Product Content List
• 1 unit of 10ml PRP SYRINGE
• 1 unit of Luer-cap
• 1 unit of Luer-adaptor
Intended Use of the Device
The device is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is prepared prior to application to a local area of soft tissue or hard tissue (including bone) site as deemed necessary by the clinical use requirements. And its intended use is for the application of PRP in order to achieve the stimulation of soft tissue and hard tissue (including bone) and acceleration of soft tissue and hard tissue (including bone) healing.
Performance of the Device Intended by the Manufacturer
PRP (Platelet Rich Plasma) is used for many years in the frame of regenerative medicine, which allows the cellular healing on bone and soft tissue recovery. Bone and soft tissue healing are occurred by the platelet concentration and re-injection locally to the related part of the body.
Concentration of platelets is very important for PRP treatments. Blood withdrawn from the patient is centrifuged to concentrate the PRP layer. Recommended G force for the concentration is 1500 G for 4 minutes. The blood separation system takes the advantage of centrifugation force effecting on the weight of the cells. The separation occurs during centrifugation when the denser blood components move due to a gravity force.
The PRP SYRINGE shall not be mixed after the centrifugation. 3-4ml of layer is discarded carefully to another syringe until the erythrocytes (Red Blood Cell layer).
The result is a convenient syringe system, collection of the whole blood and concentration of Platelet Rich Plasma. PRP SYRINGE reduces the risk of air contamination, eliminates the need of any other tubes or pipettes.
Clinical Safety Information
The safety and efficacy of this device has been proven by Risk Analysis Report and Clinical Evaluation Report, attached to the Technical Construction File of PRP SYRINGE.
Residual Risk and Side Effects Information
According to the risk assessment, risk management, risk report procedures of this device, it shows no residual risks. With respect to the requirements of Essential Requirements 6, the risk management report showed that there were no serious side effects and the performance of the product was verified by the clinical evaluation report.
This product should be used by physicians or physician-directed allied health care professionals.