(183 days)
Use of the R 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:
- · 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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
R 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 R 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.
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
The Real CPR Help 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 in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
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.
The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.
The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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 design facilitates table top use while still providing a light weight and easy to carry device for transport.
The proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback. The display of the Real CPR Help technology has been modified to provide rescuers with feedback data for chest compression depth, rate, and release. The proposed changes are also intended to support a modified pediatric electrode with a CPR feedback sensor.
The ZOLL R Series external defibrillator with modifications to its CPR feedback feature and the addition of a CPR feedback sensor to pediatric electrodes.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state numerical acceptance criteria for the modified CPR feedback feature or the pediatric electrode with the CPR feedback sensor. Instead, it refers to:
- AHA/ERC recommended rate of 100 compressions per minute.
- AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients for compression depth.
The document states that the "Real CPR Help 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 in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients." This implies that the device's performance aligns with these recommendations by providing appropriate feedback to guide users to meet them.
Without explicit numerical acceptance criteria, a table cannot be fully constructed. However, if we infer the acceptance criteria from the intended function, it would be:
| Feature/Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Chest Compression Rate Feedback | Encourage 100 compressions per minute (AHA/ERC recommended) | Provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. |
| Chest Compression Depth Feedback | Encourage ≥ 2 inches (5 cm) for adult patients (AHA/ERC recommended) | Provides voice and visual prompts to encourage a compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients. |
| Release Feedback | Provide feedback on chest compression release. | Provides feedback data for chest compression release. |
| Pediatric Electrode Function | Support CPR feedback sensor (implied to be accurate and functional) | Supports a modified pediatric electrode with a CPR feedback sensor. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Extensive performance testing ensures that the proposed ZOLL R Series performs as well as the indicated predicate device 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."
No specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is provided for the CPR feedback modifications or the pediatric electrode. The testing seems to be internal performance and safety testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. The document refers to compliance with "recognized industry and safety standards" and the device's ability to drive users toward "AHA/ERC recommendations," but it does not detail a process for establishing ground truth via experts for the performance of the CPR feedback mechanism itself during testing.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned. The testing described is general performance and safety testing, not a clinical study requiring adjudication of expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The document focuses on the device's functionality and its ability to guide users to follow established guidelines, not on a comparison of human reader performance with or without AI assistance. This device is not an AI-assisted diagnostic tool in the sense of image analysis.
6. Standalone (Algorithm Only) Performance Study:
The document implies a standalone performance for the CPR feedback algorithm in that it states the algorithm "provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate." This suggests the algorithm itself was tested to ensure its feedback mechanism is accurate and effective in guiding compressions to the specified rates and depths. However, no specific standalone study details (e.g., methodology, specific metrics, results in isolation from a human user) are provided.
7. Type of Ground Truth Used (for CPR feedback):
The implied ground truth for the CPR feedback mechanism is based on established medical guidelines and recommendations:
- AHA/ERC recommended chest compression rate (100 bpm).
- AHA/ERC recommended chest compression depth (≥ 2 inches / 5 cm for adults).
The device is designed to provide feedback to help rescuers achieve these established standards.
8. Sample Size for the Training Set:
This information is not applicable or provided. The CPR feedback feature appears to be based on an algorithm that monitors physical parameters (rate, depth, release) and provides feedback based on pre-defined thresholds derived from medical guidelines, rather than being trained on a large dataset like a machine learning model for diagnosis.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided. As above, the device's functionality seems to stem from a rules-based system implementing established medical guidelines, not from a machine learning training process that requires a dedicated training set with established ground truth.
§ 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.