(261 days)
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.
Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.
Semiautomatic Operation (AED): 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.
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.
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.
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.
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 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.
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.
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.
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.
Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.
The X Series (reviewed and cleared with K112432 on 03/21/2012) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECC, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). With the current application we are proposing to revise the X Series software to support Web Console functionality which will allow remote personnel to view the content of one or multiple (up to forty) X Series device screens. Users of the new Web Console features can only view the data on monitors remotely, and cannot operate the X Series device, silence device alarms, or initiate any patient treatment remotely - this can only be done directly on the device, at the patient's bedside.
The provided text is a 510(k) summary for the ZOLL X Series medical device, focusing on an update that adds "Web Console functionality." It does not contain information about acceptance criteria, device performance, or a study specifically proving the device meets acceptance criteria for its primary functions (defibrillation, monitoring, pacing, etc.). Instead, the document assesses the substantial equivalence of the new Web Console functionality to a predicate device.
However, I can extract information related to the demonstration of substantial equivalence for the new Web Console functionality.
Here's a breakdown based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific acceptance criteria or quantitative performance metrics for the Web Console functionality. It states that "Safety, efficacy and substantial equivalence was shown through software verification and system level validation." The basis for substantial equivalence is that the new functionality cannot control the connected devices, silence alarms, or initiate patient treatment remotely, which aligns it with the functions of the predicate device (ZOLL RescueNet Link K111296).
| Acceptance Criteria (Implied for Web Console) | Reported Device Performance (Implied for Web Console) |
|---|---|
| Ability to remotely view physiological data available on a connected X Series device. | "Web Console functionality allows medical personnel to view physiological data available on a connected X Series device." and "Users of the new Web Console features can only view the data on monitors remotely...". This is achieved by displaying data consolidated on an embedded webpage requested by a web browser via an Ethernet connection. |
| Inability for remote personnel to operate the X Series device, silence device alarms, or initiate any patient treatment remotely. This is a critical safety criterion for substantial equivalence. | "Users of the new Web Console features can only view the data on monitors remotely, and cannot operate the X Series device, silence device alarms, or initiate any patient treatment remotely - this can only be done directly on the device, at the patient's bedside." This limitation is explicitly stated and forms the basis of substantial equivalence to the predicate. |
| Performance of the Web Console functionality must be equivalent to the predicate device (ZOLL RescueNet Link K111296) in terms of data collection and display. | "The proposed Web Console functionality and predicate RescueNet Link (K111296) both collect and display data that is entered by the user (caregiver), or captured from the devices to which they are connected." "Safety, efficacy and substantial equivalence was shown through software verification and system level validation." |
Study Information for Web Console Functionality:
The document describes the assessment for the new Web Console functionality rather than the entire X Series device's core functions.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "software verification and system level validation" and "performance testing" but does not provide details on the number of cases or data points used in these tests for the Web Console functionality.
- Data Provenance: Not specified. The tests would likely involve simulated or real X Series device data, but the origin (e.g., country, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The assessment for the Web Console functionality does not appear to involve establishing ground truth through expert review in the way a diagnostic AI might. The focus is on verifying its ability to display data and its inability to control the device remotely.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of adjudication method is typically used for clinical trials involving human interpretation of medical images or data, which is not the nature of the assessment described for the Web Console functionality.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not done. The Web Console functionality is for viewing data, not for interpretation or diagnosis by AI affecting human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "software verification and system level validation" and "performance testing" are evaluations of the algorithm/software functionality itself. However, it's not a standalone diagnostic algorithm that makes decisions. It's a viewer. The crucial "standalone" aspect here is that the Web Console cannot operate the X Series remotely, confirming its role as a viewer only.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly defined in terms of clinical ground truth. For the Web Console, the "truth" would be whether it accurately displays the data transmitted from the X Series device and whether it correctly prevents remote control actions. This is verified through "software verification and system level validation" against functional requirements and specifications.
8. The sample size for the training set:
- Not applicable. The Web Console is a software update for viewing data, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this functionality.
§ 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.