(228 days)
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube. The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H2O to 30 cm H2O. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently. Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.
Acceptance Criteria and Device Performance for PYLANT MONITOR
The provided documentation describes the Pylant Monitor, a device intended to provide a visual indication of pressure within an inflatable tracheal tube cuff. The acceptance criteria for this device and its performance are detailed below, along with information about the study conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | +/- 4 cm H2O (Identical to predicate device) |
| Register within "safe zone" | All 120 tested Pylant Monitors registered within the 20-30 cm H2O "safe zone" when pressurized to 25 cm H2O, specifically hitting the "mid-point" on the scale. |
| Correct ETT cuff pressure | The Pylant Monitor successfully registered the correct ETT cuff pressure. When pressurized to 25 cm H2O, 120 units indicated the "mid point" on the scale. The document also states that the PYLANT MONITOR pressures were substantially equivalent when compared to the FDA cleared predicate device (PressureEasy K833327). |
| Visual "green" area/indication for acceptable pressure range (20-30 cm H2O) | The device has a visual "green" area on the monitor for the acceptable pressure range (20-30 cm H2O). The "set point" of approximately 25 cm H2O is the small black line centered in this 20-30 mark. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 120 randomly selected production Pylant Monitors were used for the bench testing.
- Data Provenance: The study was a bench test conducted by the manufacturer (Kal-Med, LLC). The document does not specify the country of origin of the data beyond the manufacturer being in the United States. It is an in-vitro (bench) study and therefore neither retrospective nor prospective in the clinical sense.
3. Number of Experts and their Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the test set was established using a calibrated instrument rather than expert human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was determined by a calibrated PYTON regulator, which provided a known pressure of 25 cm H2O. The device's reading was then compared against this known value.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study was a bench test evaluating the physical performance of the device against a known pressure.
- Effect Size: Not applicable as no MRMC study was conducted.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was conducted. The Pylant Monitor's ability to accurately indicate pressure was tested directly against a calibrated pressure source (PYTON regulator). The device's visual indication was the sole output evaluated.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was established by a calibrated instrument. Specifically, a calibrated PYTON regulator was used to pressurize the ETT cuff to a known 25 cm H2O.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The Pylant Monitor is a mechanical device that indicates pressure changes. It does not employ an algorithm or AI that would require a "training set" in the conventional sense of machine learning. Its design and calibration are based on established physical principles.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of mechanical device. The device's calibration is inherent in its design and manufacturing to visually represent specific pressure ranges.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).