(267 days)
- For the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations,
- To evacuate air and/or fluid from the chest cavity or mediastinum,
- To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum,
- To help re-establish and maintain normal intra-thoracic pressure gradients,
- To facilitate complete lung re-expansion to restore normal breathing dynamics.
Provided as a sterile unit and intended for single patient use, the A-9250LF Pleurevac® Plus Continuous Reinfusion Autotransfusion System is a three-chamber, collection/reinfusion system used for the collection and continuous reinfusion of autologous blood. By attaching a blood transfer bag, which is available as an accessory item, the A-9250LF Pleur-evac® Plus serves as a bag reinfusion system with a non-pyrogenic fluid path. When autotransfusion is complete, the A-9250LF Pleur-evac® Plus can serve as a water seal/dry suction chest drainage collection unit.
The provided text describes a 510(k) premarket notification for a medical device called the "Pleur-evac® Plus Continuous Reinfusion And Autotransfusion System." The purpose of this notification is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, the "Deknatel® A-9150 Pleur-evac® Plus Continuous Reinfusion & Autoinfusion System."
The document details performance data obtained from bench testing to verify this substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test Parameters | Reported Device Performance |
|---|---|
| A visual inspection must be performed to ensure that all pouched tubing is coiled correctly without kinks. | Pass (Kink) |
| No leaks in the tubing when clamped at 60 cm H2O for vacuum and at 4 cm H2O positive pressure minimum. | Pass (Tubing Clamp Leak) |
| No tubing collapse at 340 cm H2O negative pressure. | Pass (Tubing Collapse) |
| Separation force of ATS Connector from tubing. | Pass (ATS Connector Pull Test) |
| All compartments must hold the indicated volumes with liquid spillover occurring only at the spillover level. | Pass (Inter-Chamber Leak Test) |
| The unit shall be airtight when operated at negative pressure 60 cm H2O. | Pass (Leak Integrity Test) |
| The unit shall have a minimum burst strength of 5 psig (PSI Gauge) at welded joints with all openings to atmosphere sealed. | Pass (Burst Test) |
| The separation force of the tube and spring from the reinfusion port and the tube from the spike port shall be a minimum of 10 lbs axially. | Pass (Reinfusion Tube Separation Force Test) |
2. Sample sizes used for the test set and the data provenance
The sample sizes for the test set are provided in the "Quantity" column of the "Performance Data" table.
- Kink: 300
- Tubing Clamp Leak: 60
- Tubing Collapse: 300
- ATS Connector Pull Test: 60
- Inter-Chamber Leak Test: 60
- Leak Integrity Test: 60
- Burst Test: 60
- Reinfusion Tube Separation Force Test: 60
The data provenance is bench testing performed by Teleflex. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these terms are typically associated with human or animal studies, not bench testing of a device's physical properties.
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 (N/A) in this context. The "ground truth" for these performance tests is defined by the physical parameters and engineering specifications themselves, not by expert consensus or interpretations. For example, for the "Kink" test, the ground truth is simply the absence of kinks, which is determined by visual inspection against a predefined standard, not by expert interpretation. Similarly, for leak tests or burst strength tests, the ground truth is a measurable physical property that either meets or fails a numerical threshold.
4. Adjudication method for the test set
This information is not explicitly stated and is likely N/A for this type of bench testing. The tests involve objective measurements (e.g., pressure, force, visual inspection for kinks) against predefined criteria. An adjudication method, often used in clinical trials involving subjective assessments, would not typically apply here. The results are reported as "Pass," indicating compliance with the specified parameters.
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
No, an MRMC comparative effectiveness study was not done. This device is a medical apparatus (Autotransfusion System), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on engineering specifications, physical measurements, and visual inspection against predetermined criteria.
- For example, for "Tubing Clamp Leak," the ground truth is whether "No leaks in the tubing" are observed under specified pressure conditions.
- For "Burst Test," the ground truth is whether the unit satisfies a "minimum burst strength of 5 psig."
- For "Kink" test, the ground truth is a "visual inspection... to ensure that all pouched tubing is coiled correctly without kinks."
These are objective, measurable outcomes and not a "ground truth" established by expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This information is not applicable (N/A). The document describes a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set. The device's performance is verified through bench testing of physical properties, not by training.
9. How the ground truth for the training set was established
This information is not applicable (N/A), as there is no training set for a machine learning model.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).