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The Denver Pleural Effusion Shunt is indicated for use in patients with chylothorax, intractable aseptic pleural effusion. The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with: chylothorax, intractable pleural effusion.

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components: 1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff. 2. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum. 3. A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cavity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber. Except for the polyester cuff, all components of the shunt are made of silicone rubber.

This 510(k) summary describes a modification to an existing device, the Denver Pleural Effusion Shunt, specifically a change in the supplier of the silicone tubing used to fabricate the catheters. The focus of the submission and testing is to demonstrate that the modified device is substantially equivalent to the original device, not to prove the efficacy or safety of the device against specific clinical acceptance criteria in a new study. Therefore, traditional "acceptance criteria" for clinical performance are not explicitly stated or met in the same way a de novo device would.

Instead, the acceptance criteria for this submission revolve around confirming that the new silicone tubing performs equivalently to the old tubing and does not negatively impact the overall device performance or safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on the specific sample sizes for the bonding or biocompatibility tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. Given the nature of a material change submission, these tests would typically be laboratory-based (in-vitro) rather than clinical studies on human subjects.

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

This section is not applicable to this 510(k) submission. The "ground truth" for a material change submission is primarily established through engineering tests (material characterization, bonding strength, etc.) and biocompatibility tests, which are evaluated against established standards and internal specifications, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are laboratory-based.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant to a material change submission for a mechanical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This section is not applicable. This device is a mechanical shunt, not an AI algorithm. Therefore, there is no "standalone performance" in the context of AI. The performance of the device (e.g., fluid transfer, patency) is inherent to its mechanical design and material properties.

7. Type of Ground Truth Used:

The "ground truth" for this submission primarily relies on:

• Material Specifications: Comparing the properties of the new silicone tubing to the established specifications of the original tubing.
• Performance Standards: Demonstrating the new tubing's ability to bond properly and the biocompatibility of the material using recognized test methods (e.g., ISO standards for biocompatibility).
• Substantial Equivalence Principles: The core ground truth for the 510(k) is the comparison to the predicate device to determine substantial equivalence.

8. Sample Size for the Training Set:

This section is not applicable. "Training set" refers to data used to train machine learning algorithms. This submission is for a mechanical medical device, not an AI/ML product.

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

This section is not applicable for the same reasons as point 8.

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The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is indicated for use in transferring pleural fluid, resulting from chylothorax or intractable pleural effusion, from the pleural cavity to the peritoneal cavity.

The Denver® Pleural Effusion Shunt with External Pump Chamber is a sterile, non-pyrogenic device, for single use only. It is not to be resterilized. The one-piece device consists of a 15.5 Fr. fenestrated pleural catheter and a 15.5 Fr. fenestrated peritoneal catheter, separated by a flexible pump chamber containing two one-way valves. The flexible pump chamber is designed to be manually pumped by the patient or caregiver to transfer pleural fluid from the pleural cavity into the peritoneal cavity. The valves in the pump chamber permit flow in one direction only. The second valve in the pump chamber serves as a check valve for the first, helping to prevent reflux of fluid into the peritoneal catheter when the pump chamber is pumped . Each catheter has a polyester cuff located between the pump chamber and the catheter's fenestrations. When the device is placed in a patient, the pleural and peritoneal catheters are implanted into the pleural and peritoneal cavities, respectively, with the cuffs subcutaneous to permit tissue ingrowth into the cuff. The pump chamber remains outside the patient's body. The entire device is made of silicone rubber, with the exception of the cuffs, which are polyester. Both the pleural and peritoneal catheters contain an integral barium sulfate stripe to permit visualization by x-ray or fluoroscopy.

This looks like a 510(k) submission summary for a medical device. These summaries typically describe the device, its intended use, and its substantial equivalence to a predicate device, rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as one might find in a full clinical trial report or a submission for a novel device.

Based on the provided text, the device itself is a Denver® Pleural Effusion Shunt with External Pump Chamber.

Here's an analysis of the provided text with respect to your questions:

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

The provided text does not contain a table of acceptance criteria or specific quantitative performance metrics for the device itself. The submission focuses on demonstrating substantial equivalence to a predicate device.

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

The document does not describe a "test set" in the context of device performance evaluation. It is a 510(k) submission, which relies heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than on new clinical performance data from a specific study of the device in question.

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

Not applicable. No "test set" or ground truth establishment by experts is described in this type of submission.

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

Not applicable.

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 a medical device (shunt), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

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

The provided text does not mention the type of ground truth used for any performance evaluation of the new device. The basis for safety and effectiveness is primarily the substantial equivalence to predicate devices and reference to "Published studies indicate that pleuro-peritoneal shunting is a safe and effective procedure." – implying that the general procedure, not this specific device's novel performance, has established efficacy.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable.

Summary of what is present in the document regarding "acceptance criteria" and "study":

The document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The core "acceptance criteria" for a 510(k) submission are that the new device has the same intended use and technological characteristics as the predicate, or that if there are differences, those differences do not raise new questions of safety or effectiveness.

• Acceptance Criteria (Implied for 510(k) Substantial Equivalence):

  • Same Intended Use: Both the new device and the predicate device (Denver® Pleural Effusion Shunt, Catalog No. 42-9000) are intended for transferring pleural fluid from the pleural cavity to the peritoneal cavity for chylothorax or intractable pleural effusion.
  • Similar Technological Characteristics:
    • Both are single-use, nonpyrogenic, sterile, pleuro-peritoneal shunts.
    • "With the exception of the polyester cuffs and longer catheters on the Denver® Pleural Effusion Shunt with External Pump Chamber, the two devices are identical in configuration, materials and manufacturing processes."

• "Study" (as described in the document):
  The "study" presented here is a demonstration of substantial equivalence to existing predicate devices.

  • Predicate Device 1: Denver® Pleural Effusion Shunt, Catalog No. 42-9000.
    • Basis for Equivalence: Same intended use, nearly identical configuration, materials, and manufacturing processes, with minor differences (polyester cuffs, longer catheters) that are not claimed to alter fundamental safety or effectiveness.
  • Predicate Device 2 (for catheter design): Cook, Inc. Pneumothorax Set.
    • Basis for Equivalence: Both have a radiopaque catheter designed to be placed with one end in the pleural space and the other end external to the body. (This highlights a shared design feature of the externalized catheter portion).
  • Predicate Device 3 (for catheter design): Quinton Tenckhoff Peritoneal Dialysis Catheter.
    • Basis for Equivalence: Both have a radiopaque catheter designed to be placed with one end in the peritoneal cavity and the other end external to the body. (This highlights another shared design feature of the externalized catheter portion).

The document also references general "Scientific Literature": "Published studies indicate that pleuro-peritoneal shunting is a safe and effective procedure." This broadly supports the underlying medical procedure without providing specific performance data for this particular device.

In conclusion, this document primarily outlines the basis for substantial equivalence for a medical device rather than detailing specific performance "acceptance criteria" and empirical study data as would be expected for an AI or novel device approval process.

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