(177 days)
T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.
The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain consistent pressure on the arm and blood flow at the access site during apheresis procedures. This device is composed of 4 major components and was developed to enhance venous access during venipuncture and help donors maintain a consistent pressure on the arm during apheresis procedures. The catalog number for the T-Cuff is 71252.
T-Cuff is designed to maintain a consistent pressure when applied to the donor's bicep with consistent squeezing of the inflatable bulb. During the apheresis process, the device operates in two modes: Venipuncture and Collection. The mode of operation is changed by adjusting the pressure relief valve cap. During Venipuncture mode, application of T-Cuff to the donor's upper arm prior to obtaining venipuncture allows the T-Cuff to inflate to assist with vein selection. During Collection mode, the T-Cuff maintains a consistent pressure of 20-40 mmHg (millimeter of mercury) on the donor's upper arm to help facilitate optimal blood flow during apheresis procedures. T-Cuff is a non-sterile, non-single use device.
The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain pressure on the arm and, aid in the facilitation of blood flow during apheresis procedures. It operates in two modes, Venipuncture and Collection. During Venipuncture mode, the T-Cuff is inflated to higher pressure (no greater than 120 mmHg) as venipuncture is performed. Once Venipuncture is complete, the device maintains a steady, lower, consistent pressure (20 - 40 mmHg) during Collection mode. The donor squeezes a rubber bulb in continuous intervals to distribute air through the system and, facilitate optimal blood flow during apheresis procedures. The T-Cuff does not contain an energy source. Primary mechanism of action is obtained through the influx of air into the system and, by a modulating pressure relief valve that maintains defined pressure ranges.
The provided document is a 510(k) premarket notification for a medical device called "T-Cuff," a pneumatic tourniquet. The document explicitly states that the T-Cuff is substantially equivalent to a predicate device and does not present acceptance criteria or detailed results from a clinical study designed to prove the device meets acceptance criteria in the typical sense of a novel device demonstrating its efficacy or safety against pre-defined metrics.
Instead, the clinical study mentioned (Section VII.F. Clinical Studies) was designed to determine if manual and/or automatic adjustments to the draw flow rate would decrease operator interventions and overall procedure time when using the T-Cuff in apheresis procedures. The T-Cuff itself was "utilized for all donations in this study," implying it was a tool within a larger study, rather than the primary subject of a performance validation study against specific acceptance criteria for its own function (e.g., pressure accuracy, comfort, etc.).
Therefore, I cannot extract the information required by the prompt's structured questions from the provided text, as the document does not contain:
- A table of acceptance criteria and reported device performance for the T-Cuff meeting those criteria.
- Details on sample size for a test set specifically for T-Cuff performance validation.
- Information on ground truth establishment (number/qualifications of experts, adjudication methods) for T-Cuff performance, as the study focused on apheresis procedure efficiency.
- Mention of MRMC comparative effectiveness studies or standalone algorithm performance, as the T-Cuff is a physical, non-AI device.
- Specific details of the sample size for a training set or how ground truth was established for it, as this is not an AI/ML device.
The document states:
- "The primary endpoint for this study was to determine if manual and/or automatic adjustments to the draw flow rate would decrease the number of operator interventions and overall procedure time."
- "The T-Cuff was utilized for all donations in this study, and it was demonstrated that manual and automatic adjustment to the draw flow rate decreased the number of operator interventions and did not increase the overall procedure time."
- "All products collected met the FDA regulations regarding the level of residual white blood cells (
§ 878.5910 Pneumatic tourniquet.
(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.