(262 days)
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.
The entire device is for single patient use and the HME-part is for single use.
Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
Environment of Use: Hospitals, ICU, sub-acute care institutions and home.
The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices".
Speaking Valve and HME 15 / 22
The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus.
The Speaking Valve has two modes: speaking mode and HME mode.
In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.
In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.
HME DigiTop and HME DigiTop O2
The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.
The provided text is a Premarket Notification (510(k)) for a medical device called "ProTrach DualCare." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device to existing ones and presenting non-clinical studies to support safety and performance.
The document does not contain information about studies involving human subjects, clinical efficacy, or the statistical metrics often associated with AI/ML device performance (like sensitivity, specificity, AUC) from a test set with corresponding ground truth established by experts. Therefore, many of the requested items cannot be directly extracted from this document.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its performance and substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the ProTrach DualCare and its predicate device (SPIRO Speaking Valve) for several performance attributes. While explicit "acceptance criteria" (numerical thresholds) are not always stated, the comparison implies that "same" or "better" performance is the acceptance criterion for substantial equivalence.
| Acceptance Criteria (Implied) | ProTrach DualCare Performance (Reported) |
|---|---|
| Moisture Loss: Better than 28 mgH2O/l air | HME 15 Regular: 22 mgH2O/l air (Better) |
| HME 15 XtraMoist: 20 mgH2O/l air (Better) | |
| HME 22: 21 mgH2O/l air (Better) | |
| Dead Space: Less than 5.6 ml | HME 15 Regular: 4.05 ml (Less) |
| HME 15 XtraMoist: 4.05 ml (Less) | |
| HME 22: 4.62 ml (Less) | |
| Attachment and Detachment forces: Acceptable | Verified |
| Durability of devices: Acceptable | Verified |
| Simulated use: Acceptable | Verified |
| Warning label durability: Acceptable | Verified |
| Function after drop test: Acceptable | Verified |
| Function after climate testing: Acceptable | Verified |
| Function after aging: Acceptable | Verified |
| Function after transport: Acceptable | Verified |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, Leachables & Extractables): Acceptable | Acceptable results (in accordance with ISO 10993 series) |
| Risk management (ISO 14971): Compliant | Conducted |
| Usability (simulated use testing): Acceptable | Conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are primarily non-clinical engineering and biocompatibility tests. There is no mention of "test sets" in the context of clinical data or human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe studies involving expert-established ground truth for a clinical test set. The ground truth for the non-clinical tests (e.g., moisture loss, dead space) would be established by the measurement instruments and methodology prescribed by relevant engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reviewed "test set" and thus no need for an adjudication method.
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
An MRMC comparative effectiveness study was not done. This submission is for a physical medical device (speaking valve/HME) and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests: The "ground truth" for reported performance metrics like moisture loss, airflow resistance, leakage, and dead space would be derived from standardized physical measurements using laboratory equipment, following recognized testing standards (e.g., those related to HMEs and tracheostomy accessories). For biocompatibility, the ground truth is established by the results of biological tests according to ISO 10993 series.
8. The sample size for the training set
This information is not applicable/not provided. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.