(49 days)
Yes
The device description explicitly states that the Airway Confirmation Assist (ACA) function "continuously analyzes the CO2 waveform... to decide if the waveform represents a valid breath" and "based on characteristics of the valid breaths, ACA will decide if the airway is established." This decision-making process based on analyzing data patterns (waveforms) to make a determination aligns with the principles of machine learning or rule-based AI.
Yes
The device is intended for the termination of ventricular tachycardia and ventricular fibrillation, and includes functions such as defibrillation, pacing therapy, and monitoring of vital signs, all of which are therapeutic or support therapeutic interventions for patients.
Yes
The device's "Intended Use / Indications for Use" section explicitly lists functionalities such as "Pulse Oximetry," "Noninvasive Blood Pressure Monitoring," "End-Tidal CO2," "12-Lead ECG," "Invasive Pressures," and "Temperature," all of which are diagnostic measurements. Furthermore, the "12-Lead ECG" function is specifically stated "to provide a conventional diagnostic 12-Lead-ECG report."
No
The device description clearly states it is a "Defibrillator/Monitor" and a "modification of the FDA cleared HeartStart MRx Defibrillator/Monitor," indicating it is a hardware device with added software functionality.
Based on the provided text, the HeartStart MRx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- HeartStart MRx Functionality: The HeartStart MRx is a multi-functional device that primarily focuses on:
- Therapeutic interventions: Defibrillation and pacing.
- Physiological monitoring: Pulse oximetry, blood pressure, EtCO2, ECG, invasive pressures, and temperature.
- CPR feedback: Q-CPR.
- Airway confirmation: Analyzing CO2 waveforms.
None of these functions involve the in vitro examination of specimens taken from the body. The device interacts directly with the patient or monitors physiological signals from the patient.
Therefore, the HeartStart MRx falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for 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 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 the termination of certain atrial and ventricular arrhythmias.
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 the 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 noninvasive monitoring 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 measurement 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).
Invasive Pressures: The Invasive Pressures option is indicated for measuring arterial, venous, intracranial, and other physiological pressures on patients.
Temperature: The Temperature option is indicated for measure temperature in patients.
Product codes
MKJ (LDD, DRO, DPS, DXN, CCK, DQA, MWI, LIX)
Device Description
The Philips HeartStart MRx with Airway Confirmation Assist (ACA) Defibrillator/Monitor is a modification of the FDA cleared HeartStart MRx Defibrillator/Monitor. This function of the MRx used to verify airway placement and aid in assessing ventilatory status when an adult or pediatric patient is being ventilated using an endotracheal or supraglottic airway and the airway is being monitored using capnography. Based on predetermined criteria, Airway Confirmation Assist continuously analyzes the CO2 waveform coming from the capnography monitor to decide if the waveform represents a valid breath. If the Airway Confirmation Assist is enabled in the MRx, and based on characteristics of the valid breaths, ACA will decide if the airway is established. It will then report a Pass/Fail decision to the MRx. The defibrillator/monitor will display the result to the user in the configured format (graphic and text). As an adjunct to clinical examination, ACA provides additional information along with capnography to help in verifying airway placement and aiding in assessment of ventilation status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
HeartStart MRx with Airway Confirmation Assist (ACA) Defibrillator/Monitor: adult or pediatric patient
AED Therapy: at least 8 years of age
Intended User / Care Setting
HeartStart MRx: qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, advanced cardiac life support or defibrillation.
AED Mode: medical personnel trained in basic life support that includes the use of an AED.
Monitor, Manual Defib or Pacer Mode: healthcare professionals trained in advanced cardiac life support.
Setting: hospital and pre-hospital settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SMART Biphasic waveform utilized in the HeartStart MRx has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
In addition to being technologically equivalent to the predicate devices, the HeartStart MRx with Airway Confirmation Assist Defibrillator/Monitor has been subjected to performance and usability testing and it has been determined that the HeartStart MRx with Advanced Airway Confirmation Defibrillator/Monitor is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Philips HeartStart MRx Defibrillator/Monitor (K061707), Oridion Capnostream 20 (K082268), Zoll E Series Defibrillator/Monitor with Intubation Assist Option (K080903)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| 510(k) Summary | MAR 1 2 2013 | |
|---|---|---|
| Submitter: | Philips Medical Systems | |
| 3000 Minuteman Road | ||
| Andover MA, 01810 | ||
| USA | ||
| Contact Person: | Mark Puopolo | |
| Sr. Manager, Regulatory Affairs | ||
| Phone: 978.659.4244 | ||
| Fax: 978.659.3690 | ||
| mark.puopolo@philips.com | ||
| Date Prepared: | January 15, 2013 | |
| Trade Name: | HeartStart MRx with Airway Confirmation Assist | |
| Defibrillator/Monitor | ||
| Common Name: | Automatic External Defibrillator | |
| Classification | ||
| Name: | Automatic External Defibrillator | |
| Predicate Device: | Philips HeartStart MRx Defibrillator/Monitor (K061707) | |
| Oridion Capnostream 20 (K082268) | ||
| Zoll E Series Defibrillator/Monitor with Intubation Assist | ||
| Option (K080903) | ||
| Device | ||
| Description: | The Philips HeartStart MRx with Airway Confirmation Assist | |
| (ACA) Defibrillator/Monitor is a modification of the FDA | ||
| cleared HeartStart MRx Defibrillator/Monitor. This function | ||
| of the MRx used to verify airway placement and aid in | ||
| assessing ventilatory status when an adult or pediatric patient | ||
| is being ventilated using an endotracheal or supraglottic | ||
| airway and the airway is being monitored using capnography. | ||
| Based on predetermined criteria, Airway Confirmation Assist | ||
| continuously analyzes the CO2 waveform coming from the | ||
| capnography monitor to decide if the waveform represents a | ||
| valid breath. If the Airway Confirmation Assist is enabled in | ||
| the MRx, and based on characteristics of the valid breaths, | ||
| ACA will decide if the airway is established. It will then | ||
| report a Pass/Fail decision to the MRx. The | ||
| defibrillator/monitor will display the result to the user in the | ||
| configured format (graphic and text). As an adjunct to clinical |
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K130153 - page 2 of 3
examination, ACA provides additional information along with capnography to help in verifying airway placement and aiding in assessment of ventilation status.
Statement of Intended Use:
The HeartStart MRx is intended for use in the hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, advanced cardiac life support or defibrillation.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart MRx is suitable for use by medical personnel trained in basic life support that includes the use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart MRx is suitable for use by healthcare professionals trained in advanced cardiac life support.
The SMART Biphasic waveform utilized in the HeartStart MRx has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
Summary of Technological Characteristics:
In addition to being technologically equivalent to the predicate devices, the HeartStart MRx with Airway Confirmation Assist Defibrillator/Monitor has been subjected to performance and usability testing and it has been determined that the HeartStart MRx with Advanced Airway Confirmation Defibrillator/Monitor is suitable for its intended use.
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K130153 - page 3 of 3
Summary of Nonclinical Data:
HeartStart MRx with Airway Confirmation Assist Defibrillator/Monitor is manufactured under the same conditions, using the similar processes and identical materials, as the Philips HeartStart MRx Defibrillator/Monitor, the legally marketed Philips Medical Systems predicate device. In addition to being technologically equivalent, the indications for use have not changed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
Mr. Mark Puopolo Sr. Manager, Regulatory Affairs Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
Re: K130153
HeartStartMRx Defibrillator/Monitor Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulation Class: Class III Product Code: MKJ (LDD, DRO, DPS, DXN, CCK, DQA, MWI, LIX) Dated: January 23, 2013 Received: January 24, 2013
Dear Mr. Mark Puopolo:
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
4
Page 2 - Mr. Mark Puopolo
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen Faris -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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Indications for Use
510(k) Number (if known):
Device Name: The HearStart MRx with Advanced Airway Confirmation Defibrillator/Monitor
Indications for 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 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 Jeast 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 the termination of certain atrial and ventricular arrhythmias.
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 the 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 X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Page 1 of 2
n P. Faris -S
6
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black against a white background. The word is the brand name of a multinational conglomerate corporation.
510(k) Number (if known):
Device Name: The HearStart MRx with Advanced Airway Confirmation Defibrillator/Monitor
Indications for Use: [continued ... ]
End-Tidal CO2: 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 function is to provide a conventional diagnostic 12-Lead-ECG report, which may include measurement and interpretative statements.
O-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).
Invasive Pressures: The Invasive Pressures option is indicated for measuring arterial, venous, intracranial, and other physiological pressures on patients.
Temperature: The Temperature option is indicated for measure temperature in patients.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Page 2 of_ 2
Owen P. Faris -S
2013.03.12
13:22:19 -04'00'