(156 days)
The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
VasoPress DVT System, Pump Model VP500D
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VasoPress DVT System, Pump Model VP500D) that is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about acceptance criteria and specific study results proving the device meets those criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
Information that can be extracted or inferred:
- Device Name: VasoPress DVT System, Pump Model VP500D
- Intended Use/Indications for Use: "The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk."
- Regulatory Class: Class II (two)
- Product Code: JOW
- Regulation Number/Name: 21 CFR 870.5800 / Compressible Limb Sleeve
- Type of Approval: Substantial Equivalence via 510(k) premarket notification. This implies that the device's performance was compared to a predicate device's performance, but the details of that comparison are not included here.
- Standalone Performance: Since it's a pneumatic compression pump, its performance would inherently be "standalone" in the sense that it operates mechanically without human-in-the-loop interpretation like an AI diagnostic tool.
Information that CANNOT be extracted from this document:
- Table of acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics.
- Sample sizes used for the test set and data provenance: No test studies or their associated data are described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical studies with ground truth establishment are discussed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an interpretative AI system.
- The type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device that involves a training set.
- How the ground truth for the training set was established: Not applicable.
Summary Table of Available Information (based on the limits of the provided document):
| Feature | Description / Data Point |
|---|---|
| Acceptance Criteria & Reported Performance | Not detailed in this document. The FDA has made a "substantial equivalence determination" based on comparison to a predicate device, meaning the device's technological characteristics and performance are considered equivalent for its intended use. Specific quantitative performance metrics or acceptance thresholds are not provided. |
| Sample size (test set) & data provenance | Not available in this document. |
| Number & qualifications of experts for ground truth (test set) | Not applicable for this type of device and document. |
| Adjudication method (test set) | Not applicable. |
| MRMC comparative effectiveness study (effect size human + AI vs. human only) | Not applicable. This is a pneumatic compression device, not an AI interpretive system. |
| Standalone performance (algorithm only) | Yes, the device ("VasoPress DVT System, Pump Model VP500D") is a standalone external pneumatic compression device. Its performance relates to its mechanical operation (e.g., pressure cycles, duration) as compared to a predicate, not an interpretive algorithm. The specific performance data for "standalone" operation is not detailed in this letter, beyond the FDA's statement of substantial equivalence. |
| Type of ground truth used | Not applicable in the context of ground truth for diagnostic imaging or similar AI systems. For a physical device, "ground truth" would relate to its physiological effect (e.g., actual reduction in DVT incidence), which would be assessed in clinical trials not detailed in this 510(k) summary. The basis for substantial equivalence is typically comparison to a predicate device, which implies the predicate's established safety and effectiveness forms the "ground truth" for the new device's regulatory pathway. |
| Sample size for training set | Not applicable, as this is not an AI/machine learning device. |
| How ground truth for training set was established | Not applicable. |
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).