Search Results

The Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation. of symptoms related to recurrent malignant ascites and for peritoneal placement only.

The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.

The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.

The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.

The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.

The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Peritoneal Catheter and the Pleurx Drainage Kits.

The provided text describes the Pleurx Peritoneal Catheter System and its regulatory submission. It explicitly states that no clinical tests were conducted for this submission (K113854). Therefore, the information requested regarding acceptance criteria based on clinical performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as such studies were not performed for this submission.

However, the document does list non-clinical performance tests conducted to demonstrate substantial equivalence. These tests relate to the physical and biological characteristics of the device, rather than its clinical efficacy or diagnostic accuracy.

Here's what can be extracted based on the provided text, acknowledging the lack of clinical study data:

1. A table of acceptance criteria and the reported device performance

   Since no clinical studies were performed, there are no acceptance criteria related to efficacy or diagnostic performance. Instead, the document lists compliance with various non-clinical standards. The reported "performance" is that the device "meets or exceed all performance requirements."

   Characteristic	Acceptance Standard/Test/FDA Guidance	Reported Device Performance
   Biocompatibility	ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing	Meets or exceeds all performance requirements
   Residuals	ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals	Meets or exceeds all performance requirements
   Performance (Drainage Catheters)	EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use	Meets or exceeds all performance requirements
   Performance (Catheters)	EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for Common Properties	Meets or exceeds all performance requirements
   Performance (Packaging)	ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices	Meets or exceeds all performance requirements
   Performance (Biological Indicators)	ISO 11138-1,2:2006 Sterilization of healthcare products - Biological Indicators	Meets or exceeds all performance requirements
   Performance (Microbiological Methods)	ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2	Meets or exceeds all performance requirements
   Performance (Ethylene Oxide Sterilization)	ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization	Meets or exceeds all performance requirements
   Performance (Conical Fittings, Luer)	ISO 594-1:1986 Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements	Meets or exceeds all performance requirements
   Performance (Conical Fittings, Luer Lock)	ISO 594-2:1998 Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings	Meets or exceeds all performance requirements

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   No clinical test set was used for this submission. The non-clinical tests would have involved samples of the device components but details on the quantity of samples are not provided in this summary.

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)

   Not applicable, as no clinical test set requiring expert-established ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable, as no clinical test set requiring adjudication was used.

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

   Not applicable. The Pleurx Peritoneal Catheter System is a medical device for drainage, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. The Pleurx Peritoneal Catheter System is a medical device for drainage, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   Not applicable, as no clinical studies requiring ground truth were performed for this submission. The "ground truth" for the non-clinical performance tests would be the established specifications and standards for device materials, manufacturing, and functionality.

8. The sample size for the training set

   Not applicable, as there is no AI component requiring a training set.

9. How the ground truth for the training set was established

   Not applicable, as there is no AI component requiring a training set.

In summary, the provided document explicitly states: "N/A - No clinical tests were conducted for this submission." The substantial equivalence determination for the Pleurx Peritoneal Catheter System was based on non-clinical performance tests demonstrating compliance with various recognized standards, rather than clinical efficacy studies.

Ask a specific question about this device