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510(k) Data Aggregation
(86 days)
The Aspira* Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion.
The Aspira* Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.
The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira* Luer/Universal Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the Aspira* Drainage Catheter. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.
The Aspira* Pleural Drainage System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Aspira* Pleural Drainage System are the Aspira* Pleural Drainage Catheter and the Aspira* Drainage Bag.
This document describes the Aspira Pleural Drainage System*, a medical device designed for long-term intermittent drainage of pleural fluid. The submission is a Special 510(k) Premarket Notification (K110409) dated February 9, 2011, by Bard Access Systems, Inc. The purpose of this notification is to demonstrate the substantial equivalence of the modified device to a previously cleared predicate device (K071095).
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the verification and validation activities conducted to demonstrate that the Aspira* Pleural Drainage System met predetermined performance specifications. The acceptance criteria are implicitly defined by the adherence to a set of recognized international standards and internal protocols. The "reported device performance" is a general statement that the device met all pre-determined acceptance criteria.
| Acceptance Criteria (Defined by adherence to standards and in-house protocols) | Reported Device Performance |
|---|---|
| Biocompatibility: Evaluation and testing according to ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | The subject device met all pre-determined acceptance criteria. |
| Ethylene Oxide Sterilization Residuals: Evaluation according to ISO 10993-7:2008 (Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals) and AAMI TIR 19:1998 (Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals). | The subject device met all pre-determined acceptance criteria. |
| Conical Fittings (Luer Taper): Adherence to ISO 594-1:1986 (General Requirements) and ISO 594-2:1998 (Lock Fittings) for syringes, needles, and certain other medical equipment. | The subject device met all pre-determined acceptance criteria. |
| Sterile Drainage Catheters and Accessory Devices: Compliance with EN 1617:1997 (Sterile Drainage Catheters and Accessory Devices for Single Use). | The subject device met all pre-determined acceptance criteria. |
| Catheter Common Properties (Other than Intravascular): Compliance with EN 1618:1997 (Catheters Other Than Intravascular Catheters – Test Methods for Common Properties). | The subject device met all pre-determined acceptance criteria. |
| Packaging for Terminally Sterilized Medical Devices: Compliance with ISO 11607-1,2:2006 (Packaging for Terminally Sterilized Medical Devices). | The subject device met all pre-determined acceptance criteria. |
| Shipping and Handling (Package Integrity): Adherence to ISTA -1G:2005 (International Safe Transit Authority Procedure 1G) for transportation simulation testing. | The subject device met all pre-determined acceptance criteria. |
| Sterilization Validation (Ethylene Oxide): Compliance with BS EN 550:1994 (Sterilization of Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization) and ISO 11135-1:2007 (Sterilization of health care products - Ethylene Oxide – Validation and Routine Control of Sterilization Processes for Medical Devices). | The subject device met all pre-determined acceptance criteria. |
| Product-specific performance specifications: Compliance with in-house protocols for various performance aspects (e.g., proper drainage function, valve integrity, repair kit effectiveness, adapter functionality). (These are not explicitly listed but implied by the statement "in-house protocols were used to determine appropriate methods for evaluating the performance of the device.") | The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for the test set for any of the mentioned verification and validation activities. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective) as the studies are entirely non-clinical (engineering and biocompatibility testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The studies described are primarily engineering and biocompatibility tests, not clinical studies requiring expert consensus for ground truth. The "ground truth" for these tests would be the compliance with the specified international standards and internal performance specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or evaluators, which is not the case for the verification and validation activities described here. Compliance is determined against pre-defined engineering and biological criteria.
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
There was no MRMC comparative effectiveness study done. This device is a physical medical device (drainage system), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for these studies is:
- Compliance with established international standards: Such as ISO 10993, ISO 594, EN 1617, EN 1618, ISO 11607, ISTA -1G, BS EN 550, ISO 11135, and AAMI TIR 19.
- Adherence to in-house protocols and predetermined performance specifications: These would cover aspects like device functionality, integrity, and safety.
- Substantial equivalence to a predicate device (K071095): The ultimate ground truth is demonstrating that the modified device is as safe and effective as the previously cleared predicate device, based on the non-clinical tests.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/machine learning system that requires a "training set." The studies performed are for validating the physical properties and performance of a medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of medical device submission.
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