(115 days)
The Pleurx Pleural Catheter Kits 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 the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.
The Pleurx Pleural Cather System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.
The provided document describes the 510(k) submission for the CareFusion Pleurx Pleural Catheter System. This submission focuses on expanding the indications for use and adding accessories to an existing legally marketed device. Therefore, the information provided primarily concerns non-clinical testing for substantial equivalence, rather than a clinical study evaluating the device's performance against specific acceptance criteria for efficacy or accuracy in the way an AI/ML device would be assessed.
Here's a breakdown of the requested information based on the provided text, with notes where the information is not applicable (N/A) due to the nature of the device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with various recognized standards for medical device safety and performance, and the "reported device performance" is the conclusion that the device meets or exceeds these standards, demonstrating substantial equivalence to predicate devices. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, or accuracy) reported that would be typical for an AI/ML device.
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-3: 2003 (R) 2009 Biological Evaluation of Medical Devices - Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-4: 2002 (R) 2009 Biological Evaluation of Medical Devices - Part 4 Selection of Tests for Interaction with Blood | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - Part 6 Tests for Local Effects After Implantation | Met requirements |
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitivity | Met requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 Tests for Systemic Toxicity | Met requirements |
| Biocompatibility | USP Containers - Plastics, Physiochemical Tests | Met requirements |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use | Met requirements |
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for Common Properties | Met requirements |
| Performance | ISO 11070 Sterile, Single-use Intravascular Catheters | Met requirements |
| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices | Met requirements |
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems | Met requirements |
| Performance | ISO 11138-1,2:2006 Sterilization of healthcare products - Biological Indicators | Met requirements |
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2 | Met requirements |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization | Met requirements |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization | Met requirements |
| Overall Conclusion | All performance requirements based on recognized standards for safety and effectiveness | The results of the non-clinical tests show that the CareFusion Pleurx Pleural Catheter System meets or exceed all performance requirements, and are substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is N/A. The document states, "N/A - No clinical tests were conducted for this submission." The testing described is non-clinical (biocompatibility, performance characteristics like sterilization, packaging integrity, etc.) and refers to compliance with standards rather than a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is N/A as no clinical test set requiring expert ground truth was conducted.
4. Adjudication Method for the Test Set
This information is N/A as no clinical test set requiring adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
This information is N/A. This is not an AI/ML device, and no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
This information is N/A. This is not an AI/ML device.
7. The Type of Ground Truth Used
This information is N/A as no clinical ground truth was established for this submission. The "ground truth" for this submission is adherence to recognized non-clinical performance standards and substantial equivalence to legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is N/A. This is not an AI/ML device, and therefore no training set was used.
9. How the Ground Truth for the Training Set Was Established
This information is N/A. This is not an AI/ML device, and therefore no training set or its associated ground truth was established.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its "acceptance criteria" is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of national and international standards related to biocompatibility, sterilization, packaging, and general catheter performance. The submission concludes that these non-clinical tests collectively show the CareFusion Pleurx Pleural Catheter System meets or exceeds all performance requirements and is substantially equivalent to existing predicate devices. No clinical studies were conducted for this specific 510(k) submission, as it focused on expanding indications and adding accessories to an already legally marketed device by demonstrating equivalence to previously cleared devices and adherence to established non-clinical performance and safety standards.
§ 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).