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

K121050 · Becton, Dickinson & CO · NGT · Feb 7, 2013 · General Hospital

Device Facts

• Record ID: K121050
• Device Name: 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
• Applicant: Becton, Dickinson & CO
• Product Code: NGT · General Hospital
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

BD PosiFlush™ Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. 10ml BD PosiFlush™ Normal Saline. Flush Svringes are generally compatible for use with syringe pumps.

Device Story

Three-piece, sterile, single-use syringe pre-filled with 0.9% Sodium Chloride Injection, USP; sealed with tip cap. Modified from predicate by changing stopper material and adding extra thread to plunger rod/stopper insert. Used in clinical settings for flushing indwelling vascular access devices (VADs) to maintain patency. 10ml configuration compatible with syringe pumps. Operated by clinicians. Provides mechanical flushing action to clear VADs; prevents occlusion; maintains catheter function.

Clinical Evidence

Bench testing only. No clinical data. Performance verified through functional testing (container closure integrity, break loose/out/sustaining forces, pump force, dead space/expelled volume, syringe-induced reflux) and chemical/biocompatibility testing (USP <85>, <788>, <11>, <231>, <241>, <851>, <791>; ISO 10993-3, -4, -5, -10, -11). Results demonstrate equivalence to predicate.

Technological Characteristics

Three-piece syringe with 6% Luer connector. Materials identical to predicate. Sterilized via moist heat (SAL 10^-6). Complies with USP 34<11> for saline and ISO 10993 for biocompatibility. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for flushing indwelling vascular access devices in patients requiring maintenance of catheter patency. Prescription use only.

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 Pre-Filled Flush Syringe (K003553)
• 0.9% Sodium Chloride Injection, USP, BD PosiFlush SF Flush Syringe (K042061)

Submission Summary (Full Text)

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KI2050

## 510(k) Summarv

FEB 7 2013

#### 】. Submitted Bv:

Avital Merl Staff Regulatory Affairs Specialist BD Medical - Medical Surgical Systems I Becton Drive Franklin Lakes. NJ 07417 201 847 4739 Tel: [phone] Fax:

#### ri Device Name: .

Trade Name: 1) 0.9% Sodium Chloride Injection, USP, BD PosiFlush Flush Syringe 2) 0.9% Sodium Chloride Injection, USP, BD PosiFlush SF Flush Syringe

0.9% Sodium Chloride Injection Flush Syringe Common Name: Classification Name: Saline, Vascular Access Flush Class II, 21 CFR § 880.5200 Classificiation:

#### 3. Predicate Device:

Trade Name: 0.9% Sodium Chloride Injection, USP, BD Pre-Filled Flush Syringe Manufacturer: Becton, Dickinson and Company 510(k) Number: K003553

Trade Name: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SF Flush Syringe Becton. Dickinson and Company Manufacturer: 510(k) Number: K042061

#### 4. Device Description:

The modified BD PosiFlush Flush Syringe is a three-piece, sterile, single use syringe with a 6% (Luer) connector pre-filled with 0.9% Sodium Chloride Injection, USP and sealed with a tip cap. BD has altered the modified device from the predicate by changing the stopper material and adding an extra thread to the plunger rod, threaded stopper insert. All performance characteristics are equivalent to the predicate device. The 0.9% Sodium Chloride Injection, USP BD PosiFlush Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's).

This submission represents two 2 devices: the BD PosiFlush Flush Syringe, which is provided with a sterile fluid path; and the BD PosiFlush Flush SF Syringe, which is provided externally sterile for use on a sterile field. Both configurations are sterilized via moist heat.

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#### Intended Use: ri

BD PosiFlush™ Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. 10ml BD PosiFlush™ Normal Saline. Flush Svringes are generally compatible for use with syringe pumps.

#### Technological Characteristics: 6.

The principal device of this 510(k) premarket notification is the result of a design change to the predicate device (K003553 and K042061) conducted in accordance with Quality System Regulations, 21 CFR § 820. The BD PosiFlush Flush Syringe is Substantially Equivalent to the predicate device, given that:

- a) The BD PosiFlush Flush Syringe has the same intended use as the predicate device
- b) The BD PosiFlush Flush Syringe operates under the same operating principle as the predicate device
- c) The BD PosiFlush Flush Syringe barrel and stopper use a design identical to the predicate device.
- d) The BD PosiFlush Flush Syringe barrel and plunger rod use materials identical to the predicate device.
- e) The BD PosiFlush Flush Syringe pre-filled 0.9% Sodium Chloride Injection solution meets the requirements of USP 34<1 1>: Sodium Chloride Injection, as does the predicate device.
- The BD PosiFlush Flush Syringe meets the requirements of ISO 10993 as applicable f) to the intended use of the device, as does the predicate device.
- g) The BD PosiFlush Flush Syringe are sterilized to an SAL of 106 (sterile fluid path or externally sterile) via a Moist Heat sterilization process, as does the predicate device.
- h) The BD PosiFlush Flush Syringe demonstrated equivalent performance to the predicate device during design verification testing.

#### Performance: 6.

Design Verification testing included the following:

| Performance Characteristic | Acceptance Criteria |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Functional Testing | |
| Container Closure Integrity | No Dye in Solution;<br>No Leakage in the luer well or tip threads;<br>No Leakage Past the Stopper Ribs;<br>No Dye Between Stopper Ribs |
| Break Loose Force | Equivalence to Predicate |
| Break Out Force | Equivalence to Predicate |
| Sustaining Force | Equivalence to Predicate |
| Pump Force | 10ml/hr – 20N<br>1ml/hr - 13N |

# Table VI - Modified Device Performance

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.

| | 0.1ml/hr - 9N |
|----------------------------------------|----------------------------------------------------|
| Dead Space / Expelled Volume | Equivalent to labeled volume (3ml. 5ml or 10ml) |
| Syringe Induced Reflux | 0 average reflux when connected to a 4 Fr catheter |
| Sodium Chloride Injection, USP Testing | |
| Bacterial Endotoxin | Per USP <85> |
| Particulate Matter | Per USP <788> |
| Assay of NaCl | Per USP <11> |
| Heavy Metals | Per USP <231> |
| Iron | Per USP <241> |
| UV/vis | Per USP <851> |
| pH | Per USP <791> |
| Biocompatibility Testing | |
| Test | Method/Acceptance |
| Cytotoxicity | Per ISO10993-5:1999, Non-Toxic |
| Hemolysis | Per ISO10993-4:2002/A:2006, Non-Toxic |
| Acute Systemic Toxicity | Per ISO10993-11:2006, Non-Toxic |
| Intracutaneous Reactivity | Per ISO10993-10:2002/A1:2006, Non-Irritant |
| Sensitization | Per ISO10993-10:2002/A1:2006, Non-Sensitizer |
| Bacterial Mutagenicity | Per ISO10993-3, Non-Mutagenic |
| In Vitro Mouse Lymphoma | Per ISO10993-3, Non-Mutagenic |
| Mouse Embryo Assay | Per ISO10993-3, Non-Mutagenic |
| Occular Irritation | Per ISO10993-10:2002/A1:2006, Non-Irritant |
| Rabbit Pyrogen | Per ISO10993-11:2006, Non-Pyrogenic |
| Subchronic Intracutaneous Toxicity | Per ISO10993-11:2006, Non-Toxic. |
| Chemical Extractables Analysis | LC/DAD/MS & GC/MS. No significant extractables |

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### February 7, 2013

Ms. Avital Merl Staff Regulatory Affairs Specialist Becton, Dickinson and Company One Becton Drive FRANKLIN LAKES NJ 07417

Re: K121050

Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush Flush Syringe 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Flush

Svringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: February 1, 2013

Received: February 4, 2013

Dear Ms. Merl:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Merl

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Lo m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K121050

1

Device Name:

0.9% Sodium Chloride Injection, USP BD PosiFlush Flush Syringe

| Model Number | Syringe Size/Fill Volume |
|--------------|----------------------------------------------------------|
| 306544 | 3mL BD PosiFlush™ SP |
| 306545 | 5mL BD PosiFlush™ SP |
| 306546 | 10mL BD PosiFlush™ SP with Regular Plunger Rod |
| 306547 | 10mL BD PosiFlush™ SP |
| 306553 | 10mL BD PosiFlush™ SF with Regular Plunger Rod |
| 306549 | 3mL BD PosiFlush™ SP with BPC (Blunt Plastic<br>Cannula) |
| 306550 | 5mL BD PosiFlush™ SP with BPC |
| 306551 | 10mL BD PosiFlush™ SP (Regular Plunger Rod) with<br>BPC |

Over-The-Counter Use

(21 CFR 801 Subpart C)

Indications for Use:

Prescription Use

(Part 21 CFR 801 Subpart D)

X

BD PosiFlush™ Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. Catalog No. 306547 10ml BD PosiFlush™ Normal Saline Flush Syringes are generally compatible for use with syringe pumps.

AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| | Elizabeth F. Claverie |
|----------------|----------------------------------------------|
| | 2013.02.07 11:32:28 -05'00' |
| Page __ of __ | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |
| 510(k) Number: | |

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