(79 days)
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:
| Acceptance Criteria (Implied for Material Change) | Reported Device Performance |
|---|---|
| Material Equivalence: New tubing must be "very similar" to the existing tubing and meet original material specifications. | "The new tubing is very similar to the existing tubing." "The specifications of the original material have been matched as closely as possible." |
| Bonding Performance: New tubing must bond well to other shunt components. | "Testing has verified that the tubing bonds well to the other components of the shunts." |
| Biocompatibility: New tubing (and finished devices containing it) must be biocompatible. | "Biocompatibility testing has been carried out on the raw elastomer of the silicone tubing and on the finished devices." |
| Substantial Equivalence: Modified devices must be substantially equivalent to the original devices. | "The modified devices have been found to be substantially equivalent to the original devices." (FDA concurs with this finding). |
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.
§ 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.