These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.

Device Description

The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml and is supplied with a G29 x ½" or G29 x 5/8" needle.

AI/ML Overview

This document is a 510(k) summary for the SOLOGARD® LOCKING PLUS Syringe with Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested items, such as multi-reader multi-case studies, expert ground truth, and separate training/test sets, are not applicable to this type of regulatory submission for this device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria in terms of numerical performance metrics. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to predicate devices. The reported "performance" is that the device is deemed equivalent.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Becton Dickinson Single Use Hypodermic Syringes and SafeGard Medical Products, Inc. SOLOGARD® LOCKING PLUS Syringe without Needle)	"The performance and use of this device do not differ significantly from the predicate devices. Therefore, SafeGard Medical Products, Inc. believes that this device is equivalent to the predicate devices." (Stated in the 510(k) summary).
Includes a plunger locking feature to prevent accidental reuse.	"The SOLOGARD® LOCKING PLUS Syringe with needle is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse."
Intended for general purpose fluid aspiration/injection by healthcare professionals.	"The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection."

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

Not Applicable. This 510(k) summary does not describe a "test set" in the context of a performance study for the device's efficacy. The submission focuses on design comparison and intended use equivalence rather than a study with a test set of samples.

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

Not Applicable. No experts were used for establishing ground truth in a clinical study as described in this document. The equivalence determination is based on a review of device design specifications and intended use by the FDA.

4. Adjudication Method for the Test Set:

Not Applicable. There was no "test set" and thus no adjudication method employed as part of a performance study described here.

5. 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:

Not Applicable. This device is a manual hypodermic syringe, not an AI-powered system or diagnostic imaging device. No MRMC studies were conducted or relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

Not Applicable / Not Explicitly Stated. For a 510(k) for a device like a syringe, the "ground truth" for showing safety and effectiveness is primarily established through:
- Predicate Device Comparison: The established safety and effectiveness of legally marketed predicate devices.
- Engineering/Design Specifications: The design's ability to perform its intended function (e.g., fluid aspiration/injection, locking mechanism integrity). These are usually supported by internal testing data, but such data is not detailed in this summary.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an algorithm or an AI/ML-based device.

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

Not Applicable. No training set was used.

Summary

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OCT = 1 2001

510(k) Summary of Safety and Effectiveness For SOLOGARD® LOCKING PLUS Syringe with Needle

July 18, 2001

CONTACT PERSON:

Patrick Grant, Jr. SafeGard Medical Products, Inc. 52 Dragon Court Woburn, MA 01801 Phone: (781) 935-2275 Fax: (781) 935-8424

DEVICE NAME:

Trade name: SOLOGARD® LOCKING PLUS Syringe with Needle Common & Classification name: Piston Syringe

PREDICATE DEVICES:

Becton Dickinson Single Use Hypodermic Syringes and SafeGard Medical Products, Inc. SOLOGARD® LOCKING PLUS Syringe without Needle

PRODUCT DESCRIPTION:

INTENDED USE:

The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

COMPARISON TO PREDICATE DEVICES:

The SOLOGARD® LOCKING PLUS Syringe with needle is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse. In this aspect it is similar to the predicate SOLOGARD® LOCKING PLUS Syringe without Needle.

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All other aspects of the design do not vary significantly from the predicate Becton Dickinson device.

EQUIVALENCE:

The performance and use of this device do not differ significantly from the predicate devices. Therefore, SafeGard Medical Products, Inc. believes that this device is equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT - 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick Grant, Jr. President Safegard Medical Products, Incorporated 52 Dragon Court Woburn, Massachusetts 01801

Re: K012283

Trade/Device Name: Sologard Locking Plus Syringe with Needle Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF and FMI Dated: July 18, 2001 Received: July 20, 2001

Dear Mr. Grant:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Grant

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice und instills (21 CF Partier in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and aller reville) over at its 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,
L. Alatorre

A. Ulatowski Tim 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 Statement

510(k) Number (if known): _ K 0 1 22 8 3

Device Name: _SOLOGARD® Locking Plus Syringe with Needle

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Patricia Cescente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 4 012

(Optional Format 1-2-96)

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).