(231 days)
The Sterile Water for Inhalation Flex Bag USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used In institutional and non institutional care settings
The Sterile Water for Inhalation Flex Bag USP is a flexible plastic bag with a single port at the base and is pre-filled with sterile water Tubular feed sets connect the sterile water bags to unfilled humidifier chambers The humidifier chamber is then filled with sterile water from the sterile water bags via gravity
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Sterile Water for Inhalation Flex Bag USP":
Acceptance Criteria and Study for Sterile Water for Inhalation Flex Bag USP
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a "Sterile Water for Inhalation Flex Bag USP." The primary objective is to prove that the new device meets its intended performance requirements and is comparable to existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Supply of sterile water to unfilled respiratory humidifier chambers. | Fully meets intended use. |
| Classification | BTT Classification. | Meets BTT Classification. |
| Manufacturing & Packaging | Manufactured and packaged utilizing same basic processes as predicates for sterile water for inhalation USP in a disposable plastic container. | Meets manufacturing and packaging process criteria. |
| End Use | Sterile water end use is in conjunction with humidification systems. | Meets end use criteria. |
| Overall Performance | Meets intended performance requirements at all levels. | "Verification and Validation Testing demonstrates that the Cardinal Health Sterile Water for Inhalation Flex Bag meets its intended performance requirements at all levels." |
| Substantial Equivalence | Demonstrably comparable to predicate devices in terms of intended use, classification, manufacturing, packaging, and end use. | Demonstrated substantial equivalence to predicate devices (K780381, K853146, K760584). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The summary only broadly mentions "Verification and Validation Testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The type of device (sterile water in a bag) typically relies on chemical, microbiological, and physical testing, rather than expert interpretation of complex images or data to establish 'ground truth' in the way a medical AI device would.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of this device. Adjudication methods like '2+1' or '3+1' are typically used for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution. This is not relevant for the testing of a sterile water bag.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human readers interpreting medical images or data, which is not applicable to a sterile water bag.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a medical product (sterile water bag), not a software algorithm or AI.
7. The Type of Ground Truth Used
The ground truth for this device would be established through a combination of:
- Chemical Analysis: Verifying the water meets USP (United States Pharmacopeia) standards for sterile water for inhalation.
- Microbiological Testing: Confirming sterility.
- Physical Testing: Assessing bag integrity, port functionality, and compatibility with humidification systems.
- Performance Testing: Ensuring effective delivery of sterile water from the bag to humidifier chambers via gravity feed as intended.
The document refers to "Verification and Validation Testing," which implies these types of objective, measurable criteria were used to establish the "ground truth" of the device's performance characteristics.
8. The Sample Size for the Training Set
This information is not provided and is not applicable for this type of device. The concept of a "training set" is relevant for machine learning or AI models, not for a physical medical device like a sterile water bag.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for this type of device. As explained above, there is no "training set" in the context of this product. The 'ground truth' for the device itself is established through direct, objective testing and adherence to established standards (like USP).
§ 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).