(256 days)
The 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 effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleural Catheter Kits are indicated for adults only.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Valve Kit is intended to repair the Pleur X Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only.
The Pleur X LP Catheter Mini Kit is 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 the palliation of dyspnea effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.
The Pleurx Pleural Catheter 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 CareFusion Pleurx Pleural Catheter System, cleared under K160450, is a medical device for draining symptomatic, recurrent pleural effusion. The provided text indicates this 510(k) submission is for a change in material formulation and concentration, and minor design modifications to the devices previously cleared under K141965. No clinical studies were conducted for this submission. The device's acceptance criteria and performance are based on a series of non-clinical, in-vitro performance tests and biocompatibility studies.
1. Table of Acceptance Criteria and Reported Device Performance:
| 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 | The results of the non-clinical tests show that the CareFusion Pleural Catheter System is as safe, as effective, and performs as well as the legally marketed predicate devices. (This general statement applies to all biocompatibility tests listed, indicating successful completion and meeting established criteria for safety.) |
| Biocompatibility | AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices – Part 5 Tests for In Vitro Cytotoxicity | Ibid. |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices – Part 6 Tests for Local Effects After Implantation | Ibid. |
| Residuals (Ethylene Oxide) | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals | Ibid. |
| Biocompatibility (Irritation/Sensitivity) | AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10 Tests for Irritation and Skin Sensitivity | Ibid. |
| Biocompatibility (Leachable Substances) | ISO 10993-17:2002 Biological evaluation of medical devices – Establishment of allowable limits for leachable substances | Ibid. |
| Biocompatibility (Chemical Characterization) | ISO 10993-18:2005 Biological evaluation of medical devices – Chemical characterization of materials | Ibid. |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use | The results of the non-clinical tests show that the CareFusion Pleural Catheter System is as safe, as effective, and performs as well as the legally marketed predicate devices. (This general statement applies to all performance tests, indicating successful completion and meeting established criteria for functionality and safety.) |
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for Common Properties | Ibid. |
| Performance (Packaging) | ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for Terminally Sterilized Medical Devices- Part 1:Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)] | Ibid. |
| Performance (Packaging Validation) | ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for Terminally Sterilized Medical Devices- Part 2: Validation Requirements For Forming, Sealing And Assembly Processes [Including: Amendment 1 (2014)] | Ibid. |
| Performance (Accelerated Aging) | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems | Ibid. |
| Performance (Biological Indicators) | ISO 11138-1, 2nd Ed Sterilization of healthcare products - Biological Indicators - Part 1: General Requirements | Ibid. |
| Performance (Microbiological Methods) | ISO 11737-1 2nd Ed Sterilization of Medical Devices – Microbiological Methods Part 1 | Ibid. |
| Performance (EO Sterilization) | ISO 11135 2nd Ed Sterilization of Health-Care Products -Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | Ibid. |
| Performance (EO Sterilization Adoption) | AAMI TIR28:2009(R)2013 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization | Ibid. |
| Performance (Surgical Implants) | ISO 14630 Non-active Surgical Implants - General Requirements | Ibid. |
| Performance (MRI Safety - Displacement) | ASTM F2052 Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment | Ibid. |
| Performance (MRI Safety - Artifacts) | ASTM F2119 Evaluation of MR Image Artifacts from Passive Implants | Ibid. |
| Performance (MRI Safety - Heating) | ASTM F2182 A Measurement of Radiofrequency Induced Heating on or Near Passive Implants During MRI | Ibid. |
| Performance (MRI Safety - Torque) | ASTM F2213 Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | Ibid. |
2. Sample size used for the test set and the data provenance:
The document states "No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data. The performance was evaluated through non-clinical laboratory testing against recognized standards. The provenance of the data is from these laboratory tests, which are typically conducted in a controlled environment, not on human subjects or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as no clinical tests were conducted and thus no expert-established ground truth from a test set in a clinical context. The "ground truth" for non-clinical tests is established by adherence to the specified standards and the objective measurement of device performance against the requirements of those standards.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used requiring expert adjudication.
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:
Not applicable. The Pleurx Pleural Catheter System is a physical medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way typically associated with MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used:
The ground truth for the device's performance is based on the objective measurements and pass/fail criteria defined by the internationally recognized standards (e.g., ISO, AAMI, ASTM, EN) listed in the "Performance Test Summary" section. For example, biocompatibility is evaluated against the requirements of ISO 10993 standards, and physical performance against specific EN standards.
8. The sample size for the training set:
Not applicable, as no clinical or AI-based training set was used. The submission is about modifications to an existing device and relies on non-clinical testing.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
§ 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).