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CIRCULATORY SYSTEM DEVICES PANEL Thursday, July 29, 2004

CIRCULATORY SYSTEM DEVICES PANEL Thursday, July 29, 2004. Philips Medical System Heartstart Home OTC Defibrillator 510(k) K040904 Lead FDA Reviewer Oscar H. Tovar MD. Introduction. Regulatory Context - 510(k) Regulatory History of the Heartstart Home Defibrillator Review Summaries

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CIRCULATORY SYSTEM DEVICES PANEL Thursday, July 29, 2004

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  1. CIRCULATORY SYSTEMDEVICES PANELThursday, July 29, 2004 Philips Medical System Heartstart Home OTC Defibrillator 510(k) K040904 Lead FDA Reviewer Oscar H. Tovar MD

  2. Introduction • Regulatory Context - 510(k) • Regulatory History of the Heartstart Home Defibrillator • Review Summaries • Panel Questions CDRH / FDA/ DHHS

  3. FDA 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. CDRH / FDA/ DHHS

  4. Purpose 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. CDRH / FDA/ DHHS

  5. Regulatory History of the Heartstart 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. CDRH / FDA/ DHHS

  6. Regulatory Context • Definition of prescription device • Focus of FDA review • 510(k)  substantial equivalence CDRH / FDA/ DHHS

  7. Prescription 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… CDRH / FDA/ DHHS

  8. Removal 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 CDRH / FDA/ DHHS

  9. Review Focus FDA’s review, therefore, has focused primarily on the device labeling and human factors evaluation. CDRH / FDA/ DHHS

  10. Device 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; CDRH / FDA/ DHHS

  11. Device Description • Manufacturing process; • Acceptance criteria for bench tests; • Packaging (modifications to the text of the written materials) • Target population (adults and children) CDRH / FDA/ DHHS

  12. Indications 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. CDRH / FDA/ DHHS

  13. 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. CDRH / FDA/ DHHS

  14. Review SummariesLead Reviewer

  15. Duration 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. CDRH / FDA/ DHHS

  16. Treatment 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 CDRH / FDA/ DHHS

  17. Access 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, 2003 2 – Caffrey SL et al, N Engl J Med, 2002 CDRH / FDA/ DHHS

  18. 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 CDRH / FDA/ DHHS

  19. Timing 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 CDRH / FDA/ DHHS

  20. Scope of the Review FDA’s review includes different perspectives on this issue: • Clinical review • Human factors • [Risk analysis] • Device tracking • MDR reporting • Post-market study CDRH / FDA/ DHHS

  21. Clinical Review

  22. User Testing Studies CDRH / FDA/ DHHS

  23. User Testing Studies – cont’d CDRH / FDA/ DHHS

  24. 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) CDRH / FDA/ DHHS

  25. 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. CDRH / FDA/ DHHS

  26. Human Factors and Device Design Review

  27. 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 CDRH / FDA/ DHHS

  28. 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. CDRH / FDA/ DHHS

  29. Basic Activities for the HeartStart For the HeartStart, it appears that the user must accomplish the following basic activities: • Setup • Training • Operation • Storage • Maintenance CDRH / FDA/ DHHS

  30. 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 CDRH / FDA/ DHHS

  31. 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. CDRH / FDA/ DHHS

  32. Tracking and Post-Market

  33. 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). CDRH / FDA/ DHHS

  34. 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. CDRH / FDA/ DHHS

  35. Comments

  36. Comments • 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. CDRH / FDA/ DHHS

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