(103 days)
The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas:
Intensive care unit (ICU)
Recovery room
Emergency medical care
Medical emergency vehicles when the patient is being transported
During transport within and outside of the hospital
The Puritan Bennett™ Cuff Pressure Manager (CPM) continuously measures and automatically maintains cuff pressure during ventilation of patients using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, recovery room and during interhospital and intrahospital transport.
It operates in range of 5-50 cm H2O of user-set cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. The Puritan Bennett™ Cuff Pressure Manager introduces some new small features and convenient user interface to maximize safe use and usability. Both manual adjusting and one-click inflation function are provided alternatively for user's preference to start inflation. Measure mode allows user to observe the cuff pressure without device intervening before taking actions. Auto Key-lock feature help to avoid mis-operation when there's no user intervene for a long time. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. It is not intended to connect with ventilator.
The cuff pressure manager is designed with closed loop mechanism which is Pl controlled, and the software level of concern is Class C/Major concern.
The Puritan Bennett™ Cuff Pressure Manager is provided non-sterile and no re-processing is required. A sterile extension tube is equipped with the Puritan Bennett™ Cuff Pressure Manager for inflating/deflating or measuring cuff pressure. The associated accessories include:
- Extension Tube with filter Rechargeable Li-ion Battery Mounting Rack AC/DC Adaptor
The provided document describes the Puritan Bennett™ Cuff Pressure Manager (CPM) and its substantial equivalence to a predicate device (IntelliCuff Cuff Pressure Controller, K150893). The information mainly focuses on technical specifications, safety, and performance evaluations, primarily through bench testing against recognized standards. There is no mention of a study involving human or animal subjects, ground truth, expert adjudication, or multi-reader multi-case studies in the provided text.
Based on the available information, the acceptance criteria and device performance relate to technical specifications and compliance with various international standards for medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the specified technical characteristics and compliance with the referenced industry standards. The reported device performance is indicated by its adherence to these specifications and successful completion of the described tests.
| Characteristic | Acceptance Criteria (from Proposed Device Specs) | Reported Device Performance |
|---|---|---|
| Operation Altitude | -411m to 4000m above sea level | Complies with specified range |
| Operation Temperature | 0°C to 40°C / 32°F to 104°F (operating) | Complies with specified range |
| Operation Relative Humidity | 10% to 95% noncondensing (operating) | Complies with specified range |
| Electrical Safety | Class-II Type BF in accordance with IEC 60601-1 and IEC 60601-1-12 | Complies with specified standards |
| Electromagnetic Compatibility | In accordance with IEC 60601-1-2 | Complies with specified standard |
| Alarm | In accordance with IEC 60601-1-8 | Complies with specified standard |
| AC Power Input | 85 to 264 VAC / 47 to 63 Hz; 7.5 VA typical, 15 VA maximum | Operates within specified range |
| Battery Requirement | 3.6 V / 2300mAh Li-ion rechargeable battery; supports 4 hours operation | Complies with specified battery type and operation duration |
| Default Inflation Pressure Settings | 25 cm H2O | 25 cm H2O |
| Pressure Hold Default Pressure Increase | 5 cm H2O | 5 cm H2O |
| Pressure Hold Maximum Allowable Pressure | 50 cm H2O | 50 cm H2O |
| Pressure Hold Time Setting Range | 5 minutes to 30 minutes | 5 minutes to 30 minutes |
| Pressure Hold Time Factory Default Setting | 5 minutes | 5 minutes |
| Pressure Setting Range | 5 to 50 cm H2O | 5 to 50 cm H2O |
| Pressure Unit Switching | cm H2O, hPa, mbar | Supports all specified units |
| Resolution (setting/display) | +/-1cm H2O | +/-1cm H2O |
| Pressure Accuracy (Display) | ±1.5 cm H2O | Achieved ±1.5 cm H2O |
| Pressure Accuracy (Adjustment) | ±1 cm H2O | Achieved ±1 cm H2O |
| Alarm Priority (High Priority) | Low Pressure (including cuff leakage), High Pressure, Battery is depleted, Technical Errors | Functions as specified |
| Alarm Volume | 50 dB(A) ±5 dB(A) within 1 m distance | Achieved within specified range |
| Applied Pressure Range in Deflation Mode | -45 cm H2O | Achieved -45 cm H2O |
| Pressure Monitoring Resolution | ±0.01 cm H2O (0.01 mbar) | Achieved ±0.01 cm H2O |
| Essential Performance | Applied cuff pressure must be maintained and monitored. If higher or lower than set limits (±1cm H2O), must be detected and alarm activated. | Demonstrated conformance to this requirement |
| Extension Tube with Filter | Yes | Yes |
| Connector Compatibility | Compatible with endotracheal tube (ETT) or tracheostomy tube (TT) | Compatible as specified |
| Software Class of Concern | Class C/Major concern (as indicated in device description) | Verified and validated for this level of concern |
| Sterilization (Extension tube) | Sterile by EtO validation per ISO 11135:2014 and 10993-7: 2008 AC:2009 | Validated |
| Shelf Life (Extension tube) | 5 years shelf life per ASTM F1980:16 | Validated |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human-derived data. The testing described is primarily bench testing of the device's hardware and software components. For these types of tests, samples would refer to the number of devices or components tested. This information is not provided in the document.
Data provenance is not applicable in the sense of country of origin of patient data, as no clinical or patient data was used. All described tests are non-clinical, likely performed by the manufacturer, Covidien llc, in China or its designated testing facilities. The tests are retrospective in the sense that they are conducted on manufactured devices before market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "test set" requiring expert ground truth in the context of clinical images or patient data. The ground truth for the technical performance tests is established by the engineering specifications and recognized international standards themselves.
4. Adjudication method for the test set
This is not applicable as there is no clinical test set requiring expert adjudication.
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
No MRMC comparative effectiveness study was done as the device is a cuff pressure manager, not an AI-assisted diagnostic or interpretative tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to this device in the traditional sense of an "algorithm only" performance study for image analysis or diagnosis. The device itself is an automated system for managing cuff pressure, and its performance is inherently a "standalone" evaluation of its functional accuracy and safety. The performance tests ("Function and performance Test-Cuff Pressure Manager") demonstrate the algorithm (closed-loop PI control) and device's ability to maintain pressure automatically without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by:
- Technical Specifications: The design parameters and target performance values set by the manufacturer.
- International Standards: Compliance with recognized standards like IEC 60601 series for electrical safety, EMC, alarms, usability, and software, as well as ISO standards for sterilization, biological evaluation, and connectors.
- Benchmark Testing: Comparison against the predicate device's known performance characteristics (though the specific "ground truth" for this comparison is the predicate's established performance).
8. The sample size for the training set
This is not applicable as the device is not an AI/ML model that requires a training set of data in the typical sense. Its control mechanism is a PI controller, a traditional engineering control system, not a learned AI model.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model. The "ground truth" for the device's control logic is based on engineering and physiological principles for maintaining appropriate cuff pressure.
§ 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).