(46 days)
This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce The CombiPort Emergency Infusion Device. This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.
This submission describes a medical device, the CombiPort Emergency Infusion Device, which is an I.V. fluid transfer set. However, the provided text does not contain any information regarding acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI/ML or diagnostic performance studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets them, nor can I provide information on sample sizes, ground truth, expert qualifications, or MRMC studies, as these concepts are not addressed in the provided document.
The document primarily focuses on:
- 510(k) Summary: A regulatory declaration for market clearance.
- Device Description: What the device is and its intended use (transferring fluids from a container to a patient's intravascular access catheter, with high flow rates for emergency trauma).
- Substantial Equivalence: Comparing it to a previously cleared device (IV Fluid Transfer Pin, K925401) by the same applicant.
- Material Safety: Stating that materials are tested according to ISO Standard 10993.
- Safety and Effectiveness (General Statement): Mentions that finished products are tested and must meet release specifications, including physical testing and visual examination, defined by Quality Control Test Procedure documents.
The "Safety And Effectiveness" section mentions "required release specifications" and "physical testing, visual examination." While these are indications of quality control, they are not presented as a formal study with specific acceptance criteria and detailed performance results that would be used to objectively "prove" clinical effectiveness or diagnostic accuracy in the way described in your prompt (which usually applies to software, AI/ML, or more complex diagnostic devices).
In summary, based only on the provided text, the requested information cannot be extracted.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.