BECTON DICKINSON SYRINGE

• K Number: K992734
• Device Name: BECTON DICKINSON SYRINGE
• Manufacturer: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
• Date Cleared: 1999-10-01 ( 49 days)
• Product Code: MEG
• Regulation Number: 880.5860

Intended Use

The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous). The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Device Description

Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml. Function: Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical syringe with a safety feature and does not mention any AI or ML components.

Therapeutic

No.
The device is a syringe used for fluid injection and aspiration, with a safety mechanism to prevent needle sticks; it does not directly treat a disease or condition.

Diagnostic

No

The device is described as a syringe used for injections and aspirations of fluid, and a needle protection system. There is no mention of it being used to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Single-use syringe with needle protection system," which is a physical hardware device. The summary describes the function of the syringe and its needle cover mechanism, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states the device is a syringe used for "injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin." This involves introducing or removing substances from the body, not analyzing specimens outside the body.
• Intended Use: The intended use focuses on delivering or withdrawing fluids directly to or from a patient.

The device is a medical device, specifically a syringe with a safety feature, but it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous).

The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Prescription Device: The allergy and tuberculin syringes are prescription devices and are labeled appropriately. The insulin syringe is a non-prescription device and does not have the prescription statement.

Product codes

MEG

Device Description

Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml.
Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

parts of the body below the surface of the skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The sharps injury prevention feature was compared to the predicate devices using the following criteria: activation forces, security of assembly, safety barrier resistance, impact resistance. The Becton Dickinson SafetyGlide™ Syringe performed in a similar manner to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

OCT 1 1999 11992734

Summary of Safety & Effectiveness:

1. BD Contact Person:

Greg Morgan Director Regulatory Compliance BD Medical BD 1 Becton Drive, Bldg. 2, MC226 Franklin Lakes, NJ Phone: [phone] Fax: [phone] E-mail: greg w [e-mail]

• 2. Device Name: Becton Dickinson SafetyGlide™ Syringe
• 3. Predicate Devices: Becton Dickinson Syringes & SafetyGlide™ Needle

4. Product Description/Function:

4.1 Description: Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml.

4.2 Function: Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.

5. Comparison of Modified & Predicate Devices:

5.1 Descriptive Comparison to a Legally Marketed Device The Safet™Glide™ Syringe can be used in the same fashion as standard insulin / allergy / tuberculin syringes. When the SafetyGlide™ Syringe is in the "ready-to-use" position it provides the same usable needle length as standard insulin / allergy / tuberculin syringes.

Comparison has been made to the standard insulin / allergy / tuberculin syringes. The product is intended to be used for the same general injection and aspiration of fluids. The sharps injury prevention feature of the syringe contains a mechanism that covers the needlepoim after use. In the activated position the spool of the pushrod guards against accidental needle sticks during normal handling and disposal of the used syringe.

5.2 Material Changes: The only significant change in the materials is the use of a more rigid plast x resin in the sharps injury prevention feature of the SafetyGlide™ Syringe.

5.3 Manufacturing Process Changes: The manufacturing processes are being modified for the addition of the sharps injury prevention feature.

5.4 Manufacturing Site Changes: No manufacturing site changes are being made.

5.5 Packaging Component Changes: The package design is being modified to accept the larger size of the sharps injury prevention feature.

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6. Equivalence:

The sharps injury prevention feature was compared to the predicate devices using the following criteria: activation forces, security of assembly, safety barrier resistance, impact resistance. The Becton Dickinson SafetyGlide™ Syringe performed in a similar manner to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is in black and white.

Public Health Service

1 1999

OCT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory W. Morgan Director, Regulatory Compliance Becton Dickinson and Company 1 Becton Drive Franklin Lakes, New Jersey 07417

Re : K992734 SafetyGlide Syringes Models 305930, 305951, Trade Name: & 305950 Regulatory Class: II Product Code: MEG August 12, 1999 Dated: Received: August 13, 1999

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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Morgan

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtrason substantial equivalence of your device to a legally rinang or edicate device results in a classification for your markets production 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che Dffice 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 [phone] 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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Indications for Use

510(k) number: K992734

Device Name: BD SafetyGlide™ Syringe (Insulin, Allergy and Tuberculin types)

Indications for Use:

The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous).

The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Prescription Device: The allergy and tuberculin syringes are prescription devices and are labeled appropriately. The insulin syringe is a non-prescription device and does not have the prescription statement.

Here Names for PxC

sion of Dental, Infection Control. d General Hospital Devices 510(k) Number

rescription Use (Per 21 CFR 801.109)