The HeartStart Home Defibrillator should be used to treat someone who you think 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.

Device Description

The HeartStart Home Defibrillator was designed to be safe, easy and ready to use. Features of the HeartStart Home Defibrillator include self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multiparameter ECG analysis system for determining if a shock is required, and an integrated human factors design to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the HeartStart Home Defibrillator with a minimum capacity of 90 shocks and 3 hours of operating time.
The HeartStart Home Defibrillator monitors the progress of the rescue and issues voice instructions as appropriate, keeping pace with the user. The defibrillator incorporates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR, with CPR coaching available. Except during these pause intervals for CPR, the defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is needed. The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode signals; these technologies were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.
The HeartStart Home Defibrillator utilizes the same biphasic, impedance-compensating exponential waveform used in previous-generation Philips AEDs. With the standard pads cartridge installed, the HeartStart Home Defibrillators delivers 150J shocks (nominal) after a shockable rhythm has been detected, and the user presses the shock button as instructed by the defibrillator. The HeartStart Home Defibrillator offers no manual-shock capability.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Philips HeartStart Home Defibrillator, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it focuses on demonstrating safety, usability, and effectiveness through various studies. The reported performance is primarily qualitative regarding safe and successful use.

Acceptance Criterion (Inferred from studies)	Reported Device Performance (as described in the document)
Safe Use by Lay Responders	Used safely by all participants in Safety and Usability Study (n=124). All participants in mock-rescue portion of Labeling Evaluation used the defibrillator safely (n=178). All participants in Design Validations (adult n=20, infant/child n=10) used the defibrillator safely.
Successful Use by Lay Responders	Successfully used by both naïve and video-trained volunteers at 87% (n=61) and 89% (n=63) respectively in Safety and Usability Study. Majority able to use successfully in Labeling Evaluation (97% for Quick Reference Guide, 83% for Owner's Manual). All participants in adult use scenario of Design Validations used the defibrillator successfully.
Understanding of Labeling	All four major HeartStart Home labeling materials were well understood in the Labeling Evaluation (n=353).
Performance of ECG Analysis System	Sensitivity and specificity of the ECG analysis system demonstrated in bench and field studies in previous 510(k) submissions. (Specific numbers not provided in this document).
Effectiveness of Biphasic Waveform	Safety and effectiveness of the 150J biphasic waveform demonstrated in clinical trials and field studies included in previous 510(k) submissions. (Specific outcomes not provided in this document).
No Unreported Safety/Effectiveness Issues	Confirmed by Lay User Survey of existing ForeRunner and FR2 home and business customers.

2. Sample Size Used for the Test Set and Data Provenance

Safety and Usability Study: 124 volunteers. Data provenance is prospective (participants actively performing mock rescues). Country of origin is not explicitly stated but implies within the US, given the FDA filing.
Labeling Evaluation: 353 participants for the comprehension test, 178 of whom participated in the mock-rescue scenario. Data provenance is prospective. Country of origin is not explicitly stated.
Design Validations: Adult use (n=20), infant/child use (n=10). Data provenance is prospective. Country of origin is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Explicit mention of experts establishing ground truth for the test set (i.e., the usability studies and labeling evaluations) is not present. The studies assessed lay user performance against predefined safety and success criteria, rather than an expert determining the "correctness" of a diagnosis or treatment by the device or user in real-time.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the test sets. The studies appear to have directly measured participant performance against established metrics for safe and successful device use.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study is described. The studies focused on the standalone performance and usability of the device by laypersons. This device is an Automated External Defibrillator (AED), which is designed for automated analysis and instruction, not for human "reading" or interpretation in the same way as an imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the effectiveness of the device's core algorithms (ECG analysis system and biphasic waveform) was established in prior standalone studies, as referenced:

"Similarly, the sensitivity and specificity of the ECG analysis system used in the HeartStart Home Defibrillator was demonstrated in bench and field studies in previous 510(k) submissions."
"The safety and effectiveness of the 150J biphasic waveform used in the HeartStart Home Defibrillator was demonstrated in clinical trials and field studies included in previous 510(k) submissions."

The current submission references these past studies rather than conducting new standalone algorithm performance studies. Specific details like sample sizes and exact ground truth methods for these prior standalone studies are not available in this document.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the usability/labeling studies: Ground truth was essentially the predefined criteria for safe operation and successful completion of mock-rescue tasks. It's a performance-based "ground truth" rather than a medical diagnosis.
For the ECG analysis system: The document states sensitivity and specificity were demonstrated in past studies, implying a ground truth of actual cardiac rhythm (e.g., shockable vs. non-shockable) established by medical experts or confirmed by other diagnostic means.
For the biphasic waveform: The document refers to "clinical trials and field studies," suggesting ground truth tied to patient outcomes (e.g., return of spontaneous circulation, survival) or physiological measures.

8. The Sample Size for the Training Set

No information is provided regarding a "training set" in the context of machine learning. The device's algorithms (ECG analysis) were likely developed and validated using a dataset of ECGs, but this document does not detail their development or specific training set sizes. The studies described here are validation/testing studies for the device's overall performance and usability, not for algorithm training.

9. How the Ground Truth for the Training Set Was Established

As no training set is described in this document, the method for establishing its ground truth is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows a circular emblem with text around the perimeter and a stylized eagle-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol consists of three curved lines that resemble the wings and body of a bird, giving the impression of movement or flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical System c/o Ms. Teresa Skarr Manager, Regulatory and Medical Affairs 2301 Fifth Avenue, Suite 200

Re: K040904

Seattle, WA 98121-1825

Trade Name: Philips HeartStart Home Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: NSA Dated: September 14, 2004 Received: September 15, 2004

Dear Ms. Skarr:

This letter corrects our substantially equivalent letter of September 16, 2004, sent by fax, regarding the Philips HeartStart Home Defibrillator, addressed to Ms. Teresa Skarr, 2301 Fifth Avenue, Suite 200, Seattle WA 38121-1825. The name in the salutation of the letter, Mr. Smirles, was incorrect. Instead it should be Ms. Skarr.

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 of our September 16, 2004, letter) 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 (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.

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

SEP 1 6 2004

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Page 2 - Ms. Teresa Skarr

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); good manufacturing practice requirements as set forth in 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bfimmima for
Prof. D. Zuckerman, M.D.

D. Zuckerman, N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Summarv

510(k) Number: #K040904

510(k) Summary for the Philips HeartStart Home OTC Defibrillator

1. Date Summary Prepared:

September 13, 2004

2. Submitter's Name and Address

Philips Medical Systems Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121

3. Contact Person

Teresa Skarr Manager, Regulatory and Medical Affairs Philips Medical Systems Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121 Telephone: (206) 664-5290 Facsimile: (206) 664-2070 E-mail: teresa.skarr@philips.com

4. Device Name

Proprietary Name: Philips HeartStart Home Defibrillator Common Name: Defibrillator Classification Name: Automated External Defibrillator

5. Predicate Devices

The legally marketed device to which Philips Medical Systems, Heartstream claims equivalence for the HeartStart Home OTC Defibrillator is the HeartStart Home Rx Defibrillator (cleared under K020715) and the FR2 Defibrillator (cleared under K003565).

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The design, performance, and intended use of the HeartStart Home Defibrillator are substantially equivalent in safety and performance to the predicates.

6. Device Description

A non-rechargeable lithium manganese dioxide battery powers the HeartStart Home Defibrillator with a minimum capacity of 90 shocks and 3 hours of operating time.

The HeartStart Home Defibrillator monitors the progress of the rescue and issues voice instructions as appropriate, keeping pace with the user. The defibrillator incorporates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR, with CPR coaching available. Except during these pause intervals for CPR, the defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is needed. The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode signals; these technologies were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.

The HeartStart Home Defibrillator utilizes the same biphasic, impedance-compensating exponential waveform used in previous-generation Philips AEDs. With the standard pads cartridge installed, the HeartStart Home Defibrillators delivers 150J shocks (nominal) after a shockable rhythm has been detected, and the user presses the shock button as instructed by the defibrillator. The HeartStart Home Defibrillator offers no manual-shock capability.

7. Intended Use

The HeartStart Home Defibrillator should be used to treat someone who you think 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.

Comparison of Technology Characteristics 8.

The HeartStart Home OTC Defibrillator is identical to the commercially available HeartStart Home Defibrillator and incorporates many of the same technologies and features as the commercially available FR2 defibrillator.

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9. Data Used in Determination of Substantial Equivalence

The HeartStart Home OTC Defibrillator employs the same or similar technologies as the predicate devices. The safety and effectiveness of the 150J biphasic waveform used in the HeartStart Home Defibrillator was demonstrated in clinical trials and field studies included in previous 510(k) submissions. Similarly, the sensitivity and specificity of the ECG analysis system used in the HeartStart Home Defibrillator was demonstrated in bench and field studies in previous 510(k) submissions.

For the current 510(k), several reports were included for review by the Cardiovascular System Devices Panel and presented for panel discussion and public comment. Relevant reviews of the available literature and the Philips AED technology platform were conducted, including:

. Literature Review: Relevant publications in medical literature and safety databases were summarized, demonstrating the features that are important to defibrillator safety, effectiveness and usability.
. Field Performance Summary: The field performance of the HeartStart Home Defibrillator and its technology platform was reviewed, demonstrating the safety history of over 150,000 Philips AEDs that have accumulated over 160,000 service vears.
. Lay User Survey: A telephone survey was conducted of all ForeRunner and FR2 home and business customers. This survey confirmed that there were no previously unreported safety or effectiveness issues in uses of these devices by laypersons.

Additional studies supporting the safety and usability of the HeartStart Home Defibrillator were conducted, including:

Safety and Usability Study: A total of 124 volunteers with no prior exposure to . a defibrillator were randomized to attempt a mock-rescue on a manikin relying only upon the voice instructions and graphics of the defibrillator, or alternatively to view a brief training videotape prior to using the defibrillator. Safety and usability endpoints were assessed. The HeartStart Home Defibrillator was used safely by all participants and successfully used by both naïve and video trained volunteers at 87% (n = 61) and 89% (n = 63). There was no difference detected between participants who had no prior exposure or training in defibrillator use and the video-trained participants.
Labeling Evaluation: A total of 353 participants with no prior exposure to a . defibrillator were randomly assigned to review and take a multiple-choice written comprehension test on one of the four major labeling pieces for the HeartStart

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Home Defibrillator. This evaluation found that all four of the major HeartStart Home labeling materials were well understood. The users who had reviewed materials that would be available with the device during a use were asked to participate in a mock-rescue scenario with the HeartStart Home Defibrillator. Safety and usability endpoints were assessed. All participants in the mock-rescue portion of the evaluation used the HeartStart Home Defibrillator safely (n = 178). and the majority were able to use the defibrillator successfully (97% for the Quick Reference Guide, and 83% for the Owner's Manual).

. Design Validations: The design validation studies conducted by Philips prior to the initial HeartStart Home Rx Defibrillator release were included in the current 510(k) for the over-the-counter version of the device. These studies assessed safety and usability endpoints in mock-rescue scenarios for adult (n = 20) and infant/child (n = 10) use. All participants used the defibrillator safely, and all participants in the adult use scenario used the defibrillator successfully.
Post-Market Study: Philips' commitment to continue and expand its ongoing . post-market study of home use, and the plan with proposed revisions, were included in the 510(k).

The safety and effectiveness of the HeartStart Home Defibrillator has been established through extensive clinical and animal data presented in previous 510(k) submissions, as supplemented by the safety and usability data presented in the current 510(k) and summarized herein.

10. Conclusion

The safety and effectiveness data supports the substantial equivalence of the HeartStart Home Defibrillator without prescription labeling to its predicates.

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Indications for Use

510(k) Number (if known): #K040904

Device Name: Philips HeartStart Home Defibrillator

Indications for Use:

The HeartStart Home Defibrillator should be used to treat someone who you think 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhemmmme for
Division Sign Off

ardiovascular Devices

510(k) Number K042964

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.