Not Found
Unknown
The document mentions an "Inovise Audicor 12-Lead ECG Interpretive Algorithm". While algorithms can be rule-based and not necessarily AI/ML, the term "interpretive algorithm" could potentially encompass AI/ML techniques for ECG analysis. Without further details on the algorithm's implementation, it's impossible to definitively confirm or deny the presence of AI/ML.
Yes
This device performs several therapeutic functions, including manual defibrillation and external transcutaneous pacing, which are direct treatments for cardiac conditions.
Yes
The device performs multiple functions, including ECG monitoring, temperature monitoring, respiration monitoring, CO2 monitoring, invasive pressure monitoring, and 12-lead analysis, all of which acquire and interpret physiological data to aid in diagnosis.
No
The device description explicitly states that the X Series is a "light weight, portable device" that "combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description of the X Series clearly indicates it is a patient monitoring and treatment device. It directly interacts with the patient to measure physiological parameters (ECG, blood pressure, temperature, respiration, CO2, SpO2, invasive pressure) and deliver therapy (defibrillation, pacing).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. All measurements are made directly on or within the patient's body.
Therefore, the X Series falls under the category of a patient monitoring and therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The X Series 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 X Series. The X Series 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 X Series 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 X Series unit 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.
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.). use ZOLL pedirpadz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
Manual Defibrillation
Use of the X Series in the manual mode for external 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.
Semiautomatic Operation (AED)
X Series 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 X Series 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.
Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section "ECG Analysis Algorithm Accuracy" on page A-33.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
ECG Monitoring
The X Series is intended for use to monitor and/or record 3-, 5-, or 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.
CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
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.
- · Pediatric pacing.
Non-Invasive Blood Pressure Monitoring
The X Series 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 X Series 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 X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Respiration Monitoring
The X Series 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 X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate. The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The X Series 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 contraindications 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).
Product codes
MKJ, LDD, LIX, DRT, DRO, DXN, DSK, CCK, DQA
Device Description
The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series 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 X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive 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 (ZOLL X Series) adds the following features:
- Semi-automatic external defibrillation function (AED) Mode .
- CPR rate and depth monitoring .
- See-Thru CPR ECG filtering
- Inovise Audicor 12-Lead ECG Interpretive Algorithm .
- ECG Life Threatening Alarms
- Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring .
- . Oridion microMediCO2 module replaces miniMediCO2 module
- Expanded Data Logging capabilities .
- Wide-format printer option .
- . Wireless Data Transfer
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), Infant, Child, Adolescent, Adult.
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 to 21 years of age.
Adult: 21 years of age or older.
CPR monitoring function not intended for use on patients under 8 years of age.
12-lead ECG Analysis intended for use on adults (> 18 years of age).
Intended User / Care Setting
Trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the device. 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. Also intended to be used during the transport of patients.
SpO2 monitoring: in hospital-type facilities, or in mobile environments.
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)
Performance Testing: Extensive performance testing ensures that the ZOLL X Series 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)
ZOLL Propaq MD (K102468), ZOLL E Series (K072923, K110168, K070455), Inovise Audicor 12-lead Interpretive algorithm (K032145), Masimo Rainbow MX3 module (K100428), Oridion microMediCO2 module (K094012)
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
K112432 pg 1 of 6
MAR 2 1 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:
August 18, 2011
Device:
ZOLL X Series
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
K112432 pg 20f6
Description:
The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series 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 X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive 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 (ZOLL X Series) adds the following features:
- Semi-automatic external defibrillation function (AED) Mode .
- CPR rate and depth monitoring .
- See-Thru CPR ECG filtering
- Inovise Audicor 12-Lead ECG Interpretive Algorithm .
- ECG Life Threatening Alarms
- Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring .
- . Oridion microMediCO2 module replaces miniMediCO2 module
- Expanded Data Logging capabilities .
- Wide-format printer option .
- . Wireless Data Transfer
Indications for Use:
The X Series 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 device. The device 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 devicewill 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 device 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 Patient Subpopulation | Approximate 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 to 21 years of age. |
2
When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedispadz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
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 devicein 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 device is intended for use to monitor and/or record 3-, 5-, or 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:
- . As a standby when standstill or bradycardia might be expected:
- . Suppression of tachycardia.
- Pediatric pacing. .
Non-Invasive Blood Pressure Monitoring
3
The device 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.
4086
Temperature Monitoring
The device 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.
Respiration Monitoring
The device 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 device is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The device 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 contraindications 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 X Series configuration:
Semiautomatic Operation (AED)
The device is 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.
4
transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the device 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.
Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section"ECG Analysis Algorithm Accuracy" on page A-33.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
SpO2 Monitoring
The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.
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:
5
K112432 PS 60f6
The ZOLL X Series is substantially equivalent to the features and functions of the predicate units: ZOLL Propaq MD (K102468), ZOLL E Series (K072923, K110168, K070455), Inovise Audicor 12-lead Interpretive algorithm (K032145), Masimo Rainbow MX3 module (K100428) and Oridion microMediCO2 module (K094012) reviewed and cleared by the FDA.
Comparison of Technological Characteristics
The ZOLL X Series utilizes the same features and functions as the indicated predicate devices: ZOLL Propaq MD (K102468), ZOLL E Series (K072923, K110168, K070455), Inovise Audicor 12-lead Interpretive algorithm (K032145), Masimo Rainbow MX3 module (K100428) and Oridion microMediCO2 module (K094012) reviewed and cleared by the FDA.
Performance Testing:
Extensive performance testing ensures that the ZOLL X Series 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 ZOLL X Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 1 2012
ZOLL Medical Corporation c/o Mr. Charles W. Kolifrath Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824
Re: K112432
Trade/Device Name: ZOLL X Series Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ, LDD, LIX, DRT, DRO, DXN, DSK, CCK, and DQA Dated: February 3, 2012 Received: February 6, 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 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.
7
Page 2 - Mr. Charles W. Kolifrath
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,
fo C
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
l
Enclosure
8
K112432
pg 1 of 4
SECTION 4 - Indications for Use
510(k) Number (if known):
Device Name: X Series
Intended Use:
The X Series 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 X Series. The X Series 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 X Series 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 X Series unit 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 Patient Subpopulation | Approximate 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 to 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 pedirpadz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
Manual Defibrillation
Use of the X Series in the manual mode for external 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.
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 K112432
Page 1 of 4
9
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.
Semiautomatic Operation (AED)
X Series 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 X Series 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.
Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section "ECG Analysis Algorithm Accuracy" on page A-33.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
ECG Monitoring
The X Series is intended for use to monitor and/or record 3-, 5-, or 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.
CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
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:
10
- · Resuscitation from standstill or bradycardia of any etiology:
- · As a standby when standstill or bradycardia might be expected:
- · Suppression of tachycardia.
- · Pediatric pacing.
Non-Invasive Blood Pressure Monitoring
The X Series 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 X Series 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 X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Respiration Monitoring
The X Series 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 X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate. The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The X Series 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 contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.
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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).
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