0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE

K042061 · Becton Dickinson · NGT · Aug 26, 2004 · General Hospital

Device Facts

• Record ID: K042061
• Device Name: 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
• Applicant: Becton Dickinson
• Product Code: NGT · General Hospital
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes is intended for use in maintaining patency of vascular access devices (VAD's).

Device Story

Single-use, pre-filled disposable hypodermic syringe containing 0.9% Sodium Chloride Injection, USP. Used to flush vascular access devices (VADs) to maintain patency. Modified from predicate to include a new individual package wrap capable of sterilization, allowing use within sterile fields. Operated by clinicians in clinical settings. Device provides saline solution to clear catheter lines; helps prevent occlusion and maintain device function; benefits patient by ensuring reliable vascular access.

Clinical Evidence

Bench testing only. Design verification tests were performed based on risk analysis to confirm performance equivalence to the predicate device.

Technological Characteristics

Pre-filled hypodermic syringe containing 0.9% Sodium Chloride Injection, USP. Sterile, single-use. Modified packaging allows for exterior sterilization for sterile field use. SAL 10^-6.

Indications for Use

Indicated for maintaining patency of vascular access devices (VADs) in patients requiring such access.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• 0.9% Sodium Chloride Injection, USP-BD Posiflush SP Pre-filled Flush Syringe (K003553)

Submission Summary (Full Text)

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# AUG 2 6 2004

K042061

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

### 1. Submitted By:

Peter Zurlo Manager. Regulatory Affairs

B D Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417-1883

Phone: [phone] Fax:

#### 2. Device Name:

Trade Name: 0.9% Sodium Chloride Injection, USP-BD Posiflush SF Flush Syringe

Common Name: Saline Flush Syringe

Classification Name: Device, Flush, Vascular Access

#### 3. Predicate Device:

0.9% Sodium Chloride Injection, USP-BD Posiflush SP Prc-filled Flush Syringe

Manufactured by: Becton Dickinson and Company

#### 4. Device Description:

The Predicate Device, the 0.9% Sodium Chloride Injection, USP- BD Posiflush SP Pre-Filled Flush Syringe (510(k) Number: K003553) is a single use disposable Hypodermic syringe filled with 0.9% Sodium Chloride Injection, USP and is intended for use in maintaining patency of vascular access devices (VAD's). The Predicate Device is only fluid path sterile to SAL of 10-

The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications.

The Modified Device is manufactured of the same materials, has the same intended use and SAL of 106 as the Predicate Device.

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#### న్. Intended Use:

### Same intended use as the Predicate Device.

The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes is intended for use in maintaining patency of vascular access devices (VAD's).

## Technological Characteristics:

The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications.

The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10t as the Predicate Device.

#### 6. Performance:

Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construcd as an admission against interest under the US patent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's wings and body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Becton Dickinson C/O Mr. Peter Zurlo Manager, Regulatory Affairs BD Medical Surgical 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K042061

Trade/Device Name: 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringe Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: July 29, 2004 Received: August 2, 2004

Dear Mr. Zurlo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Zurlo

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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# Indications for Use Statement

| 510(k) Number (if known) | K042061 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringe |
| Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's). |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801. 109)

Kei Muler

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number

00020