(101 days)
The ZOLL E Series® Defibrillator is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument.
The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
Defibrillator Function: The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Intended Use - Manual Operation: Use of the E 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 these three conditions: Unconsciousness, Absence of breathing, and 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 E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
Intended Use - Semiautomatic Operation (AED): The E Series AED unit 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, 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.
Intended Use - 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 compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
External Pacemaker (Pacer Version Only) Intended Use - Pacemaker: This product may 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: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.
Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including, electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP).
ECG monitoring is performed by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles.
SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients.
12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias.
NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.
The ZOLL E Series® Defibrillator, which was originally reviewed and cleared by the FDA under premarket notification K042007, is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument. The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.
This 510(k) summary (K092598) describes the ZOLL E Series® Defibrillator with an added SpCO/SpMet Option. The device is a multi-parameter monitor and defibrillator, and the new option allows for monitoring of carbon monoxide (SpCO) and oxidized hemoglobin (SpMet) in arterial blood.
The submission claims substantial equivalence to existing devices and technologies. A critical point is that the SpCO/SpMet option is achieved by integrating the "Masimo Rainbow™ SET® technology," which was previously reviewed and cleared by the FDA under 510(k) K061204. This implies that the performance testing for SpCO/SpMet was conducted as part of the Masimo Rainbow™ SET® technology's clearance, and the current submission leverages that prior clearance.
Therefore, for aspects related to SpCO and SpMet monitoring, the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, etc., would primarily be found in the K061204 submission for the Masimo Rainbow™ SET® Radical 7 Pulse CO-Oximeter, rather than in this K092598 summary.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications." However, it does not provide specific numerical acceptance criteria or performance metrics for the new SpCO/SpMet option within this summary. It relies on the prior clearance of the Masimo Rainbow™ SET® technology (K061204).
2. Sample Size Used for the Test Set and Data Provenance:
The provided document (K092598) does not specify the sample size for a test set for the SpCO/SpMet option, nor does it provide data provenance (country of origin, retrospective/prospective). This information would likely be detailed in the supporting documentation for K061204.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).
4. Adjudication Method for the Test Set:
This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned in this submission (K092598) regarding the SpCO/SpMet option. The focus is on integrating an already cleared technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The SpCO/SpMet option is a monitoring device intended to display values to a human user. While the underlying algorithm operates in a standalone manner to generate the SpCO and SpMet values, the device itself is not typically evaluated in the context of "algorithm only without human-in-the-loop performance" in the way an AI diagnostic tool might be. Its performance would be assessed against a gold standard in terms of accuracy of its readings, which implies a standalone performance of the technology. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).
7. The Type of Ground Truth Used:
For pulse co-oximetry devices like those measuring SpCO and SpMet, the ground truth is typically established through measured arterial blood gas (ABG) values analyzed by a laboratory co-oximeter. This is generally considered the "gold standard" for blood gas analysis. This information would have been part of the K061204 submission.
8. The Sample Size for the Training Set:
The provided document (K092598) does not mention a training set or its sample size. The algorithm (Masimo Rainbow™ SET® technology) was already developed and cleared.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in K092598. The ground truth for the development of the Masimo Rainbow™ SET® technology (K061204) would have been established using clinically acquired arterial blood samples analyzed by a laboratory co-oximeter.
§ 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.