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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.

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has 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 consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

This document is a 510(k) premarket notification for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a Class II medical device used for intermittent drainage and palliation of symptoms related to recurrent malignant ascites. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; K152105).

The table provided details the "Substantial Equivalence" comparison between the subject device and its predicate. This section outlines various parameters where the subject device is deemed equivalent to the predicate, with a specific focus on performance, biocompatibility, packaging, sterility, sterilization method, and shelf life.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of strict numerical thresholds or target metrics for the device's clinical performance (e.g., success rates in draining ascites, complication rates). Instead, the "Performance" section within the "Substantial Equivalence" table describes the types of tests conducted to demonstrate equivalence to the predicate. Therefore, the "acceptance criteria" are implied to be meeting the established safety and performance characteristics of the predicate device as evaluated through the specified tests. The "reported device performance" is that the subject device performs similarly to the predicate under these tests.

2. Sample Size Used for the Test Set and Data Provenance

The document describes performance testing (resistance to deformation, force at break, freedom from leakage) and biocompatibility testing. However, it does not specify the sample sizes used for these tests. The data provenance is implied to be from Rocket Medical Plc. (UK manufacturer). Given the context of a 510(k) submission primarily comparing the subject device to a predicate, these tests would typically be prospective experimental studies performed on samples of the subject device. The document does not mention any clinical studies using human patients for the direct evaluation of this specific device's general performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes a 510(k) substantial equivalence submission, which relies heavily on laboratory-based performance testing and adherence to recognized standards (e.g., for biocompatibility). It does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnostic accuracy, as might be seen for an AI or imaging device. The "ground truth" for the performance tests would be defined by the measurement instruments and protocols used in the laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" here refers to physical performance and biocompatibility tests, not clinical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic data (e.g., imaging devices with AI assistance) to assess the impact of the device on reader performance. The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device for draining fluids, not a diagnostic tool requiring human interpretation for its primary function.

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

No, a standalone performance evaluation (in the context of an algorithm or AI) was not done. This device is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used

For mechanical performance and material properties, the "ground truth" is established by objective measurements against defined engineering specifications and international standards (e.g., ISO standards for breaking force, leakage).
For biocompatibility, the "ground truth" is established by validated laboratory assays (e.g., cytotoxicity tests, sensitization tests) according to recognized standards like ISO 10993.
For sterility, the "ground truth" is established by specific sterility testing methods to confirm a Sterility Assurance Level (SAL) of 10⁻⁶.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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