(80 days)
The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit.
The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.
The Mergenet Medical, Inc. Trach-Assist device, an airway connector, was determined to be substantially equivalent to existing predicate devices based on a comparison of design and performance characteristics.
Here is a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied by Predicate Devices) | Trach-Assist Performance |
|---|---|---|
| Permits direct suctioning of patient secretions | Yes (via a port and standard suction catheter) | Yes: |
- Via a port and use of a standard suction catheter (Trach-Assist H)
- Allows direct connections of a Closed suction catheter system (Trach-Assist I) |
| Has a reservoir for collection of secretions | Yes (for water drainage in predicate Hudson RCI Water Trap), No (for predicate Swivel connectors) | Yes: Within the housing. (This is a differentiating feature, collecting secretions instead of only water and is deemed not to raise new safety issues, implying its acceptance as a design improvement.) |
| Standard 15 mm / 22 mm fittings | Yes | Yes |
| Internal Volume | Not available (for predicate swivel connectors and HME), N/A (for water trap) | 36 ml - "T"
29.6 ml - "H" (These values demonstrate specific performance, and are not directly compared to a numeric criterion from the predicates, but are implicitly acceptable as the device was found substantially equivalent.) |
| Resistance to flow | (Example from predicate Sontek Bodai: 0.17 cm H2O @ 30 Lpm, 0.66 cm H2O @ 50 Lpm, 0.95 cm H2O @ 70 Lpm) | 0.12 cm H2O @ 30 Lpm
0.60 cm H2O @ 50 Lpm
0.93 cm H2O @ 70 Lpm
(Trach-Assist-H highest resistance values). These values are comparable to or better than the predicate device's measured resistance, indicating acceptable performance within established ranges for similar devices.) |
| Duration of use | Single patient use, not specified | Single patient use up to 24 hours. (This aligns with and further specifies the predicate's general use, indicating acceptable duration.) |
| Provided clean, non-sterile | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a separate "test set" sample size or data provenance in the context of a clinical study or performance evaluation with a population of patients. The evaluation appears to be based on:
- Engineering bench testing: For parameters like internal volume and resistance to flow.
- Comparison of design features: Against existing predicate devices.
There is no mention of human subject data, retrospective or prospective studies, or country of origin for such data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the submission does not describe a study involving expert review for establishing ground truth on clinical outcomes or diagnoses. The "ground truth" for the device's technical specifications (e.g., resistance to flow, internal volume) would have been established through standard engineering and laboratory measurements by qualified personnel at the manufacturer.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described test set requiring adjudication in the context of clinical expert review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence based on design and performance characteristics compared to predicate devices, not on the improvement of human readers with or without AI assistance. The device itself is a physical medical device, not an AI-driven diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done. The device is a physical connector, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this submission is based on:
- Technical specifications and measurements: For properties like internal volume and resistance to flow.
- Design characteristics: Compared against the physical features and functions of legally marketed predicate devices.
- Established regulatory classifications and performance of predicate devices: The FDA's determination of substantial equivalence relies on the known safety and effectiveness of the products it is compared against.
8. Sample Size for the Training Set
This information is not applicable. The submission does not describe a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set for an AI/ML algorithm.
§ 868.5810 Airway connector.
(a)
Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.