Substantially Equivalent 510(k) Device Information
Applicant: ITL Corporation, Ltd., Fyshwick, Canberra, Australia
510(k) number: BK980008
Product: Bloodpack Needle Protector (BNP)
Date: 4/7/98
Summary of Safety and Effectiveness
Identification of predicate device(s):
Medsep Phlebotomist Protection Device
Manufactured by Medsep Corporation
BK900034
Fenwal Needle/Tube Sampling Protector Needle Safety Cover
Manufactured by Baxter Healthcare Corporation
BK920003
Medisystems Apheresis Needle with Guard
Manufactured by Medisystems Corporation
BK932074
Description of the Device:
The Bloodpack Needle Protector (BNP) is a disposable, single-use, non-sterile needle protector, which is used as an aid in preventing accidential needle stick injuries upon completion of blood collection procedures. The BNP is designed such that it is compatible with current bloodpack needle sets produced by most major manufacturers.
The hinged assembly allows the BNP to be included on the bloodpack needle assembly at the time of manufacture or during the collection process (i.e. before needle insertion or just prior to withdrawal). After the venopuncture is made, blood flow must be established before the BNP is engaged. The BNP employs a two-stage engagement and locking mechanism. The first stage of engagement is for stabilizing and adjusting the needle hub, while preparing for shielding the needle. The second stage shields and locks the needle, which prevent sharp exposure. An audible click can be heard when the needle assembly has been pulled into the locked position. The needle shielding is always engaged away from the needle and behind the needle assembly.
Intended Use:
The Bloodpack Needle Protector is an aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
Comparison of device characteristics to predicate:
| Technological Characteristics |
| Characteristic |
Predicate Devices: Medsep, Fenwal and Medisystems |
Device:
BNP |
Explanation
(if necessary) |
| Intended use |
Use in avoiding needle sticks in healthcare workers after collection of blood samples (Medsep and Fenwal) |
Same |
|
| Materials |
Polypropylene (Medsep, Fenwal, and Medisystem) |
Same |
|
| Sterilization |
Not Sterile (Fenwal) |
Same |
|
| Technological aspects of the Sharps injury prevention components and how they integrate into the device |
The protector fits over the needle and tubing. The tubing is then pulled with one hand until the assembly is locked into place (Medsep and Medisystem) |
Same |
|
| Design |
The needle is secured inside the protector by folding and locking the device over the needle. (Medsep) |
Same |
|
Clinical Testing:
Following successful clinical trials in 1996, the Australian Red Cross Blood Service in the Australian Capital Territory (ACT), located in Canberra, Australia, began using the BNP in all of its blood collections from July 1996 to the present. Since the introduction of the BNP, there have been no needlestick injuries reported. The average annual collection at the ACT is 18,000.
Another prospective clinical trial was conducted to evaluate the impact of the BNP on factors such as donor comfort, procedural utility and safety, during and after standard blood collection. The trial involved 14 Phlebotomists and 1,000 donors. The results from the trial are summarized in the table below.
| Clinical Trial Results |
| Inquiry |
Result |
| Donor Comfort |
96.6% of donors reported comfort level on needle withdrawal as either no different, comfortable, or very comfortable |
| Prevention of needle hub rotation |
99.9% of users agreed or strongly agreed that the BNP prevented rotation of the needle hub. |
| Ease of engagement |
99.8% of users found the BNP easy or very easy to engage. |
| Ease of withdrawal |
98.9% of users found this easy or very easy. |
| Ease of disposal |
All of users found disposal of the BNP easy or very easy. |
| Bumping of needle hub |
No users, with one exception, found that the BNP bumped the needle hub. |
| Sharp points after shielding |
No users noted any sharp points once the needle was engaged in the BNP. |
Conclusion:
The intended use, design, materials of fabrication, and performance of the BNP are the same as the predicate devices. Therefore, the BNP is substantially equivalent to the predicate devices and devices marketed in interstate commerce prior to May 28, 1976.
|
