(265 days)
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."
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Displacement Volume | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Resealing Capacity | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Interface Testing | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Declogging | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Aging | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Biocompatibility | ISO 10993-1, -5, -7, -12, -17, -18 | Met standards and performed as well as predicate |
| Sterilization | ISO 11135, ISO 11138-1, ISO 11737-1, AAMI TIR28, ANSI/AAMI ST72 | Met standards and performed as well as predicate |
| EO Residuals | ISO 10993-7 | Met standards and performed as well as predicate |
| Packaging | AAMI/ANSI/ISO 11607-1, -2 | Met standards and performed as well as predicate |
| Risk Management | BS EN ISO 14971 | Met standards and performed as well as predicate |
| Performance | EN ISO 14630, BS EN 1617, BS EN 1618 | Met standards and performed as well as predicate |
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.
§ 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.