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 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.

AI/ML Overview

This document describes a Special 510(k) submission for a medical device called "0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe" (K161552). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K141311) due to a change in the supplier specific formulation for the stopper material.

I will focus on the provided information to answer your request, specifically looking for acceptance criteria and the study proving it.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests." It lists the tests but does not provide a specific table enumerating the acceptance criteria values themselves or the quantitative performance measurements obtained for each test. Instead, it states that the device "met predetermined acceptance criteria per BD's internal specification" and "have been verified to meet the established performance criteria above."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	All tests (Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Occular irritation, Partial thromboplastin Time, Sensitization, Pyrogenicity, Genotoxicity, Chemical extractable analysis) met the requirements of the FDA Guidance Use of International Standard ISO 10993-1.
Design Verification	Met predetermined acceptance criteria per BD's internal specification for: - Container Closure Integrity - Break Out/Sustaining force - Stopper Separation - Leakage - Pump Force - Ship Test - Dead Space - Syringe Induced Reflux

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the tests (biocompatibility or design verification). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. The studies were conducted by Becton, Dickinson and Company.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the clearance is for a pre-filled syringe (a medical device, not an AI or diagnostic tool that requires human expert interpretation for ground truth). The "ground truth" for the performance tests would be based on established engineering and biological standards and verified by internal testing protocols.

4. Adjudication Method:

This is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable as the device is a pre-filled syringe, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

This is not applicable as the device is a pre-filled syringe and does not involve an algorithm.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" would be established by:

Established industry standards and regulations (e.g., ISO 10993 for biocompatibility).
BD's internal specifications and engineering requirements for device functionality and integrity (e.g., for leakage, break force, dead space).

8. Sample Size for the Training Set:

This is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reasons as point 8.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed across two main categories:

Biocompatibility Testing:
- Methodology: Evaluated in accordance with 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.
- Tests Performed: 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).
- Conclusion: The tests confirmed that the device met the requirements outlined in the standards, indicating it is biocompatible.
Design Verification Testing:
- Methodology: Conducted to ensure the device met "predetermined acceptance criteria per BD's internal specification." The specific methodologies for each test (e.g., how "Container Closure Integrity" was tested) are not detailed but would be standard industry practices for syringe manufacturing.
- Tests Performed: Container Closure Integrity, Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux.
- Conclusion: The testing demonstrated that the subject device "met predetermined acceptance criteria."

Overall Conclusion from the Document:

The submission concludes that the BD PosiFlush™ SP Syringes "have been verified to meet the established performance criteria above." The results of this design verification and biocompatibility 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" as the predicate device, thereby proving substantial equivalence.

Summary

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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 (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

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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)

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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Special 510(k) Summary

Submitted By:	John BlewittRegulatory Affairs ManagerBecton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Phone: (201)847-5473Fax: (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 AccessFlush
	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 AccessFlush
	Product Code:	NGT

Device Description

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

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 DeviceBD PosiFlush™ SP Syringe(K161552)	Predicate DeviceBD PosiFlush™ SP Syringe(K141311)
Manufacturer	Becton, Dickinson and Company	Becton, Dickinson and Company
Intended Use	The BD PosiFlush™ SP Syringeis intended to be used only forthe flushing of indwellingvascular access devices (VAD's).Catalog number 306547 10 mLBD PosiFlush™ SP Syringes aregenerally compatible for use withsyringe pumps.	The BD PosiFlush™ SP Syringeis intended to be used only forthe flushing of indwellingvascular access devices (VAD's).Catalog number 306547 10 mLBD PosiFlush™ SP Syringes aregenerally compatible for use withsyringe pumps.
Operating Principle	The BD PosiFlush™ SP Syringeis a three-piece, sterile, single usesyringe with a 6% (Luer)connector pre-filled with 0.9%Sodium Chloride Injection, USP,and sealed with a tip cap.	The BD PosiFlush™ SP Syringeis a three-piece, sterile, single usesyringe with a 6% (Luer)connector pre-filled with 0.9%Sodium Chloride Injection, USP,and sealed with a tip cap.
Materials	Barrel: PolypropylenePlunger Rod: PolypropyleneTip Cap: Polypropylene w/White ColorantStopper Lubricant: SiliconeStopper Material: Styrene-butadiene rubber	Barrel: PolypropylenePlunger Rod: PolypropyleneTip Cap: Polypropylene w/White ColorantStopper Lubricant: SiliconeStopper Material: Styrene-butadiene rubber
Packaging	Flow wrapShelf CartonCase Carton	Flow wrapShelf CartonCase Carton
Specification	0.9% Sodium Chloride Injection,USP, BD PosiFlush™ SPSyringe is provided in 3 mL, 5mL and 10 mL configurations.All three sizes utilize a consistent10 mL syringe barrel diameter	0.9% Sodium Chloride Injection,USP, BD PosiFlush™ SPSyringe is provided in 3 mL, 5mL and 10 mL configurations.All three sizes utilize a consistent10 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).

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).