(28 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar formulation and physical properties to previous tubing | The tubing produced by the new supplier is "very similar in formulation and physical properties" to the tubing previously used. |
| Dimensional specifications comparison | The dimensional specifications of the new tubing were compared. (Specific details of "within specification" are not provided in this summary). |
| Physical property specifications comparison | The physical property specifications of the new tubing were compared. (Specific details of "within specification" are not provided in this summary). |
| Bond strength between tubing and shunt body within specification | Testing was conducted to ensure the bond strength between the new tubing and the shunt body remains within specification. (Specific details of "within specification" are not provided in this summary). |
| Friction fit between tubing and nylon connectors within specifications | Testing was conducted to ensure the friction fit between the new tubing and the nylon connectors used in shunt revision is within specifications. (Specific details of "within specification" are not provided in this summary). |
| Expected response to surface treatment process for reduced friction | Testing was conducted to ensure the new tubing responds as expected to a surface treatment process that reduces surface friction. (Specific details of "expected response" are not provided in this summary). |
| Biocompatibility for long-term contact with blood meets acceptable standards | Testing was conducted to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with blood. (Specific details of "acceptable standards" or the results of the biocompatibility tests are not provided in this summary). |
| Substantial equivalence to legally marketed shunt (overall device performance) | The shunt with the tubing produced by the new supplier has been found to be substantially equivalent to the legally marketed shunt. This is the overarching conclusion related to the device performance in meeting the acceptance criteria for this 510(k) modification. |
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.
§ 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.