(28 days)
The ZOLL M Series EtCO2 LoFlo™ Option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in intubated and non-intubated adult, pediatric and infant patients requiring ventilator support, procedural sedation, transport, anesthesia and other clinical vonditions where EtCO, monitoring is deemed appropriate by the attending care giver. The M Series EtCO2 LoFlo™ Option uses nasal and nasal/oral sampling cannulas and sidestream on-airway adapter kits.
The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.
The ZOLL M Series EtCO2 Option with LoFlo™ Sidestream CO2 is a sidestream sampling system using a 50ml/minute low sampling rate to measure the EtCO2 of non-intubated and intubated infant, pediatric and adult patients using specially designed sampling cannulas and on-airway adapter kits.
The LoFlo™ Sidestream CO2 module includes Respironics Novametrix CAPNOII infrared absorption technology. The module is contained in a small plastic enclosure with a short cable that connects to the same M Series connector used by the existing EtCO2 Capnostat 3 sensor. The module uses the same hardware communications interface to the M Series as the existing Capnostat 3 sensor and a slightly expanded software communications protocol.
The provided text describes a 510(k) summary for the ZOLL M Series EtCO2 LoFlo™ Option. It states that "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications" and concludes that "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."
However, the document does not provide specific details on the acceptance criteria (e.g., threshold values for accuracy, precision, etc.) or the detailed results of the performance testing. It also lacks information on the methodology of such a study, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
Therefore,Based on the provided document (K042417), I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them because the document does not contain this specific information.
The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent performance study with specific acceptance criteria and results. The document states:
- "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications."
- "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."
This indicates that internal testing was conducted to ensure the device met its own specifications and to support the substantial equivalence claim. However, the details of these tests, including specific acceptance criteria, reported performance values, sample sizes, and ground truth methodologies, are not included in this 510(k) summary.
Without this specific information in the provided text, I cannot complete the requested table or answer the detailed questions about the study design.
§ 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.