The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized defibrillation is indicated for termination of atrial fibrillation.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Non-Invasive External Pacing:
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

12-Lead ECG:
The 12-Lead ECG option is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms.

Non-Invasive Blood Pressure:
The NIBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients.

Endtidal CO2:
The EtCO2 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients.

Pulse Oximetry:
The SpO2 option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.

The HeartStart MRx is a fully featured, external defibrillator/monitor intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or Basic Life Support, in a hospital or pre-hospital environment.

Device Description

The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).

In manual mode, the HeartStart MRx is a full-featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation, perform synchronized cardioversion and provide non-invasive external pacing.

In AED mode, the HeartStart MRx, allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient's rhythm and advises the user to provide a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display.

In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform.

The HeartStart MRx can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.

Additionally, the HeartStart MRx is offered with the following optional functionality:

Non-Invasive External Pacing:
The pacing option is intended for treating patients with symptomatic bradycardia. This parameter is used by ACLS trained clinicians typically performed in a hospital environment.

12-Lead ECG:
The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.

Non-Invasive Blood Pressure:
The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.

Endtidal CO2:
The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and also provides a respiration rate. This parameter is used by ACLS trained clinicians and performed in both the pre-hospital and hospital environments.

Pulse Oximetry:
The SpO2 option is intended for use when it is beneficial to assess a patient's arterial oxygen saturation level. This parameter is used by trained clinicians and performed in both the pre-hospital and hospital environments.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the HeartStart MRx device:

Acceptance Criteria and Device Performance

The submission focuses primarily on demonstrating substantial equivalence to predicate devices through technical comparisons and bench testing. It does not explicitly state numerical acceptance criteria in the format of sensitivity, specificity, or similar performance metrics. Instead, the "acceptance criteria" are implied to be meeting specifications through bench testing and being substantially equivalent to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Meets device specifications (hardware/software)	Bench testing demonstrated the performance of the device meets its specifications.
Substantially equivalent to predicate devices (Heartstream XL Defibrillator/Monitor and ZOLL M Series Defibrillator)	Technical comparison and bench testing concluded that the HeartStart MRx does not raise any different questions regarding safety or effectiveness compared to predicate devices.

Note: The document states, "The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J." This refers to the predicate device's performance, which the HeartStart MRx is claiming equivalence to, rather than new performance data for the MRx itself.

Study Details

Based on the provided text, the study conducted for the HeartStart MRx was a bench testing study.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved "bench testing" which typically refers to laboratory testing of the device hardware and software, rather than a clinical dataset of patient records.
- Data Provenance: Not applicable in the context of bench testing. The data would be generated directly from the device and test equipment in a lab setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a bench testing study. Ground truth in this context would likely be engineering specifications and validated test procedures.
Adjudication method:
- Not applicable as this was a bench testing study.
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 study was done. The document explicitly states: "The tests used in the determination of substantial equivalence included only bench testing." The device is a defibrillator/monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance assessment was conducted in the form of "bench testing" which evaluates the device's hardware and software against specifications. While not an "algorithm-only" study in the modern AI sense, it assesses the device's inherent functionality.
The type of ground truth used:
- Engineering specifications and design requirements. For example, the device would be tested to ensure its output waveform, energy delivery, ECG acquisition accuracy, and other parameters meet predefined technical standards.
The sample size for the training set:
- Not applicable. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically refers to the development and refinement of its internal logic and parameters based on engineering principles and established medical guidelines, rather than learning from a vast dataset.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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Ro31187 510(k) Summary

Date Summary Prepared

April 4, 2003

Submitter's Name and Address

Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation 3000 Minuteman Road Andover, MA 01810-1099

Contact Person

Peter Ohanian Philips Medical Systems Cardiac and Monitoring Systems Cardiac Resuscitation Telephone: (978) 659-3397 Facsimile: (978) 659-7360

Device Name

Proprietary Name:	HeartStart MRx
Common Name:	Defibrillator/Monitor
Classification Names:	Low-Energy Defibrillator, Arrhythmia Detection & Alarms
	(Automatic External Defibrillator), External Transcutaneous
	Pacemaker (noninvasive), ECG, Non-Invasive Blood
	Pressure, End Tidal Carbon Dioxide, Pulse Oximeter, and
	Cardiac Monitor.

Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for the HeartStart MRx are as follows:

Philips Medical Systems (formally Agilent Technologies) Heartstream XL . Defibrillator/Monitor, and
. ZOLL Medical Corp. M Series Defibrillator

The design of the HeartStart MRx is substantially equivalent in safety and performance to the devices listed above.

Device Description

The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).

In manual mode, the HeartStart MRx is a full-featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation

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allows users to select energy levels for external and internal defibrillation, perform synchronized cardioversion and provide non-invasive external pacing.

In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform.

The HeartStart MRx can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.

Additionally, the HeartStart MRx is offered with the following optional functionality:

Non-Invasive External Pacing:

The pacing option is intended for treating patients with symptomatic bradycardia. This parameter is used by ACLS trained clinicians typically performed in a hospital environment.

12-Lead ECG:

The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.

Non-Invasive Blood Pressure:

The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.

Endtidal CO2:

The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and also provides a respiration rate. This parameter is used by ACLS trained clinicians and performed in both the pre-hospital and hospital environments.

Pulse Oximetry:

The SpO2 option is intended for use when it is beneficial to assess a patient's arterial oxygen saturation level. This parameter is used by trained clinicians and performed in both the pre-hospital and hospital environments.

Features

ECG monitoring through pads or separate monitoring electrodes .
Alarms on Heart Rate Limits and shockable rhythms ●
Built-in strip chart printer ●
Display for viewing waveforms and messages ●

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Automated self test with indicator .
Internally stored event summary which may be printed .
Voice prompts in AED mode .
Adiustable ECG size .
Adjustable volume control .
Setup mode, automatic self tests and error handling .
. Lithium Ion battery
Internal Defibrillation .
External Paddles with patient contact indicator .
3, 5. and 12 Lead ECG cables .
Battery Charging Kit .
PCMCIA Data card for data and event capture .
Data recording, management, and transfer .
Event Review .
AC Power Module .
DC Power Module .

Intended Use

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Non-Invasive External Pacing:

The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

12-Lead ECG:

The 12-Lead ECG option is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms.

Non-Invasive Blood Pressure:

The NIBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients.

{3}------------------------------------------------

Endtidal CO2:

The EtCO2 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients.

Pulse Oximetry:

The SpO2 option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.

Comparison of Technology Characteristics

The HeartStart MRx employs the same fundamental scientific technologies as the commercially available predicate devices used for comparison. The HeartStart MRx acquires and analyzes ECG signals, utilizes the same shock advisory criteria, and advises the user to deliver a shock when required utilizing voice prompts as in the Heartstream XL. Heart rate alarms, noninvasive pacing and pulse oximetry functions are provided, as in the Heartstream XL. The HeartStart MRx's 12-Lead ECG, NIBP, and EtCO2 technologies are substantially equivalent to the ZOLL M Series defibrillator.

Tests Used in Determination of Substantial Equivalence

The tests used in the determination of substantial equivalence included only bench testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification

Conclusion from Testing

Based on the results of the testing described above, it is concluded that the HeartStart MRx does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes coiled around it and wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Phillips Medical Systems c/o Mr. Peter Ohanian Director, Quality and Regulatory Affairs 3000 Minuteman Road, MS 0222 Andover. MA 01810

K031187 Heartstart MRX, Model M3535A Regulation Number: 870.1025, 870.5300, 870.5550 Regulation Name: Arrhythmia Detector and Alarm, DC-defribrillator, External Transcutaneous cardiac pacemaker Regulatory Class: Class III Product Code: MKJ, LDD, DRO Dated: July 24, 2003 Received: July 29, 2003

Dear Mr. Ohanian:

Re:

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. Iisting 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 - Mr. Peter Ohanian

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), 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) you may obtain. 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. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use 03/187

510(k) Number (if known): K031187

Device Name: Philips Medical Systems, HeartStart MRx

Indications for Use: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarmythmias at 150J. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Non-Invasive External Pacing:

The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

12-Lead ECG:

Non-Invasive Blood Pressure:

The NIBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients.

Endtidal CO2:

The EtCO2 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients.

Pulse Oximetry:

The SpO2 option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A ND/OR --------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

or	Over-The-Counter Use
(Division Sign-Off)

Philips Medical Systems

510(k) Number	KC3
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Page 1 of 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.