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 with a LuerLock connector and is supplied without needle.

AI/ML Overview

The provided text describes the SOLOGARD® LOCKING PLUS Syringe, asserting its equivalence to a predicate device. However, the document does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific pass/fail acceptance criteria values. It broadly states "Results indicated that the device performance was equivalent to that of the predicate device." While this is a summary of the performance, it does not provide quantitative or qualitative criteria for what constitutes success in the tests mentioned (fluid flow, dynamometer, simulated use).

Acceptance Criteria	Reported Device Performance
Fluid Flow	Equivalent to predicate device
Dynamometer	Equivalent to predicate device
Simulated Use	Equivalent to predicate device
(Specific criteria, e.g., flow rate values, force thresholds, successful lock engagements, are not provided in the document.)	(Specific performance values are not provided in the document.)

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

The document mentions "engineering analyses of the fluid flow and dynamometer and simulated use testing" but does not specify the sample size (number of syringes) used for these tests. The data provenance is not explicitly mentioned (e.g., country of origin). It's a general submission for FDA clearance in the USA. Given the context, the testing would likely have been conducted in a controlled lab setting, possibly in the USA, as part of the manufacturer's (SafeGard Medical Products, Inc.) development and validation process. The studies appear to be prospective in nature, as they were conducted to demonstrate the syringe's performance for this specific 510(k) submission.

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

This question is not applicable to this type of device submission. The SOLOGARD® LOCKING PLUS Syringe is a mechanical device, and its performance is evaluated through engineering and functional tests rather than requiring expert interpretation of results like medical imaging or diagnostic tests.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when there's an ambiguity in interpreting data, often in clinical studies with human assessors. For engineering and functional tests of a syringe, the results are objectively measured (e.g., flow rate, force readings, successful locking mechanism engagement), and thus, an adjudication method in this sense is not needed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple human readers interpret cases, and the AI's impact on their performance is assessed. The SOLOGARD® LOCKING PLUS Syringe is a medical instrument (hypodermic syringe) without a diagnostic or interpretive component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a physical syringe, not an algorithm. The "locking feature" is a mechanical design element, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the SOLOGARD® LOCKING PLUS Syringe's performance would be established by objective engineering measurements and functional testing results. For example:

Fluid Flow: Measured flow rates and pressures under specified conditions.
Dynamometer: Measured forces required for plunger depression and locking mechanism engagement/disengagement (if applicable, though the goal is prevention of withdrawal).
Simulated Use: Demonstrating the consistent and reliable engagement of the plunger locking feature under conditions simulating clinical use, preventing subsequent withdrawal and accidental reuse.

The "ground truth" here is adherence to design specifications and established performance characteristics of the predicate device, demonstrated through physical testing.

8. The Sample Size for the Training Set

This question is not applicable. The SOLOGARD® LOCKING PLUS Syringe is a mechanical device, not one developed using machine learning or AI that would require a "training set" of data. Its design and performance are based on engineering principles and physical testing.

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

This question is not applicable, as there is no "training set" for this type of medical device.

Summary

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MAR 1 7 2000

K993609

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

October 20, 1999

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 Common & Classification name: Piston Syringe

PREDICATE DEVICE:

Becton Dickinson Single Use Hypodermic Syringes

PRODUCT DESCRIPTION:

INTENDED USE:

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

COMPARISON TO PREDICATE DEVICE:

The SOLOGARD® LOCKING PLUS Syringe is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse. All other aspects of the design do not vary significantly from the predicate device.

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EQUIVALENCE:

In order to demonstrate that the locking feature did not effect the safety and efficacy of the device design, engineering analyses of the fluid flow and dynamometer and simulated use testing of the locking feature were conducted. Results indicated that the device performance was equivalent to that of the predicate device.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the bird image. The text is in all capital letters.

MAR 1 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Patrick Grant, Jr Chief Financial Officer SafeGuard Products, Incorporated 52 Dragon Court Woburn, Massachusetts 01801

Re : K993609 Trade Name: SOLOGARD® LOCKING PLUS Syringe Regulatory Class: II Product Code: MEG Dated: February 15, 2000 February 17, 2000 Received:

Dear Mr. Grant, Jr.:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, 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 regulation (21 CFR Part 820) and that, through periodic (GMP) GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Grant, Jr.

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 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 Statement

510(k) Number (if known):

Device Name: _SOLOGARD® Locking Plus Syringe

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 _________________________________________________________________________________________________________________________________________________________

Patricio Cuenca

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

(Optional Format 1-2-96)

General Hospital Devices:
510(k) Number K993609

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).