(22 days)
The BD L-Cath™ single and dual lumen peripherally inserted central catheters intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.
The BD L-Cath™ Midline™ Catheter intended use shall be for the administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.
Becton Dickinson obtained the L-Cath™ catheter product lines through the purchase of Luther Medical Inc, a California based company, in January 1999. Luther Medical obtained market clearance from the US Food and Drug Administration (FDA) during 1993 for the L-Cath™ peripherally inserted central catheters through the premarket notification [510(k)] process. Becton Dickinson currently markets the L-Cath single lumen, dual lumen, and midline catheters. These catheters have a plastic bushing material that is used for the purpose of catheter assembly and/or extension tubing with a female luer lock adapter.
The primary modification addressed in this 510(k) submission relates to a material modification in the bushing component. The modifications to the devices pertain to a modified bushing material that is known as PC Makrolon RX2530-1118, which has been tested by Becton Dickinson's supplier and meets FDA & ISO standards. The bushing material is used in all three types of catheters to join the tubing to the female luer lock adapter. The material modification affects only the bushing that is seated within the luer adapters of the BD L-Cath™ PICC and BD L-Cath™ Midline products. The formulation modification is a linear polycarbonate with the same end groups, formulation, additives, and colorants. The only difference being a higher molecular weight for the modified material.
This document is a 510(k) premarket notification for a material modification to the BD L-Cath™ family of catheters. It is not a study that proves a device meets acceptance criteria through performance data. Instead, it argues for "substantial equivalence" to a previously cleared device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this document because a clinical performance study was not conducted or required for this type of submission.
Here's what can be extracted based on the provided text, and where gaps exist:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating "substantial equivalence" based on material modification rather than performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No "test set" in the context of a clinical performance study is mentioned. The submission describes a material modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. No "ground truth" establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No "adjudication method" for a test set is mentioned.
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
This information is not provided in the document. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This refers to a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No "ground truth" in the context of a clinical performance study is mentioned.
8. The sample size for the training set
This information is not provided in the document. No "training set" in the context of machine learning is relevant here.
9. How the ground truth for the training set was established
This information is not provided in the document. No "training set" or "ground truth" for a training set is relevant here.
Summary of what the document does state:
The core of this submission is to demonstrate that a material modification to the bushing component of the BD L-Cath™ catheters does not alter the safety or effectiveness of the device, making it substantially equivalent to the previously cleared devices.
- Device: BD L-Cath™ Single Lumen, BD L-Cath™ Dual Lumen, and BD L-Cath™ Midline Intravascular Catheters.
- Modification: Change in the bushing material from an unspecified polycarbonate to PC Makrolon RX2530-1118. The only difference noted is a "higher molecular weight for the modified material."
- Support for Substantial Equivalence:
- The modified material has been tested by the supplier and "meets FDA & ISO standards." (Details of these tests and specific results are not included in this summary).
- "The L-Cath products have the same technological characteristics with no changes in part geometry or performance, and have the same formulation, additives, and colorants as the current device material."
- "The following qualities of the three devices are the same and support substantial equivalence: Indications for use, fundamental scientific technology, gauge sizes of the devices, visualization of blood return and potential for blood exposure during use."
- The "intended use and technological characteristics... have not been altered."
Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed under the general controls provisions of the Act. This determination is based on the argument that the material modification does not introduce new questions of safety or effectiveness.
§ 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.”