(126 days)
The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions 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 guidelines.
The devices are indicated for:
- The palliation of dyspnea due to pleural effusion
- Providing pleurodesis (resolution of the pleural effusion).
The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.
The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of pleural effusions. 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 pleural cavity. The IPC System will consist of the IPC and components necessary for its' use such as convenience kits to aid in the implantation of the Rocket IPC.
The Rocket IPC System, a fenestrated silicone drainage catheter for pleural effusions, underwent performance testing in accordance with applicable FDA Guidance documents and ISO standards. The device demonstrated satisfactory performance against predefined acceptance criteria for various physical and functional characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to deformation | 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 | The minimum force at break for connections shall be 15 N. (Nominal outside diameter >4 mm) | PASS |
| Force at break - Drainage catheters and all other parts of the system | 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 | Neither the drainage system nor any components shall leak at the maximum negative pressure stated by the manufacturer. | PASS |
| Impact resistance - Collection device | The collection device shall not leak. | PASS |
| Impact resistance - Suction Source | The suction source shall not show any loss of vacuum greater than 2%. | PASS |
| Flow Rate | Calculate the arithmetic average of three determinations and express it as water flow rate through the catheter in millilitres per minute. | PASS |
2. Sample Sizes Used for the Test Set and Data Provenance:
For the performance tests listed in the table, a sample size of 3 devices was used for each test. The document does not specify the country of origin of the data or whether the study was retrospective or prospective, as these were bench tests performed on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not interpretation by human experts to establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not an adjudication process by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted. The document describes bench testing for device performance and a comparison of technological characteristics to a predicate device, but not a study involving human readers with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
This information is not applicable as the device is a physical medical device (catheter system), not an algorithm or AI system. The performance tests focused on the device's physical and functional properties.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests was established by objective, measurable criteria defined in referenced international and national standards (e.g., EN 1617:1997, EN 1618:1997, ASTM F1980). These standards define the acceptable performance limits for the device's physical and functional characteristics.
8. Sample Size for the Training Set:
This information is not applicable as the submission describes a physical medical device and its bench testing, not an AI or algorithm-based device that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
§ 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).