(251 days)
The Sterile Water for Inhalation Flexoval® Bottle is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional care settings by qualified staff. The Sterile Water for Inhalation is intented for use in all patient populations including adults, pediatrics, infants and neonates.
The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a spikeable cap at the base and is pre-filled with sterile water. The bottle is 1 liter in volume and is made of Low-Density Polyethylene (LDPE). The bottle has one administration port (cap) which is clear and natural in color. The bottle has one standard hanger that is integrated at the base of the bottle also has a multi-color adhesive label affixed by an automatic labeler. The product is sterilized by heat in an autoclave. The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.
This document is a 510(k) Premarket Notification from Hometa Inc. for their "Sterile Water for Inhalation in 1L Flexoval® Bottles." It focuses on demonstrating substantial equivalence to a predicate device, "Sterile Water for Inhalation Flex Bag, USP" by Cardinal Health Inc.
The document does not describe an AI/ML-driven medical device evaluation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for an AI/ML device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.
The study described in this document is primarily focused on non-clinical testing to ensure the new device (Sterile Water for Inhalation in Flexoval Bottles) performs equivalently to the existing predicate device (Sterile Water for Inhalation Flex Bag). The testing includes:
- Functional Testing (per ISO 15747): Resistance to temperature, pressure, and leakage; penetration ability of the insertion point; adhesion strength and impermeability of the insertion point; transparency; resistance to dropping; and hanger integrity.
- Physicochemical and Biological Testing (per USP methods and internal validated methods): Total Organic Carbon, Conductivity, Oxidizable Substances, Process Bioburden, Sterility, and Bacterial Endotoxins.
- Sterilization Validation (per ISO 17665): Moist heat sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6, using Geobacillus stearothermophilus as a biological indicator.
- Biocompatibility Testing (per ISO 10993 series): Extractable/leachables testing, toxicological risk assessment, cytotoxicity, sensitization testing, intracutaneous reactivity test, and material-mediated pyrogenicity.
The "acceptance criteria" discussed in this document are the standards and requirements for these non-clinical tests to demonstrate that the new device is safe and effective and performs as intended, similar to the predicate. The reported "performance" is that the device met these standards.
Therefore, I cannot provide the requested table or details related to AI/ML device evaluation. The information in the provided text pertains to the substantial equivalence of a medical consumable (sterile water) based on physical, chemical, and biological properties, not an AI/ML algorithm.
§ 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).