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The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

The BIOTEQ Drainage Catheter Set (One Step Type), BT-PD1-series percutaneous drainage catheter with hydrophilic coating, is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a "J", a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either Direct Access Technique or Seldinger Technique to provide access.

The provided document is a 510(k) summary for a medical device (BIOTEQ Drainage Catheter Set (One Step Type)). It details the device's indications for use, description, and a comparison to predicate devices to establish substantial equivalence.

However, the document explicitly states in "5.10 Clinical Testing" that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the details requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria from this document, as no clinical testing was performed or submitted for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies is presented.
2. Sample sizes used for the test set and the data provenance: No test set was used for clinical performance evaluation.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no clinical ground truth was established by experts.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
9. How the ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (Sterilization Validation, Shelf-life, Biocompatibility, Performance) to demonstrate substantial equivalence to legally marketed predicate devices, rather than clinical performance data against specific acceptance criteria. The "Performance" referred to in Section 5.9 is likely related to physical performance characteristics of the device (e.g., flow rate, material strength, radiopacity, etc.), and not clinical outcomes.

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