Search Results

The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only.

The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

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

The provided text primarily details a 510(k) premarket notification for the "PleurX Peritoneal Catheter System" and clarifies its indications for use, rather than presenting a study with specific acceptance criteria and performance data in a quantitative manner. The document asserts that the device is substantially equivalent to a legally marketed predicate device (CareFusion PleurX Peritoneal Catheter System: K160437).

However, I can extract the following information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and states that "Bench-level testing was carried out... to demonstrate substantial equivalence."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified for any bench-level or clinical literature review.
• Data Provenance:
  • Bench-level testing: Conducted by the manufacturer (CareFusion).
  • Clinical information: Derived from a "clinical literature review." Details on the scope (e.g., country of origin, retrospective/prospective nature of the studies reviewed) are not provided in this excerpt.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided. The document primarily refers to bench testing and a literature review, not a test set requiring expert ground truth establishment in the typical sense of a diagnostic or AI study.

4. Adjudication Method for the Test Set:

Not applicable, as no described test set with expert ground truth establishment is present in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study is not mentioned as having been conducted. The submission relies on non-clinical testing and a clinical literature review to support substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is a physical medical device (catheter system), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• For non-clinical testing: Performance against established engineering and design specifications for medical devices, inferred from "predicate devices and leak testing."
• For clinical information: The "clinical literature review" served as the basis for understanding safety and efficacy, implying published clinical data from existing studies constituted the "ground truth" for the claims made regarding the device's performance in managing ascites.

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/algorithm-based device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Ask a specific question about this device

The PleurX Peritoneal Catheter System is indicated for intermittent. Iong term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the Pleur X Valve.
The Pleur X LP Catheter Mini Kit is intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.

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 document describes a 510(k) premarket notification for the PleurX Peritoneal Catheter System. This submission is for modifications to an existing device, not a new AI-powered diagnostic system. Therefore, the questions related to AI-specific performance metrics (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable.

The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests and the standards they adhere to. It does not provide specific numerical acceptance criteria or reported device performance values in a table format. Instead, it indicates that testing was conducted according to these standards to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

This is not an AI/software device. The "test set" here refers to the samples used in bench testing. The document does not specify the sample sizes for each bench test conducted. The data provenance is from "bench-level testing" and is therefore not country-specific or retrospective/prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical device, not an AI diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and the functionality of the device as measured by standard laboratory equipment and methodologies.

4. Adjudication method for the test set

Not applicable. The performance testing involves objective measurements against established engineering and biocompatibility standards, not subjective expert adjudication.

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. This is not an AI device, so no MRMC study was conducted related to AI assistance.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established engineering standards for medical devices, material science properties, biocompatibility assays, and sterilization effectiveness.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" for an algorithm.

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

Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning.

Ask a specific question about this device

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