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The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion

The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs. The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs. Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.

Here's a breakdown of the acceptance criteria and study information for the Automatic Continuous Effusion Shunt (ACES) System, based on the provided FDA 510(k) summary:

This device is a Class II medical device (Peritoneo-venous shunt), product code KPM. Its primary function is to move fluid from the pleural cavity to the peritoneal cavity in adult patients with chylothorax or intractable aseptic pleural effusion.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details non-clinical performance and biocompatibility testing. It doesn't present specific numerical acceptance criteria (e.g., "flow rate must be X mL/day") with corresponding numerical performance results. Instead, for most tests, the acceptance criterion is implied as "Pass" and the reported performance is simply "All samples passed the acceptance criteria."

Note: The document states that the biocompatibility evaluation supports an implant duration of 12 months, beyond which removal is recommended, and that chronic toxicity and carcinogenicity were "Not evaluated".

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

The document does not explicitly state the numerical sample sizes for each test in the "Non-Clinical Performance Tests" or "Biocompatibility" sections. For most tests, it simply states "All samples passed the acceptance criteria."

• Test Set Sample Size: Not specified numerically for individual tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is a 510(k) summary for a US FDA submission, the tests were likely conducted in accordance with recognized international standards (ISO, ASTM) and GLP (Good Laboratory Practice) guidelines, often performed by contract research organizations. The testing appears to be prospective bench and animal (biocompatibility) testing rather than human clinical data.

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

This information is not applicable as the studies described are non-clinical (bench and animal testing). There is no "ground truth" established by human experts in the context of diagnostic performance for these types of engineering and biological safety tests. The ground truth for these tests is defined by the objective measurement and standards outlined in the test methods.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for evaluating diagnostic performance where expert disagreement needs to be resolved.

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

No, a MRMC comparative effectiveness study was not done. The provided document details bench and biocompatibility testing for a medical device (a shunt system), not a diagnostic algorithm that requires human reader interpretation. No mention of AI assistance or human reader improvement appears in this summary.

6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. The ACES System is a physical medical device, not a software algorithm or AI model.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on pre-defined engineering specifications, standard test methods (e.g., pressure thresholds, flow rates, tensile strength values), and visual inspection criteria.

For biocompatibility tests, the "ground truth" is based on established biological safety endpoints and accepted international standards (ISO, USP) for reactions in in-vitro assays and animal models. For example, "non-cytotoxic," "non-sensitizer," and "no systemic toxic effects" represent the ground truth for biological safety.

8. The Sample Size for the Training Set

This is not applicable. The ACES System is a physical medical device, not a machine learning model. There is no "training set."

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

This is not applicable as there is no training set for a physical medical device.

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Peritoneovenous shunting is indicated for patients with malignant intractable ascites (including patients with chylous ascites, hepatorenal syndrome, and idiopathic ascites), not responding to standard medical management, and not considered candidates for portal-venous shunting

The 17Fr valved peel-away introducer is intended for use in the percutaneous insertion of catheters in the peritoneal space.

The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal catheter of an BD Curve Ascites Shunt.

The Ascites Shunt is a fully implantable device that transfers fluid from the peritoneal space to the circulatory system to provide symptom relief for patients with malignant or non-malignant intractable ascites.

The provided text is a 510(k) summary for the BD Curve Ascites Shunt. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical tests were conducted. Therefore, the study described is a non-clinical bench-level testing study.

Here's the breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance Test Summary" but does not explicitly provide a table of acceptance criteria with corresponding device performance values. Instead, it lists the standards against which various performance characteristics were evaluated. The conclusion states that the device "performs as well as the legally marketed predicate devices."

Note: The detailed quantitative acceptance criteria and specific performance results are not provided in this summary but are implicitly confirmed as "met" by the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated in the provided text for each specific test. The term "bench-level testing" implies laboratory-based tests on device samples, but the exact number of units tested for each characteristic is not given.
• Data Provenance: The testing was "bench-level," indicating it was conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. There is no information regarding the country of origin of the "data" as it pertains to patient data, as this was a non-clinical study. The study is prospective in the sense that the testing was conducted specifically for this 510(k) submission, but it is not a clinical prospective study on human subjects.

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

This question is not applicable. For non-clinical bench testing, "ground truth" as it relates to expert clinical judgment is not established. Performance is measured against predefined technical specifications and international standards (e.g., ISO, AAMI).

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

This question is not applicable for non-clinical bench testing. Performance is typically assessed against quantitative thresholds or qualitative observations by laboratory personnel, not by medical experts adjudicating clinical outcomes.

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:

This question is not applicable. The device is an Ascites Shunt, a physical medical device, not an AI-based diagnostic or assistive software. No MRMC study was conducted.

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

This question is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical tests consisted of established international and national standards (e.g., ISO, AAMI, ANSI, BS EN) and the performance characteristics of legally marketed predicate devices. The device's performance was compared to these defined standards and predicate device characteristics to demonstrate substantial equivalence, rather than to clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set:

This question is not applicable as this was a non-clinical study for a physical medical device, not a machine learning model requiring a training set.

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

This question is not applicable for the same reason as above.

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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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Peritoneo-venous shunting is indicated for patients with:

• chronic liver disease whose ascites has not responded to surgical correction of their underlying disease and to medical management.
• persistent ascites who are not considered candidates for portal-venous shunting.
• persistent ascites that is non-responsive to standard medical management.
• peritoneal intra-abdominal neoplasms with massive ascites to help relieve abdominal distension and intra-abdominal pressure.
  Peritoneo-venous shunting should also be considered for patients with hepatorenal syndrome and idiopathic ascites.

The Denver Ascites shunt is made of a fenestrated peritoneal catheter, which collects the ascites fluid; a one-way valve, which allows flow from the peritoneum to the venous system but no reverse flow; and a venous catheter, which discharges the ascites fluid into the central venous system.
The fluid transfer happens automatically when the patient lies down, because of the pressure differential between the peritoneal cavity and the central venous system. The spontaneous rate of transfer can be supplemented by manual pumping of the chamber. Pumping may also help limit buildup of fibrinous debris in the chamber.
All components of the shunt are made of silicone rubber.

1. Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample size for the test set regarding the various physical and biocompatibility tests. It broadly mentions "comparing" and "testing to ensure/verify" without enumerating samples.
• The data provenance is not specified (e.g., country of origin).
• The study is retrospective in nature, focusing on the characterization and comparison of the new tubing material against established specifications of the previously used tubing and the legally marketed device.

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 ground truth for the test set for device performance heavily relies on established engineering specifications, material science standards, and biocompatibility guidelines rather than expert consensus on interpretative outputs (like in imaging devices).

4. Adjudication method for the test set:

• This information is not applicable and not provided. The tests described are objective measurements against pre-defined specifications, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI. This submission is for a material change in a medical device (Denver Ascites Shunt).

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

• This question is not applicable to this medical device submission. The device is a physical shunt; there is no "algorithm" in the sense of a software-based diagnostic or assistive tool. The "standalone" performance refers to the device's physical and biological integrity as a component of the shunt system.

7. The type of ground truth used:

• The ground truth used for this study is based on established engineering specifications, material property standards, and biocompatibility standards. These are objective, quantitative criteria for material composition, physical dimensions, mechanical properties (bond strength, friction fit), and biological safety. The "legally marketed shunt" served as the primary reference for substantial equivalence.

8. The sample size for the training set:

• This information is not applicable and not provided. This modification involves a change in a physical component (tubing) of a medical device, not a machine learning algorithm that requires a training set.

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

• This information is not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this device modification.

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Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management *persistent ascites who are not considered candidates for portal-venous shunting *persistent ascites which is non-responsive to standard medical management *primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure *persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.

The provided text describes a 510(k) premarket notification for the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits. This document focuses on demonstrating substantial equivalence to existing devices, not on proving device performance through a clinical study with acceptance criteria in the manner typically associated with new AI/software devices.

Therefore, many of the requested fields cannot be directly answered from the provided text as it describes a different type of regulatory submission. The submission is for a medical device (a shunt) and focuses on manufacturing process changes rather than a new diagnostic or therapeutic algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the context of a clinical performance study. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to previously cleared devices (K894756 and K913728) based on having the "same intended use, materials, configuration and dimensional specifications," with the only differences being "a surface treatment as part of the manufacturing process" and "No TDMAC-Heparin is applied."
• Reported Device Performance: Not reported in terms of specific clinical metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the "manufacturing process changes... should not raise new issues of safety and/or effectiveness."

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

• Not applicable. The document does not describe a performance study with a test set. It focuses on comparison to a predicate device and manufacturing process changes.

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. No test set or ground truth establishment by experts is described in this regulatory 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 device is a physical shunt, not an AI software.

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

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

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

• Not applicable. Since no clinical performance study is described, no ground truth is created or used in the context of algorithm evaluation.

8. The sample size for the training set

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

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

• Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary of what the document actually states regarding "acceptance criteria" (implicitly substantial equivalence) and "proof":

The document argues for the substantial equivalence of the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits to previously cleared devices (K894756 and K913728) based on the following:

• Acceptance Criteria (implicit for 510(k) pathway): The new device must have the same intended use, materials, configuration, and dimensional specifications as the predicate devices, and any differences (in this case, a surface treatment and absence of TDMAC-Heparin) should not raise new issues of safety and/or effectiveness.
• Study/Justification for Meeting Criteria: The "study" here is essentially the detailed comparison presented in the submission.
  • Comparison Basis: The devices have the "same intended use, materials, configuration and dimensional specifications" as the Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728).
  • Differences:
    1. "The devices covered by this submission undergo a surface treatment as part of the manufacturing process."
    2. "No TDMAC-Heparin is applied to the devices covered by this submission."
  • Proof of Equivalence despite differences: The submitter states, "The manufacturing process changes that are the subject of this submission should not raise new issues of safety and/or effectivenenss." They further support this by stating the devices are "substantially equivalent to Smith & Nephew Ventilation Tubes in that they both undergo this surface treatment as part of the manufacturing process," implying a precedent for the safety of the surface treatment itself.

In essence, the "study" is a regulatory comparison and justification rather than a typical clinical performance trial with predefined endpoints and statistical analyses.

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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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