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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® PLEURX Pleural Catheter Kit and Denver® PLEURX Home Drainage Kit are indicated for intermittent, longterm drainage of symptomatic, recurrent, malignant pleural effusion. The devices are indicated for the palliation of dyspnea due to malignant pleural effusion and for providing pleurodesis.

The Denver® PLEURX Pleural Catheter Kit (#50-7000) is a sterile device, for single use only, and is not to be resterilized. The kit contains the PLTURX Catheter; a specifically matched drainage line that can be configured for either wall suction or a vacuum bottle; and the components needed to place the catheter within the pleural space and to dress the catheter exit site after placement. The PLEURX Catheter contained in the kit is a flexible, fenestrated silicone catheter with a cuff and a valve. The fenestrated portion of the catheter is inserted into the pleural space utilizing a peel-away introducer (Seldinger technique). The portion of the catheter containing the cuff is tunneled subcutaneously, and the remaining portion is left external to the body. A radiopaque stripe runs the entire length of the catheter. The Denver® PLEURX Home Drainage Kit (#50-7500), an accessory to the Denver® PLEURX Pleural Catheter Kit, is a sterile, disposable device designed for single use only, and is not to be resterilized. The kit contains drainage lines, vacuum bottles, and the components needed to drain the effusion and to redress the catheter exit site.

The provided text describes a 510(k) premarket notification for the "Denver® PLEURX Pleural Catheter Kit" and "Denver® PLEURX Home Drainage Kit." This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a de novo clinical study with pre-defined acceptance criteria and statistical analysis to "prove" device performance against those criteria.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not present in this document.

The document details clinical testing that was performed under IDE #930085 to evaluate the device's effectiveness, but it does not specify quantitative acceptance criteria or statistical methodologies to prove meeting them in the way a robust performance study would. Instead, it describes observed outcomes related to the indicated uses.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence. While clinical testing was performed and outcomes reported, the text does not present pre-defined numerical "acceptance criteria" against which these outcomes were measured to "prove" device performance in a statistical sense for market clearance. The reported performance refers to the observed results of the clinical evaluation.

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

• Sample Size: Not specified in this document. The text refers to "subjects" but does not give a number.
• Data Provenance: The clinical evaluation was conducted under IDE #930085. The country of origin is not specified, but the submitter is Denver Biomaterials, Inc. in Golden, Colorado, USA, suggesting the study likely took place in the US. It was a prospective clinical evaluation, as implied by the IDE number and the description of "subjects" receiving treatment.

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

• This information is not provided in the document. The clinical evaluation describes patient-reported outcomes (dyspnea rating, quality of life) and a clinical outcome (pleurodesis), which would typically be assessed by treating physicians or study investigators, but specific details on "experts" for ground truth establishment are absent.

4. Adjudication method for the test set

• This information is not provided in the document.

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 information is not applicable/not provided. The device is a pleural catheter kit, not an imaging analysis AI or diagnostic tool where MRMC studies involving human readers and AI assistance would typically be performed.

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

• This information is not applicable/not provided. The device is a physical medical device (catheter kit), not a software algorithm.

7. The type of ground truth used

• The "ground truth" in this context refers to the outcomes measured in the clinical evaluation. These include:
  • Patient-reported outcomes: Relief of dyspnea (subjective rating), improvement in quality of life (subjective rating).
  • Clinical outcomes: Achievement of pleurodesis (a medical condition that would be diagnosed by a physician based on clinical findings and imaging), and absence of symptomatic recurrence of effusion.

8. The sample size for the training set

• This information is not applicable/not provided. This is a physical 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/not provided for the reasons stated above.

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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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The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.

The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage.

As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration.

Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure.

The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle.

The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.

The provided text describes a medical device, the Denver Paracentesis Needle, and its equivalency to other similar devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document is a "Summary of Safety and Effectiveness" which is a type of submission to regulatory bodies (like the FDA, indicated by "K960456" which is likely a 510(k) premarket notification number) for medical devices. The purpose of this type of document is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.

Therefore, the requested information cannot be extracted from the provided text for the following reasons:

1. Acceptance criteria and reported device performance (quantitative): The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity, precision) or acceptance thresholds for the Denver Paracentesis Needle. The "Performance Testing" section only mentions a comparison of "drainage rates" to a predicate device and concludes they have "similar drainage performance." This is a qualitative statement, not a reporting of specific performance values against pre-defined criteria.
2. Sample size and data provenance: No information on sample sizes for test sets or data provenance is provided.
3. Number and qualifications of experts: Not applicable as there is no mention of expert-established ground truth for a diagnostic or AI-driven device.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic or imaging device.
6. Standalone performance: Not applicable in the context of AI performance. The device's standalone performance is its mechanical function.
7. Type of ground truth: Not applicable in the context of AI/diagnostic device ground truth. The "ground truth" for this device would be its functional ability (e.g., draining fluid effectively), which is implicitly assessed by showing substantial equivalence to existing devices.
8. Sample size for training set: Not applicable as this is not an AI/machine learning device.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a functional comparison (drainage rates), rather than an in-depth study of specific performance metrics with defined acceptance criteria typically seen for diagnostic devices or AI algorithms.

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