and 3 Chicago Airports2 etc.

1 – Late Breaking Clinical Trials. AHA, 20032 – Caffrey SL et al, N Engl J Med, 2002


Chain of Survival

Chain of survival developed by the American Heart Association (AHA):

●Early Access (call 911 or the EMS) because other conditions can cause an unresponsive victim (stroke, choking, etc).

●Early CPR: “Pump and Blow”

●Early defibrillation: Use the AED

●Early Advanced Care: EMS personnel


Timing of CPRTiming of CPR

The timing of CPR relative to defibrillation is one concern for this type of device. CPR should precede defibrillation in the chain of survival, according to AHA (2000).

The design of the device allows:

●witnessed patient collapse prompt application of AED within 4 minutes.

●Unwitnessed non-shockable rhythm no shock delivery CPR


Scope of the ReviewScope of the Review

FDA’s review includes different perspectives on this issue:

Clinical reviewHuman factors [Risk analysis]Device trackingMDR reportingPost-market study

Clinical Review


User Testing Studies

Safety and Useability Study

simulated use testing of the accuracy and speed of lead placement, delivery of a shock and safety to the user of the shock delivery.

Liberty Lay User Survey

assess safety and effectiveness of the ForeRunner and FR2, from a telephone survey of corporate and individual customers

Sarapo Design Validation

assess whether the intended users can use the defibrillator appropriately. A study of 10 potential home users (non-medical administrative support staff from off site medical procurement office) and 10 potential corporate users (safety officers at a paper mill).


User Testing Studies – cont’d

Sarapo Infant/Child Cartridge

to show that users who had viewed the training video could recognize the need to change from adult pads to infant/child pads and successfully change the cartridges

Liberty Label Evaluation

WRITTEN: assess participants’ comprehension of 1 of 4 labeling items - 353 volunteers took a written test after reading one of four pieces of labelingSIMULATION: 190 subjects were tested on how to set up and place pads based on their understanding of the labeling.

Liberty Marketing Survey

Roper ASW Consumer Survey. Assess awareness and knowledge of SCA and defibrillators

Vantis Survey. Profile consumer and Physician interest in home defibrillators

Medscape e-Detailing Survey. Assess physician interest on defibrillators in their practices


Field Performance Summary

Philips reported:● 150,000 units distributed

• Approximately 200,000 uses (calculated)

●59 device malfunctions.●4 AEDs - FR2 - failed in a use-related

event (compromise the delivery of therapy)


Comments on the User Testing

●Testing was preceded by a script read to the subject, informing them:

• Mannikin was a simulated victim of sudden cardiac arrest;

• Victim required immediate help;

• AED was to be used to help the victim;

• EMS had already been called.

●Testing was designed to test accuracy and speed of application of electrode pads and whether a shock was able to be delivered safely.

Human Factors and Device Design

Review


Background

●Human Factors examines all aspects of a system’s interface that are necessary for safe and effective use.

●“Use” includes the installation, calibration, operation, maintenance, repair, and ultimately, the disposal of the system or its components

●Training and labeling are part of the use interface of a device


Background

●Delivering medical care is only one part of a device’s use

●In devices for emergency use, concern with preparing a device and maintaining readiness are extremely important.


Basic Activities for the HeartStart

For the HeartStart, it appears that the user must accomplish the following basic activities:

●Setup

●Training

●Operation

●Storage

●Maintenance


Operation of the HeartStart

Operation:● determine that a patient is unresponsive● notify 9-1-1● turn on the device● expose the patient 's chest● place electrodes● respond to the device’s instructions (possibly

pressing a “Shock” button, possibly perform CPR)● attend to the patient until arrival of emergency

personnel


Comments on Usability Testing

●Philips’ usability testing covered some aspects of device setup and device operation.

●Philips’ usability testing did not cover training, storage, or maintenance.

Tracking and Post-Market


Device Tracking

●FDA considers this a tracked device, requiring the sponsor to have processes in place to promptly identify users in the event of a recall

●Sponsor proposes use of a registration card - database of shipment records

●In case of a recall – multiple methods of notification will be used (e.g., websites, collaboration with consumer organizations, public warnings).


Post-Market Surveillance

●Medical Device Reporting• Will be same as for prescription device

●Post-market study• Follow-up survey of US customers after one

year, or after use of the device (whichever comes first).

• Tied to customer re-ordering pads• Purpose: assess perception of safety and

effectiveness following use of the device.

Comments


CommentsComments

●Uncertainty about the public safely using the AEDs given the increased access.

●Sponsor has presented data that characterizes the human factors attributes of the device and labeling.

●Survival rates and adverse events with home use of AEDs have not been directly evaluated.

CIRCULATORY SYSTEM DEVICES PANEL Thursday, July 29, 2004 Philips Medical System Heartstart Home OTC...

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