(150 days)
The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube.
The set is intended for single patient use only.
The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set:
- sampling line .
- airway adapter with tube and luer connected. .
The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine.
The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.
This document describes the Carinal VitaLine™ Set, an accessory for capnographs designed to measure CO2 in intubated neonates and infants. The submission focuses on demonstrating substantial equivalence to a predicate device, the Microstream FilterLine ICU (K980327).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail thresholds in this document for each performance characteristic. Instead, the document presents a comparison of the Carinal VitaLine™ Set's performance characteristics against the predicate device's characteristics to demonstrate similarity and thus substantial equivalence.
| Feature | Predicate Device (Microstream FilterLine ICU - K980327) | Carinal VitaLine™ Set Performance |
|---|---|---|
| Rise time | 215 mSec | 240-280 mSec |
| Pressure Drop | 35 mbar Max @ 50ml/min | 33±6 mBar at 50 mL/min |
| Delay Time | 2.7 Sec typical @ 50ml/min | 2.8 Sec @ 50mL/min |
| Tensile Strength | ≥2kg @30 cm/min | ≥2kg @30 cm/min |
2. Sample Sizes and Data Provenance
The document states that bench tests were performed. It does not provide specific sample sizes (e.g., number of units tested) for each bench test. The data provenance is implied to be from internal testing conducted by Oridion Medical 1987 Ltd., based in Jerusalem, Israel. The study type is retrospective, as it involves testing a developed product to compare its performance against a predicate.
3. Number of Experts and Qualifications
This submission does not involve human readers or experts for establishing ground truth, as it is a technical performance comparison of a medical device accessory through bench testing.
4. Adjudication Method
Not applicable, as this is a technical performance comparison of a medical device accessory through bench testing, not a study involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is a capnograph accessory, and the study focuses on its technical performance characteristics rather than diagnostic accuracy or human reader performance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the form of bench tests. These tests evaluated the device's inherent performance characteristics (Tensile Strength, Leak Tightness, Pressure Drop, Rise Time, and Delay Time) independent of human operators, comparing them directly to the predicate device.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" or reference for comparison was the performance specifications and characteristics of the predicate device (Microstream FilterLine ICU, K980327). The goal was to demonstrate that the Carinal VitaLine™ Set performed similarly enough to be considered substantially equivalent.
8. Sample Size for the Training Set
Not applicable. This submission describes testing for a medical device accessory, not a machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).