(57 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 is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI).
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.
The X Series (reviewed and cleared under K133269 and K133484) 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 ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). The currently marketed ZOLL X Series device (K133269 and K133484) uses the Masimo Rainbow SET technology to offer the SpO2, SpCO and SpMet functionality. With the current application, we are proposing to revise the X Series software to optionally support additional monitoring parameters - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), offered by the Masimo Rainbow SET Technology board that is installed in the currently marketed X Series device (K133269 and K133484).
The provided text describes ZOLL X Series device and its substantial equivalence to predicate devices, particularly concerning new monitoring parameters. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the ZOLL X Series (K142915) is an update to an existing device (K133269 and K133484) to include additional monitoring parameters: Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI), and Perfusion Index (PI). These parameters are enabled by the Masimo Rainbow SET Technology board, which was already installed in the device, through new software and licenses.
The key acceptance criterion is demonstrating substantial equivalence to the predicate device, the Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028), for these new monitoring parameters. The reported performance is that the ZOLL X Series, utilizing the same Masimo Rainbow SET Technology, has the same performance specifications as the predicate device for SpHB, SpOC, PVI, and PI.
| Acceptance Criteria (for new monitoring parameters) | Reported Device Performance (for SpHB, SpOC, PVI, PI) |
|---|---|
| Substantial equivalence to Masimo Radical 7 Pulse CO-Oximeter (K110028) in performance specifications. | X Series and predicate Masimo Radical 7 Pulse CO-Oximeter (K110028) utilize the same Masimo Rainbow SET Technology and therefore have the same performance specifications. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" for the new parameters in the context of a prospective clinical study directly for K142915. Instead, it relies on the performance of the Masimo Rainbow SET Technology, which was already established in the predicate device (K110028).
- Sample Size for Test Set: Not applicable/not explicitly stated for K142915. The evaluation for the new parameters leverages the performance data from the predicate device (Masimo K110028).
- Data Provenance: The performance of the Masimo Rainbow SET Technology board and its software for these parameters was "established and subsequently cleared by the agency under K110028." This implies the original data for K110028 would have included clinical or performance data for these specific parameters. The provenance of that original data (country, retrospective/prospective) is not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The substantial equivalence argument for the new monitoring parameters within K142915 hinges on the fact that the underlying technology and software for these parameters were already cleared under K110028 (Masimo Radical 7 Pulse CO-Oximeter). There is no mention of a new expert panel or ground truth establishment specifically for the K142915 submission regarding these parameters.
4. Adjudication method for the test set
Not applicable. As noted above, the submission relies on previously cleared technology and software.
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
Not applicable. This device is a medical monitoring and defibrillation system, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance of the algorithm (Masimo Rainbow SET Technology software) for the additional parameters (SpHB, SpOC, PVI, PI) was established as part of the clearance for the predicate device, Masimo Radical 7 Pulse CO-Oximeter (K110028). The current submission states that the ZOLL X Series incorporates this same "relevant license and the software code" whose "performance of which was established under K110028." This implies a standalone evaluation of the algorithm's performance for these parameters occurred within K110028.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the original Masimo K110028 clearance related to SpHB, SpOC, PVI, and PI. For physiological monitoring parameters like these, ground truth typically involves a reference standard measurement method (e.g., laboratory blood analysis for hemoglobin, or invasive continuous measurement for pressure/perfusion indices).
8. The sample size for the training set
The document does not provide information about a "training set" for the software in K142915. The evaluation relies on the already established performance of the Masimo Rainbow SET Technology from K110028. If machine learning was involved in the development of the Masimo algorithm, such information would have been part of the K110028 submission, but it's not referenced here for K142915.
9. How the ground truth for the training set was established
Not applicable, as no training set information is provided in this document for the K142915 submission.
§ 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.