(422 days)
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No
The document describes standard physiological monitoring and defibrillation functions. There is no mention of AI, ML, or any advanced algorithms that would typically be associated with these technologies. The description of the EtCO2 measurement is based on infrared absorption, a well-established physical principle.
Yes.
The device performs therapeutic actions such as defibrillation, cardioversion, and non-invasive external pacing, which are treatments for specific medical conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly lists several diagnostic functions such as "Pulse Oximetry," "Non-Invasive Blood Pressure Monitoring," "End-Tidal CO2," and "ECG Monitoring," all of which are used to assess a patient's physiological state. The "Device Description" also details the CO2 monitoring function (EtCO2, Capnogram, AwRR) which is used to monitor respiratory status.
No
The device is described as a defibrillator/monitor with various hardware components and functions (defibrillation, pacing, SpO2, NBP, EtCO2, ECG monitoring). The description focuses on the physical device and its measurement techniques, not solely on software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The HeartStart XL+ is a defibrillator/monitor with various physiological monitoring capabilities (ECG, NBP, SpO2, EtCO2). These functions involve direct interaction with the patient's body or monitoring of exhaled breath, not the analysis of samples taken from the body.
- Intended Use: The intended use describes therapeutic interventions (defibrillation, pacing) and direct physiological monitoring.
- Device Description: The description focuses on how the device measures physiological parameters like CO2 in exhaled breath, not on analyzing biological samples.
The device is a medical device used for patient monitoring and therapy, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MKJ, LDD, DRO, MHX, DXN, CCK, DQA
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 on CO2 functionality to identify valid breaths for numeric display and alarm conditions such as Apnea.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-verification and validation activities were completed which included safety and bench testing. HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor was tested according to the applicable EMC, safety, performance standards as described. The non-clinical testing was completed with passing results according to its Pass/Fail criteria. No clinical studies were necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
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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)
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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. |
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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
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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 |
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| 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). |