(456 days)
The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.
The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).
This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.
The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.
The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.
The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.
Here's an analysis of the provided information, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Biocompatibility Standards Compliance: | |
| ISO 10993-5 (in-vitro cytotoxicity) | Acceptable |
| ISO 10993-10 (irritation and skin sensitization) | Acceptable |
| ISO 10993-18 (chemical characterization) | Acceptable |
| Material Performance: | |
| Bond strength of new diffuser material | Met pre-defined performance specifications |
| Cleaning Durability: | |
| Performance after cleaning per Instructions for Use | Verified |
| Useful Life: | |
| Performance up to 120 cleaning cycles | Verified |
| Flow Rate: | 6-15 LPM (Unchanged from predicate) |
| Pop-off Safety Valve Pressure: | 6 PSI (410 mbars) (Unchanged from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.
- Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.
4. Adjudication Method for the Test Set
This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring 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
This question is not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on:
- Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
- International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no training set for an AI model.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).