(453 days)
The TRACOE® cuff pressure monitor (cpm) is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes.
Patient Population: Adult, pediatic, neonatal patients who have high-volume-low-pressure cuffed endotracheal/ tracheostomy tubes.
The TRACOE® cuff pressure monitor (cpm) inflates or measures the intra-cuff pressure in the range of 20 – 100 cmH2O. It is intended for endotracheal or tracheostomy tubes with high-volume low-pressure (HVLP) cuffs.
The cpm consists of a pressure gauge/manometer and a bulb. Between the manometer and the bulb is a male Luer connector air outlet which is connected to the (pilot balloon valve) of the endotracheal/tracheostomy tube HVLP cuff. Opposite the Luer connector is an integrated air release valve that can be opened and closed with a knurled screw.
To inflate the HVLP cuff, the male Luer connector of the cpm is inserted into the inflation line (pilot balloon valve) of the endotracheal/tracheostomy tube, HVLP cuff and the knurled screw is closed, the bulb is then squeezed to inflate the HVLP cuff. As the pressure increases in the HVLP cuff the pressure value is displayed on the manometer. Once the cuff is inflated to the required cuff pressure the cpm is disconnected from the inflation line (pilot balloon valve).
To measure the HVLP cuff pressure, the knurled screw is closed and the male Luer connector is inserted into the open end of the cuff inflation line. The manometer will display the current HVLP cuff pressure. If the pressure is too low the bulb can be squeezed to inflate the cuff, or if the pressure is too high the knurled screw can be opened to release the cuff pressure. Once the required cuff pressure is achieved the cpm is disconnected from the inflation line (pilot balloon valve).
The TRACOE® cuff pressure monitor can be used for adult, pediatric, and neonatal patients. It is reusable and provided non-sterile. A sterile connection tube (REF 702, 1.0 m) is supplied with the TRACOE® cpm which provides an extension tube for inflating or measuring cuff pressure. The TRACOE® cuff pressure monitor is not suitable for continuous monitoring of HVLP cuff pressure.
The TRACOE® cuff pressure monitor is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes. It is designed for use with adult, pediatric, and neonatal patients.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | Confirmed Luer connections in accordance with ISO 594-1. |
| Luer connections | Passed. |
| Bench Testing: | |
| Cuff filling | Passed. |
| Pressure accuracy | Passed. |
| Ability to maintain pressure | Passed. |
| Comparison Testing with Predicate Device (Endotest K951046): | |
| Accuracy of pressure readings | The device performed as well or better than the predicate device. |
| Connection Tube Testing: | |
| Sterilization (including sterilant residuals) | Passed in accordance with ISO 11135, ISO 11737-1, and ISO 10993-7. |
| Simulated distribution and packaging validation | Passed in accordance with ISO 11135, ISO 11737-1, and ISO 10993-7. |
| Pressure Range Validation: | Validated to a pressure range of 20 - 100 cm H₂O. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for any specific test. The text mentions "Performance and mechanical testing" and "Comparison testing" but doesn't provide the number of units or measurements used for these tests.
- Data Provenance: The testing was conducted by TRACOE Medical GmbH for regulatory submission to the FDA. The nature of the tests indicates they are conducted in a retrospective manner to demonstrate the device meets pre-defined acceptance criteria, likely in a laboratory or testing environment. The country of origin of the data would be Germany, where the company is based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies described are non-clinical, mechanical, and bench testing. These types of tests typically rely on standardized measurement equipment and protocols rather than expert human interpretation for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the studies described are non-clinical testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to establish a consensus ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a "cuff pressure monitor," a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical, manual instrument and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical testing would be derived from calibrated reference standards and objective measurements according to established engineering and medical device testing protocols (e.g., ISO standards for Luer connections, calibrated pressure gauges for accuracy, etc.).
8. The sample size for the training set:
This information is not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI or machine learning model that requires training data.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.
§ 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).