(244 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.
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:
| Test | Test Method or Standard Reference | Sample Size | Final Report | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Resistance to deformation | EN 1617:1997 4.2 (including Annex A) | 3 | NPD QA 1050 | The drainage system or any component intended to operate under negative pressure shall not show deformation sufficient to impair the function of the device at the maximum negative pressure stated by the manufacturer. | PASS |
| Force at break – Connections | EN 1617:1997 4.3.1; EN 1618: 1997 Annex F | 3 | NPD QA 1054 and 1055 | The minimum force at break for connections shall be 15 N. (Nominal outside diameter >4mm). | PASS |
| Force at break – Drainage catheters and all other parts of the system | EN 1617:1997 4.3.2; EN 1618: 1997 Annex B | 3 | NPD QA 1054 | The minimum force at break for catheter and all other parts of system shall be 20 N. (Nominal outside diameter >4mm). | PASS |
| Freedom from leakage – During aspiration or vacuum | EN 1617:1997 4,5; EN 1618:1997 Annex D | 3 | NPD QA 1051 | Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer. | PASS |
| Impact resistance – Collection device | EN 1617:1997 4.6 (including Annex B) | 3 | NPD QA 1052 | The collection device shall not leak. | PASS |
| Impact – resistance – Suction Source | EN 1617:1997 4.6 (including Annex B) | 3 | NPD QA 1053 | The suction source shall not show any loss of vacuum greater than 2%. | PASS |
| Flow Rate | EN 1618:1997 Annex D | 3 | NPD QA 1053 | Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute. (No specific numerical acceptance criterion is provided in the table, but it passed the test). | PASS |
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.
§ 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.