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Table of Contents:
- The Name or Trade Name of The Medical Device
- The Name and The Address of The Manufacturer
- Product Content List
- Intended Use of The Product
- The Performance of The Device Intended by The Manufacturer
- Clinical Safety Information
- Residual Risk Information and Side Effect Information
- User Profile
- Storage, Shelf Life and Handling Information
- Precautions, Warnings, Measures to Be Taken and Limitations
- Patient Profile and Possible Contraindicative Situations
- Symbols and Explanations
The Name or Trade Name of the Medical Device
The product is a PRP KIT, sterile, single use medical device.
The Name and the Address of the Manufacturer
Product Content List
- 2 units of PRP Tube(s)
- 1 unit of Re-suspension Tube
- 1 unit of Long Needle
- 1 unit of Holder
- 1 unit of 1ml Injector
- 1 unit of 5ml Injector
- 1 unit of 30G needle
- 1 unit of 21G needle
- 1 unit of Blood Collection Needle
Intended Use of the Product
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.
The 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 is occurred by the platelet concentration and re-injection locally to the related part of the body.
Concentration of platelets with buffy coat layer is very important for PRP treatments. Currently accepted technique for avoiding coagulation of the whole blood, referred to Sodium Citrate. The procedure uses anticoagulated blood, collected by routine phlebotomy. Buffered Citrate Solution blocks the coagulation by mixing gently the whole blood together with 3,20% concentrated 0,1M of Sodium Citrate. This preparation is then centrifuged to concentrate the PRP layer. Recommended G force for the concentration is 830 G. The blood separation system takes the advantage of centrifugational 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 Tube shall not be mixed after the centrifugation. 2ml of layer is harvested carefully above the erythrocytes. (Red Blood Cell layer) The collected PRP layer is moved to Re-suspension tube for re-suspension process.
The result is a convenient tube system, collection of the whole blood and concentration of Platelet Rich Plasma. PRP Tubes included in PRP KIT are interior sterilized using irradiation. PRP KIT 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 File of PRP Kit.
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 with adequate training in the use of the device.
Apply the following instructions to obtain Platelet Rich Plasma by using PRP KIT:
- Open the box.
- Open the sterile blister package.
- Attach Blood Collection Needle to Holder.
- Apply the Blood Collection Needle to sanitized part of the patient’s arm. (Venous)
- Attach PRP Tube inside the holder to Blood Collection Needle. (Routine Phlebotomy)
- PRP Tube is a vacuumed tube. The tube collects enough amount of blood and stops itself. (Apply both tubes, without removing the Blood Collection Needle from the vessel.)
- Centrifuge both tubes in a centrifuging device at 830 G for 8 minutes. Buckets shall be compatible for PRP Tubes (16 X 100 mm tube size).
- Attach Long Needle to 5ml Luer-lok Syringe.
- Collect the PRP by sticking the Long needle into the PRP Tube above the RBC Layer (Do not open the Lid of the tube unless it is not performed under Laminar Flow Conditions)
- Collect carefully 2ml of PRP Layer.
- Carry PRP to the Re-suspension Tube.
- Apply again the same protocol for the other PRP Tube.
- Carry again PRP to the Re-suspension tube.
- You have app. 4 ml of PRP inside the Re-suspension tube. (Re-suspension tube is 5 ml capacity sterile tube)
- Gently shake the Re-suspension tube for 30 seconds to homogenize the settlement of the possible clumped cells in the plasma milieu. (Re-suspension process)
- Attach the application needle (Green Needle - 21G) to 1ml Luer-Lok syringe.
- Collect the re-suspended PRP inside from the Re-Suspension Tube.
- Change application needle (green needle - 21G) to injection needle (yellow needle - 30G)
- Apply the injection method to the patient.
Storage, Product Life and Handling Information
- Do not expose to direct sunlight.
- Do not use if the inner sterile blister package is damaged or opened.
- Shelf life (Product Lifecycle) is the expiration date on the label.
Precautions, Warnings, Measures to Be Taken and Limitations
- Use proper safety precautions to guard against needle sticks.
- Follow manufacturer instructions when using centrifuge.
- Do not use sterile component of this kit if package is opened or damaged.
- Do not open the lids of the tubes.
- Single use device, do not reuse.
- The user should be thoroughly familiar with the equipment and the surgical procedure prior to using this device.
- The patient should be made aware of general risks associated with treatment and possible adverse effects.
- Do not dispose of this product in the unsorted municipal waste stream.
- Long Needle is not intended to be used on human. It is just intended to be used to collect PRP Layer inside from the PRP Tube(s).
Patient Profile and Possible Contraindicative Situations
Platelet rich plasma is an autologous application technique and it is used on the same patient. Due to this information, platelet-rich plasma applications are inherently safe from infectious diseases such as HIV, Hepatitis, Creutzfeldt-Jakob disease.
As an autologous technique; however, Platelet-Rich Plasma can be used safe and effectively to all patients, there may have a need for further studies on pregnant and newborns.
Possible Contraindicative Situations
- Platelet Dysfunction Syndrome
- Critical Thrombocytopaenia
- Hemodynamic instability
- Auto-immune diseases
- Acute Chronic infections
- Chronic Liver Pathology
- Anti-coagulation Therapy (ASA therapy etc.)
- Pregnancy (for cosmetic indications)
Symbols and Explanations (Product Label & IFU)
European Medical Devices Directive 93/42/EEC of 14 June 1993
Notified Body: Notice (2195)
Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC.
Indicates the manufacturer's catalog number so that the medical device can be identified NOTE: Synonyms for "catalogue number" are "reference number" and "reorder number"
Indicates the manufacturer's batch code so that the batch or lot can be identified
Use by date
Indicates the date after which the medical device is not to be used.
Sterilized Using Irradiation
Indicates a medical device that has been sterilized using irradiation.
Sterilized Using Ethylene Oxide
Indicates a medical device that has been sterilized using ethylene oxide.
Do Not Re-sterilize
Indicates a medical device that is not to be re-sterilized.
Do Not Use if Package is Damaged
Keep Away from Sunlight
Indicates a medical device that needs to be protected from moisture.
Indicates the temperature limits to which the medical device can be safely exposed.
Do Not Reuse
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
Consult Instructions for Use
Indicates the need for the user to consult the instructions for use.
Electronic Instruction Manual
Indicates on product packaging that relevant information for use of the product is available in electronic form in addition to, printed paper form.
Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
TF01.IFU.R09 | Release Date: 05/03/2014 | Revision Date: 08/04/2020