BECTON DICKINSON BLUNT PLASTIC CANNULA

K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI · Jun 3, 1998 · General Hospital

Device Facts

• Record ID: K974363
• Device Name: BECTON DICKINSON BLUNT PLASTIC CANNULA
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: FMI · General Hospital
• Decision Date: Jun 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.

Device Story

Sterile, single-use plastic cannula; pre-lubricated with medical-grade silicone to reduce septum insertion forces. Replaces hypodermic needles for accessing injection sites and vials designed for needleless access. Used by clinicians to provide access to fluid paths for injection/aspiration of fluids and to flush pre-slit injection sites. Prevents accidental needlesticks. Device stem diameter allows compatibility with various pre-slit septums (Baxter InterLink, Abbott LifeShield, McGaw SafeLine).

Clinical Evidence

Bench testing only. Evaluated flushing effectiveness by measuring residual red blood cells in blood-filled injection sites. Variables included cannula brand, flush volume (3cc/10cc), syringe rotation, and insertion depth. Results demonstrated superior flushing effectiveness for the B-D Blunt Plastic Cannula compared to competitive devices.

Technological Characteristics

Plastic cannula; pre-lubricated with medical-grade silicone. 0.80" outside diameter stem. Single-use. Sterile.

Indications for Use

Indicated for use as a needleless access device for injection/aspiration of fluids and flushing of pre-slit injection sites, replacing hypodermic needles to prevent accidental needlesticks.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Becton Dickinson Blunt Plastic Cannula (K964654)

Reference Devices

• Baxter InterLink® Syringe Cannula
• Abbott LifeShield® Blunt Steel Cannula
• McGaw SafeLine® Blunt Cannula
• Abbott LifeShield® BlunTip™ Cannula

Submission Summary (Full Text)

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### 3 1098 JUN

K974363

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

### B-D Contact Person 1.0

Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 Franklin Lakes, NJ 07417-1884 [phone] - Phone [phone] - FAX

#### 2.0 Device Name

Becton Dickinson Blunt Plastic Cannula

### 3.0 Predicate Device

Becton Dickinson Blunt Plastic Cannula

### 4.0 Product Description/Function

- Product Description No change from B-D® Blunt Plastic Cannula 510(k) 964654. 4.1 Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites, as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated with medical grade silicone to reduce septum insertion forces.
### Product Identification

| B-D® Blunt Plastic Cannula | Cat. # 303345 |
|----------------------------------------------|---------------|
| B-D® Blunt Plastic Cannula with 3cc Syringe | Cat. # 303346 |
| B-D® Blunt Plastic Cannula with 5cc Syringe | Cat. # 303347 |
| B-D® Blunt Plastic Cannula with 10cc Syringe | Cat. # 303348 |

Reference product drawing, Tab 4.

#### 4.2 Product Function

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needleless IV access cannula. The B-D® Blunt Plastic Cannula provides access to the fluid path for injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. As indicated in section 1.0, these devices can also be used to flush pre-slit injection sites.

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## 5.0 Supporting Date for More Effective Injection Site Flushing Claim

| Claim | Predicate Device | Testing |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| The B-D® Blunt Plastic Cannula<br>flushes compatible pre-slit injection<br>sites more effectively than<br>competitive cannula | • Baxter InterLink®<br>Syringe Cannula<br>• Abbott LifeShield®<br>Blunt Steel Cannula<br>• McGaw SafeLine®<br>Blunt Cannula<br>• Abbott LifeShield®<br>BlunTip™ Cannula | Injection Site Flushing<br>Evaluation, Becton<br>Dickinson Test Protocol |

#### 5.1 Injection Site Flushing Evaluation

### Test Description:

The B-D® Blunt Plastic Cannula and competitive cannula were used to flush compatible blood filled injection sites per Becton Dickinson protocol (Tab 4). The number of red blood cells remaining in the injection site measured flushing effectiveness. The experiment was designed to examine the following variables: (1)Cannula brand, (2)Quantity of flush(3 or 10cc), (3) Rotation of syringe during flush, and (4) Cannula insertion depth.

The 0.80" outside diameter of the B-D® Blunt Plastic Cannula stem allows access to the Baxter InterLnk®, Abbott LifeShield®, and McGaw SafeLine® pre-slit septums. Unlike the B-D® Blunt Plastic Cannula, competitive cannula are not compatible with all of these injection sites.

The test accounted for the following variables for flushing injection sites:

- (1) Cannula Brand
- (2) Quantity of Flush The quantity of flush was limited to 3cc and 10cc of saline. For both quantities, the flow rate was 1cc/sec.
- (3) Rotation of Syringe The effect of rotation was examined by allowing rotation for some trials and no rotation for others. However, rotation was not performed with the Abbott LifeShield® pre-slit septum due to the restrictive internal diameter of the site.
- (4) Cannula insertion depth Cannula insertion depth, the length of the cannula within the site, was tested at full and partial insertion of the cannula into the site. For partial insertion, a spacer was placed over the cannula to reduce the length of the cannula within the site by .080". Because the stem length of each cannula and the septum thickness of each injection site varied, spacers were made so that the cannula insertion depth was identical for each cannula/site combination for full and partial insertion for a given experiment.

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### Summary/Conclusion:

As noted in Section 7.1 of the 510(k), we developed four(4) experiments to assess the flushing effectiveness of competitive cannula. The experiments compared the performance of the cannula in their respective, compatible pre-slit injection sites. Flushing effectiveness was assessed by counting the remaining red blood cells in the injection site after flushing. The injection sites were flushed under controlled test conditions which reflect hospital protocol or user technique.

Conclusion: The B-D® Blunt Plastic Cannula was observed to provide superior flushing effectiveness as compared to the competitive cannula tested.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 JUN

Mr. Gregory W. Morgan · Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 Franklin Lakes, New Jersey 07417-1884

Re : K974363 Becton Dickinson Blunt Plastic Cannula Trade Name: Requlatory Class: II Product Code: FMI Dated: February 18, 1998 Received: March 16, 1998

Dear Mr. Morgan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Morgan

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamaim.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (If known) K974363

Device Name: B-D Blunt Plastic Cannula

Indications for Use:

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH

Patrina Cusimano

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices .. 510(k) Number_________________________________________________________________________________________________________________________________________________________________

**Prescription Use**
(Per 21 CFR 801.109)