(210 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.
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).
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.
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 and 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.
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 ZOLL X Series Defibrillator/Monitor cleared under 510k application K112432 is a light weight, 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 monitor (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). X Series software has been revised to support the OneStep Pediatric CPR Electrode. This electrode was previously cleared for use with the ZOLL R Series (K120907). As in the R Series, the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" from the Indications For Use for CPR Monitoring currently cleared for the X Series (K112432).
The ZOLL X Series Defibrillator/Monitor (K133269) received 510(k) clearance based on its substantial equivalence to predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907). The modification primarily involved a software revision to support the OneStep Pediatric CPR Electrode for pediatric CPR monitoring. The submission did not include a traditional study with acceptance criteria and reported device performance metrics in the typical sense of a diagnostic or predictive AI algorithm.
Instead, the acceptance criteria are implicitly tied to demonstrating that the modified device performs as well as the predicate devices and meets its functional and performance specifications, especially concerning the new pediatric CPR monitoring feature.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a modification to an existing device, the "acceptance criteria" are not presented as specific performance metrics and thresholds (e.g., sensitivity, specificity) but rather as compliance with existing safety and performance standards, and comparison to predicate devices. The document explicitly states: "Extensive performance testing in the software verification and system level validation 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."
Therefore, a table of specific quantitative acceptance criteria and reported device performance values cannot be constructed from the provided text in the way one would for a diagnostic AI. The acceptance criteria essentially were:
| Feature/Function | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Device Performance and Safety | The device performs as well as the indicated predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907) and meets all its functional requirements and performance specifications. The device complies with applicable sections of recognized industry and safety standards. | "Extensive performance testing in the software verification and system level validation 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." (Direct quote from the document, page 5) This statement serves as the reported performance, indicating successful fulfillment of the criteria. |
| CPR Monitoring Function (Pediatric Patients) | The revised software enables the X Series device to provide CPR monitoring for Pediatric patients using the OneStep Pediatric CPR Electrode, as previously cleared for the ZOLL R Series (K120907). The contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" is removed from the Indications For Use. The device should provide CPR timing and numeric display of actual rate and depth of chest compressions for pediatric patients, equivalent to the R Series. | "Support for the CPR monitoring feature of the OneStep Pediatric CPR Electrode is added through a software revision. As in the R Series (K120907), the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication 'The CPR monitoring function is not intended for use on patients under 8 years of age'..." (page 1) "As in the R Series (K120907), the electrode will enable the X Series device to provide pediatric CPR monitoring information specifically, the CPR timer and the numeric display of the actual rate and depth of chest compression." (page 5) |
| Substantial Equivalence to Predicate Devices | The device's features and functions are substantially equivalent to the predicate devices. | "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." (Page 5) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the modified pediatric CPR monitoring algorithm. Instead, the assessment relies on software verification and system-level validation. This implies engineering tests rather than a cohort of patient data.
- Sample Size for Test Set: Not applicable/not specified as clinical test data in the provided document.
- Data Provenance: Not applicable, as no clinical test data for the specific modification is detailed. The assessment was based on engineering and validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission is based on engineering verification, system-level validation, and comparison to predicate devices. There is no mention of a test set requiring expert-established ground truth in the context of diagnostic performance for the new feature or the overall device.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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 MRMC comparative effectiveness study was mentioned. The device provides CPR monitoring feedback; it is not described as an AI system assisting human readers in interpreting clinical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device's CPR monitoring function provides automated feedback (rate and depth) but operates with a human rescuer in the loop. The document doesn't describe a "standalone algorithm" performance study in the absence of human interaction. The functions described are inherent to the device and its sensors, providing real-time data to the user.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the pediatric CPR monitoring feature, the "ground truth" would implicitly be the physical measurements of chest compression rate and depth, compared against the AHA/ERC recommended targets (e.g., 100 compressions per minute, 1.5-2.0 inches depth). This "truth" is established by physical measurement standards rather than expert clinical consensus or pathology. The document, however, does not detail the specific methodology for verifying the accuracy of these measurements. It states that "performance testing" and "software verification and system level validation" were performed.
8. The Sample Size for the Training Set
Not applicable. The document describes a software revision for a medical device. There is no mention of a "training set" for a machine learning or AI algorithm in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning or AI algorithm is mentioned.
§ 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.