H5N1 real- time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay

Transcription

1 Case Study 1: H5N1 real- time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay Detection kit that can accurately and rapidly detect all known strains of the H5N1 Avian Influenza A virus in a single test.

2 Case Study 2: 1. Blood Glucose Test System 2. Pregnancy Test 3. HIV Test Strip These are 3 self-testing IVD system. What are their risk classification?

3 Case Study 3: Urine test strip A paper strip, impregnated with test reagents, intended to be used either manually or in combination with an instrument to detect various urinary analytes such as glucose, protein, nitrite, blood, leukocytes, ph, nitrite or bilirubin.

4 Case Study 4: Thermometer Do they have the same risk classification? What about this one?

5 Case Study 5: An ECG treadmill test is to checks for changes in heart function during physical stress. Is the treadmill by itself a medical device?

6 Case Study 6: Pulmonary Artery Catheter A flexible tube with an inflatable balloon at its distal end that floats from the superior vena cava to the pulmonary artery where it measures, e.g. pulmonary arterial pressures, cardiac output, venous blood values, and other vital parameters. What is the appropriate risk classification rule? If the catheter is coated with Heparin (an anticoagulant), would that rule still be the correct rule?

7 Case Study 7: Blood Bank Refrigerator A refrigerator specially designed to store whole blood and blood components, e.g. blood cells or plasma, at temperatures ranging from 1 to 6 degrees Celsius, and that has an integrated alarm that warns against unexpected temperature increase. Is this a medical device? Why? If yes, what is the risk classification?

8 Case Study 8: First Aid Kit A convenient collection of equipment and materials used in an emergency for the rapid, initial treatment of an injury. Contents of First-Aid Boxes 20 x Individually wrapped sterile adhesive dressings 1 x Crepe bandage 5 cm 1 x Crepe bandage 10 cm 5 x Absorbent gauze (packets of 10 pieces) 1 x Hypoallergenic tape 4 x Triangular bandages 1 x Scissors 4 x Safety pins 2 x Disposable gloves (pairs) 2 x Eye shield 2 x Eye pad 1 x Resuscitation mask (one way) What is the risk classification of the above configuration?

9 Case Study 9: Central Venous Catheterization Kit A packaged collection of equipment that typically includes a catheter and an introducer used for inserting central venous catheters. Guidewire Syringe Dilator Syringe Introducer Needle What is the risk classification of the above procedure kit? Catheter

10 Case Study 10: Breast Pump A device used to extract milk from the breast, typically for collecting and feeding to an infant.

11 Case Study 11: Insulin Needle Destruction Unit Portable insulin-needle destruction device for use at home by diabetics. It uses a small 9.6 volt rechargeable battery to deliver an electrical current that disintegrates the needles. The device is intended for gauge insulin hypodermic needles that are 5/16 to 1/2 inch in length. It can be used with most insulin pens and with disposable insulin syringes from 1/3 to 1 cubic centimeter in volume

12 Case Study 12

13 Case Study 13 What is the risk classification of a cardiovascular stent? Does the risk class change if the stent is coated with drug to reduce restenosis? What if the stent is coated with antibodies?

14 Case Study 14 Demineralized bone matrix is used to fill bony voids or gaps that have been surgically created, or for filling osseous defects in non-weight bearing applications Demineralized bone matrix has osteoinductive potential and is osteoconductive. It is composed of demineralized bone from human donors in a biocompatible carrier. The demineralized bone powder is produced by the removal of minerals from cortical bone. It is not intended to provide structural support of the bone during the healing process.