(157 days)
The BODY FORCE is a medical device used on patients who have experienced an abdominal/ pelvic crush injury. The purpose is to prevent a decrease in the central blood volume during transportation to a trauma center.
Indications for use are: (Tourniquet)
- Uncontrollable hemorrhaging in the leg(s)
The BODY FORCE is a composite board, measuring eighteen inches (18") long and eight inches (8") wide and seven-eighths inches (7/8") thick with a loose strap on one side that is two inches (2") wide and seventy inches (70") long. On the other side is a strap that is also two inches (2") wide but only six inches (6") long with a metal ratchet sewn into it. The straps are sewn into a three sixteenth inch (3/16") X fourinch (4") wide stainless steel hinges, with a non-removable pin. The hinges will be held down to the plate by a cam-lock that passes through the board in slots that enable it to be adjusted to several different sizes. There is also a long gated eyebolt that locks into the center of the board that is designed to be used as a bilateral tourniquet for the lower extremities.
The provided document is a 510(k) premarket notification for a medical device called "BODY FORCE," a compressible limb sleeve intended for abdominal/pelvic crush injuries and as a tourniquet.
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission to the FDA for substantial equivalence to a predicate device, not a report of performance testing against specific criteria.
Therefore, I cannot provide the requested information from the given text.
To address your request, the document would need to include:
- A section detailing specific performance metrics (e.g., pressure exerted, effectiveness in reducing blood flow, durability, ease of use).
- Quantitative measurements for these metrics.
- A description of a study (e.g., clinical trial, bench testing, animal study) conducted to evaluate these metrics.
- Details about sample size, ground truth, expert involvement, etc., for any such study.
§ 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).