(422 days)
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.
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.
The provided document is a 510(k) summary for the Philips HeartStart XL+ Defibrillator/Monitor with End-Tidal CO2 Monitoring. It describes the device and its intended uses, but it does not contain a study or acceptance criteria related to a specific AI algorithm's performance in a diagnostic or predictive capacity.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards for the overall defibrillator/monitor device, not a specific AI component or a study proving its AI components meet acceptance criteria.
Therefore, many of the requested elements about an AI study cannot be extracted from this document, as it doesn't describe such a study.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document lists various IEC and EN ISO standards that the device was tested against. The "reported device performance" is a general statement that "The non-clinical testing was completed with passing results according to its Pass/Fail criteria." Specific numerical performance metrics against acceptance criteria for each standard are not detailed in this summary.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 Medical Electrical Equipment- Part 1: General Requirements for basic safety and essential performance | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-1-2 Medical Electrical Equipment- General Requirements for safety- Collateral standard: Electromagnetic compatibility | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-4 Medical Electrical Equipment- Part 2-4: Particular requirements for basic safety of cardiac defibrillators | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-1-8 Medical electrical equipment: General requirements tests and guidance for alarm systems | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-30 Medical electrical equipment: Particular requirements for the safety, automatic cycling non-invasive blood pressure monitoring equipment | "Completed with passing results according to its Pass/Fail criteria." |
| IEC 60601-2-27 Medical electrical equipment: Particular requirements for the safety, specification for electrocardiographic monitoring equipment | "Completed with passing results according to its Pass/Fail criteria." |
| EN ISO 9919 Medical electrical equipment Part 2-27: Particular requirements for the basic safety of pulse Oximeter equipment. | "Completed with passing results according to its Pass/Fail criteria." |
| EN ISO 21647 Medical electrical equipment - Particular requirements for the basic safety and essential of respiratory gas monitors | "Completed with passing results according to its Pass/Fail criteria." |
Regarding the device's End-Tidal CO2 function, the document describes its mechanism rather than performance metrics:
- "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."
- "The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR)."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states, "No clinical studies were necessary to demonstrate substantial equivalence." The testing mentioned is non-clinical (bench testing) against standards. There is no test set of patient data described for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical studies or ground truth establishment by experts are described for an AI component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
5. 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. The document explicitly states: "No clinical studies were necessary to demonstrate substantial equivalence." There is no mention of an MRMC study or AI assistance for human readers. The device itself (HeartStart XL+ Defibrillator/Monitor) is the subject, not an AI component assisting human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. The device is a "Defibrillator/Monitor" intended for use by "qualified medical personnel." It's an integrated medical device, not a standalone AI algorithm being evaluated for human-in-the-loop or standalone performance. The document describes the technical function of CO2 monitoring, which is a physical measurement, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided.
8. The sample size for the training set
- Not applicable / Not provided.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
{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 Systems3000 Minuteman RoadAndover MA, 01810USA |
|---|---|
| Contact Person: | Carlene ComrieRegulatory Affairs DirectorPhone: (708)207-1998Carlene.Comrie@philips.com |
| John PardoQuality & Regulatory Affairs DirectorPhone: (978)659-7510John.Pardo@philips.com | |
| Date Prepared: | January 22, 2015 |
| Trade Name: | HeartStart XL+ with End-Tidal Carbon Dioxide MonitoringDefibrillator/Monitor |
| Common Name: | Automatic External Defibrillator |
| ClassificationName: | Automatic External Defibrillator |
| ClassificationRegulation: | 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 AssistOption (K080903)Zoll R Series with NIBPand ETCO2 Option (K090989) |
| DeviceDescription: | The Philips HeartStart XL+ with End-Tidal Carbon DioxideMonitoring Defibrillator/Monitor is a modification of theFDA cleared HeartStart XL+ Defibrillator/Monitor. Thisfunction of the XL+ modification is to measure the partial |
| pressure of carbon dioxide in a sample of the patient's exhaledbreath. The HeartStart XL+ may be used to monitor carbondioxide in both intubated and non-intubated patients. | |
| The partial pressure of carbon dioxide is derived bymultiplying the measured carbon dioxideconcentration with the ambient pressure. From the partialpressure measurement, the end-tidal carbon dioxide (EtCO2)is derived. | |
| EtCO2 is the peak CO2 value measured during expiration. Itis used to monitor the patient's respiratory status. The EtCO2measurement uses a technique based on the absorption ofinfrared 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+ providesan EtCO2 value, a CO2 waveform(Capnogram), and an airway respiration rate (AwRR). TheAwRR relies onCO2 functionality to identify valid breaths fornumeric display and alarm conditions such as Apnea. | |
| Statement ofIntended Use: | The HeartStart XL+ is intended for use in a hospital setting byqualified medical personnel trained in the operation of thedevice and qualified by training in basic life support,advanced life support or defibrillation. |
| When operating as a semi-automated external defibrillator inAED Mode, the HeartStart XL+ is suitable for use by medicalpersonnel trained in basic life support that includes the use ofan AED. | |
| When operating in Monitor, Manual Defibrillation or Pacingmodes, the HeartStart XL+ is suitable for use by healthcareprofessionals trained in advance life support. | |
| Statement(s) ofIndication for Use: | The HeartStart XL+ is a defibrillator/monitor. The device isfor use by qualified medical personnel trained in the operationof the device and certified by training in basic life support,advanced life support or defibrillation. It must be used by oron 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 MedicalElectrical Equipment- Part1: General Requirements forbasic safety and essentialperformance | Basic Safety and EssentialPerformance |
| IEC 60601-1-2 MedicalElectrical Equipment-General Requirements forsafety- Collateral standard:Electromagneticcompatibility | ElectromagneticCompatibility |
| IEC 60601-2-4 MedicalElectrical Equipment- Part2-4: Particular requirementsfor basic safety of cardiacdefibrillators | Cardiac Defibrillators |
| IEC 60601-1-8 Medicalelectrical equipment:General requirements testsand guidance for alarmsystems | Alarms |
| IEC 60601-2-30 Medicalelectrical equipment:Particular requirements forthe safety, automatic cyclingnon-invasive blood pressuremonitoring equipment | NBP (Non-Invasive BloodPressure) |
| IEC 60601-2-27 Medicalelectrical equipment:Particular requirements forthe safety, specification forelectrocardiographicmonitoring equipment | ECG |
| EN ISO 9919 Medicalelectrical equipment Part 2-27: Particular requirementsfor the basic safety of pulse | Basic Safety and EssentialPerformance of PulseOximeter 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 resultsaccording to its Pass/Fail criteria. The Philips HeartStart XL+with End-Tidal Carbon Dioxide MonitoringDefibrillator/Monitor is manufactured under the sameconditions, using the similar processes and identical materials,as the Philips HeartStart XL+ Defibrillator/Monitor, thelegally marketed Philips Medical Systems predicate device. Inaddition to being technologically equivalent, the indicationsfor use have not changed. | ||||
| Clinical Testing: | No clinical studies were necessary to demonstrate substantialequivalence | |||
| Conclusion: | Philips considers that the Philips HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor to beas safe, as effective, and performance is substantiallyequivalent to the predicate device(s). |
§ 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.