(73 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Resistance to deformation | Meets criteria (implied as "Same" as predicate) |
| Force at break - connections | Meets criteria (implied as "Same" as predicate) |
| Force at break - drainage catheters and all other parts | Meets criteria (implied as "Same" as predicate) |
| Freedom from leakage | Meets criteria (implied as "Same" as predicate) |
| Biocompatibility: (evaluated against ISO 10993 standards) | |
| Cytotoxicity | Meets criteria (implied as "Same" as predicate) |
| Sensitization | Meets criteria (implied as "Same" as predicate) |
| Irritation | Meets criteria (implied as "Same" as predicate) |
| System toxicity | Meets criteria (implied as "Same" as predicate) |
| Subchronic toxicity | Meets criteria (implied as "Same" as predicate) |
| Genotoxicity | Meets criteria (implied as "Same" as predicate) |
| Implantation | Meets criteria (implied as "Same" as predicate) |
| Exhaustive extraction | Meets criteria (implied as "Same" as predicate) |
| Summary report and biological risk assessment | Meets criteria (implied as "Same" as predicate) |
| Packaging Components and Materials Performance: | |
| APET tray, blue field wrap, uncoated Tyvek 1073B/PET pouch, folding carton | Meets predicate's performance (implied as "Same") |
| Sterility: | |
| Achieves Sterility Assurance Level (SAL) 10⁻⁶ | Achieves SAL 10⁻⁶ (implied as "Same" as predicate) |
| Sterilization Method: | |
| Ethylene Oxide (EtO) | Effective (implied as "Same" as predicate) |
| Shelf Life: | |
| 3 years | Demonstrates 3 years (implied as "Same" as predicate) |
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.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.