(59 days)
The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.
The DigiVent™ Chest Drainage System consists primarily of a collection chamber and a Controller Unit. Pressure regulator, drainage tubing (with kink prevention), positive- and negative pressure relief valves, and hangers complete the system. Thoracic catheters (chest tubes) are not included.
This document describes the Millicore AB DigiVent™ Chest Drainage System. Based on the provided text, a comprehensive study with specific acceptance criteria and detailed results proving the device meets these criteria is not detailed. The document states that "Design verification and validation testing provided in this premarket notification for the DigiVent™ Chest Drainage System demonstrates that it meets its specifications," but it does not elaborate on what those specifications or the results of the testing were.
Therefore, the following information is an interpretation based on the general context of device approval documents and the lack of specific details in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
As the specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text, this table will reflect the types of criteria generally expected for such a device and the general assertion of performance provided in the document.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance | |
| Air evacuation | Met (implied by "evacuate air") |
| Fluid evacuation | Met (implied by "evacuate fluid") |
| Prevention of reaccumulation | Met (implied by "prevent air and/or fluid from reaccumulating") |
| Re-establishment of intrathoracic pressure | Met (implied by "re-establish and maintain normal intrathoracic pressure gradients") |
| Facilitation of lung re-expansion | Met (implied by "facilitate complete lung re-expansion") |
| Restoration of breathing dynamics | Met (implied by "restore normal breathing dynamics") |
| Safety and Reliability | |
| Kink prevention | Met (explicitly mentioned: "drainage tubing (with kink prevention)") |
| Positive pressure relief | Met (explicitly mentioned: "positive- and negative pressure relief valves") |
| Negative pressure relief | Met (explicitly mentioned: "positive- and negative pressure relief valves") |
| Adherence to specifications | Met (explicitly stated: "demonstrates that it meets its specifications") |
| Substantial equivalence to predicate devices | Achieved (stated in K062302 approval letter) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data). It generically mentions "Design verification and validation testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Ground truth establishment, if any, for performance testing is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The DigiVent™ Chest Drainage System is a medical device for drainage, not an AI-assisted diagnostic or imaging tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not an algorithm or AI system. Its performance would inherently be in conjunction with human use (e.g., a clinician connecting and monitoring it).
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing. Given it's a physical device, ground truth would likely be based on objective physical measurements and functional performance against defined engineering and safety standards, rather than expert consensus on medical images or pathology.
8. The Sample Size for the Training Set
This information is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.