(178 days)
THE DEDICE IS DESIGNED TO DE INSELTED INTO THE PERIORERAL DENDES SYSTEM FOR THE INFOSION OF SOUTHOUS INTO THE CENTRAL varies system.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Midclavicular Catheter.
The provided text is a 510(k) summary for a medical device called the "Midclavicular Catheter" or "Cavafix." It outlines the device's description, materials, and substantial equivalence to previously cleared devices. However, this document does not contain the type of information requested about acceptance criteria, detailed study design, or performance evaluation from a clinical or technical perspective.
Specifically, the document focuses on:
- Device identification: Product name, trade name, classification.
- Substantial equivalence: Comparing the device to existing predicate devices (K861479 Cavafix and SoloPICC).
- Material compatibility: Stating materials were tested according to ISO Standard 10993.
- Safety and effectiveness (general statement): Mentioning that finished products are tested to meet release specifications, including physical testing and visual examination, as per Quality Control Test Procedure documents and GMPs.
This information is typical for a 510(k) submission seeking clearance based on substantial equivalence, rather than a de novo approval or clinical trial report that would detail specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only broadly states "All finished products are tested and must meet all required release specifications."
- Sample size used for the test set and the data provenance: Not mentioned. The "testing" referred to appears to be internal manufacturing quality control, not a clinical or performance study of a defined "test set."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such study is described.
- Adjudication method: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no external "ground truth" performance study is detailed. The ground truth for internal quality control would be the device specification itself.
- The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”