(165 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 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 compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) 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 LNOP® 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® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance 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. Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. The proposed enhancement to the R Series will provide the user with a simplified user interface. The ZOLL R Series BLS Defibrillator combines an AED operating mode with manual override capability.
The provided text states that "Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications" and that "Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."
However, specific acceptance criteria or detailed results of those performance tests are not explicitly described in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (ZOLL R Series K060559) and lists its intended uses and specifications for various functions (defibrillation, pacing, SpO2 monitoring, CPR monitoring) but it does not contain a table of acceptance criteria and reported performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of specific performance metrics.
Based on the provided text, here's what can be inferred and what information is missing:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: This is not present in the document.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details about specific test sets, sample sizes, or data provenance are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is given.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: The document does not mention an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device has an "ECG Rhythm Analysis Algorithm Accuracy" section mentioned (on page 29, not included here), the details of any standalone performance study for this algorithm are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not specified for any testing done.
- The sample size for the training set: No information on a training set is provided.
- How the ground truth for the training set was established: No information on a training set is provided.
The document only states the following regarding performance testing:
Acceptance Criteria and Reported Device Performance
The document broadly states that the device "meets all of its functional requirements and performance specifications."
The basis for acceptance is stated as "Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."
The Study that Proves the Device Meets Acceptance Criteria:
The document describes "Performance Testing" as:
"Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."
The conclusion drawn from this testing is:
"Testing of the R Series Defibrillator with BLS Option demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness."
This suggests that the "study" was primarily functional testing to ensure that the new device, as a modification of a previously cleared predicate (K060559), did not degrade existing performance and maintained substantial equivalence. Specific details of this "extensive performance testing" are not provided in this 510(k) summary. It references "Specifications for the ECG rhythm analysis function are provided in this section, 'ECG Rhythm Analysis Algorithm Accuracy' on page 29," which implies more specific data exists but is not included in this extract.
§ 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.