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.

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.

Manual Defibrillation Therapy: 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.

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

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Non-Invasive Blood Pressure Monitoring: The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

Endtidal CO2 Monitoring: The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

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.

Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:

The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg).
The Q-CPR option is not for use when CPR is contraindicated.

Device Description

The HeartStart MRx monitor/defibrillator with Q-CPR™ option is a lightweight, portable monitor/defibrillator, one of the United States models, with an option to provide visual and audible feedback to the rescuer on the quality of CPR.

In manual mode, the HeartStart MRx monitor/defibrillator with Q-CPR™ option is a fullfeatured 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 monitor/defibrillator with Q-CPR™ option, 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 monitor/defibrillator with Q-CPR™ option utilizes impedance compensating biphasic truncated exponential therapy waveform.

The HeartStart MRx monitor/defibrillator with Q-CPR™ option can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.

Additionally, the HeartStart MRx monitor/defibrillator with Q-CPR™ option is offered with the following optional functionality: Non-Invasive External Pacing, 12-Lead ECG, Non-Invasive Blood Pressure, Endtidal CO2, Pulse Oximetry.

AI/ML Overview

The document describes the HeartStart MRx monitor/defibrillator with Q-CPR™ option as a device that provides CPR feedback. However, it does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria, particularly for the Q-CPR™ functionality in a quantitative manner as requested. Instead, it relies on substantial equivalence to predicate devices and general bench testing.

Based on the provided text, here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for the Q-CPR™ option's performance itself (e.g., accuracy of depth, rate detection). Instead, it states the Q-CPR™ option "provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time)."

The "reported device performance" is essentially that the device "meets its specification" through bench testing. No specific quantitative performance metrics for the Q-CPR™ feedback accuracy are provided in this summary.

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

The document states, "Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification." However, it does not specify:

The sample size used for the test set.
The data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts or how ground truth was established for the performance evaluation of the Q-CPR™ features. The primary method described is bench testing against specifications.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned in the document, as it relies on bench testing rather than expert-reviewed cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The document focuses on the device's equivalence to existing devices and its technical specifications, not on human reader performance improvement with or without AI assistance.

6. Standalone Performance Study:

A standalone performance evaluation of the algorithm specifically for the Q-CPR™ functionality is not detailed in terms of quantitative metrics (e.g., accuracy of detecting correct compression depth/rate). The document broadly states "Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification." This implies some form of standalone testing was done against internal specifications, but no data from such a study is provided.

7. Type of Ground Truth Used:

The type of "ground truth" for the Q-CPR™ function, if any formal ground truth was established for its performance accuracy, is not explicitly stated. Given the context of "bench testing," the "ground truth" likely refers to predefined engineering specifications and simulated inputs rather than expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This type of device approval summary often focuses on the final product and its validation rather than details of potential machine learning model training, if any were involved (which is unlikely given the 2005 date and the nature of the device).

9. How the Ground Truth for the Training Set was Established:

As no training set is mentioned, information on how its ground truth was established is also not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The primary "study" described that proves the device meets (or is equivalent to) acceptance criteria is bench testing and biocompatibility testing.

Bench Testing: This included hardware and software testing. The goal was to "demonstrate that the performance of the device meets its specification." This testing covered the overall device, including the Q-CPR™ functions, by ensuring its output aligned with internal design and performance specifications.
Biocompatibility Testing: This was conducted "on the patient-contact materials of the Q-CPR™ sensor" to ensure safety.

The conclusion from these tests was that the HeartStart MRx monitor/defibrillator with Q-CPR™ option "does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices" and is "substantially equivalent" to them. This indicates a reliance on regulatory equivalence rather than a detailed, standalone clinical performance study specifically for the Q-CPR™ feedback accuracy.

Summary

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KOS1134

SEP - 8 2005

510(k) Summary 17.

Date Summary Prepared

April 25, 2005

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:Common Name:Classification Names:	HeartStart MRx monitor/defibrillator with Q-CPRTM optionMonitor/defibrillatorLow-Energy Defibrillator, Arrhythmia Detection & Alarms(Automatic External Defibrillator), External TranscutaneousPacemaker (noninvasive), ECG, Non-Invasive BloodPressure, End Tidal Carbon Dioxide, Pulse Oximeter, andCardiac Monitor; Cardiopulmonary Resuscitation (CPR)Aid
------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for The legally marketsd abitor/defibrillator with Q-CPR™ option are as follows:

Philips Medical Systems HeartStart MRx monitor/defibrillator, and .
F milips Medical Corp. Zoll AED Plus with CPR-D Padz external defibrillator .

The design of the HeartStart MRx monitor/defibrillator with Q-CPR™ option is The design of the Ticanolar. while in the neformance to the devices listed above.

Device Description

The HeartStart MRx monitor/defibrillator with Q-CPR™ option is a lightweight, portable The HeartStart MrX moniton/defibriliation with & St of the United model and external demoniator, one thouse on option to provide visual and audible feedback to the rescuer on the quality of CPR.

CONFIDENTIAL Page 17-1

page 1 of 2

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In AED mode, the HeartStart MRx monitor/defibrillator with Q-CPR™ option, 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 quide 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 monitor/defibrillator with Q-CPR™ option utilizes impedance compensating biphasic truncated exponential therapy waveform.

The HeartStart MRx monitor/defibrillator with Q-CPR™ option can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.

Additionally, the HeartStart MRx monitor/defibrillator with Q-CPR™ option 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 frained 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.

PHILIPS MEDICAL SYSTEMS HEARTSTART MRX MONITOR/DEFIBRILLATOR WITH Q-CPR™ OPTION ONFIDENTIAL Page 17-2

page 2 of 4

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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 .
Automated self test with indicator .
Internally stored event summary which may be printed .
Voice prompts in AED mode .
Adjustable 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 .

Indications for Use

The HeartStart MRx monitor/defibrillator with Q-CPR™ option 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.

Manual Defibrillation Therapy

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.

Non-Invasive External Pacing Therapy

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

Pulse Oximetry:

The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

page 3 of 4

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

Non-Invasive Blood Pressure Monitoring

The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

Endtidal CO2 Monitoring

The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

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.

Q-CPR

The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:

The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg).
. The Q-CPR option is not for use when CPR is contraindicated.

Comparison of Technology Characteristics

The HeartStart MRx monitor/defibrillator with Q-CPR™ option is the same as the HeartStart MRx monitor/defibrillator, except for the added Q-CPR™ functions. The HeartStart MRx monitor/defibrillator with Q-CPR™ option employs the same fundamental scientific technologies as the commercially available predicate devices used for comparison. The HeartStart MRx monitor/defibrillator with Q-CPR™ option 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 HeartStart MRx monitor/defibrillator without the Q-CPR™ option. Heart rate alarms, noninvasive pacing, pulse oximetry, 12-Lead ECG, NIBP, and EtCO2 technologies and functions are identical to those in the HeartStart MRx monitor/defibrillator. The HeartStart MRx monitor/defibrillator with Q-CPR™ option's AED and CPR assist technologies and functions are substantially equivalent to those of the Zoll AED Plus with CPR-D Padz external defibrillator.

Tests Used in Determination of Substantial Equivalence

The tests used in the determination of substantial equivalence included bench testing and biocompatibility testing. Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification. Biocompatibility testing was conducted on the patient-contact materials of the Q-CPR ™ sensor.

Conclusion from Testing

Based on the results of the testing described above, it is concluded that the HeartStart MRx monitor/defibrillator with Q-CPR™ option 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.

PHILIPS MEDICAL SYSTEMS HEARTSTART MRX MONITOR/DEFIBRILLATOR WITH Q-CPR™ OPTION CONFIDENTIAL Page 17-4

Page 4 of 4

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Image /page/4/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2005

Philips Medical System c/o Mr. Peter Ohanian Director, Quality and Regulatory Affairs Cardiac and Monitoring Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099

Re: K051134

Trade Name: Heartstart MRx with Q-CPR Option Models M3535A or M3536A Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO, DPS, DXN, CCK, DQA, MWI LIX Dated: August 29, 2005 Received: August 30, 2005

Dear Mr Ohanian:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocated on a levice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfed in the Medical Device the enactment date of the Medical Device Amendments, or to econmored prior co rize) 2011-11-11
11 accordance 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 I ou may, merelore, manot 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 r your device is olastined (sonal controls. Existing major regulations affecting your device can may be subject to back added as the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 – Mr. Peter Ohanian

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease or advised that I DA 5 168aanse or our device complies with other requirements of the Act that I DA has Inade a determinations administered by other Federal agencies. You must of any I cuclar studies and regurenents, including, but not limited to: registration and listing Compry with an the Nec 3 requiremER Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820), and if applicable, the electronic forth in the quant) by evelise (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro fiscis (Seeins (Seeting your device as described in your Section 510(k) I mis icher will anow you to begin maing of substantial equivalence of your device to a legally premarket notincation: "The PDF Intellight on 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 If you desire specific davis at (240) 276-0295. Also, please note the regulation entitled, Connact the Office of Compuner as (et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Взяткитоков

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

Enclosure

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2. Indications for Use

510(k) Number (if known): K051134

Device Name: Philips Medical Systems, HeartStart MRx monitor/defibrillator with Q-CPR™ option

The HeartStart MRx monitor/defibrillator with Q-CPR™ option 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.

Manual Defibrillation Therapy

Non-Invasive External Pacing Therapy

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

Pulse Oximetry

The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Non-Invasive Blood Pressure Monitoring

The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

and/or

[continued ... ]

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Use X

Over-The-Counter Use ___

(21 CFR 807 Subpart C)

(Per 21 CFR 801 Subpart D)

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

ocurrence of CPRH @ffice of Device Evaluation (ODE)

Division Sian-Offi Division of Cardlovoscular De

PHILIPS MEDICAL SYSTEMS

CONFIDENTIAL
Page 2-1

page 1 of 2

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510(k) Number (if known): K051134

Device Name: Philips Medical Systems, HeartStart MRx monitor/defibrillator with Q-CPR™ option

Indications for Use: [continued ... ]

Endtidal CO2 Monitoring

The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

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.

Q-CPR

The Q-CPR option is contraindicated as follows:

The Q-CPR option is contraindicated for use on neonatal and pediatric patients . (under 8 years of age or weighing less than 25 kg).
- The Q-CPR option is not for use when CPR is contraindicated.
Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

and/or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mataay
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K051134

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.