(69 days)
The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition ;- I.V. fluids or drugs.
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 Soft Tip Multi- Lumen Central Venous Catheter . A Soft Tip Multi- Lumen Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.
This document is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes a "Soft Tip Multi-Lumen Central Venous Catheter" and claims substantial equivalence to a previously cleared device. Due to the nature and date of the provided document, much of the requested information about device performance studies and AI-related details is not present and cannot be inferred. This document predates the widespread use of advanced AI in medical devices and the specific reporting requirements for such studies.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Materials tested to ISO Standard 10993 and determined suitable for intended use. | "The Soft Tlp Multi-Lumen Central Venous Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product." |
| Must meet all required release specifications (physical testing, visual examination). | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)." |
| Physical testing defined by Quality Control Test Procedure documents, conforming to product design specifications. | "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| No new issues of safety or effectiveness raised compared to the predicate device. | "There are no new issues of safety or effectiveness raised by The Soft Tip Multi-Lumen Central Venous Catheter." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "all finished products are tested" for release, implying manufacturing quality control, but not a specific sample size for a statistically robust pre-market test set.
- Data Provenance: Not specified. The testing appears to be internal quality control ("All finished products are tested," "physical testing is defined by Quality Control Test Procedure documents").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "ground truth" for the device seems to be compliance with internal specifications and physical testing parameters, rather than expert consensus on a clinical outcome.
4. Adjudication method for the test set
- Not applicable/Not specified. The document describes internal testing and visual examination for product release, which typically follows predefined standards and does not involve adjudication by multiple experts in the sense of clinical study data interpretation.
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
- No. This document describes a physical medical device (catheter) from 1997. MRMC studies, especially those involving AI assistance, are not applicable to this type of product and were not prevalent at the time of this filing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This document describes a physical medical device (catheter) from 1997. Standalone algorithm performance studies are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the purposes of this 510(k) submission, the "ground truth" for the device's acceptable performance seems to be its adherence to internal product design specifications, ISO standards (10993 for materials), and established Quality Control Test Procedures for physical testing and visual examination. There is no mention of clinical outcomes data, pathology, or expert consensus on clinical diagnostic performance.
8. The sample size for the training set
- Not applicable/Not specified. This document does not describe a machine learning or AI-driven device that requires a training set. The mentioned "testing" refers to manufacturing quality control.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there is no training set for an AI model, this information is not relevant to the provided text.
§ 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.”