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

Device Description

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SP and SF Syringe (also referred to as BD PosiFlush " SP and 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 BD PosiFlush™ SP Syringe is provided with a sterile fluid path, and the BD PosiFlush™ SF Syringe is provided externally sterile for use on a sterile field. Both configurations are sterilized via moist heat. The modified BD PosiFlush™ SP Syringe and BD PosiFlush™ SF Syringe, the subject of this 510(k), includes a new resin material in the barrel of the prefilled syringe.

AI/ML Overview

The provided text describes a 510(k) summary for the BD PosiFlush™ SP and SF Syringes, which are prefilled syringes containing 0.9% sodium chloride for flushing vascular access devices. The submission focuses on a change in the resin material for the syringe barrel and asserts substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting the absence of information typically found in AI/algorithm-focused submissions:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a medical device (prefilled syringe), not an AI/algorithm. Therefore, the "device performance" here refers to the physical and chemical properties of the syringe and its contents, not a diagnostic accuracy or algorithmic output. The performance is assessed relative to a predicate device or established standards.

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Functional Testing
Container Closure Integrity	No Dye in SolutionNo Leakage in the luer well or tip threadsNo Leakage Past the Stopper RibsNo Dye Between Stopper Ribs	Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met. Specific results are not detailed in this summary for each test).
Break Loose Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Break Out Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Sustaining Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Retaining Ring Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Tip Cap Removal Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Sodium Chloride Injection, USP, Testing	Per USP Monograph, Sodium Chloride Injection	Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met. Specific results are not detailed in this summary for each test).
Bacterial Endotoxin		Met USP Monograph requirements.
Particulate Matter		Met USP Monograph requirements.
Assay of NaCl		Met USP Monograph requirements.
Heavy Metals		Met USP Monograph requirements.
Iron		Met USP Monograph requirements.
pH		Met USP Monograph requirements.
Biocompatibility Testing	Per ISO10993 SeriesLC/DAD/MS, GC-MS, ICP; acceptable extractable test.	Performed in an equivalent manner to the predicate device and is safe and effective when used as intended. (Implies all criteria were met, specifically acceptable extractable test as specified).

Note: The reported device performance generally states "performed in an equivalent manner to the predicate device and is safe and effective when used as intended" or implies meeting USP Monograph requirements. Specific quantitative results for each test are not detailed in this summary.

Absent Information (Typical for AI/Algorithm Studies)

The following information is not applicable or not provided in this 510(k) summary because the device is a physical medical device (syringe with saline), not an AI/algorithm.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device. Testing involves batches of syringes, not a "test set" of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on established engineering and chemical standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, ground truth is based on established engineering specifications, chemical analysis standards (e.g., USP Monograph), and biocompatibility standards (e.g., ISO 10993).
The sample size for the training set: Not applicable (no AI/algorithm).
How the ground truth for the training set was established: Not applicable (no AI/algorithm).

Conclusion of the Study (Non-Clinical Testing)

The company performed non-clinical testing based on a risk analysis. The results of these tests demonstrated that the modified BD PosiFlush™ SP and SF Syringe performed in an equivalent manner to the predicate device. This equivalence, combined with adherence to established standards (USP Monograph, ISO 10993 series), is deemed sufficient to prove the device's safety and effectiveness.

Clinical testing was explicitly stated as "not required" for this submission.

The conclusion is that the device has been validated to meet the established performance criteria based on non-clinical tests, and performs as safely and effectively as the legally marketed predicate devices.

Summary

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510(k) Summary - K141311

JUL 2 5 2014

Submitted By:	Juma HoshinoRegulatory Affairs SpecialistBD Medical - Medical Surgical Systems1 Becton DriveFranklin Lakes, NJ 07417Phone: (201)847-4260; Fax: (201)847-5307
Date Prepared:	July 24, 2014
Trade Name:	0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe
Common Name:	0.9% Sodium Chloride Injection Flush Syringe
Classification Name:	Saline, Vascular Access Flush (Class II, 21 CFR §880.5200)
Product Code:	NGT
Predicate Device:	K1210500.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe

Device Description

Intended Use

Technological Characteristics

The subject BD PosiFlush™ SP and SF Syringe is equivalent to that of the predicate BD PosiFlush™ SP and SF Syringe in intended use, materials and performance characteristics. The new syringe barrel resin material does not raise any new questions regarding safety or effectiveness.

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	Element of Comparison	Equivalence
SyringeMaterials	Barrel	Equivalent to predicate.
	Plunger Rod	Identical to predicate.
	Stopper	Identical to predicate.
	Stopper Lubricant	Identical to predicate.
	Tip Cap	Identical to predicate.
Solution		Identical to predicate.
Sterilization Method		Identical to predicate.
Sterile		Identical to predicate.
SAL		Identical to predicate.
Shelf Life		Identical to predicate.

Non-Clinical Testing

BD has performed the following non-clinical testing based on the risk analysis conducted and the results of these tests demonstrate that the BD PosiFlush™ SP and SF Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.

Performance Characteristic		Acceptance Criteria
Functional Testing	Container Closure Integrity	No Dye in SolutionNo Leakage in the luer well or tip threadsNo Leakage Past the Stopper RibsNo Dye Between Stopper Ribs
	Break Loose Force	Equivalence to Predicate
	Break Out Force	Equivalence to Predicate
	Sustaining Force	Equivalence to Predicate
	Retaining Ring Force	Equivalence to Predicate
	Tip Cap Removal Force	Equivalence to Predicate
Sodium ChlorideInjection, USP, Testing	Bacterial Endotoxin	Per USP Monograph, Sodium Chloride
	Particulate Matter	Injection
	Assay of NaCl
	Heavy Metals
	Iron
	pH
Biocompatibility Testing		Per ISO10993 SeriesLC/DAD/MS, GC-MS, ICP; acceptableextractable test.

Clinical Testing

Clinical testing was not required for this submission.

Substantial Equivalence Statement

The 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 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. The modified device does not raise new concerns of safety and effectiveness.

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Conclusion

The 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes and 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 BD PosiFlush™ SP and SF Syringes perform as intended and based on the non-clinical tests performed the subject device is as safe, as effective and performs as safely and effectively as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

Public Health Service

July 25, 2014

Becton, Dickinson and Company Ms. Juma Hoshino Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K141311

Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: June 24, 2014 Received: June 25, 2014

Dear Ms. Hoshino

We have reviewed your Section 510(k) promarket 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 docs 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 cither 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. Hoshino

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejasbri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clipical 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 Statement

510(k) Number (if known): K141311

Device Name: 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe 0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth Signed by Sreekanth G Gutala -S

Digitally signed by Sreekanth Gutala ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=200054 0490, cn=Sreekanth Gutala -S Date: 2014.07.25 10:22:08 -04'00'

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).