This change in syringe plunger tip formulation is for the Becton Dickinson syringe. Products include: General purpose and insulin syringes. Sterile and non-sterile syringes. Syringes with and without needles attached. No design changes are being made.

AI/ML Overview

The Becton Dickinson Single Use Hypodermic and Insulin Syringes, with an alternate latex-free rubber formulation for the plunger tip, were assessed for functional equivalence to the predicate device.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Alternate Plunger Tip)
Leak Test (ISO 7886 and ISO 8537)	Passed; demonstrated equivalence to current plunger tip formulation.
Autoclavibility	Satisfactorily passed (autoclaved at 270°F, 15 minutes, then passed ISO leak testing).
Syringe Infusion Pump Performance	Demonstrated equivalent performance to natural rubber plunger tip samples.
Chemical Testing	Acceptable per ISO and USP requirements.
Biocompatibility	Satisfactorily completed.
Plunger Actuation Forces	Equivalent or superior to the current plunger tip.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, it indicates these were conducted for the alternate plunger tip formulation to demonstrate equivalence to the current plunger tip formulation (predicate device).
The data provenance is not specified in terms of country of origin, but it is a retrospective evaluation aiming to demonstrate equivalence to an existing product.

3. Number of Experts and Qualifications

This information is not provided. The study involves laboratory and performance testing of a medical device, not a diagnostic assessment typically requiring expert interpretation of clinical images or data.

4. Adjudication Method

Not applicable. This was a technical performance study on a physical device, not an assessment requiring adjudication of diagnostic interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns a material change in a syringe plunger tip and its functional equivalence, not a comparative effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This submission is for a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the equivalence study was established by comparing the performance indicators of the alternate plunger tip formulation against the established functional performance and specifications of the predicate device's (current plunger tip formulation) performance and relevant international standards (ISO, USP). Essentially, the predicate device's measured performance served as the "ground truth" for comparison for each test.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

Summary

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JUN 25 1998 SUMMARY OF SAFETY AND EFFECTIVENESS DATA

B-D Contact Person 1.0

Peter Zurlo Becton Dickinson & Company Manager, Regulatory Affairs 1 Becton Drive, Building 2 Franklin Lakes, NJ 07417-1884 (201) 847-6447 - Phone (201) 848-0457 - FAX

2.0 Device Name

Becton Dickinson Single Use Hypodermic and Insulin Syringes

3.0 . Predicate Device

Becton Dickinson Single Use Hypodermic and Insulin Syringes

Product Description/Function 4.0

Types This change in syringe plunger tip formulation is for the Becton 4.1 Dickinson syringe. Products include:
- General purpose and insulin syringes. 1.1.1
- Sterile and non-sterile syringes. 1.1.2
- 1.1.3 Syringes with and without needles attached.

No design changes are being made.

Intended Use These syringes are intended for general purpose fluid 4.2 aspiration/injection and insulin injection.

Comparison of Modified and Predicate Devices 5.0

Design Changes No design changes are being made. 5,1
5.2 Changes
- 5.2.1 Labeling - The syringe labeling will be revised to include :

"This product does not contain natural rubber latex."

Or (optionally) :

"Latex Free".

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5.2.2 Material Change: Becton Dickinson added an alternate latex free rubber formulation used for its molded syringe plunger tip in 1988.

6.0 Equivalence

The following data demonstrates functional equivalence to the Becton Dickinson predicate plunger tip and fitness for use.

Syringe barrels molded with the alternate plunger tip formulation have demonstrated equivalence to barrels molded with the current plunger tip formulation.

6.1 Leak Test - Syringes with the altemate plunger tip formulation passed ISO 7886 and ISO 8537 syringe leakage tests (as did control samples with current plunger tip formulation).
6.2 Autoclavibility (for syringes that require autoclavibility resistance) -Syringes assembled with the alternate plunger tip satisfactorily passed autoclavibility testing. (Syringes were autoclaved at 270°F, 15 minutes then tested for ISO leakage resistance testing. All samples tested passed ISO leak testing.)
6.3 Syringe Infusion Pump Performance (for syringes used in infusion pumps) - Syringes assembled with the altemate plunger tip demonstrated equivalent performance to natural rubber plunger tip samples in syringe pump application testing.
6.4 Chemical Testing - Testing has been performed per ISO and USP requirements. Results were acceptable.
Biocompatibility Biocompatibility testing was satisfactorily completed on the 6.5 altemate plunger tip.
6.6 Plunger Actuation Forces - Forces for the alternate plunger tip are equivalent or superior to the current plunger tip.
Manufacturing Process Changes No manufacturing process changes are 6.7 being made.
૯.૪ Manufacturing Site Changes - No manufacturing site changes are being made.
6.9 Packaging Component Changes - No packaging components are being changed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in black, with its wings forming a shape that resembles human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 1998

Mr. Peter Zurlo ·Manager, Regulatory Affairs Becton Dickinson Consumer Products 1 Becton Drive Franklin Lakes, New Jersey 07417-1883

K980580 Re : Becton Dickinson Syringes Trade Name: Regulatory Class: II Product Code: EMF June 9, 1998 Dated: Received: June 10, 1998

Dear Mr. Zurlo:

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 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). 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.

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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Zurlo

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance a (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at it toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timoth U 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 ol

510(k) Number (if known):_

Becton Dickinson Syringes Device Name:

Indications For Use:

The general use syringes are intended for the aspiration and Insulin syringes are intended for the injection of fluids. injection of insulin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Crescentz

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices

510(k) Number K9801580

Prescription Use_ (Per 21 CFR 801.109)

ಂದ

Over-The-Counter Use Insul

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).