Not Found
No
The document describes a defibrillator with various monitoring functions (ECG, SpO2, EtCO2, NIBP) and a CPR feedback system. There is no mention of AI or ML in the intended use, device description, or performance studies. The CPR feedback is described as providing visual and audio prompts based on recommended rates and depths, which is a rule-based system, not AI/ML.
Yes
Explanation: The device is indicated for defibrillation, synchronized cardioversion, external cardiac pacing, and monitoring of vital signs, all of which are therapeutic interventions or support clinical decision-making for therapeutic actions.
Yes
Explanation: The device is indicated for "multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and transport." It also describes the "advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia", and in "ECG monitoring mode, the unit is intended to be used when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology." These functions indicate that the device collects and analyzes physiological data to determine a medical condition or state, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is an "External Defibrillator" and describes hardware components like a display, electrodes, and capabilities for pacing, monitoring, and printing, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of the ZOLL R Series focuses on external medical interventions and monitoring:
- Defibrillation: Delivering electrical shocks to the heart.
- Pacing: Providing electrical stimulation to the heart.
- Monitoring: Measuring vital signs like SpO2, EtCO2, and NIBP.
- CPR Feedback: Providing guidance on chest compressions.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples from the patient. All its functions are related to external interaction with the patient's body or monitoring physiological parameters directly.
Therefore, the ZOLL R Series, as described, falls under the category of a therapeutic and monitoring medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Defibrillator Function
Intended Use - Manual Operation
Use of the R Series products in the manual 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.
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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
R 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 R 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 section, "ECG Rhythm Analysis Algorithm Accuracy" on page A-29.
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.
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Intended Use - Real CPR Help
The Real CPR Help 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 compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
External Pacemaker (Optional)
Intended Use - Pacemaker
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, quinidine, 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.
Noninvasive pacing can 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 might 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 might prevent tachycardia.
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33 lb. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended.
Intended Use - SpO2 Monitoring
The R Series pulse oximeter, with the Masimo SET technology and the LNCS series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
Intended Use - EtCO2 Monitoring
The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
This option uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece.
The R Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.
The following substances can influence CO2 measurements made with the CAPNOSTAT 5 CO2 sensor:
- · elevated oxygen levels
- · nitrous oxide
- · halogenated agents
The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide compensation. Halogenated anesthetic agents alter CO2 readings, but the R Series unit will monitor CO2 within specifications when these agents are present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias measured carbon dioxide values by up to an additional 3 mmHg.
The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream CO2 Sensor and mainstream airway adapters.
The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Intended Use - NIBP
The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.
The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Product codes
MKJ, CCK, DXN, LDD, LIX, DRT, DRO, DQA
Device Description
The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The design facilitates table top use while still providing a light weight and easy to carry device for transport.
The proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback. The display of the Real CPR Help technology has been modified to provide rescuers with feedback data for chest compression depth, rate, and release. The proposed changes are also intended to support a modified pediatric electrode with a CPR feedback sensor.
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
The ZOLL R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Intended User / Care Setting
The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback.
Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: 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.
R 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.
The unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
The R Series pulse oximeter, with the Masimo SET technology and the LNCS series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
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 R Series performs as well as the indicated predicate device 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)
K110361, K111594, K110978, K110742
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
K120907 pg lof. 5
SEP
2 5 2012
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Charles W. Kolifrath
(978) 421-9786
Date Summary Prepared:
March 23, 2012
Device:
ZOLL R Series® modification to CPR feedback feature and addition of CPR feedback sensor to pediatric electrode
Classification:
Defibrillator, Low-energy - DC (LDD) : Class II (21 CFR 870.5300)
Automatic External Defibrillators (MKJ): Class III (21 CFR 870.5310)
Cardiopulmonary Resuscitation Aid (LIX): Class III (21 CFR 870.5200)
Cardiac Monitors (including Cardiotachometers and Rate Alarms) (DRT): Class II (21CFR 870.2300)
External Transcutaneous Cardiac Pacemakers (Non-invasive) (DRO): Class II (21 CFR 870.5550)
Oximeters (DQA): Class II (21 CFR 870.2700)
System, Measurement, Blood-Pressure, Non-Invasive (DXN): Class II (21 CFR 870.1130)
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK): Class II (21 CFR 868.1400)
Description:
The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical
1
K120907 pg.2015
personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The design facilitates table top use while still providing a light weight and easy to carry device for transport.
The proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback. The display of the Real CPR Help technology has been modified to provide rescuers with feedback data for chest compression depth, rate, and release. The proposed changes are also intended to support a modified pediatric electrode with a CPR feedback sensor.
Indications For Use
Defibrillator Function
Intended Use - Manual Operation
Use of the R Series products in the manual 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.
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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
R 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 R 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 section, "ECG Rhythm Analysis Algorithm Accuracy" on page A-29.
2
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.
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Intended Use - Real CPR Help
The Real CPR Help 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 compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
External Pacemaker (Optional)
Intended Use - Pacemaker
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, quinidine, 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.
Noninvasive pacing can 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 might 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 might prevent tachycardia.
3
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33 lb. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended.
Intended Use - SpO2 Monitoring
The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
Intended Use - EtCO2 Monitoring
The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
This option uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece.
The R Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.
The following substances can influence CO2 measurements made with the CAPNOSTAT 5 CO2 sensor:
- · elevated oxygen levels
- · nitrous oxide
- · halogenated agents
The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide compensation. Halogenated anesthetic agents alter CO2 readings, but the R Series unit will monitor CO2 within specifications when these agents are present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias measured carbon dioxide values by up to an additional 3 mmHg.
The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream CO2 Sensor and mainstream airway adapters.
The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Intended Use - NIBP
The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.
4
K120907 pg 5 of 5
The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Substantial Equivalence:
The features and functions of the proposed ZOLL R Series are substantially equivalent to the currently marketed ZOLL R Series (K110361) cleared for use on March 8, 2011 and the currently marketed ZOLL E Series (K111594) cleared for use on August 17, 2011. The features and functions of the modified pediatric electrode are substantially equivalent to the currently marketed Bio-Detek One-Step Pediatric Electrode (K110978) cleared for use on May 13, 2011 and the currently marketed Bio-Detek One-Step CPR Electrode (K110742) cleared for use on April 13, 2011.
Comparison of Technological Characteristics
The proposed ZOLL R Series features design characteristics and technologies that are very similar to those of the indicated predicate device, and utilizes the same interpretive features and functions as those of the currently marketed ZOLL R Series (K110361).
Performance Testing:
Extensive performance testing ensures that the proposed ZOLL R Series performs as well as the indicated predicate device 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
Performance and safety testing of the proposed ZOLL R Series demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
5
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 25 2012
Zoll Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824
Re: K120907
Trade/Device Name: Zoll R Series Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ. CCK. DXN, LDD, LIX, DRT, DRO, DQA. Dated: September 11, 2012 Received: September 12, 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.
6
Mr. Charles W. Kolifrath
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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/CDRHQffices/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, Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K120907 pg 1 of 3
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): Device Name: ZOLL R Series
Defibrillator Function
Intended Use - Manual Operation
Use of the R Series products in the manual 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.
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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
intention one of one 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 I hey are opomisally accessitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the R 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 section, "ECG Rhythm Analysis Algorithm Accuracy" on page A-29.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must usest and When the patient is less than oryears of ago at all and therapy to determine patient's exact age or weight.
| 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 Evanuation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120807
8
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Intended Use - Real CPR Help
The Real CPR Help 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 compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
External Pacemaker (Optional)
Intended Use - Pacemaker
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, quinidine, 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.
Noninvasive pacing can 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 or the might provide an alternative to transvenous therapy that avoids the risks of puong might provent infection, hemorrhage, embolization, phlebitis, and mechanical ulsplacement, infoction, fromothiage, online in fibrillation associated with endocardial pacing.
· Suppression of tachycardia.
· Ouppression of taonyourdia:
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia.
Pediatric Pacing
Pediative Pacing pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), pediatio hands not the the cause burns. Periodic inspection of the underlying skin is recommended.
Intended Use - SpO2 Monitoring
intended USe — Spoz Monttoning
The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of exterial existen The R Senes pulse oxincer, with the mastinous, noninvasive monitoring of atterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult
saturation (SpO2) and pulse rate during both no motion and patient in a bearite Saturation (Opoz) and paise fate and neonatal patients in a hospital or prehospital environment.
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Intended Use - EtCO2 Monitoring
The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
This option uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece.
The R Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.
The following substances can influence CO2 measurements made with the CAPNOSTAT 5 CO2 sensor:
- · elevated oxygen levels
- nitrous oxide
- · halogenated agents
The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide compensation. Halogenated anesthetic agents alter CO2 readings, but the R Series unit will monitor CO2 within specifications when these agents are present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias measured carbon dioxide values by up to an additional 3 mmHg.
The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream CO2 Sensor and mainstream airway adapters.
The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |
Intended Use - NIBP
The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial I he LOLE I resting patients in critical care and in-hospital transport.
The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table:
| Pediatric 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 | 12-21 years of age |