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.

AI/ML Overview

This document describes the safety and effectiveness of the Becton Dickinson SafetyGlide™ Syringe, comparing it to predicate devices. The syringe includes a needle protection system designed to prevent accidental needle sticks after use.

Here's an analysis of the provided text based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Activation Forces	Performed in a similar manner to the predicate device.
Security of Assembly	Performed in a similar manner to the predicate device.
Safety Barrier Resistance	Performed in a similar manner to the predicate device.
Impact Resistance	Performed in a similar manner to the predicate device.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "sharps injury prevention feature was compared to the predicate devices."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparison appears to be based on physical performance parameters rather than expert clinical assessment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The comparison appears to be based on direct testing of performance parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a syringe, and the study focuses on physical performance characteristics, not on the interpretation of medical images or data by multiple readers. The prompt mentions "human readers improve with AI vs without AI assistance," which is not applicable to a device like a syringe.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is a physical syringe, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used:

The ground truth used for this study appears to be performance metrics against established engineering standards or the performance of legally marketed predicate devices. The criteria (activation forces, security of assembly, safety barrier resistance, impact resistance) are measurable physical properties, not clinical outcomes, pathology, or expert consensus in a diagnostic sense.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is a physical medical device and not an AI or machine learning model. Therefore, no training set size is mentioned.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for a physical device.

Summary

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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: 201 847 4344 Fax: 201 8-47 4855 E-mail: greg w morgan@bd.com

1. Device Name: Becton Dickinson SafetyGlide™ Syringe
1. 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 (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact che Dffice 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) 638-2041 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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Indications for Use

510(k) number: K992734

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

Indications for Use:

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)

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).