(71 days)
The ZOLL E Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The device 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 device is light weight and easy to carry for transport.
Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where 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).
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.
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.
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
The ZOLL E Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The device 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 device is light weight and easy to carry for transport.
The proposed enhancements to the ZOLL E Series are intended to provide personnel trained in its use with improved CPR feedback. The design of the previously approved CPRReadyCharge (K091265) feature has been simplified. The display of the previously approved Real CPR Help (K062177) technology has been enhanced to provide rescuers with feedback data for chest compression depth, rate, and release.
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.
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry. Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated.
The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm).
The pacing output pulse is delivered to the heart by specially designed ZOLL MFE Pads placed on the back and the precordium.
The unique design of the E Series products allow clear viewing and interpretation of the electrocardiogram (ECG) on the display without offset or distortion during external pacing.
The E Series products will defibrillate, cardiovert and monitor ECG using either defibrillation paddles or ZOLL Multi-Function Electrode (MFE) Pads. The pacer version of the E Series paces using ZOLL MFE Pads.
ENERGY SELECT, CHARGE, and SHOCK controls are located on the paddles and front panel. When using MFE Pads, you must use the controls on the front panel of the unit. To switch from paddles to MFE Pads, remove the Multi-Function cable from the apex paddle and connect the MFE pads to the Multi-Function cable.
You cannot activate the Advisory function unless MFE Pads are attached to the Multi-Function Cable and used as the ECG monitoring lead.
Adult and pediatric MFE Pads, and ECG electrodes (not the ECG cable) are disposable, single use items.
The provided text is a 510(k) summary for the ZOLL E Series device, which details its intended use, classification, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain specific information about the acceptance criteria or a dedicated study proving the device meets those criteria, as typically found in clinical performance data sections.
The document mostly focuses on the substantial equivalence of the enhanced CPR feedback and simplified CPRReadyCharge features to previously cleared ZOLL E Series products (K091265, K062177, and K110168). It mentions "Extensive performance testing ensures that the device meets all of its functional requirements and performance specifications" and "Safety testing assures the device complies with applicable sections of recognized industry and safety standards," but it does not elaborate on the details of these tests, including specific acceptance criteria, study designs, sample sizes, or ground truth establishment.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's an attempt to answer based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance and safety testing of the device demonstrates that its features, functions and incorporated ECG advisory processing algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."
However, it does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity for rhythm analysis, accuracy for CPR depth/rate) nor specific reported numerical performance values for these criteria for the device being submitted (K111594). It implicitly relies on the performance of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "Extensive performance testing" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The establishment of ground truth for any performance testing is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The enhancements are primarily related to CPR feedback display and simplification of features, not to diagnostic interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
The document mentions "incorporated ECG advisory processing algorithm" but does not detail any standalone performance study specifically for this algorithm. Its performance is asserted to be "substantially equivalent" to predicate devices. For the CPR monitoring function, it describes the purpose of the feedback ("encourage rescuers to perform chest compressions") rather than providing a standalone accuracy study for depth or rate measurement.
7. Type of Ground Truth Used
This information is not provided in the document.
8. Sample Size for the Training Set
This information is not provided in the document. The document refers to enhancements to existing, FDA-cleared technology, implying incremental changes rather than a new algorithm requiring a large, explicitly defined training set for submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
In summary: The 510(k) summary for ZOLL E Series (K111594) primarily focuses on demonstrating substantial equivalence through technological characteristics and general statements about performance and safety testing. It lacks detailed information on specific acceptance criteria, quantitative performance metrics, study designs (sample sizes, expert involvement, ground truth, adjudication methods) for either testing sets or training sets, which would typically be found in direct performance studies.
§ 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.