(69 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 provided text is a 510(k) Premarket Notification Summary for the BD OneCath™ Peripherally Inserted Central Catheter (PICC). This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics like sensitivity, specificity, etc.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance measurements, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's why the requested information is absent and what the document does provide:
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A table of acceptance criteria and the reported device performance: This is not available because 510(k) submissions for devices like PICCs typically do not involve establishing specific performance criteria like accuracy, sensitivity, or specificity as one would for an AI/CAD diagnostic device. The "performance" demonstrated here is primarily through non-clinical testing to show the new device characteristics are comparable to the predicate.
- Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) for this type of device are met if the device can demonstrate "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Reported Device Performance:
- Nonclinical Tests conducted: Biocompatibility testing of the new polyurethane tubing.
- Nonclinical Tests conducted: Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts).
- Key Technological Improvement: The new polyurethane tubing has "improved radiopacity and resistance to alcohol" compared to the predicate device (BD L-Cath PICC).
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned because there wasn't a clinical performance study in the way requested for an AI/CAD diagnostic device. The evaluation was primarily through non-clinical laboratory testing of materials and device integrity.
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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): Not applicable. There was no "ground truth" derived from expert consensus on patient data described in the document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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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: Not applicable. This device is a physical medical device (PICC), not an AI/CAD diagnostic software, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of submission is typically based on established engineering standards, material science testing results, and comparison to the predicate device's known performance for safety and efficacy.
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The sample size for the training set: Not applicable. There is no "training set" in the context of developing an AI model for this physical medical device.
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How the ground truth for the training set was established: Not applicable.
In summary: The provided document is for a traditional medical device (Catheter) seeking 510(k) clearance, which focuses on demonstrating "substantial equivalence" through non-clinical testing and comparison to a predicate device. It does not involve the types of studies, metrics, or data sets that would be associated with AI/CAD diagnostic devices referenced in your prompt.
§ 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.”