What is the regulatory pathway for HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING?

Philips HeartStart XL+ Defibrillator Monitor (K110825); Philips HeartStart MRx Defibrillator/Monitor (K130153); Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903); Zoll R Series with NIBP and ETCO2 Option (K090989).

Who can help prepare an FDA 510(k) submission like HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING

Q: Who is the manufacturer of HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING?

Philips Medical Systems filed the 510(k) submission for HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659).

Q: What is the FDA product code for HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING?

MKJ. It is classified under 21 CFR 870.5310 as a Class 3 device in the Cardiovascular panel.

K133659 · Philips Medical Systems · MKJ · Jan 23, 2015 · Cardiovascular

Device Facts

Record ID	K133659
Device Name	HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
Applicant	Philips Medical Systems
Product Code	MKJ · Cardiovascular
Decision Date	Jan 23, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5310
Device Class	Class 3
Attributes	Therapeutic

Intended Use

The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automated external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.

Device Story

Defibrillator/monitor for hospital use by trained medical personnel; provides AED, manual defibrillation, pacing, and multi-parameter monitoring (ECG, SpO2, NBP, EtCO2). EtCO2 module uses infrared absorption to measure CO2 concentration in exhaled breath; calculates partial pressure of CO2 and derives EtCO2 (peak expiratory CO2) and airway respiration rate (AwRR). Device displays capnogram, numeric EtCO2, and AwRR; triggers alarms for conditions like apnea. Output assists clinicians in assessing respiratory status, CO2 elimination, and O2 delivery. Modification of existing HeartStart XL+ to integrate EtCO2 monitoring.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing and validation of safety and performance standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-4, IEC 60601-1-8, IEC 60601-2-30, IEC 60601-2-27, EN ISO 9919, and EN ISO 21647.

Technological Characteristics

Multi-parameter defibrillator/monitor. Sensing: Infrared absorption for EtCO2, ECG electrodes, SpO2 sensors, NBP cuffs. Connectivity: Integrated monitoring system. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-4 (defibrillators), IEC 60601-1-8 (alarms), IEC 60601-2-30 (NBP), IEC 60601-2-27 (ECG), EN ISO 9919 (SpO2), EN ISO 21647 (respiratory gas).

Indications for Use

Indicated for patients with suspected cardiac arrest (unresponsive, not breathing, pulseless) for AED therapy; pulseless/unresponsive ventricular fibrillation or tachycardia for asynchronous defibrillation; atrial/ventricular arrhythmias for synchronous cardioversion; symptomatic bradycardia for non-invasive pacing; and general monitoring of oxygen saturation (SpO2), arterial blood pressure (NBP), exhaled carbon dioxide (EtCO2), and ECG heart rate/morphology.

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 HeartStart XL+ Defibrillator Monitor (K110825)
Philips HeartStart MRx Defibrillator/Monitor (K130153)
Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903)
Zoll R Series with NIBP and ETCO2 Option (K090989)

Related Devices

K993036 — ZOLL M SERIES ETCO2 OPTION · Zoll Medical Corp · Feb 28, 2000
K080903 — ZOLL E SERIES WITH INTIBATION ASSIST OPTION · ZOLL Medical Corporation · Dec 4, 2008
K062115 — CARBON DIOXIDE MONITOR, MODEL OLG-2800A · Nihon Kohden America, Inc. · Dec 27, 2006
K170820 — Capnograph and Oximeter · Cmi Health, Inc. · Jul 18, 2018
K024300 — MICROCAP PLUS/NPB-75 · Oridion Medical 1987 , Ltd. · Apr 3, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 23, 2015 Philips Medical Systems Carlene Comrie Director, Regulatory Affairs 22100 Bothel Everett Wav Bothel, WA 98021 Re: K133659 Trade/Device Name: HeartStart XL+ Defibrillator/Monitor with End-Tidal CO2 Monitoring Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DRO, MHX, DXN, CCK, DQA Dated: December 19, 2014 Received: December 24, 2014 Dear Carlene Comrie, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Melissa A. Torres -S For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. ## Indications for Use 510(k) Number (if known): K133659 Device Name: HeartStart XL+ Defibrillator/Monitor with End Tidal CO2 Monitoring Indications for Use: The HeartStart XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician. AED Therapy: AED mode is used in the presence of suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. Manual Defribillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation (cardioversion) is indicated for termination of certain atrial and ventricular arrhythmias. Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia. Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level. Non-Invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure. End-Tidal CO2 The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. ECG Monitoring: ECG monitoring is indicated to be used for monitoring, alarming and recording of the patient's heart rate and morphology. | Prescription Use X | AND/OR | Over The Counter Use | |-------------------------------------------------------------------|--------|---------------------------------------------------------------------| | (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) | #### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) Summary | Submitter: | Philips Medical Systems 3000 Minuteman Road Andover MA, 01810 USA | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Carlene Comrie Regulatory Affairs Director Phone: (708)207-1998 Carlene.Comrie@philips.com | | | John Pardo Quality & Regulatory Affairs Director Phone: (978)659-7510 John.Pardo@philips.com | | Date Prepared: | January 22, 2015 | | Trade Name: | HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor | | Common Name: | Automatic External Defibrillator | | Classification Name: | Automatic External Defibrillator | | Classification Regulation: | 21 CFR 870.5310 | | Device Class: | Class III | | Product Code: | MKJ, LDD, DRO, MHX, DXN, CCK, DQA | | Predicate Device: | PhilipsHeartStart XL+ Defibrillator Monitor (K110825) Philips HeartStart MRx Defibrillator/Monitor (K130153) Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903) Zoll R Series with NIBPand ETCO2 Option (K090989) | | Device Description: | The Philips HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor is a modification of the FDA cleared HeartStart XL+ Defibrillator/Monitor. This function of the XL+ modification is to measure the partial | | pressure of carbon dioxide in a sample of the patient's exhaled breath. The HeartStart XL+ may be used to monitor carbon dioxide in both intubated and non-intubated patients. | | | The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide concentration with the ambient pressure. From the partial pressure measurement, the end-tidal carbon dioxide (EtCO2) is derived. | | | EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient's respiratory status. The EtCO2 measurement uses a technique based on the absorption of infrared radiation by some gases. It indicates the change in: | | | · The elimination of CO2. • The delivery of O2 to the lungs. | | | The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR). The AwRR relies onCO2 functionality to identify valid breaths for numeric display and alarm conditions such as Apnea. | | | Statement of Intended Use: | The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. | | When operating as a semi-automated external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. | | | When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support. | | | Statement(s) of Indication for Use: | The HeartStart XL+ is a defibrillator/monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician. | {4}------------------------------------------------ {5}------------------------------------------------ #### AED Therapy AED mode is used in the presence of suspected cardiac arrest on patients 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 (cardioversion) is indicated for termination of certain atrial and ventricular arrhythmias. #### Non-Invasive External Pacing The pacing option is indicated for treating patients with symptomatic bradycardia. ### Pulse Oximetry The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level. #### Non-Invasive Blood Pressure Monitoring The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure. #### End-tidal CO2 The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. #### ECG Monitoring ECG monitoring is indicated to be used for monitoring, alarming and recording of the patient's heart rate and morphology. Summary of Technological Characteristics: In addition to being technologically equivalent to the predicate devices, the HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor has been subjected to performance and usability testing and it has been determined that the HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor suitable for its {6}------------------------------------------------ intended use. #### Summary of Non-Verification and validation activities were completed which included safety and bench testing. HeartStart XL+ with Endclinical Data: Tidal Carbon Dioxide Monitoring Defibrillator/Monitor was tested according to the applicable EMC, safety, performance standards as described below: | Standard | Type | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | IEC 60601-1 Medical Electrical Equipment- Part 1: General Requirements for basic safety and essential performance | Basic Safety and Essential Performance | | IEC 60601-1-2 Medical Electrical Equipment- General Requirements for safety- Collateral standard: Electromagnetic compatibility | Electromagnetic Compatibility | | IEC 60601-2-4 Medical Electrical Equipment- Part 2-4: Particular requirements for basic safety of cardiac defibrillators | Cardiac Defibrillators | | IEC 60601-1-8 Medical electrical equipment: General requirements tests and guidance for alarm systems | Alarms | | IEC 60601-2-30 Medical electrical equipment: Particular requirements for the safety, automatic cycling non-invasive blood pressure monitoring equipment | NBP (Non-Invasive Blood Pressure) | | IEC 60601-2-27 Medical electrical equipment: Particular requirements for the safety, specification for electrocardiographic monitoring equipment | ECG | | EN ISO 9919 Medical electrical equipment Part 2- 27: Particular requirements for the basic safety of pulse | Basic Safety and Essential Performance of Pulse Oximeter Equipment | {7}------------------------------------------------ | | Oximeter equipment. | | | | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|--| | | EN ISO 21647 Medical | Basic Safety of respiratory | | | | | electrical equipment - | gas monitors. | | | | | Particular requirements for | | | | | | the basic safety and essential | | | | | | of respiratory gas monitors | | | | | | The non-clinical testing was completed with passing results according to its Pass/Fail criteria. The Philips HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor is manufactured under the same conditions, using the similar processes and identical materials, as the Philips HeartStart XL+ Defibrillator/Monitor, the legally marketed Philips Medical Systems predicate device. In addition to being technologically equivalent, the indications for use have not changed. | | | | | Clinical Testing: | No clinical studies were necessary to demonstrate substantial equivalence | | | | | Conclusion: | Philips considers that the Philips HeartStart XL+ with End- Tidal Carbon Dioxide Monitoring Defibrillator/Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | | | |