HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS

K061707 · Philips Medical Systems · MKJ · Aug 11, 2006 · Cardiovascular

Device Facts

• Record ID: K061707
• Device Name: HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
• Applicant: Philips Medical Systems
• Product Code: MKJ · Cardiovascular
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. 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 Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation. Noninvasive 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. Noninvasive Blood Pressure Monitoring The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure. End-tidal CO2 The EtCO2 option is intended for nonitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. 12-Lead ECG The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. Q-CPR The O-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 that 25 kg). The Q-CPR option is not for use when CPR is contraindicated. Invasive Pressure The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients. Temperature The Temperature option is indicated for measuring temperature in patients.

Device Story

HeartStart MRx is a portable external defibrillator/monitor; provides manual/semi-automatic (AED) defibrillation, non-invasive pacing, and multi-parameter monitoring (ECG, NIBP, SpO2, EtCO2, invasive pressure, temperature). Inputs include ECG signals (pads/electrodes), pressure transducers, temperature probes, and pulse oximetry sensors. Device processes signals to display waveforms, vital sign trends, and alarms; provides voice prompts in AED mode; includes Q-CPR feedback for resuscitation guidance. Operated by qualified medical personnel in clinical settings. Output used by clinicians for real-time patient assessment and therapeutic decision-making (defibrillation/pacing). Benefits include rapid intervention for cardiac arrest and continuous physiological monitoring.

Clinical Evidence

Bench testing only. Hardware and software testing performed to demonstrate device performance meets specifications.

Technological Characteristics

Portable defibrillator/monitor; lithium-ion battery powered; includes ECG, NIBP, SpO2, EtCO2, invasive pressure, and temperature modules. Connectivity via PCMCIA data card for event capture/transfer. Software performs signal analysis for shock advisory criteria and physiological monitoring. Sterilization not applicable (external use).

Indications for Use

Indicated for patients requiring defibrillation (ventricular tachycardia/fibrillation), pacing (symptomatic bradycardia/asystole), or physiological monitoring (ECG, NIBP, SpO2, EtCO2, invasive pressure, temperature). AED mode for patients >=8 years, unresponsive, pulseless, not breathing. Q-CPR contraindicated for neonates/pediatrics <8 years or <25 kg.

Regulatory Classification

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.

Predicate Devices

• Philips Medical Systems HeartStart MRx Monitor/Defibrillator (K031187, K051134)
• ZOLL Medical Corp. M Series IBP Option and Temperature Option (K011865)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a stylized font above a circular emblem. The emblem contains a wavy line representing water, with four stars arranged around it. The logo is presented in black and white, with a simple, clean design.

# ILIPS

### 510(k) Summary 4

AUG 1 1 2006

## Date Summary Prepared

June 12, 2006

## Submitter's Name and Address

Philips Medical Systems Ultrasound and Monitoring Business Group Cardiac Systems 3000 Minuteman Road Andover, MA 01810-1099

## Contact Person

Songhua Zhang Regulatory Specialist Philips Medical Systems

Telephone: [phone] Facsimile: [phone] Email: [e-mail]

## Device Name

| Proprietary Name: | HeartStart MRx Invasive Pressure Option and Temperature<br>Option |
|-------------------|----------------------------------------------------------------------|
| Common Name: | Invasive Blood-Pressure Measurement System<br>Electronic Thermometer |

Classification names:

| Classification | ProCode | Description |
|---------------------|---------|----------------------------------------------------|
| 870.5300, Class II | 74 LDD | Low-Energy Defibrillator |
| 870.1025, Class III | 74 MKJ | Defibrillators, Automatic, External |
| 870.5200, Class III | 74 LIX | Cardiopulmonary Resuscitation Aid |
| 870.5550, Class II | 74 DRO | External Transcutaneous Pacemaker<br>(noninvasive) |
| 870.2340, Class II | 74 DPS | Electrocardiograph Device |
| 870.1130, Class II | 74 DXN | Non-Invasive Blood Pressure |
| 868.1400, Class II | 74 CCK | End Tidal Carbon Dioxide |
| 870.2700, Class II | 74 DQA | Pulse Oximeter |
| 870.2300, Class II | 74 MWI | Monitor, Physiological, Patient |
| 870.1110, Class II | 74 DSK | Blood Pressure Computer |
| 880.2910, Class II | 80 FLL | Clinical Electronic Thermometer |

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Image /page/1/Picture/1 description: The image shows the Philips logo. The logo is a shield shape with the word "PHILIPS" at the top. Below the word is a circle containing a stylized image of four stars and three wavy lines. The logo is black and white.

## Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for the HeartStart MRx Invasive Pressure Option and Temperature Option are as follows:

- Philips Medical Systems HeartStart MRx Monitor/Defibrillator K031187, K051134, and t
- ZOLL Medical Corp. M Series IBP Option and Temperature Option K011865 .

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). The HeartStart MRx can also be used for ECG monitoring of a patient, non-invasive external pacing, 12-Lead ECG, non-invasive blood pressure, end-tidal CO2 (EtCO2), pulse oximetry (SpO2), Q-CPR™, invasive pressure and temperature measurements.

## 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
- Adiustable 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
- Trending Store the vital sign trends for physiologic data that are being monitored by the . user
- Cerebral Perfusion Pressure .
- . Pulse rate from SpO2 or Invasive Pressure

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Image /page/2/Picture/1 description: The image shows a logo for Philips. The logo is in black and white and features the word "PHILIPS" at the top. Below the word is a shield-like shape containing a circle with a wavy line across the middle. There are also some small symbols resembling stars or crosses within the circle.

Image /page/2/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The text is black against a white background.

## Intended Use

The Intended use/Indications for Use information is provided in the "Indications for Use Statement" section.

## Comparison of Technology Characteristics

The HeartStart MRx with Invasive Pressure and Temperature Options 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 previous HeartStart MRx. Heart rate alarms, noninvasive pacing, pulse oximetry, 12-Lead ECG, NIBP, EtCO2, Q-CPR™ functions are provided, as in the HeartStart MRx. The HeartStart MRx's Invasive Pressure and Temperature functionalities 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 specifications.

## Conclusion from Testing

Based on the results of the testing described above, it is concluded that the HeartStart MRx with Invasive Pressure and Temperature Options 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/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 1 2006

Philips Medical Systems c/o Mr. Songhua Zhang Regulatory Specialist Ultrasound and Monitoring Business Group Cardiac Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K061707

Trade/Device Name: HeartStart MRx Invasive Pressure Option and Temperature Option Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: June 12, 2006 Received: June 16, 2006

Dear Mr. Zhang:

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 for ase stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies with openaiss. You must that FDA has made a decemination administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other registretion and listing or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not any assesses as set comply with all the Act S requirements, mercessed on any active requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if caplicable, the elect CFR Part 807); labeling (21 CFR Part 001); good and 10 applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 51 - 52 - 32 - 52 - 5 - 5 - 5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 6 - 1 - 6 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 - 5 -I his letter will anow you to ocgin mancemig your antial equivalence of your device to a legally premarket notification. The FDA inding of substanted by 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 advice for your aconso [phone]. Also, please note the regulation entitled, contact the Office of Comphance at (210) 215 - 11 - 11 - 1 - 1 - 1 - 1 - 1 may obtain "Misbranding by relectics to premarket notified.com
other general information on your responsibilities under the Act from the 2000 628, 200 other geleral Information on your responsive Assistance at its toll-free number [phone] or Manufacturers, International and Oolisaner Provinces of Corporation of the Support/index.html.

Sincerely yours,

Blümmerman fr

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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#### Indications for Use Statement 3

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

Device Name: Philips Medical Systems, HeartStart MRx Defibrillator/Monitor

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

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

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

## Noninvasive 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.

## Noninvasive Blood Pressure Monitoring

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

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K06/707

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## Indications for Use - Continued

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

Device Name: Philips Medical Systems, HeartStart MRx Defibrillator/Monitor

## End-tidal CO2

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

## 12-Lead ECG

The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

## Q-CPR

The O-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 that 25 kg).

The Q-CPR option is not for use when CPR is contraindicated.

## Invasive Pressure

The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.

## Temperature

The Temperature option is indicated for measuring temperature in patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2 Page

Blumema

Division of Cardlovascut 510(k) Number

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