If the person is an infant or child younger than eight years old or weighs if the person is an thant of child Johnsylange. If the child appears less than 55 lbs (20 kg), aco (and/Child Key. Do not delay treatment to oldemarger, do not as act age or weight. If in doubt, do not use the Infant/Child Key.

Device Description

The Philips HeartStart FRx Defibrillator is an automated external defibrillator (AED) for the treatment of ventricular fibrillation, the most common cause of sudden cardiac arrest (SCA). Features of the Philips HeartStart FRx Defibrillator include estimated exponential therapy impedance-compensating biphasic waveform, SMART Analysis System (PAS) for determining if a shock is required and integrated human factors designs for use by lay responders and pre-connected electrodes.

A non-rechargeable lithium manganese dioxide battery powers the Philips HeartStart FRx Defibrillator with a minimum capacity of 200 shocks or 4 hours of operating time.

The HeartStart FRx Defibrillator issues voice instructions appropriate to the stage of the rescue and keeps pace with the user's actions. The defibrillator incorporates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR and otherwise attend to the patient. The defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is required. The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode analysis. 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 FRx Defibrillator utilizes the same biphasic, impedance-compensating exponential waveform used in previous-generation Philips AEDs. The HeartStart FRx Defibrillator delivers 150J shocks (nominal) when the user presses the shock button as instructed by the defibrillator (50J nominal with Infant/Child Key). The HeartStart FRx Defibrillator offers no manual-shock capability.

AI/ML Overview

Here's an analysis of the provided text regarding the Philips HeartStart FRx Defibrillator, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary for a defibrillator, not an AI or medical imaging device. Therefore, many standard AI/ML study components like "test set," "ground truth," "experts," "adjudication," "MRMC," and "training set" are not applicable in the context of this traditional medical device submission. The focus here is on functional performance and substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a structured, quantitative table as one might find for a more complex diagnostic device or AI algorithm. Instead, the "acceptance criteria" for this defibrillator are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device (Philips HeartStart OnSite M5066A Defibrillator) and by showing that it performs in a similar manner and introduces no new safety or efficacy issues.

The performance characteristics are described qualitatively and through the statement that testing demonstrates substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and Efficacy (Overall): No new issues of safety or efficacy compared to the predicate device.	"Testing demonstrates that the FRx performs in a manner substantially equivalent to the M5066A predicate and demonstrates that the introduction of the FRx does not raise and new issues of safety or efficacy." "The introduction of the HeartStart FRx Defibrillator does not present new issues of safety or effectiveness."
Fundamental Scientific Technology: Employs the same core technology for sensing and delivering therapy.	"The HeartStart FRx Defibrillator employs the same fundamental scientific technology as the commercially available Philips HeartStart OnSite M5066A Defibrillator." "The HeartStart FRx Defibrillator utilizes the same biphasic, impedance-compensating PHILIPS waveform used in previous-generation Philips AEDs."
Shock Delivery: Delivers effective therapy (e.g., 150J nominal).	"The HeartStart FRx Defibrillator delivers 150J shocks (nominal)..."
Analysis System: Continuously and automatically analyzes patient ECG to determine if a shock is required, ensuring validity.	"The defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is required and integrated human factors designs... The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode... designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm."
Battery Capacity: Minimum capacity for operations.	"A non-rechargeable lithium manganese dioxide battery powers the Philips HeartStart FRx Defibrillator with a minimum capacity of 200 shocks or 4 hours of operating time."
Intended Use: Applicable for persons suspected to be in sudden cardiac arrest (unresponsive, not breathing normally).	This is the stated indication for use.
Infant/Child Key Functionality: Guidance for use with pediatric patients.	"If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key." (This implies the device functions correctly in this mode.)

Study Details (Applicable to Traditional Device Submissions)

For a device like a defibrillator submitting via 510(k), the "study" is primarily focused on bench testing, validation against existing standards, and comparison to the predicate device's established performance. It's not a clinical trial in the sense of an AI algorithm, but rather a demonstration of functional and safety equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Patient Data/ECGs): The document does not specify a "test set" in terms of patient ECGs or clinical cases. The testing would involve simulated rhythms, performance under various electrical and environmental conditions, and comparison of waveforms to the predicate. The "data provenance" (country of origin, retrospective/prospective) for such engineering bench tests is not typically detailed in this type of summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For a defibrillator, "ground truth" isn't established by expert consensus on diagnostic images or data. The "truth" is whether the device accurately detects shockable rhythms (e.g., ventricular fibrillation) and delivers the specified energy, which is verified through engineering tests against known electrical signals.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there's no "ground truth" set by human experts, there's no adjudication process. Performance is objectively measured against electrical standards and the predicate device.
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
- Not Applicable. This is a standalone medical device, not an AI-assisted diagnostic tool. There are no human "readers" or AI assistance involved in its primary function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The defibrillator's core function (analyzing ECG, determining shock advisability) is an "algorithm only" process before human intervention to press the shock button. The device autonomously decides if a shock is needed. This is implicitly what the "testing demonstrates" refers to in terms of the analysis system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- "Ground truth" for a defibrillator involves adherence to electrical and performance standards. This includes:
  - Known Electrical Rhythms: Testing with simulated ECGs representing shockable (e.g., VF) and non-shockable rhythms, generated by specialized equipment.
  - Energy Output Measurement: Verification that the device delivers the specified joules.
  - Impedance Testing: Performance across a range of patient impedances.
  - Environmental Testing: Performance under various temperature, humidity, and vibration conditions.
The sample size for the training set
- Not Applicable. This device doesn't employ a machine learning algorithm in the sense of a "training set" for classification or prediction. Its "algorithm" is based on established signal processing and pattern recognition rules for cardiac rhythms.
How the ground truth for the training set was established
- Not Applicable. See point 7.

Summary of the Study (as described in the 510(k)):

The study primarily involved engineering and bench testing to demonstrate that the Philips HeartStart FRx Defibrillator is substantially equivalent to its predicate device, the Philips HeartStart OnSite M5066A Defibrillator. This equivalence was demonstrated by showing that:

It uses the same fundamental scientific technology.
It has similar performance characteristics.
It performs in a similar manner.
Its introduction does not raise new issues of safety or efficacy.

This type of submission relies heavily on a comparison to a device already cleared by the FDA, rather than novel clinical trial data for new technology.

Summary

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FEB 2 5 2005

13 510(k) Summary

510(k) Number (if known): K050004

510(k) Summary for the Philips HeartStart FRx Defibrillator

Date Summary Prepared 1. February 24, 2005
Submitter's Name and Address 2. Philips Medical Systems Heartstream 2301 5th Avenue, Suite 200 Seattle, WA 98121
1. Contact Person Tish Treherne Requiatory Specialist Philips Medical Systems Heartstream Telephone: (206) 664-5283 Facsimile: (206) 664-2070

Device Name and Classification Information 4.

Philips HeartStart FRx Defibrillator Proprietary Name: Defibrillator Common Name: Classification Names: Automated External Defibrillator Device Classification: Class III Automated External Defibrillator Regulation: 21 CFR § 870.5310 MK1 Product Code :

Predicate Devices 5.

Fredicate Devices device to which Philips Medical Systems, The Tegally marketed device to the Philips HeartStart FRx Heartstream is the Philips HeartStart OnSite M5066A Defibrillator (K020715).

The design and intended use of the FRx is substantially equivalent in THC acong r afformance to the HeartStart OnSite M5066A.

Device Description 6.

Device Description
The Philips HeartStart FRx Defibrillator is an automated external The Philips HeartStart TTXx Donomiator fibrillation, the most common cause of sudden cardiac arrest (SCA). Features of the Philips common cause of sudden cardido arroot (Self-Calibration, and self-calibration, and HeartStart TRX Dellibrillato: Include estimated exponential therapy impedance-compensating - biphable - transmiss System (PAS) for

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determining if a shock is required and integrated human factors designs actormining in & of lay responders and pre-connected electrodes.

A non-rechargeable lithium manganese dioxide battery powers the Philips A hon-rechargedblo killiator with a minimum capacity of 200 shocks or 4 hours of operating time.

The HeartStart FRx Defibrillator issues voice instructions appropriate_to The Fleartolan FTA Bollband keeps pace with the user's actions. The the stage of the rocates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR and otherwise predention "intorvals" to "cally analyzes the patient's ECG to determine if continuously and actomatically afibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode assess the £50 valiany as 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 FRx Defibrillator utilizes the same biphasic, impedance-The Heartourt FFX Delia waveform used in previous-generation Philips Compensating Oxponsibilition delivers 150J shocks (nominal) ALDs. The ficur(Start r... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . shock button as instructed by the defibrillator (50J nominal with Shock button as instructed by HeartStart FRx Defibrillator offers no manual-shock capability.

Intended Use 7.

The HeartStart FRx Defibrillator is indicated for use on a person suspected to be in sudden cardiac arrest who is:

Unresponsive when shaken .
. Not breathing normally

Indications for Use 8.

The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:

. Unresponsive when shaken
Not breathing normally .

If in doubt, apply the pads. A training class in CPR/AED use is II in Goubt, apply the page:

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Comparison of Technology Characteristics 9.

The HeartStart FRx Defibrillator employs the same fundamental scientific technology as the commercially available Philips HeartStart OnSite M5066A Defibrillator.

Data Used in Determination of Substantial Equivalence 10.

The HeartStart FRx Defibrillator employs the similar technologies to provide similar performance characteristics as the predicate device.

Testing demonstrates that the FRx performs in a manner substantially equivalent to the M5066A predicate and demonstrates that the introduction of the FRx does not raise and new issues of safety or efficacy.

11. Conclusion

The introduction of the HeartStart FRx Defibrillator does not present new issues of safety or effectiveness.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines forming its wings.

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical System c/o Ms. Tish Treherne Regulatory Affairs Specialist 2301 Fifth Avenue, Suite 200 Seattle, WA 98121-1825

Re: K050004

Trade Name: Philips HeartStart FRx Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: January 27, 2005 Received: January 28, 2005

Dear Ms. Treherne:

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). and Coometer fore, 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 such additional controls. Existing major regulations affecting your device can he 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.

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Page 2 - Ms. Tish Treherne

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 that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I 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 CI R Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) I mis lotter will and in your to one finding of substantial equivalence of your device to a legally prematics notification "The 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 its you dome effice of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Blimmo for

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

Enclosure

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Indications for Use 14

510(k) Number (if known):

Philips HeartStart FRx Defibrillator, model 861304 Device Name:

Indications for Use:

The HeartStart FRx Defibrillator should be used on a person you think is in sudden cardiac arrest. A person in sudden cardiac arrest is:

Unresponsive when shaken .
Not breathing normally .

If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HeartStart FRx Defibrillator.

If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the Infant/Child Key. If the child appears older/larger, do not use the Infant/Child Key. Do not delay treatment to determine the child's exact age or weight. If in doubt, do not use the Infant/Child Key.

Caution: Federal Law (USA) restricts this device to the sale by or on the order of a physician.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Kamiyama

Division Sign-Off) Division of Cardiovascular Devices 510/k) Number

Page 1 of 1

SECTION 14 PAGE 1

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.