BECTON DICKINSON TWINPAK

K974006 · Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI · Jan 22, 1998 · General Hospital

Device Facts

• Record ID: K974006
• Device Name: BECTON DICKINSON TWINPAK
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: FMI · General Hospital
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

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 Abbott LifeShield, 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 Story

TWINPAK assembly comprises a 20G x 1/2" steel syringe filling device (SFD) and a blunt plastic cannula housed in a protective shield. SFD replaces sharp hypodermic needles for drawing medications from vials/ampoules. Once filled, SFD is detached; syringe is reattached to blunt cannula for IV access. Used in clinical settings by healthcare providers. SFD features ground blunt point geometry (45-degree bevel) to reduce sharpness compared to standard needles, minimizing vial stopper penetration force and particulate generation. Benefits include reduced risk of needlestick injuries and improved safety during vial access.

Clinical Evidence

Bench testing only. No clinical data. Testing included dose drawing accuracy, vial stopper particulate matter generation, vial stopper access (leakage), and ampoule access. Comparative testing against predicates showed equivalent performance in dose drawing and vial access. Specific claims regarding reduced sharpness (10x less sharp than standard needles) and reduced vial stopper penetration force were supported by force transducer testing in dental dam and various vial stoppers (n=30 per group).

Technological Characteristics

20G x 1/2" stainless steel cannula with ground blunt point (45-degree bevel). Components include polypropylene shield/cap/hub and epoxy adhesive. Lubricated with silicone. Mechanical device; no energy source or software. Sterilization method not specified.

Indications for Use

Indicated for use as a syringe filling device for drawing fluids/medications from vials and ampoules, and as a blunt cannula for accessing split septum IV sites for fluid injection/aspiration. No specific patient population or contraindications stated.

Regulatory Classification

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.

Predicate Devices

• Becton Dickinson Blunt Plastic Cannula and Tubing Adapter (K964654)
• Becton Dickinson 20G hypodermic needle (Pre-amendment)
• Becton Dickinson Interlink® Vial Access Cannula (K920422 and K883538)
• Becton Dickinson Tubing Adapter (Pre-amendment)

Submission Summary (Full Text)

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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 [phone] - Phone [phone] - 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.
- 2. 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 Access<br>Cannula | 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.

| CLAIM<br>1 | SFD cannula is 10 times less<br>sharp than an equivalent gauge<br>standard hypodermic needle | Penetration force testing in<br>Dental Dam |
|------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| CLAIM<br>2 | Vial stopper penetration force is<br>substantially reduced when<br>comparing the SFD to the B-D<br>Vial Access Cannula | Penetration force testing in<br>various 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.

20

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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)

OR

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

(Optional Format 1-2-96)

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