Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biocompatibility of a prefilled syringe, with no mention of AI or ML.

Therapeutic

No.
The device is described as a prefilled syringe for flushing indwelling vascular access devices, which is a supportive function rather than directly treating a medical condition.

Diagnostic

No

Explanation: The device is a syringe prefilled with saline solution used for flushing indwelling vascular access devices, which is a maintenance function, not a diagnostic one. It does not identify or detect a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a three-piece, sterile, single use syringe prefilled with saline, which is a physical hardware device. The submission describes a change to a material component (stopper).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "only for the flushing of indwelling vascular access devices." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The device is a prefilled syringe with saline solution. This is a medical device used for a procedure (flushing), not for analyzing biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

The device is clearly intended for a procedural application related to maintaining vascular access devices, which falls under the category of general medical devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

indwelling vascular access devices

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141311

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles, stacked one behind the other.

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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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

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3

Special 510(k) Summary

| Submitted By: | John Blewitt
Regulatory Affairs Manager
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Phone: (201)847-5473
Fax: (201)847-5307 | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Date Prepared: | January 4, 2017 | |
| Subject Devices: | Trade Name: | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™
SP Syringe |
| | Common Name: | 0.9% Sodium Chloride Injection Flush Syringe |
| | Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access
Flush |
| | Product Code: | NGT |
| Predicate Devices: | Trade Name: | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™
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
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.

4

| Device Characteristics | Subject Device
BD PosiFlush™ SP Syringe
(K161552) | Predicate Device
BD PosiFlush™ SP Syringe
(K141311) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Intended Use | The BD PosiFlush™ SP Syringe
is intended to be used only for
the flushing of indwelling
vascular access devices (VAD's).
Catalog number 306547 10 mL
BD PosiFlush™ SP Syringes are
generally compatible for use with
syringe pumps. | The BD PosiFlush™ SP Syringe
is intended to be used only for
the flushing of indwelling
vascular access devices (VAD's).
Catalog number 306547 10 mL
BD PosiFlush™ SP Syringes are
generally compatible for use with
syringe pumps. |
| Operating Principle | The BD PosiFlush™ SP 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. | The BD PosiFlush™ SP 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. |
| Materials | Barrel: Polypropylene

Plunger Rod: Polypropylene

Tip Cap: Polypropylene w/
White Colorant

Stopper Lubricant: Silicone

Stopper Material: Styrene-
butadiene rubber | Barrel: Polypropylene

Plunger Rod: Polypropylene

Tip Cap: Polypropylene w/
White Colorant

Stopper Lubricant: Silicone

Performance Data

5

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).