(148 days)
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
The TTCF Gas Delivery System is a gas supply and humidification system mounted on a medical stand. Components include an oxygen blender, a flow meter, pressure relief valve, humidifier, and pressure monitor. A blended source of compressed air and oxygen allow choosing flow rate and FiO2 of the mixture. Flows are delivered at 6-15 LPM. Oxygen concentrations are available from 21% to 77%.
The provided text describes a 510(k) submission for the CS Medical TTCF Gas Delivery System. This is a medical device, not an AI/ML software. Therefore, the questions regarding acceptance criteria, study details, ground truth, and expert evaluation are not applicable in the context of AI/ML performance.
The document primarily focuses on establishing "substantial equivalence" of the new device to a legally marketed predicate device (Transtracheal Systems, Inc., TTHF-1000, K981078). This involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Here's a breakdown of the information provided, re-contextualized to the device clearance process:
1. Acceptance Criteria and Reported Device Performance:
The concept of "acceptance criteria" for an AI/ML model's performance (e.g., sensitivity, specificity thresholds) is not relevant here. Instead, the "acceptance criteria" for device clearance are focused on demonstrating:
- Hazard Analysis: Acceptable and mitigated potential hazards (following ISO 14971).
- Electrical Safety: Demonstrated for individual components.
- Effectiveness: Demonstrated for individual components by previous 510(k) clearance (i.e., the components themselves are already proven safe and effective).
- Biocompatibility: Plastic materials meet ISO 10993.
- Substantial Equivalence: The device is designed, labeled, and verified for performance and safety in a manner that makes it substantially equivalent to the predicate device.
Reported Device Performance (against the concept of substantial equivalence):
- Indications for Use: Same as predicate device (treatment of hypoxemia with delivery of transtracheal high flows of heated and humidified air/oxygen mixture to self-breathing adult patients with a cuff deflated fenestrated tracheostomy tube).
- High Flow Oxygenation: Same as predicate (high flow oxygenation for treatment of hypoxemia in self-breathing adult patient populations).
- Heated/Humidified Air-Oxygen Mixtures: Same as predicate.
- Open System Support: Both devices support an open system.
- Flow Rates: Same as predicate (6-15 LPM delivering oxygen mixture up to 77%).
Differences noted but deemed not to impact substantial equivalence:
- Intended Use Environment: TTHF-1000 for home use, TTCF for hospital use.
- System Delivery Pressure: Substantially lower for the TTCF system at the catheter.
- Oxygen Supply: TTCF uses facility piped oxygen, predicate uses an air compressor.
2. Sample Size for Test Set and Data Provenance:
This section is not applicable to traditional medical device clearance. No "test set" in the AI/ML sense (e.g., a dataset of images with ground truth labels) was used. The evaluation involves engineering testing and comparison to an existing device.
3. Number of Experts and their Qualifications:
This is not applicable. The evaluation does not involve clinical experts establishing ground truth for a dataset. The clearance process relies on regulatory experts at the FDA reviewing the manufacturer's provided documentation.
4. Adjudication Method:
This is not applicable. No adjudication of expert opinions on a dataset was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable. The device is a gas delivery system, not an AI diagnostic or assistive tool for human readers.
6. Standalone Performance Study:
This is not applicable in the AI/ML sense. The "effectiveness" of individual components was "demonstrated... by previous 510(k) clearance," meaning the sub-components had their own standalone performance verified previously. The current submission demonstrates the system's integration and safety.
7. Type of Ground Truth Used:
This concept is not applicable. There's no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of validating an AI/ML algorithm's performance. The "truth" in this context is adherence to safety standards, engineering specifications, and functional equivalence to a predicate device.
8. Sample Size for Training Set:
This is not applicable. The device is not an AI/ML algorithm, so there is no training set.
9. How Ground Truth for Training Set was Established:
This is not applicable for the same reason as above.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).