(199 days)
The Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.
The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).
The provided document is a 510(k) Premarket Notification for the Rocket Platinum Cured Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests, primarily bench testing. It does not describe a study involving an AI/machine learning device; therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, expert consensus for ground truth, training set information) are not applicable.
Below is a summary based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them for this specific type of medical device (a physical catheter).
The Rocket Platinum Cured Catheter underwent a series of non-clinical performance tests to demonstrate its safety and effectiveness and its substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document includes "Table 9.1: Summary of Verification Testing" which details specific acceptance criteria and the results.
| Test | Test Method or Standard Reference | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance to deformation | EN 1617:1997 4.2 (including Annex A) | 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 - Drainage catheters and all other parts of the system | EN 1617:1997 4.3.2; EN 1618: 1997 Annex B | The minimum force at break for catheter and all other parts of system shall be 20 N. (Nominal outside diameter >4 mm) | PASS |
| Freedom from leakage - During aspiration or vacuum | EN 1617:1997 4.5; EN 1618:1997 Annex D | Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer (73.2-73.6 cmHg). | PASS |
| Impact resistance - Collection device | EN 1617:1997 4.6 (including Annex B) | The collection device shall not leak. | PASS |
| Impact resistance - Suction Source | EN1617:1997 4.6 (including Annex B) | The suction source shall not show any loss of vacuum greater than 2 %. | PASS |
| Flow Rate | EN 1618:1997 Annex D | Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute. (Note: The "PASS" result indicates this calculation was performed and confirmed to be within expected performance for the device's function, implying it met an implicit expected range, though not explicitly stated as a numerical range in the acceptance criteria shown). | PASS |
Additional performance data in "Table 9.2: Summary of Further Testing Performed" (Biocompatibility tests):
| Test | Results |
|---|---|
| MEM Elution GLP Report | PASS |
| ISO Guinea Pig Maximization Sensitization Test | Did not elicit a sensitization response |
| ISO Intracutaneous Reactivity Test | PASS |
| ISO Acute Systemic injection Test | PASS |
| Rabbit Pyrogen Test (Material Mediated) ISO | Requirements Met |
| Subacute 14-day Intra Peritoneal Toxicity Study in Mice | PASS |
| The Salmonella Typhimurium Reverse Mutation Assay | Non-Mutagenic |
| Chromosome Aberration Assay | PASS |
| In Vivo Mouse Micronucleus Assay | Non-Mutagenic |
| In Vitro Mouse Lymphoma Assay | Non-Mutagenic |
| Intramuscular Implant Test Thirteen Week Duration | Non-Irritant |
| Intramuscular Implant Test Six Month Duration | No-Irritant |
| Chemical Characterization | Refer to Test |
| RA Final Evaluation of Local Tissue Effects of ZASEM222 Catheter Assembly following intramuscular Implantation in the Rabbit. (ZASEM222 is now renamed as ZASEM297). | Refer to Test |
| Biological Risk Assessment, ZASEM222 Platinum Cured Silicone Catheter including ZDLTR043 Steel Dilator). | Refer to Test |
| MT Transport Study Report J15474-TX-1 | (Result not explicitly stated as PASS/FAIL, implies report available) |
| EtO Residual Test Reports IPC | Original Catheter in substantial equivalence 510k |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing: For the tests listed in Table 9.1, the sample size used was 3 units for each specific test (e.g., Resistance to deformation, Force at break, Freedom from leakage).
- Data Provenance: The tests are non-clinical bench tests performed on the device itself.
- Country of Origin: The submitter is Rocket Medical Plc., located in Washington, Tyne & Wear, United Kingdom. The tests would likely have been conducted in the UK or by a contracted lab.
- Retrospective or Prospective: These are prospective laboratory performance tests designed to evaluate the physical and biological characteristics of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is largely not applicable as the studies are focused on physical and biological performance of the catheter, not diagnostic image analysis or clinical decision support where expert medical interpretation forms ground truth. The "ground truth" for these tests is established by objective physical measurements (e.g., force, leakage, flow rate, chemical composition) and standardized biological assay results against predefined specifications in recognized international standards (e.g., ISO, EN, ASTM). The "experts" involved would be qualified laboratory technicians and scientists following validated test protocols.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML device relying on human consensus for ground truth. These are objective engineering and biocompatibility tests. Results are determined by direct measurement against quantitative or qualitative pass/fail criteria from international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI/ML devices where human readers (e.g., radiologists) interpret cases with or without AI assistance. The Rocket Platinum Cured Catheter is a physical medical device (catheter) for drainage, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- International Standards: Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, EN 1617/1618 for catheters).
- Objective Bench Test Measurements: Quantifiable physical properties (e.g., force, pressure, flow rate, deformation) measured in controlled laboratory settings.
- Biocompatibility Assay Results: Biological responses (e.g., cytotoxicity, sensitization, pyrogenicity, toxicity, irritation) observed in standardized in vitro and in vivo models.
- Predetermined Specifications: The device's performance is measured against internal design specifications and requirements derived from the relevant standards, ensuring
PassorFail.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a physical device, there is no AI/ML training set or associated ground truth to establish.
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).