0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

K153481 · Becton, Dickinson and Company · NGT · Apr 4, 2016 · General Hospital

Device Facts

• Record ID: K153481
• Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: NGT · General Hospital
• Decision Date: Apr 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.

Device Story

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is a sterile, single-use, three-piece syringe prefilled with 0.9% sodium chloride injection, USP. It features a 6% (luer) connector and is sealed with a tip cap. The device is used in clinical settings to flush indwelling vascular access devices to maintain patency. It is provided externally sterile for use on a sterile field. The device functions as a manual delivery system for the saline solution. The primary modification from the predicate is a change in primary packaging materials from Tyvek to medical-grade paper and multi-layer film.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional testing (container closure, break loose/out force, sustaining force, pump force, dead space, reflux), USP testing for saline solution (endotoxin, particulates, assay, heavy metals, pH), and biocompatibility testing (ISO 10993 series).

Technological Characteristics

Three-piece, sterile, single-use syringe with 6% (luer) connector. Prefilled with 0.9% sodium chloride injection, USP. Sterilized via moist heat. Primary packaging: medical grade paper and multi-layer film. Complies with ISO 11607 for packaging and various USP standards for saline solution.

Indications for Use

Indicated for flushing indwelling vascular access devices.

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 and SF Syringe (K121050)

Submission Summary (Full Text)

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

April 4, 2016

Becton, Dickinson and Company John Blewitt Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, NJ 07417

Re: K153481

Trade/Device Name: 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: March 4, 2016 Received: March 7, 2016

Dear Mr. Blewitt:

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.

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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

510(k) Number (if known)

K153481

Device Name

0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe

Indications for Use (Describe)

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

| Submitted By: | John Blewitt<br>Regulatory Affairs Manager<br>Becton, Dickinson and Company<br>Medication and Procedural Solutions<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Phone: [phone]; Fax: [phone] |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 1, 2016 |
| Trade Name: | 0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe |
| Common Name: | 0.9% Sodium Chloride Injection Flush Syringe |
| Classification Name: | Saline, Vascular Access Flush |
| Classification<br>Regulation | 21 CFR §880.5200 |
| Class | Class II |
| Product Code: | NGT |
| Predicate Device: | K121050<br>0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP and SF Syringe |

## Device Description

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SF Syringe is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is sterilized via moist heat and provided externally sterile for use on a sterile field.

## Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.

#### Comparison of Technological Characteristics

The subject 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is equivalent to that of the predicate 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe in intended use, materials and performance characteristics. The subject device 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe, includes a change from Tyvek to new primary packaging materials consisting of medical grade paper and multi-layer film. Based on results of performance testing conducted, the subject device is substantially equivalent to the predicate device.

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# Performance

Performance Testing conducted to support substantial equivalence

| Performance<br>Characteristic | Predicate Device | Subject Device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| | K121050: 0.9% Sodium Chloride<br>Injection, USP, BD PosiFlush™ SF<br>Syringe | 0.9% Sodium Chloride Injection,<br>USP, BD PosiFlush™ SF Syringe |
| Functional Testing | | |
| Container Closure Integrity | No dye in solution;<br>No leakage in the luer well or tip<br>threads;<br>No leakage past the stopper ribs;<br>No dye between stopper ribs | Identical to predicate |
| Break Loose Force | No leakage beyond stopper ribs | Identical to predicate |
| Break Out Force | Acceptable forces required to<br>remove plunger rod | Identical to predicate |
| Sustaining Force | Consistent plunger rod forces | Identical to predicate |
| Pump Force | 10ml/hr - 20N<br>1ml/hr - 13N<br>0.1ml/hr - 9N | Identical to predicate |
| Dead Space / Expelled<br>Volume | Equivalent to labeled volume on<br>barrel | Identical to predicate |
| Syringe Induced Reflux | 0 average reflux when connected<br>to a 4 Fr catheter | Identical to predicate |
| Package Integrity | Per ISO 11607 | Equivalent to predicate |
| Package Stability | Per ISO 11607 | Equivalent to predicate |
| Sodium Chloride Injection, USP Testing | | |
| Baxterial Endotoxin | Per USP <85> | Identical to predicate |
| Particulate Matter | Per USP <788> | Identical to predicate |
| Assay of NaCl | Per USP <11> | Identical to predicate |
| Heavy Metals | Per USP <231> | Identical to predicate |
| Iron | Per USP <241> | Identical to predicate |
| UV/vis | Per USP <851> | Identical to predicate |
| pH | Per USP <791> | Identical to predicate |
| Biocompatibility Testing | | |
| Cytotoxicity | Per ISO10993-5:1999, Non-Toxic | Identical to predicate |
| Hemolysis | Per ISO10993-4:2002/A:2006, Non-<br>Toxic | Identical to predicate |
| Acute Systemic Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Intracutaneous Reactivity | Per ISO10993-10:2002/A1:2006,<br>Non-Irritant | Identical to predicate |
| Sensitization | Per ISO10993-10:2002/A1:2006,<br>Non-Sensitizer | Identical to predicate |
| Bacterial Mutagenicity | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| In Vitro Mouse<br>Lymphoma | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Mouse Embryo Assay | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Occular Irritation | Per ISO10993-10:2002/A1:2006 | Identical to predicate |
| | Non-Irritant, | |
| Rabbit Pyrogen | Per ISO10993-11:2006, Non-<br>Pyrogenic | Identical to predicate |
| Subchronic<br>Intracutaneous Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Chemical Extractables<br>Analysis | LC/DAD/MS & GC/MS, No<br>significant extractables | Identical to predicate |

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# Clinical Testing

Clinical testing was not required for this submission.

# Substantial Equivalence Statement

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate devices.

# Conclusion

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes have been validated to meet the established performance criteria. The results of the analysis and verification studies demonstrate that the 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF syringes are substantially equivalent to the predicate devices.