EASYSAFE RETRACTING NEEDLE SYRINGE by SAF-T-MED, INC.

The primary intended use of the EasySafe™ Retracting Needle Syringe is to inject fluid intramuscularly (IM) into the body. The secondary intended uses are:

to help prevent sharps injuries when using the product for its primary intended use, and;
to help reduce wasted medication when using the product for its primary intended use.

Device Description

Not Found

AI/ML Overview

The provided text describes the safety and effectiveness of the EasySafe™ Retracting Needle Syringe (K973792).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Measurement	Reported Device Performance	Comments from Document
Effectiveness	Successful IM injection	100% success rate	"All injections were successfully completed."
Safety - Sharps Injuries	No reported injuries	0 injuries reported	"No injuries of any kind were reported."
Safety - Biocompatibility	Safe for intended purpose	Found to be safe	"results indicating that, from a biocompatibility standpoint, the product is safe for its intended purpose."
Safety - Sterilization	Sterilization Assurance Level (SAL) of 10^-6	SAL of 10^-6 confirmed	"Sterilization to a SAL of 10^-6 was confirmed during the tests."
Safety - Pyrogenicity	Acceptable pyrogenicity	Acceptable results obtained	"Pyrogenicity was also evaluated and acceptable results obtained."

Study Details

2. Sample size used for the test set and data provenance

Sample Size (Effectiveness & Safety): Over 1,000 IM injections were administered.
Data Provenance: The study was a "simulated use study." The geographic origin of the study is not explicitly stated, but the manufacturer is based in Illinois, USA. The study appears to be prospective (a "recent simulated use study").

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Experts (Effectiveness & Safety - Simulated Use): "A wide variety of clinicians" participated. The exact number and their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.
Experts (Effectiveness - Focus Groups): "Twenty clinicians" indicated no impediments. Their specific qualifications are not detailed.

4. Adjudication method for the test set

The text does not describe an adjudication method for the simulated use study. The assessment of "successfully completed" injections and "no injuries of any kind" likely came directly from the clinicians observing or participating in the simulated use, without a separate adjudication process mentioned.

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

There is no MRMC comparative effectiveness study mentioned in the provided text. This study pertains to a medical device (syringe), not an AI/imaging diagnostic tool that would typically involve human readers.

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

This question is not applicable as the device is a physical medical instrument (syringe), not an algorithm or AI. The performance tests ("bench testing") represent a form of standalone testing against established physical standards.

7. The type of ground truth used

Effectiveness: Direct observation of injection completion in a simulated setting.
Safety (Injuries): Direct observation and reporting of injuries in a simulated setting.
Bench Testing (Effectiveness & Safety): Compliance with "applicable performance standards established by the International Standards Organization (ISO)" and "comparability with legally-marketed predicate devices for a variety of safety factors." This indicates a ground truth based on established engineering and regulatory standards.
Biocompatibility, Sterilization, Pyrogenicity: Laboratory test results against specified standards (e.g., SAL of 10^-6).

8. The sample size for the training set

This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require training sets.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

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JAN 2 9 1998

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '973792'. The numbers are written in a simple, slightly irregular style, typical of handwriting.

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

510(k) Number:	K973792
Proprietary Name:	EasySafe™ Retracting Needle Syringe
Common Name:	Retracting Needle Syringe
Manufacturer:	Saf-T-Med, Inc.1250 South Grove, Suite 200Barrington, IL 60010
Predicate Device Information:	A claim of substantial equivalence is made to:USMI SafeSnap™ Syringe, K925039BD syringe (pre-Ammendment device)
Device Claims:	For the injection of fluid intramuscularly (IM) intothe body, while helping to reduce the risk of sharpsinjuries and reducing the amount of wastedmedication.

In compliance with the requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification.

Effectiveness

In a recent simulated use study, over 1,000 IM injections were administered by a wide variety of clinicians to test the effectiveness of the product in injecting fluids intramuscularly into a patient. All injections were successfully completed.

Bench testing of the product confirms its compliance with the applicable performance standards established by the International Standards Organization (ISO).

In focus groups twenty clinicians indicated that they saw no impediments to being able to effectively administer injections to patients using the product.

Safety

In a recent simulated use study, over 1,000 IM injections were administered by a wide variety of clinicians to test the effectiveness of the product in injecting fluids into a patient. No injuries of any kind were reported.

Bench testing of the product confirms its comparability with legally-marketed predicate devices for a variety of safety factors, including but not limited to graduation accuracy and needle guard puncture resistance.

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Biocompatability testing was performed by outside contract laboratories, with the results indicating that, from a biocompatability standpoint, the product is safe for its intended purpose.

A variety of design factors are intended to improve upon patient and clinician safety during use of the product. While sample size requirements have precluded a broad statistical study of the impact of such factors on injury rates, clinicians have reacted in a unanimous fashion to those factors.

A detailed risk analysis was performed on the product and, based on information currently available, the risk of harm from the product appears to be relatively low.

Sterilization validation was conducted by an outside contract laboratory. Sterilization to a SAL of 10° was confirmed during the tests. Pyrogenicity was also evaluated and acceptable results obtained.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized eagle emblem, which is a common symbol associated with the U.S. government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1998

Mr. James Erbs President Saf-T-Med, Incorporated 1250 South Grove, Suite 200 Barrington, Illinois 60010

Re : K973792 Easysafe Retracting Needle Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: December 30, 1997 January 2, 1998 Received:

Dear Mr. Erbs:

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, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory 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

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Page 2 - Mr. Erbs

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.

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 requlation (21 CFR Part 801 and additionally 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" (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

ny A 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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K973792 510(k) Number (if knowf)): EasySafe" Retracting Needle Syringe Device Name:

Indications For Use:

The primary intended use of the EasySafe™ Retracting Needle Syringe is to inject fluid intramuscularly (IM) into the body. The secondary intended uses are:

1. to help prevent sharps injuries when using the product for its primary intended use, and;
1. to help reduce wasted medication when using the product for its primary intended use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palatine Cossinote

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 792 510(k) Number /

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(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).