(194 days)
To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.
EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs. The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. System components include a mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model. The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) premarket notification letter and a summary of the device (EzVena IPC, EzVena SQS) and its comparison to a predicate device (Flowtron ACS900) for establishing substantial equivalence.
This document focuses on:
- Device Description and Intended Use: Explaining what the device is and what it's used for (intermittent pneumatic compression to prevent DVT).
- Comparison to Predicate Device: Highlighting similarities and minor differences between the EzVena devices and the legally marketed Flowtron ACS900.
- Non-Clinical Testing: Listing various tests (biocompatibility, electrical safety, EMC, software validation, etc.) conducted according to recognized standards to demonstrate safety and effectiveness for substantial equivalence. No clinical testing was deemed necessary.
- Cybersecurity and Other Compliance: Addressing compliance with relevant FDA guidance.
- Conclusion of Substantial Equivalence: Stating that the EzVena devices are substantially equivalent to the predicate.
There is no mention of a defined set of acceptance criteria (e.g., performance thresholds for sensitivity, specificity, accuracy, or specific measurements) that the device must meet, nor is there a description of a study designed to demonstrate that the device achieved these specific performance acceptance criteria. The "testing" mentioned refers to non-clinical engineering and bench tests, primarily to ensure safety, electromagnetic compatibility, and proper software function, rather than clinical performance against specific metrics.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about MRMC studies, standalone performance, or ground truth establishment based on the provided text.
§ 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).