(76 days)
The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.
The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer. The BD OneCath PICC is available in both single and dual lumens.
I am sorry, but based on the provided document, I cannot fulfill your request for information on the acceptance criteria and a study proving the device meets them.
The document is a Premarket Notification [510(k)] Summary for the BD OneCath™ Peripherally Inserted Central Catheter. It primarily focuses on demonstrating "substantial equivalence" to a predicate device (BD L-Cath PICC), rather than presenting specific acceptance criteria and a detailed study proving the device meets those criteria for performance metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria and Reported Device Performance: This document states that "Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted." It concludes from these nonclinical tests that the BD OneCath PICC and the predicate device are substantially equivalent. However, it does not provide specific numerical acceptance criteria for these tests (e.g., "pull strength must be X Newtons" or "biocompatibility results must meet ISO X standard with Y score") nor does it report the specific performance results against such criteria. The "Conclusion" is a qualitative statement of substantial equivalence.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: These are all concepts related to the evaluation of algorithms or diagnostic devices against a "ground truth" using a test set and a training set. The BD OneCath is a physical medical device (a catheter), not an algorithm or a diagnostic tool that produces a read-out to be compared with a ground truth. Therefore, these types of studies (MRMC, standalone, etc.) are not applicable in this context and are not mentioned in the document. The "tests" mentioned are physical and biocompatibility tests on the material and components, not clinical studies in the typical sense of evaluating diagnostic performance.
In summary, the provided document is a regulatory submission for a physical device, aiming to prove substantial equivalence through non-clinical testing of materials and physical components. It does not contain the specific information you are looking for regarding acceptance criteria, study methodologies for performance metrics (like sensitivity/specificity), or details about expert-reviewed ground truth, which are typically associated with diagnostic software or imaging devices.
§ 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.”