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The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

The provided text describes the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a 510(k) premarket notification for a Class II medical device used for intermittent drainage of symptomatic, recurrent malignant ascites and palliation of related symptoms.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Beyond these specific tests, the document also mentions compliance with numerous ISO and EN standards related to biocompatibility, sterilization, packaging, and quality management systems (Sections 9.1 and 9.2). The overall conclusion is that "the Rocket IPC design met all specifications and is adequate for its intended use" (Section 10.1).

2. Sample Size used for the test set and the data provenance:

• Sample Size: For the specific performance tests listed in the table, the sample size used was 3 for each test.
• Data Provenance: The document does not explicitly state the country of origin for the test data, but the applicant's address is United Kingdom (Washington, Tyne and Wear, NE38 9BZ, United Kingdom). It does not specify if the testing was retrospective or prospective, but bench testing on new devices is typically considered prospective for that specific testing, even if the overall design builds on existing knowledge.

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 tests performed are engineering/performance bench tests against established standards, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication method for the test set:

• This information is not applicable as the tests are objective material/performance characteristic evaluations, not assessments requiring human adjudication of subjective data.

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:

• No, an MRMC comparative effectiveness study was not done. This document describes the regulatory submission for a physical medical device (catheter kit) and its performance characteristics, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical catheter kit for drainage, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the performance tests was defined by the acceptance criteria of the referenced ISO and EN standards. These standards stipulate objective physical and functional requirements (e.g., minimum force at break, no leakage, no significant deformation). In essence, the standard is the ground truth for these engineering tests.

8. The sample size for the training set:

• This information is not applicable as this is a physical medical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

• This information is not applicable as this is a physical medical device.

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