(267 days)
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
It is used by health professionals (doctor or nurse) specifically trained in this tool.
The CuffGuard has a pressure sensor and software that can monitor and automatically adjust the cuff pressure.
The accessories associated include:
- Connection tube with filter
- Power supply
- Micro USB connection cable
- Fixation clamp and its tilt block)
The FDA 510(k) clearance letter for CuffGuard specifies the device's technical characteristics and performance data to support its substantial equivalence to a predicate device. However, it does not include a detailed study proving the device meets specific acceptance criteria in a clinical context with human readers or standalone performance metrics. The provided document focuses on bench testing and software validation.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
Description of Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, the Hamilton Medical Intellicuff, and compliance with relevant electrical safety and software standards. The "reported device performance" is largely presented as a comparison to the predicate's specifications and confirmation of standard compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (CuffGuard) |
|---|---|---|
| Pressure Range | 5 – 50 cmH2O (Predicate) | 5 – 40 cmH2O |
| Accuracy of Control | +/- 2 cmH2O (Predicate) | +/- 2 cmH2O |
| Adjustment Accuracy | +/- 1 cmH2O (Predicate) | +/- 1 cmH2O |
| Display Accuracy | +/- 1 cmH2O (Predicate) | +/- 1 cmH2O |
| Electrical Safety | Compliant to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 | Compliant to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 |
| EMC | Compliant to IEC 60601-1-2 | Compliant to IEC 60601-1-2 |
| Software V&V | As recommended by FDA Guidance for Device Software Functions | Documentation provided, enhanced level |
| Leaks, Pressure, Alarms | Yes (Predicate) | Yes (Leak, Pressure, Stop sound, Audible, Visual) |
| Cuff Control | Yes (Predicate) | Yes (Deflate, Inflate, Time-limited hold) |
| Units Choice | Yes (Predicate) | Yes |
| Power | Battery and AC power supply (Predicate) | Battery and AC power supply |
| Portability | Yes (Predicate) | Yes |
Study Proving Acceptance Criteria:
The document states: "The following performance data were provided in support of the substantial equivalence determination." These data primarily consist of:
- Electrical safety and electromagnetic compatibility (EMC) testing: Conducted on the CuffGuard device, confirming compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-2 standards.
- Software Verification and Validation Testing: Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software documentation level for CuffGuard is "enhanced."
- Evaluation of Pressure Range Difference: The difference in pressure range (CuffGuard: 5-40 cmH2O vs. Predicate: 5-50 cmH2O) was "evaluated on the SW verification and validation." The justification states this difference is "not clinically significant" as 40 cmH2O is a "realistic physiological limit and common clinical practice."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not mention any clinical test set sample size, data provenance, or whether data was retrospective or prospective. The performance evaluation described is entirely non-clinical (bench testing and software validation).
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 no clinical test set using expert ground truth is described in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring adjudication is described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The CuffGuard is described as an "endotracheal tube cuff controller," a hardware device with embedded software for automatic pressure adjustment, not an AI-assisted diagnostic tool that human readers would interpret. The document explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (bench testing) was performed for the device's technical specifications and software functionality, but not in the context of an AI-driven "algorithm only" performance study. The device's core function is automatic pressure control, which is inherently "standalone" in its operation once user-defined parameters are set. The reported performance metrics (e.g., pressure accuracy, alarm functions) reflect this standalone operational capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the technical performance was based on engineering specifications, compliance with international standards (IEC 60601 series), and the established performance of the predicate device. For the software, the ground truth was derived from the requirements defined during the software development life cycle, validated through verification and validation testing against these requirements.
8. The sample size for the training set
This information is not applicable as the device is a cuff controller based on established physical principles and software logic, not a machine learning model that requires a "training set" for its core function as described.
9. How the ground truth for the training set was established
This information is not applicable as no training set for a machine learning model is mentioned or relevant to the described device. The "ground truth" for the device's functional performance was established through engineering design, compliance with regulatory standards, and validation against specification requirements.
§ 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).