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BD PosiFlush™ Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. 10ml BD PosiFlush™ Normal Saline. Flush Svringes are generally compatible for use with syringe pumps.

Device Description

The modified BD PosiFlush Flush 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. BD has altered the modified device from the predicate by changing the stopper material and adding an extra thread to the plunger rod, threaded stopper insert. All performance characteristics are equivalent to the predicate device. The 0.9% Sodium Chloride Injection, USP BD PosiFlush Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's). This submission represents two 2 devices: the BD PosiFlush Flush Syringe, which is provided with a sterile fluid path; and the BD PosiFlush Flush SF Syringe, which is provided externally sterile for use on a sterile field. Both configurations are sterilized via moist heat.

AI/ML Overview

This document describes the 510(k) summary for the BD PosiFlush Flush Syringe, which is a modified version of a predicate device. The primary change is the stopper material and an added extra thread to the plunger rod. The submission focuses on demonstrating substantial equivalence to the predicate device through performance testing.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The document states that "Design Verification tests were performed based on the risk analysis conducted, and the results of these tests demonstrate that the BD PosiFlush Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended."

The table below summarizes the acceptance criteria and indicates that the reported device performance met these criteria, demonstrating equivalence to the predicate device.

Performance Characteristic	Acceptance Criteria	Reported Device Performance (as stated in document)
Functional Testing
Container Closure Integrity	No Dye in Solution; No Leakage in the luer well or tip threads; No Leakage Past the Stopper Ribs; No Dye Between Stopper Ribs	Performed in an equivalent manner to the predicate device
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
Pump Force	10ml/hr – 20N; 1ml/hr - 13N; 0.1ml/hr - 9N	Performed in an equivalent manner to the predicate device
Dead Space / Expelled Volume	Equivalent to labeled volume (3ml, 5ml or 10ml)	Performed in an equivalent manner to the predicate device
Syringe Induced Reflux	0 average reflux when connected to a 4 Fr catheter	Performed in an equivalent manner to the predicate device
Sodium Chloride Injection, USP Testing
Bacterial Endotoxin	Per USP	Performed in an equivalent manner to the predicate device
Particulate Matter	Per USP	Performed in an equivalent manner to the predicate device
Assay of NaCl	Per USP	Performed in an equivalent manner to the predicate device
Heavy Metals	Per USP	Performed in an equivalent manner to the predicate device
Iron	Per USP	Performed in an equivalent manner to the predicate device
UV/vis	Per USP	Performed in an equivalent manner to the predicate device
pH	Per USP	Performed in an equivalent manner to the predicate device
Biocompatibility Testing
Cytotoxicity	Per ISO10993-5:1999, Non-Toxic	Performed in an equivalent manner to the predicate device
Hemolysis	Per ISO10993-4:2002/A:2006, Non-Toxic	Performed in an equivalent manner to the predicate device
Acute Systemic Toxicity	Per ISO10993-11:2006, Non-Toxic	Performed in an equivalent manner to the predicate device
Intracutaneous Reactivity	Per ISO10993-10:2002/A1:2006, Non-Irritant	Performed in an equivalent manner to the predicate device
Sensitization	Per ISO10993-10:2002/A1:2006, Non-Sensitizer	Performed in an equivalent manner to the predicate device
Bacterial Mutagenicity	Per ISO10993-3, Non-Mutagenic	Performed in an equivalent manner to the predicate device
In Vitro Mouse Lymphoma	Per ISO10993-3, Non-Mutagenic	Performed in an equivalent manner to the predicate device
Mouse Embryo Assay	Per ISO10993-3, Non-Mutagenic	Performed in an equivalent manner to the predicate device
Occular Irritation	Per ISO10993-10:2002/A1:2006, Non-Irritant	Performed in an equivalent manner to the predicate device
Rabbit Pyrogen	Per ISO10993-11:2006, Non-Pyrogenic	Performed in an equivalent manner to the predicate device
Subchronic Intracutaneous Toxicity	Per ISO10993-11:2006, Non-Toxic	Performed in an equivalent manner to the predicate device
Chemical Extractables Analysis	LC/DAD/MS & GC/MS. No significant extractables	Performed in an equivalent manner to the predicate device

2. Sample size used for the test set and the data provenance

The document states that "Design Verification testing included the following" and lists various tests. However, it does not specify the sample sizes used for each of these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The testing is described as "Design Verification testing," which implies it was conducted specifically for this submission to prove equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily laboratory or analytical tests against established standards (e.g., USP, ISO 10993) rather than interpretations requiring expert consensus on clinical data.

4. Adjudication method for the test set

This information is not applicable and therefore not provided in the document, as the tests outlined are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. 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

This is not applicable to this device. An MRMC study or AI assistance is not mentioned or relevant for a pre-filled saline flush syringe.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. This is a medical device, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for the performance evaluation is based on established regulatory and industry standards. This includes:

USP (United States Pharmacopeia) for chemical and particulate testing (e.g., USP , , , , , , ).
ISO 10993 (Biological evaluation of medical devices) for biocompatibility testing (e.g., ISO 10993-5, -4, -11, -10, -3).
Performance specifications of the predicate device for functional characteristics like force measurements and reflux.

8. The sample size for the training set

This is not applicable and therefore not provided in the document. This device does not involve machine learning algorithms that require a training set.

9. How the ground truth for the training set was established

This is not applicable and therefore not provided in the document, as there is no training set for this type of device.

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