(263 days)
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.
For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air
- Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen
The provided text describes a medical device called TrachVox, a Tracheal HME with speech valve and suction port. The submission is a 510(k) premarket notification and focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set details) are not directly applicable or available in this type of submission.
However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices, which implicitly serves as the "study" for establishing substantial equivalence.
Here's a breakdown of the available information structured to answer your request where possible, and indicating when information is not present:
Acceptance Criteria and Study Details for TrachVox
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission establishes substantial equivalence by comparing the TrachVox device's attributes and performance characteristics to those of legally marketed predicate devices. The "acceptance criteria" here are implicitly defined by the attributes and performance ranges of these predicate devices, which the TrachVox aims to match or perform comparably to.
| Attribute | Predicate Device Performance (Implicit Acceptance Criteria) | Reported TrachVox Device Performance |
|---|---|---|
| For spontaneously breathing tracheostomy patients | Yes | Yes |
| Incorporated speech valve | Yes | Yes |
| Provides heat and humidity | Yes | Yes |
| Can provide supplemental oxygen | Yes | Yes |
| Intended to connect to tracheostomy tube of spontaneously breathing patient | Yes | Yes |
| Can connect to an ET tube of spontaneously breathing patient | Yes | Yes |
| Intended for single patient up to 24 hours | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, ICU | Home, Hospital, sub-acute, ICU |
| Placement in various locations in circuit | Yes | Yes |
| Supplemental oxygen connection | Yes | Yes |
| Standard 15/22 mm connectors | Yes | Yes |
| Dead Space (ml) | (Not explicitly stated for predicates, implied to be comparable) | 9.5 ml |
| Resistance to flow | (Not explicitly stated for predicates, implied to be comparable) | 0.23 cm H₂O @ 30 Lpm |
| 0.9 cm H₂O @ 60 Lpm | ||
| Weight | (Not explicitly stated for predicates, implied to be comparable) | 2.9 gm |
| Normally closed suction slit valve | Yes | Yes |
| Speech valve normally open for inhalation | Yes | Yes |
| Allows exhalation to atmosphere freely | Yes | Yes |
| Method for diverting exhaled air through vocal cord for facilitating speech (Speech valve) | Mechanically similar mechanisms on predicates | Cover suction valve with fingers, depress housing, compressing foam and closes off exhalation to atmosphere vents |
| Method for revert to normal exhalation after speaking | Mechanically similar mechanisms on predicates | Remove finger, foam spring-action raises housing, opening exhalation to atmosphere vents |
| Moisture output (mg H₂O/l) ISO 9360 | (Not explicitly stated for predicates, but implies compliance with ISO 9360 standards) | 20.1 mg H₂O /l @ 500 ml TV |
| Moisture output (mg H₂O/l) ISO 9360 with supplemental oxygen | (Not explicitly stated for predicates, but implies compliance with ISO 9360 standards) | 14.9 mg H₂O /l @ 10 Lpm |
| Housing components - polypropylene | Yes | Yes |
| HME media | Foam | Foam |
| Valve | Silicone | Silicone |
| None under Section 514 | Yes | Yes |
| ISO 5356-1 Conical 15/22 | Yes | Yes |
| ISO 9360 - HME moisture output | Yes | Yes |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (defined by substantial equivalence to predicate devices) is primarily a comparative analysis of specifications and functional features. For quantitative metrics like Dead Space, Resistance to Flow, Weight, and Moisture Output, it is implied that bench testing was conducted on the TrachVox device to obtain these performance values, and these values were deemed acceptable when compared to relevant predicate devices or industry standards (like ISO 9360).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission relies on engineering specifications and bench testing of the single device model, not a patient-based "test set" in the context of clinical trials or AI/diagnostic studies.
- Data Provenance: The data primarily comes from engineering design specifications and bench testing of the TrachVox device itself, and comparison to publicly available specifications/regulatory submissions of predicate devices. The country of origin for the data generation would be the manufacturer, Engineered Medical Systems, in Indianapolis, IN, USA. The data is prospective in the sense that the new device's performance was measured.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving human interpretation of data where "ground truth" is established by experts.
4. Adjudication method for the test set:
- Not applicable. No expert adjudication was done for this type of submission.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the TrachVox's performance metrics (dead space, resistance, moisture output) would be derived from direct physical measurements and laboratory bench testing according to established engineering and ISO standards (e.g., ISO 9360 for HME moisture output, ISO 5356-1 for connectors). For functional features, the "ground truth" is its design and operational mechanism. For the comparison to predicate devices, the "ground truth" is the regulatory and published specifications of those predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning study.
§ 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.