The FR2 is intended to be used with disposable Heartstream defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.

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.

The 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 (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.

At the discretion of emergency care personnel, the M3860A FR2 with ECG display enabled can also be used with the FR2 ECG Cable to display the rhythm of a responsive or breathing patient, regardless of age. The FR2 and ECG Cable system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2 ECG Cable, the FR2 evaluates the patient's ECG and disables it's shock capability.

Device Description

The Heartstream FR2 is an automated external defibrillator available in two models, including one with ECG display and manual shock capability. Features include selftesting, impedance-compensating biphasic truncated exponential waveform, multiparameter Patient Analysis System (PAS), and human factor designs 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.

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.

An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2's main crystal display screen. Three lead wires, connected to standard disposable ECG electrodes, are labeled according to AAMI or IEC conventions. If a potentially shockable rhythm is detected (using the existing FR2 PAS algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are generated.

AI/ML Overview

The provided 510(k) summary for the Heartstream FR2 AED with ECG Cable (K013425) does not contain specific acceptance criteria or a detailed study description proving that the device meets such criteria.

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with predefined acceptance criteria. This is common for 510(k) submissions, where the primary goal is to show that a new device is as safe and effective as a legally marketed one, often through design comparison and limited bench testing.

Therefore, many of the requested details cannot be extracted from the provided text. However, I can still address the available information and highlight what is missing.

Description of Acceptance Criteria and Study

The provided 510(k) summary does not explicitly state specific acceptance criteria for the Heartstream FR2 AED with ECG Cable or detail a study designed to prove the device meets such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The primary "study" mentioned is bench testing to ensure the ECG Cable meets specifications appropriate for its intended application.

The core argument for substantial equivalence is that "The Heartstream FR2 employs the same technologies as the predicate devices used for comparison. The FR2 acquires and analyzes ECG signals, and utilizes the same shock advisory criteria like the predicates and the FR2 without the ECG Cable."

Therefore, the "acceptance criteria" can be inferred to be that the ECG Cable functions as intended and does not negatively impact the overall safety and effectiveness of the existing FR2 AED, which itself would have met performance criteria in its original 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in 510(k) summary)
ECG Cable performs to specifications.	"Bench testing demonstrates that the performance of the ECG Cable meets specifications is appropriate for its intended application."
ECG Cable does not introduce new safety or effectiveness issues.	"The modifications proposed to include an optional ECG Cable to the FR2 accessory offerings do not present new issues of safety or effectiveness."
Device (with ECG Cable) maintains functions for displaying Lead II ECG and heart rate.	"An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2's main crystal display screen."
Device (with ECG Cable) maintains ability to detect potentially shockable rhythms and disable shock capability.	"If a potentially shockable rhythm is detected (using the existing FR2 PAS algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are generated... While connected to the FR2 ECG Cable, the FR2 evaluates the patient's ECG and disables its shock capability."

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

Test Set Sample Size: Not specified. The document mentions "bench testing," which typically involves testing a sample size of devices, but the exact number is not provided.
Data Provenance: The bench testing would have been conducted internally by Philips Medical System Heartstream. No details on country of origin of data or whether it was retrospective or prospective are provided, as it's primarily an engineering verification rather than a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic algorithms). The described "bench testing" is an engineering validation of the ECG cable's technical performance against specifications, not a clinical study requiring expert consensus on a test set.

4. Adjudication method for the test set

Not applicable. As the "study" is bench testing for technical performance, there would be no need for an adjudication method in the human-interpretation sense. The determination of whether the cable meets specifications would be based on predefined engineering metrics and testing protocols.

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, an MRMC comparative effectiveness study was not done. This type of study is not relevant to the approval of an ECG cable accessory for an AED in this 510(k) submission. The device is not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in the context of bench testing. The "bench testing" mentioned evaluates the ECG cable's ability to "meet specifications." This implies testing the cable's performance in isolation or as integrated into the AED system, but without human intervention in the measurement of its core technical function. The FR2's existing Patient Analysis System (PAS) algorithm, which is the "standalone" algorithm for rhythm analysis, is stated to be unchanged and used with the ECG cable.

7. The type of ground truth used

Engineering specifications/predefined electrical and signal integrity standards. For bench testing of the ECG cable, the "ground truth" would be the expected electrical signals, noise levels, frequency response, and general signal quality metrics defined by the device's design and relevant industry standards (e.g., AAMI or IEC conventions for lead wires, as mentioned).

8. The sample size for the training set

Not applicable. The submission describes an accessory (ECG cable) for an existing device. It does not involve a machine learning model that would require a "training set." The FR2's existing Patient Analysis System (PAS) algorithm was developed prior to this submission and would have had its own validation data, but that information is not part of this specific 510(k).

9. How the ground truth for the training set was established

Not applicable. (See point 8).

Summary

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K013425

JAN 1 4 2002

14.PreMarket Notification Summary

510(k) Summary for the Heartstream FR2 AED

Date Summary Prepared 1.

October 15, 2001

2. Submitter's Name and Address

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

3. Contact Person

Tamara Yount Philips Medical System Heartstream Telephone: (206) 664-5141 Facsimile: (206) 664-5001

4. Device Name

Proprietary Name: Heartstream FR2 AED with ECG Cable 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 Heartstream FR2 AED with ECG Cable is the Heartstream FR2 AED, Laerdal Heartstart 3000, Heartstream XLT Defibrillator/Monitor and the Active Corporation ActiveECG device.

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

6. Device Description

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A non-rechargeable lithium manganese dioxide battery powers the FR2 with a typical capacity of 300 shocks or 12 hours of operating time.

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.

7. Intended Use

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, or advanced life support, or other physician-authorized emergency medical response.

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

. Unresponsiveness
. Absence of breathing

At the discretion of emergency care personnel, the M3860A FR2 with ECG display enabled can also be used with the FR2 ECG Cable to display the rhythm of a responsive

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or breathing patient, regardless of age. The FR2 and ECG Cable system provides a nondiagnostic display for attended patient monitoring. While connected to the FR2 ECG Cable, the FR2 evaluates the patient's ECG and disables its shock capability.

Comparison of Technology Characteristics 8.

The modified Heartstream FR2 AED with the ECG Cable employs the same fundamental scientific technologies as the Laerdal Heartstart 3000, the Heartstream XLT Defibrillator/Monitor and the Active Corporation ActiveECG device.

Data Used in Determination of Substantial Equivalence 9.

The Heartstream FR2 employs the same technologies as the predicate devices used for comparison. The FR2 acquires and analyzes ECG signals, and utilizes the same shock advisory criteria like the predicates and the FR2 without the ECG Cable.

Bench testing demonstrates that the performance of the ECG Cable meets specifications is appropriate for its intended application.

10. Conclusion

The modifications proposed to include an optional ECG Cable to the FR2 accessory 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2002

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

Re: K013425

Trade Name: Heartstream FR2 AED with an ECG Cable Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ and DPS Dated: October 15, 2001 Received: October 16, 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.

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,

Bram 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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11.Indications for Use

A013425

510(k) Number (if known): To be assigned

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

Indications For Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R013423

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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.