(101 days)
The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 2.5 mL/sec for 4F and 5.0 mL/sec for 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.
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This document is a 510(k) premarket notification decision letter for the Cathtong™ II PICC Catheter, not a study report. Therefore, it does not contain the detailed information required to fill out all the fields in your request about acceptance criteria and the study proving the device meets them.
The 510(k) summary (which is typically a separate document from this decision letter) for K170486 would provide information on how substantial equivalence was demonstrated, often including performance data. However, based only on the provided text, I can infer some performance-related criteria:
Based on the "Indications for Use" section, the following performance specifications are provided, which could be considered acceptance criteria:
| Acceptance Criteria | Reported Device Performance (from "Indications for Use") |
|---|---|
| Maximum Recommended Infusion Rate (4F Dual Lumen) | 2.5 mL/sec |
| Maximum Recommended Infusion Rate (5F Dual Lumen) | 5.0 mL/sec |
| Maximum Pressure of Power Injection | 325 psi |
The document does not provide the following information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described in this letter.
- 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 described in this letter.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described in this letter.
- 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 medical catheter, not an AI or imaging diagnostic device that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of medical device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not described in this letter, as specific studies are not detailed.
- The sample size for the training set: Not applicable; this is a physical medical device, not an AI algorithm requiring a training set in that context. Any "training" would refer to manufacturing process validation.
- How the ground truth for the training set was established: Not applicable.
To obtain the detailed study information you're asking for, you would typically need to refer to the full 510(k) submission or a summary of safety and effectiveness, which are usually publicly available on the FDA website for successful applications. This particular document is the FDA's decision letter confirming substantial equivalence.
§ 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.”