(269 days)
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.
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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."
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"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).
- Predicate Device 1: Denver® Pleural Effusion Shunt, Catalog No. 42-9000.
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.
§ 876.5955 Peritoneo-venous shunt.
(a)
Identification. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) Backflow specification and testing to prevent reflux of blood into the shunt.