Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated to reduce septum insertion forces.

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needleless IV access cannula. The B-D Blunt Plastic Cannula provides access to the fluid path and prevents accidental needlesticks in this application.

Device Description

B-D® Blunt Plastic Cannula is a molded plastic blunt tipped cannula for use in preslit IV safety systems, (i.e. Baxter InterLink® , Abbott LifeShield®, and McGaw SafeLine™). The B-D Blunt Plastic Cannula is intended for penetration of pre-slit IV port septums or vials designed for penetration with needleless IV access cannula (i.e. Abbott LifeShield® Single Dose Vials). B-D® Blunt Plastic Cannula, InterLink® Syringe Cannula, and McGaw SafeLine™ Blunt Cannula are all plastic devices. LifeShield® Blunt Cannulas is a two (2) piece design which has a plastic hub with a blunt steel cannula attached.

B-D® Blunt Plastic Cannula is molded from copolyester resin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting studies for the B-D® Blunt Plastic Cannula, based on the provided document:

Acceptance Criteria and Device Performance for B-D® Blunt Plastic Cannula

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance (B-D® Blunt Plastic Cannula)
General Equivalence Tests (Section 6.1):
Injection Site Peak Penetration Force (6.1.1)	Performed at an acceptable level in all sites; forces within the range of predicate devices (InterLink® Syringe Cannula, McGaw SafeLine™) and Abbott LifeShield®). Consistency between old and new device performance.	Performance was acceptable in all sites. Differences (lower or higher than predicates) were attributed to dimensional differences in stem ODs, but overall forces were within the range of predicate devices.
Lipid Flow Rate Testing (6.1.2)	Equivalent flow rates to all predicate devices. No significant particle generation during infusion.	Flow rates were equivalent to all predicate devices. Filter examination showed no concerning particle generation.
Lipid Compatibility (6.1.3)	No leakage due to physical changes/material degradation after 24-hour lipid infusion. No damage observed on luer slip magnification.	No leakage due to physical changes or material degradation. Magnification (20X) revealed no damage to luer slips, indicating no impact on cannula function.
Microbial Ingress Testing (6.1.4)	Did not compromise microbial barrier efficacy of pre-slit needleless septums after 200 penetrations. No microbial ingress.	Did not compromise microbial barrier efficacy. No microbial ingress was found in any of the six challenged cannula and injection site combinations, even with added stress of wiping septums and changing cannulas after every fourth penetration.
Leakage Testing (6.1.5)	No drops of water forming and falling off within 30 seconds at 45 psi pressure after 200 penetrations.	No leakage observed due to the B-D® Blunt Plastic Cannula.
Gravity Flow Rate (6.1.6)	Acceptance criteria were not explicitly stated but implied comparison to predicate devices and acceptable clinical performance.	Flow rate was greater than the Abbott LifeShield® 18G Blunt Steel Cannula. While lower than McGaw SafeLine™ and InterLink® Syringe Cannula due to a smaller ID, the reduced ID/OD allowed access to all systems.
Particulate Matter Generation (6.1.7)	Produced equivalent or reduced particulate matter compared to predicate devices after 200 penetrations.	Produced equivalent or reduced particulate matter compared to the predicate devices.
Specific Claims Tests (Section 6.2):
Peak Penetration Forces in Abbott LifeShield® Single Dose Vials (6.2.1)	Maintained stopper integrity despite potential higher forces due to larger OD.	Slightly higher penetration forces were observed due to larger cannula OD, but subsequent tests confirmed this did not affect stopper integrity.
Full Dose Draw / Vial Integrity (6.2.2)	Maintained vial integrity (no leakage) and allowed aspiration of full fluid volume after pressurization with 10cc air.	Vial integrity was maintained through pressurization (10cc air = 10 ml fluid +/- 10%). The cannula successfully allowed for vial penetration and aspiration of fluid without leakage.
Vial Particulate Matter Generation (6.2.3)	No particulates of vial stopper material observed on filters.	No particulates of vial stopper material were observed on filters for either the B-D® Blunt Plastic Cannula or the predicate device during fluid aspiration from vials.

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

The document does not explicitly state the total number of individual devices or injection sites/vials included in each test. However, it mentions specific quantities for certain test procedures:

Microbial Ingress Testing (6.1.4): Injection sites were penetrated two hundred (200) times with various cannulas. Six combinations of cannula and injection sites were challenged.
Leakage Testing (6.1.5): Injection sites were penetrated two hundred (200) times with various cannulas.
Particulate Matter Generation (6.1.7): Injection sites were penetrated two hundred (200) times with cannula.

Data Provenance: The studies appear to be retrospective in the sense that they are laboratory tests conducted on existing materials and designs, comparing a new device to already marketed predicate devices. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Becton Dickinson).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of human experts or their qualifications to establish ground truth for the test set. These are largely engineering and performance tests based on measurable physical and biological parameters, rather than human interpretation.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the tests are objective laboratory measurements (e.g., force, flow rate, presence of microbes/particles, leakage).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, where the AI assists the human reader. The current device is a sterile medical accessory, and its performance is evaluated through physical, mechanical, and biological compatibility tests.

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

This question is not applicable to the B-D® Blunt Plastic Cannula. The device itself is a physical medical accessory, not an AI algorithm. Its performance is inherent to its design and material properties.

7. The type of ground truth used:

The "ground truth" for these tests is established by:

Physical measurements: E.g., peak penetration force, flow rate (ml/min), pressure (psi), volume (cc/ml), particle size (>10 µm, >100 µm).
Absence/Presence criteria: E.g., absence of microbial ingress, absence of leakage, absence of visible particulates.
Comparisons to predicate devices: Performance is deemed acceptable if it is equivalent, superior, or within an acceptable range compared to established, legally marketed predicate devices.
Material analysis: Fourier Transform Infrared (FTIR) analysis for particle characterization.

8. The sample size for the training set:

This concept is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of AI. The development process would have involved design, prototyping, and iterative testing, but not machine learning training.

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

Not applicable, as there is no training set for an AI model.

Summary

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Attachment 5

K964654

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

B-D Contact Person 1.0

Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson and Company 1 Becton Drive, Building 2 1 Dector Lakes, NJ 07417-1884 (201) 847-4344 Phone (201) 847-4855 FAX

APR - 2 1997

Device Name 2.0

Becton Dickinson , B-D® Blunt Plastic Cannula

Predicate Device 3.0

Becton Dickinson InterLink® Syringe Cannula

Product Description / Function 4.0

Product Description 4.1

Sterile, single-use plastic cannula used to penetrate pre-slit septums covering Sterile, single-use plastic canhula used to penetration with needleless IV access
injection sites as well as, vials designed for penetration with needleless W access
the site injection sites as well as, vials designed for periodically insertion forces.
cannula. The cannula is pre-lubricated to reduce septum insertion forces.

Product Function 4.2

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to The B-D" Blunt Plastic Cannual replaces 1rypod for penetration with needleless IV
access injection sites, as well as, vials designed for pension access to the fluid path access injection sites, as well as, vials designed for the fluid path
access cannula. The B-D Blunt Plastic Cannula provides access to the fluid path access cannula. The B-D Blunt Plastic Outmola provides prevents accidental for injection needlesticks in this application.

Comparison of Modified and Predicate Devices 5.0

Comparison to Legally Marketed Devices 5.1

Companson to Legally Markets - - - - - - - - - - - - - - - - - - - - - - - - - -

DEVICE	510(k) NUMBERS OF DEVICE
Becton Dickinson InterLink® SyringeCannula	K920422 & K883638
Abbott LifeShield® Blunt Steel 18g x 1"Cannula	K854547
McGaw SafeLine™ Blunt Cannula	K931377

These products are compared to the B-D® Blunt Plastic Cannula in the following manner

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5.1.1 Design :

B-D" Blunt Plastic Cannula is a molded plastic blunt tipped cannula for use in preslit IV safety systems, (i.e. Baxter InterLink® , Abbott LifeShield®, and McGaw SafeLine™). The B-D Blunt Plastic Cannula is intended for penetration of pre-slit IV port septums or vials designed for penetration with needleless IV access rv por Sopenme of theShield® Single Dose Vials). B-D® Blunt Plastic Cannula, InterLink® Syringe Cannula, and McGaw SafeLine™ Blunt Cannula are all plastic devices. LifeShield® Blunt Cannulas is a two (2) piece design which has a plastic hub with a blunt steel cannula attached.

DESIGN COMPARISONS TO PREDICATE DEVICES

B-D "Blunt" Mask Cannula				B-D Interlink's System Mask Cannula				Symetry Mask Cannula				Safesite Shield Blunt Cannula
Design	Single MoldedComponent	Single MoldedComponent	Single MoldedComponent	Molded Hub withBlunt SteelCannula

5.1.2. Material:

B-D® Blunt Plastic Cannula is molded from copolyester resin. Shield material is the same as the B-D InterLink® Syringe Cannula .

	B-D BluntPlasticCannula	B-D InterlinkSyringeCannula	McGawSafeLineBlunt Cannula	LifeShield BluntCannulas
Cannula Stem / Hub	copolyester	polypropylene	copolyester	steel /polypropylene
Lubricant			unknown	unknown

MATERIAL COMPARISONS TO PREDICATE DEVICES

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5.1.3. Product Use:

B-Dª Blunt Plastic Cannula is a molded, plastic, blunt tipped cannula for use in preslit IV safety systems (i.e. Baxter InterLink®, Abbott LifeShield®, and McGaw SafeLine™). The B-D® Blunt Plastic Cannula Is comparable in all systems in terms of injection site insertion forces, ability of injection sites to withstand 200 cannula insertions without damage, which would impact, particulate generation, leakage and or microbial ingress. B-D® Blunt Plastic Cannula is designed to access vials which are designed for needleless IV access cannula (i.e. Abbott LifeShield® single dose saline).

Applicable claims	For use in IV preslitseptums and needlelessaccess vials	For use inInterLink®injection sites	For use with McGawSafeLine™ System	Use with onlyprepierced IVreseals
ClaimsPackage Contents	Sterile, Non toxic andNon -pyrogenic	Sterile, Non toxicand Non -pyrogenic	Sterile, Non toxic andNon -pyrogenic	Sterile, Non toxicand Non -pyrogenic

PRODUCT USE COMPARISON OF PREDICATE DEVICES

Manufacturing Process Changes 5.2

No manufacturing process changes are being made.

5.3 -Manufacturing Site Changes

No manufacturing site changes are being made.

5.2 Packaging Component Changes

No packaging component changes are being made.

6.0 Equivalence

6.1 Testing to Support General Equivalence:

The following table lists specific tests used to demonstrate general equivalence for the B-D Blunt Plastic Cannula in pre - slit safety systems

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6.1.1	Injection Site Peak Penetration Force
6.1.2	Lipid Flow Rate Testing
6.1.3	Lipid compatibility
6.1.4	Microbial Ingress
6.1.5	Leakage
6.1.6	Gravity Flow Rate
6.1.7	Particulate Matter

Injection Site Peak Penetration force 6.1.1

Test Description:

Cannula are inserted axially into injection sites. The injection site penetration test measures the peak axial force required for the cannula to penetrate the slit septum of the needleless injection site.

Conclusions:

B-D® Blunt Plastic cannula performed at an acceptable level in all sites. Differences both lower than the predicate (InterLink® Syringe Cannula , McGaw SafeLine™) and higher forces (Abbott LifeShield®) are a result of the dimensional differences between the stem OD's. Based on the average force levels in all injection sites with predicate devices, forces for the B-D" Blunt Plastic Cannula are within this range.

6.1.2 Libid Flow Rate testing:

Test Description:

Laboratory syringe infusion pump testing was conducted to determine flow rates through a series cannula as a function of time and volume of fluid being infused. Additionally the fluid was filtered to determine if there was any particle generation during course of flow rate testing. The fluid used in evaluations was Intralipid" 20% fat emulsion. Two different volumetric flow rates were evaluated for a duration of 6 hours. Volumetric flow rate accuracy was determined based on weight of the fluid delivered per each test cycle. Fluids were filtered at cannula inlet per manufactures recommendations (syringe output) and outlet of the cannula string. Filters used were a membrane type with a porosity of 1.2jum (filter porosity was minimum recommended by 20% Intralipid® manufacturer's literature). After infusion was complete, the outlet filters were removed and allowed to dry under laminar flow hood and then microscopically examined at 30X magnification. All particles larger than 10;um were counted and presented for characterization or identification using optical microscopic and Fourier transform infra red (FTIR) analysis techniques.

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Conclusions:

Flow rates are equivalent for the B-D® Blunt Plastic Cannula to all predicate devices.

Lipid Compatibility: 6.1.3

Test Description:

Lipid infusion thru B-D® Blunt Plastic cannula molded were conducted for a 24 hour period. Each luer slip torque to a specified level (32in/oz) over a luer post in order to prestress the slip and ears.

Conclusion:

No leakage due to physical changes as a result material degradation were Examination of the luer slips via magnification (20X) revealed no observed. damage which would effect the function of the cannula.

Microbial Ingress Testing: 6.1.4

Test Description:

Injection sites were penetrated two hundred (200) times with various cannula. Injection sites were then subjected to a microbial challenge.

Conclusions:

Based on the data it can be concluded that the B-D® Blunt Plastic cannula when used in pre slit needleless septums did not compromise the microbial barrier efficacy. Microbial ingress did not occur for the six (6) combinations of cannula and injection sites challenged in this study. Recommended aseptic technique, such as, swabbing the intection site with an antiseptic agent prior to each insertion and using a new sterile cannula for each insertion were also challenged in this test, in as far as, the septum was wiped and cannula changed after every fourth penetration. Even with this added stress of the microbial challenge, no ingress was found.

Leakage testing 6.1.5

Test Description:

Injection sites were penetrated two hundred (200) times with various cannula. Iniection sites were then subjected to a pressure test. A cannula with the luer slip sealed (to prevent leakage through cannula) was inserted into site. Pressure (45 ps) was initiated and held for 30 seconds. Criteria for failure was that no drops of water would form and fall off within this time.

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Conclusions:

Islons: caused by the B-D® Blunt Plastic Cannula.

Flow Rate Testing 6.1.6

Test Description:

Flow rate testing to determine equivalency by using a typical IV drip gravity set-up (0.9% 100ml saline bag and adapters) connected to a cannula. Height of the bag was held at a constant (39 inches) to simulate arterial prossure Flow was initiated and timed and volume measured to give a flow rate in ml/min.

Conclusions:

B-D® Blunt Plastic Cannula flow rate is greater than the Abbott LifeShield® 18 G Blunt Steel Cannula. The larger ID of the McGaw SafeLine™ and the InterLink® Syringe Cannula allow for greater flow rates. However, the B-D® Blunt Plastic Cannula's reduced ID / OD provides access to all systems, not only McGaw SafeLine™ and Baxter InterLink®.

6.1.7 Particulate matter generation

Test Description;

Iniection sites were penetrated two hundred (200) times with cannula. During each penetration solution was flushed through the cannula and septum and collected on a filter. This filter was then examined and visible particles, greater than 100 um, were counted and identified via Fourier transform infra red (FTIR) technique as septum material.

Conclusions:

B-D® Blunt Plastic Cannula produced equivalent or reduced particulate matter as compared to the predicate devices.

Supporting data for specific claims 6.2

The following table lists tests to support specific product claims beyond general equivalence.

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Peak Penetration forces in Abbott LifeShield® Single dose vials. 6.2.1

Test Description:

Test Desorription.
Cannula were attached to a force transducer and penetrated through the vial stopper in an axial direction. Peak penetration forces were recorded.

Conclusions:

Slightly higher penetration forces observed with the B-D® Blunt Plastic Cannula are a result of the larger cannula OD. This increase does not effect stopper integrity based on subsequent tests.

Full dose draw/ Vial integrity. 6.2.2

Test description:

Air (10cc) is aspirated into a syringe with cannula attached. Cannula are penetrated through vial stoppers. Air is injected into the vial and is allowed to pressurize the vial for 10 seconds. Plunger rod of syringe is then released and fluid is aspirated into syringe. After the syringe has stopped filling, fluid is measured using scale on the syringe. If vial integrity is compromised the equalization of pressure in the vial would not displace the same volume of fluid aspirated, as the volume of air injected. This test is designed to determine if the cannula OD or other design features of the B-D® Blunt Plastic Cannula has an effect on the sealing ability of the Abbott LifeShield® Single dose vial stopper for full dose drawing as compared to the predicate device.

Conclusions:

Vial integrity is maintained through pressurization of vial with full injection of air Into vial (10cc air = 10 ml fluid (+ /- 10%) ). B-Dª Blunt Plastic Cannula can be used for vial penetration and aspiration of fluid from vial without leakage.

6.2.3 Vial particulate matter generation testing.

Test Description:

Cannula were attached to a syringes. Syringe was drawn with 10cc of air. Air was injected into a vial and fluid allowed to be drawn from the vial. Vial was then inverted and the cannula distal tip was at a position close the bottom of vial, to allow for maximum draw of fluid. Fluid was then expelled onto a filter. Filters were then examined for visible particulate matter.

Conclusion: No particulates of vial stopper material were observed on filters for either device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).