Not Found
No
The document describes a multi-functional vital signs monitor and defibrillator with added features like an AED mode and a 12-lead ECG interpretive algorithm. While the 12-lead analysis involves interpretation, the description does not mention AI or ML, and the device description focuses on standard medical device functions and algorithms.
Yes
The device includes therapeutic functions such as manual and semi-automatic defibrillation, and external transcutaneous pacing, which are used to treat cardiac conditions.
Yes
The device performs various monitoring functions, such as ECG monitoring, Non-Invasive Blood Pressure Monitoring, Temperature Monitoring, SpO2 Monitoring, Respiration Monitoring, CO2 Monitoring, Invasive Pressure Monitoring, and 12-Lead Analysis, all of which are used to gather data and assess a patient's medical condition. The 12-lead ECG Analysis specifically states it is "intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers." These functions clearly fall under the definition of diagnostic activities.
No
The device description explicitly states that the Propaq MD is a "light weight, portable device" that "combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor." These are all hardware components, indicating it is not a software-only device. The submission describes adding "additional software features" to an existing hardware device.
Based on the provided text, the Propaq MD 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.
- Propaq MD Functionality: The Propaq MD is a multi-functional device that directly monitors physiological parameters of the patient in vivo (within the living body). Its functions include:
- ECG Monitoring
- Manual and Semiautomatic Defibrillation
- External Transcutaneous Pacing
- Non-Invasive Blood Pressure Monitoring
- Temperature Monitoring
- SpO2 Monitoring
- Respiration Monitoring
- CO2 Monitoring
- Invasive Pressure Monitoring
- 12-Lead Analysis (analyzing ECG data acquired directly from the patient)
None of these functions involve the examination of specimens taken from the body. The device interacts directly with the patient to acquire data.
Therefore, the Propaq MD falls under the category of a medical device used for monitoring, treatment, and diagnosis based on direct physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care and the use of the Propag MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
- Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.
- Semiautomatic Operation (AED): The Propaq MD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the Propaq MD in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.
- ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3, 5, 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.
- External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.
- Non-Invasive Blood Pressure Monitoring: The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user.
- Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.
- SpO2 Monitoring: The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user.
- Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator.
- CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
- Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring.
- 12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.
Product codes (comma separated list FDA assigned to the subject device)
MKJ, LIX, LDD, DRT, DRO, DXN, DSK, CCK, DQA
Device Description
The ZOLL Propaq MD device (reviewed and cleared by the agency under application K100654) is being revised with additional software features. The Propaq MD is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the Propaq MD combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application.
Additionally, the proposed configuration adds the following features:
- Semi-automatic external defibrillation function (AED) Mode .
- . Inovise Audicor 12-Lead ECG Interpretive Algorithm
- ECG Life Threatening Alarms .
- Expanded Data Logging capabilities .
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
Newborn (neonate) (Birth to 1 month of age), Infant (1 month to 2 years of age), Child (2 to 12 years of age), Adolescent (12-21 years of age), Adult (21 years of age or older).
For 12-Lead Analysis: Adults (> 18 years of age).
Intended User / Care Setting
Trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. Physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. Usage may be in an ambulance or at the scene of an emergency and during the transport of patients.
For Semiautomatic Operation (AED): Emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
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)
Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
APR 2 5 2012
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Chuck Kolifrath (978) 421-9786
Date Summary Prepared:
September 16, 2011
Device:
ZOLL Propaq MD
Classification: Class III
Automated External Defibrillators (MKJ) Cardiopulmonary Resuscitation Aid (LIX) Low-Energy - Defibrillators (LDD) Cardiac Monitors - including Cardiotachometer and Rate Alarms (DRT) External Transcutaneous Cardiac Non-Invasive Pacemaker (DRO) Noninvasive Blood Pressure Measurement System (DXN) Blood Pressure Computer (DSK) Carbon Dioxide Gas Analyzer (CCK) Oximeter (DQA)
1
Description:
The ZOLL Propaq MD device (reviewed and cleared by the agency under application K100654) is being revised with additional software features. The Propaq MD is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the Propaq MD combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application.
Additionally, the proposed configuration adds the following features:
- Semi-automatic external defibrillation function (AED) Mode .
- . Inovise Audicor 12-Lead ECG Interpretive Algorithm
- ECG Life Threatening Alarms .
- Expanded Data Logging capabilities .
Indications for Use:
The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care and the use of the Propag MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
| Pediatric Subpopulation | Approx. Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedi padz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
2
The following indications for use are identical to the previous configuration of the Propaq MD (reviewed and cleared by the FDA under application K100654):
Manual Defibrillation
Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- . Unconsciousness
- Absence of breathing .
- Absence of pulse. .
This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.
The patient population will range from newborn (neonate) to adult.
ECG Monitoring
The Propaq MD is intended for use to monitor and/or record 3, 5, 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
External Transcutaneous Pacing
This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any etiology: .
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidline, digitalis, b- blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes- Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.
As a standby when standstill or bradycardia might be expected:
3
Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction. drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
Suppression of tachycardia: .
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
Pediatric Pacing: .
Pacing can be performed on pediatric patients weighing 33 lbs. (15kg) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.
Non-Invasive Blood Pressure Monitoring
The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.
Temperature Monitoring
The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The patient population will range from newborn (neonate) to adult.
SpO2 Monitoring
The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. The patient population will range from newborn (neonate) to adult.
4
Respiration Monitoring
The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The patient population will range from newborn (neonate) to adult.
CO2 Monitoring
The Propaq MD is intended for use to make continuous noninyasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contra-indications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
The following indications for use represent additional features being added in the proposed Propaq MD configuration:
Semiautomatic Operation (AED)
The Propaq MD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the Propaq MD in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- · Unconsciousness.
- · Absence of breathing.
- · Absence of pulse.
5
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).
Substantial Equivalence:
The proposed ZOLL Propaq MD is substantially equivalent to the features and functions of the predicate units: ZOLL Propaq MD (K100654), ZOLL E Series (K072923) and Inovise Audicor 12-lead Interpretive algorithm (K032145).
Comparison of Technological Characteristics
The proposed ZOLL Propaq MD utilizes the same features and functions as the indicated predicate devices: ZOLL Propaq MD (K100654), ZOLL E Series (K072923) and Inovise Audicor 12-lead Interpretive algorithm (K032145).
Performance Testing:
Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
Conclusion
The information provided in this 510(k) demonstrates that the features and functions of the proposed ZOLL Propaq MD are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 5 2012
Zoll Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824
Re: K112761
Trade/Device Name: ZOLL Propaq MD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LIX, LDD, DRT, DRO, DXN, DSK, CCK, and DQA Dated: April 20, 2012 Received: April 23, 2012
Dear Mr. Kolifrath:
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
7
Page 2 - Mr. Charles W. Kolifrath
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-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.
R. Zukerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Propaq MD
Intended Use:
The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care and the use of the Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
| Pediatric Subpopulation | Approx. Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedi padz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
Manual Defibrillation
·
Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- Unconsciousness .
- Absence of breathing .
- Absence of pulse. ●
This product should be used only by qualified medical personnel for converting ventricular
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K112761 |
|---|---|
| --------------- | --------- |
Page 1 of 4
9
fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.
The patient population will range from newborn (neonate) to adult.
Semiautomatic Operation (AED)
The Propaq MD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the Propaq MD in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- · Unconsciousness.
- · Absence of breathing.
- Absence of pulse.
When the patient is less than 8 years of age or weighs less that 55 Ibs. (25 Kg), use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
ECG Monitoring
The Propag MD is intended for use to monitor and/or record 3, 5, 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.
External Transcutaneous Pacing
This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
· Resuscitation from standstill or bradycardia of any etiology:
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidline, digitalis, bblockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes- Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an
10
emergency than endocardial or other temporary electrodes.
· As a standby when standstill or bradycardia might be expected:
Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, . perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
· Suppression of tachycardia:
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
· Pediatric Pacing:
Pacing can be performed on pediatric patients weighing 33 Ibs. (15kg) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.
Non-Invasive Blood Pressure Monitoring
The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.
Temperature Monitoring
The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The patient population will range from newborn (neonate) to adult.
Sp02 Monitoring
The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar i hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. The patient population will range from newborn (neonate) to adult.
11
Respiration Monitoring
The Propag MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The patient population will range from newborn (neonate) to adult.
CO2 Monitoring
The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. The patient population will range from newborn (neonate) to adult. .
Invasive Pressure Monitoring
The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contra-indications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis is intended for use on adults (> 18 years of age).