0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe

K161552 · Becton, Dickinson and Company · NGT · Feb 2, 2017 · General Hospital

Device Facts

• Record ID: K161552
• Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: NGT · General Hospital
• Decision Date: Feb 2, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.

Device Story

Three-piece, sterile, single-use syringe; prefilled with 0.9% sodium chloride injection, USP; sealed with tip cap. Used for flushing indwelling vascular access devices; 10 mL configuration compatible with syringe pumps. Operated by clinicians in clinical settings. Device maintains patency of vascular access devices; prevents occlusion; benefits patient by ensuring reliable access for medication/fluid delivery.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, hemolysis, systemic toxicity, sensitization, pyrogenicity, genotoxicity, chemical extractables). Design verification testing included container closure integrity, break-out/sustaining force, stopper separation, leakage, pump force, ship test, dead space, and syringe-induced reflux. All results met predetermined acceptance criteria.

Technological Characteristics

Three-piece syringe; barrel/plunger rod/tip cap: polypropylene; stopper: styrene-butadiene rubber; lubricant: silicone. 6% luer connector. Sterilization: moist heat per ISO 17665 (SAL 10^-6). Biocompatibility per ISO 10993-1. Configurations: 3 mL, 5 mL, 10 mL (all use 10 mL barrel diameter).

Indications for Use

Indicated for flushing indwelling vascular access devices in patients requiring such maintenance.

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 Syringe (K141311)

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

February 2, 2017

Becton Dickinson And Company John Blewitt Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, New Jersey 07045

Re: K161552

Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: June 3, 2016 Received: June 6, 2016

Dear John 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,

Michael J. Ryan -S

for Tina Kiang, PhD Acting 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) K161552

Device Name

0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SP

Indications for Use (Describe)

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span> </span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> </span> |

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### Special 510(k) Summary

| Submitted By: | John Blewitt<br>Regulatory Affairs Manager<br>Becton, Dickinson and Company<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Phone: [phone]<br>Fax: [phone] | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Date Prepared: | January 4, 2017 | |
| Subject Devices: | Trade Name: | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™<br>SP Syringe |
| | Common Name: | 0.9% Sodium Chloride Injection Flush Syringe |
| | Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access<br>Flush |
| | Product Code: | NGT |
| Predicate Devices: | Trade Name: | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™<br>SP Syringe |
| | 510(k) Reference: | K141311 |
| | Common Name: | 0.9% Sodium Chloride Injection Flush Syringe |
| | Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access<br>Flush |
| | Product Code: | NGT |

### Device Description

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP (also referred to as BD PosiFlush™ SP 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 BD PosiFlush™ SP Syringe is provided with a sterile fluid path, which is sterilized via moist heat.

The change described in this submission is the qualification of a supplier specific formulation for stopper material for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes.

### Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.

#### Technological Characteristics

The subject BD PosiFlush™ SP Syringes are equivalent to that of the predicate BD PosiFlush™ SP Syringes in intended use, fundamental scientific technology, operating principles, product design, and performance characteristics.

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| Device Characteristics | Subject Device<br>BD PosiFlush™ SP Syringe<br>(K161552) | Predicate Device<br>BD PosiFlush™ SP Syringe<br>(K141311) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Intended Use | The BD PosiFlush™ SP Syringe<br>is intended to be used only for<br>the flushing of indwelling<br>vascular access devices (VAD's).<br>Catalog number 306547 10 mL<br>BD PosiFlush™ SP Syringes are<br>generally compatible for use with<br>syringe pumps. | The BD PosiFlush™ SP Syringe<br>is intended to be used only for<br>the flushing of indwelling<br>vascular access devices (VAD's).<br>Catalog number 306547 10 mL<br>BD PosiFlush™ SP Syringes are<br>generally compatible for use with<br>syringe pumps. |
| Operating Principle | The BD PosiFlush™ SP Syringe<br>is a three-piece, sterile, single use<br>syringe with a 6% (Luer)<br>connector pre-filled with 0.9%<br>Sodium Chloride Injection, USP,<br>and sealed with a tip cap. | The BD PosiFlush™ SP Syringe<br>is a three-piece, sterile, single use<br>syringe with a 6% (Luer)<br>connector pre-filled with 0.9%<br>Sodium Chloride Injection, USP,<br>and sealed with a tip cap. |
| Materials | Barrel: Polypropylene<br><br>Plunger Rod: Polypropylene<br><br>Tip Cap: Polypropylene w/<br>White Colorant<br><br>Stopper Lubricant: Silicone<br><br>Stopper Material: Styrene-<br>butadiene rubber | Barrel: Polypropylene<br><br>Plunger Rod: Polypropylene<br><br>Tip Cap: Polypropylene w/<br>White Colorant<br><br>Stopper Lubricant: Silicone<br><br>Stopper Material: Styrene-<br>butadiene rubber |
| Packaging | Flow wrap<br>Shelf Carton<br>Case Carton | Flow wrap<br>Shelf Carton<br>Case Carton |
| Specification | 0.9% Sodium Chloride Injection,<br>USP, BD PosiFlush™ SP<br>Syringe is provided in 3 mL, 5<br>mL and 10 mL configurations.<br>All three sizes utilize a consistent<br>10 mL syringe barrel diameter | 0.9% Sodium Chloride Injection,<br>USP, BD PosiFlush™ SP<br>Syringe is provided in 3 mL, 5<br>mL and 10 mL configurations.<br>All three sizes utilize a consistent<br>10 mL syringe barrel diameter |
| Sterilization | Per ISO 17665 | Per ISO 17665 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | 3 Years | 3 Years |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |

Performance Data

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Modifications to BD PosiFlush™ SP Syringes were evaluated using a risk management process. This risk assessment process was performed in accordance with ISO14971. The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing

Biocompatibility evaluation was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016. The battery of testing included the following tests and assessments. Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4), Acute systemic toxicity (per ISO10993-11), Sub-Chronic Toxicity (Per ISO10993-11), Intracutaneous reactivity (per ISO10993-10), Ocular irritation (per ISO 10993-10), Partial thromboplastin Time (ISO 10993-4), Sensitization (per ISO10993-10), Pyrogenicity (per ISO 10993-11), Genotoxicity (per ISO 10993-3) and Chemical extractable analysis (per ISO 10993-18).

Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests; Container Closure Integrity, Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux were performed to demonstrate that the subject device met predetermined acceptance criteria per BD's internal specification.

## Substantial Equivalence

The BD PosiFlush™ SP Syringes have been verified to meet the established performance criteria above. The results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device and demonstrated the same intended use, fundamental scientific technology and operating principles.

### Conclusion

The subject BD PosiFlush™ SP Syringes are substantially equivalent to the legally marketed predicate device, BD PosiFlush™ SP Syringes (K141311).