The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.

Device Description

Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.

The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, specifically the BD PosiFlush Heparin Lock Flush Syringe. The purpose of this document is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, rather than to establish new performance criteria for a novel device or an AI/ML algorithm.

Therefore, the concepts of "acceptance criteria," "study proving the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" as they relate to AI/ML device validation are not applicable to this document.

This document describes a change to an existing device (qualifying a new stopper material) and relies on design verification testing and biocompatibility testing to demonstrate that the modified device remains substantially equivalent to the predicate device and does not affect the safety and efficacy.

Key information provided in the document relevant to device validation (though not in the context of AI/ML performance):

Acceptance Criteria & Reported Performance:
- The document 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 of acceptance criteria values or the reported performance data for each test. It only states that the device "met predetermined acceptance criteria per BD's internal specification" and "results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device."
- Tests Conducted:
  - Container Closure Integrity
  - Break Loose/Break Out/Sustaining force
  - Stopper Separation
  - Leakage
  - Pump Force
  - Ship Test
  - Dead Space
  - Syringe Induced Reflux
- Biocompatibility testing was conducted in accordance with ISO 10993-1, including: Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Ocular irritation, Partial thromboplastin Time, Sensitization, Pvrogenicity, Genotoxicity, and Chemical extractable analysis. The document states "Biocompatibility evaluation was conducted..." and implies successful completion, but does not provide specific acceptance criteria or reported results.
Sample Size and Data Provenance: Not applicable in the context of an AI/ML test set. The document refers to "design verification testing" and "biocompatibility testing" which would have involved a certain number of manufactured units, but the sample sizes for these tests are not explicitly stated in this summary.
Ground Truth Experts/Adjudication Method/MRMC/Standalone Performance/Type of Ground Truth/Training Set Details: These concepts are entirely irrelevant to this type of device submission, which is for a physical medical device with a material change, not an AI/ML diagnostic or therapeutic algorithm. The "ground truth" for a device like this would be established through established physical and chemical testing standards, not expert consensus on medical images or outcomes data in the sense of AI/ML.

In summary, the provided document does not contain the information required to answer the questions as they are framed for an AI/ML device. It focuses on the substantial equivalence of a physical medical device after a material change.

Summary

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

February 27, 2017

Becton Dickinson And Company Aakash Jain Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07045

Re: K163591

Trade/Device Name: BD Posiflush Heparin Lock Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: December 16, 2016 Received: December 20, 2016

Dear Aakash Jain:

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,

Susan Runno DDS, MA

For Tina Kiang 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)

Device Name

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe

Indications for Use (Describe)

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.

Type of Use (Select one or both, as applicable)
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X 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:	Aakash JainSenior Regulatory Affairs SpecialistBecton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Phone: (201)847-5879Fax: (201)847-5307
Date Prepared:	February 8, 2017
Subject Devices:	Trade Name:	Heparin Lock Flush Solution, USP-BD PosiFlush™ Heparin Lock Flush Syringe
	Common Name:	Heparin, Vascular Access Flush
	Classification:	Class II, 21 CFR §880.5200
	Product Code:	NZW
Predicate Devices:	Trade Name:	Heparin Lock Flush Solution, USP-BD PosiFlush™ Heparin Lock Flush Syringe
	510(k) Reference:	K090680
	Common Name:	Heparin, Vascular Access Flush
	Classification:	Class II, 21 CFR §880.5200
	Product Code:	NZW
DeviceCharacteristics	Subject DeviceBD PosiFlush™ Heparin Lock FlushSyringe(K163591)	Predicate DeviceBD PosiFlush™ Heparin Lock FlushSyringe(K090680)
Manufacturer	Becton, Dickinson and Company	Becton, Dickinson and Company
Intended Use	The Heparin Lock Flush Solution,USP, BD PosiFlush™ Heparin LockFlush Syringes are intended formaintenance of patency of vascularaccess devices only.	The Heparin Lock Flush Solution,USP, BD PosiFlush™ Heparin LockFlush Syringes are intended formaintenance of patency of vascularaccess devices only.
OperatingPrinciple	The BD PosiFlush™ Heparin LockFlush Syringe is a three-piece,sterile, single use syringe with a 6%(Luer) connector pre-filled withheparin sodium, USP in either10U/mL or 100U/mL concentration0.9% Sodium Chloride Injection,USP, and sealed with a tip cap.	The BD PosiFlush™ Heparin LockFlush Syringe is a three-piece, sterile,single use syringe with a 6% (Luer)connector pre-filled with heparinsodium, USP in either 10U/mL or100U/mL concentration 0.9%Sodium Chloride Injection, USP, andsealed with a tip cap.
Materials	Barrel: PolypropylenePlunger Rod: PolypropyleneTip Cap: Polypropylene w/ Blue (10units/mL) or Yellow (100 units/mL)ColorantStopper Lubricant: SiliconeStopper Material: BromobutylRubber	Barrel: PolypropylenePlunger Rod: PolypropyleneTip Cap: Polypropylene w/ Blue (10units/mL) or Yellow (100 units/mL)ColorantStopper Lubricant: SiliconeStopper Material: Styrene-butadieneRubber
Packaging	Flow wrapShelf CartonCase Carton	Flow wrapShelf CartonCase Carton
Specification	Provided in 3 mL and 5 mL in either10U/mL or 100U/mLconfigurations. All sizes utilize aconsistent 10 mL syringe barreldiameter.	Provided in 3 mL and 5 mL in either10U/mL or 100U/mL configurations.All sizes utilize a consistent 10 mLsyringe barrel diameter.
DeviceCharacteristics	Subject Device	Predicate Device
	BD PosiFlush™ Heparin Lock FlushSyringe(K163591)	BD PosiFlush™ Heparin Lock FlushSyringe(K090680)
Shelf Life	10U/mL- 18 Months100U/mL- 24 Months	10U/mL- 18 Months100U/mL- 24 Months
Sterilization	Per ISO 17665	Per ISO 17665
SAL Level	SAL 10-6	SAL 10-6
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1

Device Description

The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.

Intended Use

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe are intended for maintenance of patency of vascular access devices only.

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Technological Characteristics

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

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Performance Data

Modifications to BD PosiFlush™ Heparin Lock Flush Syringe 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 (ISO10993-4). Sensitization (per ISO10993-10). Pvrogenicity (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 Loose/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™ Heparin Lock Flush 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™ Heparin Lock Flush Syringes are substantially equivalent to the legally marketed predicate device, BD PosiFlush™ Heparin Lock Flush Syringes (K090680)

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).