When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads. DO NOT DELAY TREATMENT TO DETERMINE THE CHILD'S EXACT AGE/WEIGHT.

The Heartstream FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response.

Device Description

The Heartstream FR2 is an automated external defibrillator available in two models, including one model with ECG display and manual shock capability. Features include self-testing, impedance-compensating biphasic truncated exponential waveform, multiparameter Patient Analysis System (PAS), and human factors design to facilitate use by lay responders.

A non-rechargeable lithium manganese dioxide battery powers the FR2 with a typical capacity of 300 shocks or 12 hours of operating time. An optional rechargeable lithiumion battery with a typical capacity of 100 shocks and 4 hours of operating time, and its companion charger, will also be available.

Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2 advises a shock and arms - if the ECG spontaneously converts to a nonshockable rhythm prior to a responder pressing the shock button, the FR2 disarms.

If significant artifact is detected in the ECG, Heartstream's PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2 directs the responder to press the shock button to deliver a biphasic shock to the patient.

Event and incident data can be recorded during FR2 use with an optional data card having a recording capacity of four hours of event and ECG data (or thirty minutes with voice recording).

The FR2 has an optional Training and Administration Pack that is used for device training and for customizing FR2 set-up options. Use of the Training and Administration Pack converts the FR2 to a training device with ten training "scripts" that simulate different SCA scenarios.

The FR2 also has an infrared communication port to facilitate communication of set-up parameters.

AI/ML Overview

The provided text describes a 510(k) summary for the Heartstream FR2 AED but does not contain specific acceptance criteria or details of a study proving the device meets those criteria, beyond general statements about bench testing and simulated use testing.

Therefore, I cannot populate most of the requested sections with specific information. However, I can infer some general points from the document.

Here's an attempt to answer based on the provided text's limitations:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. It generally states that "Bench testing demonstrated that the performance of the M3848A and M3849A meets specifications" and "simulated use testing that the M3848A and M3849A are appropriate for the intended users." The focus of this 510(k) is on the substantial equivalence of a modified device (adding M3848A and M3849A accessories) to a predicate device, rather than a de novo submission that would typically detail extensive performance studies against new criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be accurately constructed from the given text.

Here's what can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or detailed performance data are reported in this 510(k) summary. The summary only broadly states that the device "meets specifications" and is "appropriate for the intended users" based on testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing mentioned is "Bench testing" and "simulated use testing," implying laboratory or controlled environments, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. Given the nature of bench and simulated use testing for an AED, ground truth would likely be established through engineering specifications, simulated physiological responses, or adherence to established standards, rather than expert interpretation of patient data in the context of this 510(k) summary.

4. Adjudication method for the test set
Not specified.

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. This document describes an Automated External Defibrillator (AED), which is a standalone device for rhythm analysis and shocking. It does not involve "human readers" or "AI assistance" in the context of diagnostic image interpretation or similar tasks where MRMC studies are typically performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. An AED's primary function is to automatically analyze ECG and detect shockable rhythms. The summary states: "Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm." This confirms standalone algorithmic performance. The "simulated use testing" would likely evaluate this standalone performance in simulated scenarios.

7. The type of ground truth used
Not explicitly stated, but for an AED's rhythm analysis, ground truth would typically be based on:
* Defined ECG waveforms: Synthetic or recorded ECGs representing various rhythms (shockable, non-shockable, artifact) with known classifications.
* Physiological models: Simulated cardiac arrest scenarios where the "true" state of the heart rhythm is controlled.

8. The sample size for the training set
Not specified. This 510(k) focuses on a modification rather than the initial development of the core algorithm, so details on original training sets are not included.

9. How the ground truth for the training set was established
Not specified. For the original AED algorithm development, ground truth for training data would likely have been established by expert cardiologists or electrophysiologists annotating large databases of ECG recordings, often correlated with patient outcomes.

Summary

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16. 510(k) Summary

K04157

510(k) Summary for the Heartstream FR2 AED

with the M3848A and M3849A

1. Date Summary Prepared

December 11, 2001

2. Submitter's Name and Address

Philips Medical Systems Heartstream 2401 Fourth Avenue, Suite 500 Seattle. WA 98121

3. Contact Person

Tamara Yount Philips Medical Systems Heartstream Telephone: (206) 664-5000 Facsimile: (206) 664-5001

4. Device Name

Heartstream FR2 AED with M3848A and M3849A Proprietary Name: Common Name: Automated external defibrillator Classification Names: Low-Energy Defibrillator

5. Predicate Devices

The legally marketed device to which Philips Medical Systems, Heartstream claims equivalence for the modified Heartstream FR2 AED with the M3848A and M3849A is the Heartstream FR2 AED. The modified device is also substantially equivalent to the Medtronic/Physio-Control LifePak 500.

The design and intended use of the modified Heartstream FR2 AED is substantially equivalent in safety and performance to the devices named above.

Device Description 6.

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Event and incident data can be recorded during FR2 use with an optional data card having a recording capacity of four hours of event and ECG data (or thirty minutes with voice recording).

The FR2 also has an infrared communication port to facilitate communication of set-up parameters.

Intended Use 7.

The Heartstream FR2 is indicated for use on victims of sudden cardiac arrest exhibiting the following signs:

Unresponsiveness .
Absence of breathing .

Comparison of Technology Characteristics 8.

The modified Heartstream FR2 AED with the M3848A employs the same fundamental scientific technologies as the commercially available Heartstream FR2 AED. The modified device is also similar to the Medtronic/Physio-Control LifePak 500.

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Data Used in Determination of Substantial Equivalence 9.

The modified Heartstream FR2 with the M3848A and M3849A employs the similar the modified in provide similar performance characteristics as the predicate devices.

Bench testing demonstrated that the performance of the M3848A and M3849A meets specifications. In addition, it was demonstrated by simulated use testing that the M3848A and M3849A are appropriate for the intended users.

10. Conclusion

The modifications proposed to include the M3848A and M3849A to the FR2 accessory product offerings do not present new issues of safety or effectiveness.

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Image /page/3/Picture/1 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 a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Ms. Tamara Yount Senior Regulatory Affairs Associate Philips Medical Systems 2401 Fourth Avenue, Suite 500 Seattle, WA 98121-1436

Re: K014157

Heartstream FR2 AED with M3848A and M3849A Regulation Number: 21 CFR 870.1025 Regulation Name: Automatic External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: December 17, 2001 Received: December 19, 2001

Dear Ms. Yount:

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). 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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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 be 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. Tamara Yount

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 begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dale Hill

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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12.Indications for Use

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems, Heartstream FR2 Automated External Defibrillator (AED)

Indications for Use: The Heartstream FR2 is indicated for use on persons experiencing the symptoms of sudden cardiac arrest:

Lack of responsiveness .
. Lack of breathing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denk Tuh
Division of Cardiovascular & Respiratory Devices
510(k) Number K014157

Prescription Use

Over-The-Counter Use _

PHILIPS MEDICAL SYSTEMS, HEARTSTREAM HEARTSTREAM FR2 AED, WITH THE M3848A AND M3849A રૂદ

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.