The syringe filling device replaces standard, sharp hypodermic needles and all other syringe filling devices and accessories for syringe filling from vials and ampoules. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The blunt plastic cannula is intended for use with Abott Life Shield, McGaw Safeline and Baxter Interlink systems. The B-D TWINPAK offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.

Device Description

The B-D® TWINPAK™ is an assembly consisting of currently marketed and previously approved devices incorporated into a protective shield - TWINPAK comprises the following legally marketed devices.

B-D Blunt Plastic Cannula {cleared for marketing 510(K) #K964654]
Syringe Filling Device {SFD} This is a 20G x ½" steel cannula, which is exactly the same as legally marketed device by Becton Dickinson, B-D® Tubing Adapter, Reorder #8210.
Devices (1) and (2) without their respective original shields are assembled into a plastic shield, as shown in figure. A plastic cap is also placed over the syringe filling device. The TWINPAK™ can be sold by itself or with a syringe.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Becton Dickinson TWINPAK™, based on the provided document:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Statement / Method	Reported Device Performance
Dose Drawing	"The cannula geometry allows for the full dose to be withdrawn from the vial and to determine equivalence with predicate devices." Measurement tolerance: +/- 0.2cc for single dose vials, +/- 0.1cc for multiple dose vials.	"The SFD is equivalent for dose drawing to the predicate devices and the full dose can be withdrawn."
Vial Stopper Particulate Matter	"To determine if vial stopper particulate matter is generated with the SFD and predicate devices." Filters examined for visible stopper particulate matter.	"The SFD is equivalent to the predicate devices for generation of vial stopper particulate matter during vial access."
Vial Stopper Access (Leakage)	"To determine if equivalent vial stopper leakage occurs while aspirating fluids with the SFD and predicate devices." Leakage defined as fluid dripping.	"The SFD is equivalent for vial stopper access to the predicate devices."
Ampoule Access	"The criteria to determine that the SFD could access an ampoule was if the SFD cannula was longer than the shoulder length of the ampoule (as defined by ISO 9187-1 and ISO 9187-2)."	"The SFD cannula length is greater than the shoulder length for all ampoules identified under nominal dimensions. The SFD is equivalent to the predicate device for the ability to access ampoules."
Sharpness (vs. Standard Hypodermic)	"SFD cannula is 10 times less sharp than an equivalent gauge standard hypodermic needle." Measured by peak penetration force in Dental Dam (higher force = less sharp).	"The SFD is 10 times less sharp than an equivalent gauge standard hypodermic needle."
Vial Stopper Penetration Force (vs. B-D Vial Access Cannula)	"Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula." Measured by peak penetration force in various vial stoppers.	"Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula."

Study Details

Sample Size used for the test set and the data provenance:
- Dose Drawing: 30 vials per cannula type.
- Vial Stopper Particulate Matter: 30 vials per cannula type.
- Vial Stopper Access:
  - 30 single dose vials (penetrated one time each, total 30 penetrations per cannula type).
  - 30 multiple dose vials (penetrated ten times each, total 300 penetrations per cannula type).
- Penetration force testing in Dental Dam: 30 cannula per cannula type.
- Penetration force testing into various vials: 30 cannula per cannula type.
- Data Provenance: Not explicitly stated, but the submission is from Becton Dickinson and Company, implying internal testing/data. It is a retrospective study since it was conducted as part of the 510(k) submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as these are performance characteristic tests (e.g., force measurements, visual inspection for particulate matter, leakage observation, dimensional comparison), not diagnostic interpretations requiring expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable due to the nature of the tests.
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:
- No. This is a medical device (syringe filling device and blunt plastic cannula) clearance, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Dose Drawing, Vial Stopper Particulate Matter, Vial Stopper Access, and Penetration Force Testing: The ground truth is based on quantitative measurements (e.g., fluid volume, force readings) and direct visual observations against defined criteria (e.g., "visible stopper particulate matter," "fluid dripping").
- For Ampoule Access: The ground truth is established by dimensional comparison against international standards (ISO 9187-1 and ISO 9187-2).
The sample size for the training set:
- Not applicable. This is not a machine learning model.
How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model.

Summary

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K974006

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

B-D Contact Person 1.0

10.00

4 424 . - - - - - - - - -

JAN 2 2 1998

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

2.0 Device Name

Becton Dickinson TWINPAK TH

Predicate Device 3.0

Becton Dickinson Blunt Plastic Cannula and Tubing Adapter

Product Description/Function 4.0

Product Description 4.1

The B-D® TWINPAK™ is an assembly consisting of currently marketed and previously approved devices incorporated into a protective shield - TWINPAK comprises the following legally marketed devices.

B-D Blunt Plastic Cannula {cleared for marketing 510(K) #K964654] 1.
1. Syringe Filling Device {SFD} This is a 20G x ½" steel cannula, which is exactly the same as legally marketed device by Becton Dickinson, B-D® Tubing Adapter, Reorder #8210.

Devices (1) and (2) without their respective original shields are assembled into a plastic shield, as shown in figure. A plastic cap is also placed over the syringe filling device. The TWINPAK™ can be sold by itself or with a syringe.

4.2 Product Function

The syringe filling device replaces standard, sharp hypodermic needles and all other syringe filling devices and accessories for syringe filling from vials and ampoules. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The B-D® TWINPAK™ offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.

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Comparison of Modified and Predicate Devices -- Predicate, legally marked device; 5.0 The following products are referenced as predicate devices:

Device	510(k) #
Becton Dickinson 20G hypodermic needle	Pre-amendment device
Becton Dickinson Interlink® Vial AccessCannula	K920422 and K883538
Becton Dickinson Tubing Adapter	Pre-amendment device

These products are compared to the syringe filling device of B-D® TWINPAK™.

5.1 Design

いよノムリノロロ

エレ・エレ

The syringe filling device is a standard 20G x 1/2" steel cannula. The cannula has a ground blunt point geometry with 45" bevel. This is exactly the same design as B-D Tubing Adapter,

5.2 Material

Material Comparison to Predicate Devices

	Syringe Filling Device	B-D Tubing Adapter	B-D Hypodermic Needle
Cannula	Stainless Steel	Stainless Steel	Stainless Steel
Lubricant	Silicone	Silicone	Silicone
AK Shield	Polypropylene	N/A	N/A
Cap	Polypropylene	N/A	N/A
Cannula hub	Polypropylene	Polypropylene	Polypropylene
Adhesive	Epoxy	Epoxy	Epoxy

5.3 Manufacturing Process

The manufacturing process used for the syringe filling device is exactly the same as that of B-D Precision Glide Needle and B-D Tubing Adapter. The process includes cannulating the steel cannula to molded plastic hub using epoxy adhesive. The TWINPAK™ shield and cap are manufactured by injection molding.

5.4 Product Use

The syringe filling device component of B-D® TWINPAK™ is for use in drawing up fluids/medications from vials and ampoules without requiring other accessories. Standard B-D hypodermic needle is also used for the same use. B-D Interlink® Vial Access Cannula is for use in drawing up medications from single dose vials only. The syringe filling device is comparable to predicate devices in dose drawing, vial penetration forces, vial stopper leakage and particulate matter generation.

ﻤﺴﺎﻧﺪ

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Safety and Effectiveness ર્સ્ડ

5.5.1 The syringe filling device was tested to demonstrate a general equivalency in safety and effectiveness measures with predicate devices. Following lests were conducted as measures of safety and effectiveness for the intended use/application:
- a. Dose drawing
- b. Vial Stopper Particulate Matter
- c. Vial Stopper Access
- d. Ampoule Access

6.0 Equivalence

۳ ۱۰ ۱۰ ۱

いんしたいい

Testing to Support General Equivalence 6.1

The following table lists specific tests used to demonstrate general equivalence for the Syringe Filling Device (SFD) to predicate devices when aspirating fluids.

a. Dose Drawing
b. Vial Stopper Particulate Matter
c. Vial Stopper Access
d. Ampoule Access

Dose Drawing - Test Description 6.1.1

Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1 mi doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The measurement tolerance for the single dose vials was +/- 0.2cc and for the multiple dose vial was +/- 0.1cc. This test is designed to determine if the cannula geometry allows for the full dose to be withdrawn from the vial and to determine equivalence with predicate devices. Thirty vials per cannula type were tested.

Conclusion - The SFD is equivalent for dose drawing to the predicate devices and the full dose can be withdrawn.

Vial Stopper Particulate Matter - Test Description 6.1.2

Cannula are attached to a syringe. Air is aspirated Into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is withdrawn. The fluid is measured using the scale of the syringe. The fluid in the syringe is dispensed into a filter. The filters were than examined for visible stopper particulate matter. This test is designed to determine if vial stopper particulate matter is generated with the SFD and predicate devices. Thirty vials per cannula type were tested.

ﻜﺴﺎ

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Conclusions - The SFD is equivalent to the predicate devices for generation of vial stopper particulate matter during vial access.

Vial Stopper Access - Test Description 8.1.3

Cannula are attached to a syringe. Air is aspirated into the syringe, the amount of air corresponds to the dose to be drawn. The dose was defined as the full volume for the single dose vials and ten 1ml doses per vial for the multiple dose vial. Cannula are penetrated through the vial stoppers and the vials are inverted. The air is injected into the vials and the appropriate dose is aspirated. During pressunzation and aspiration any leakage was noted. Leakage is defined as fluid dripping. This test is designed to determine if equivalent vial stopper leakage occurs while aspirating fluids with the SFD and predicate devices. Thirty single dose vials were penetrated one time each for a total of 30 penetrations per cannula type. Thirty multiple dose vials were penetrated ten times each for a total of 300 penetrations per cannula type.

Conclusions - The SFD is equivalent for vial stopper access to the predicate devices.

8.1.4 Ampoule Access

エレ、ニレ

い上ノムリノロリ

The ability to access ampoules was assessed by a dimensional comparison between the SFD cannula geometry and ampoule dimensions as defined by ISO 9187-1 (Injection equipment for medical use - Ampoules for Injectables) and ISO 9187-2 (Injection equipment for medical use - One-point-cut ampoules). The criteria to determine that the SFD could access an ampoule was if the SFD cannula was longer than the shoulder length of the ampoule. If the cannula lenath is greater than the shoulder length then fluids would be able to be aspirated using normal protocols The SFD cannula length is greater than the shoulder length for all ampoules identified under nominal dimensions. This evaluation was intended to show equivalence for accessing ampoules with the SFD and predicate devices.

Conclusion - The SFD is equivalent to the predicate device for the ability to access ampoules.

7.0 Testing to Support Specific Claims

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

CLAIM1	SFD cannula is 10 times lesssharp than an equivalent gaugestandard hypodermic needle	Penetration force testing inDental Dam
CLAIM2	Vial stopper penetration force issubstantially reduced whencomparing the SFD to the B-DVial Access Cannula	Penetration force testing invarious vials

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Penetration force testing in Dental Dam - Test Description 7.1

Cannula were attached to a force transducer and penelrated through cannout were attached to chone Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.

Background

Dental Dam is a thin (.012 inches thick) latex rubber material that has been used to evaluate the penetration force of hypodermic and intravenous catheter needles. Peak penetration force is inversely proportional to the cannula sharpness, i.e. the higher the force, the less sharp the cannula.

Conclusions

The SFD is 10 limes less sharp than an equivalent gauge standard hypodermic needle.

Penetration force testing into various vials Test Description 72
Cannula were attached to a force transducer and penetrated through various drug vial stoppers in an axial direction. Peak penetration forces were recorded. The sample size was 30 cannula per cannula type.

Conclusions

Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, connected by flowing lines. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 2 2 1000

Mr. Gregory W. Morgan Manager, Regulatory Affairs Division Quality Assurance Becton Dickinson & Company 1 Becton Drive, Building 2 07417-1884 Franklin Lakes, New Jersey

Re : K974006 Becton Dickinson Twinpak Trade Name: Regulatory Class: II Product Code: FMI Dated: December 8, 1997 Received: December 9, 1997

Dear Mr. Morgan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. . A . . . . . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Morgan

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-204% or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):	K974006
Device Name:	Becton Dickinson TWINPAK™
Indications For Use:

The syringe filling device replaces standard, sharp hypodermic needles and all other syringe The syringe filling device replaces standard, Sharp nypoules. Once the synings is a filling devices and accessories for synnge . The synnge is the restlached to the blunt filled, the filing device is deached into injociting spiration of fluids. The blunt plastic cannula is intended for use with Abott Life Shieline, McGaw Safeline in and Baster plastic cannula is imended for use with About the Convenion of deithering a syninge filling filling filling filling for any Interink® systems. The B-D TVVNPAR Oners the Conventorious of Controller of fluids.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuscinita

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 924000

Frescription Use_ (Per 21 CFR 801 . 109)

Over-The-Counter Use .........................................

(Optional Format 1-2-96)

્રમું

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).