For subcutaneous and intramuscular use.
The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.
The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.

Device Description

The NMT Safety Syringe is a standard piston syringe with integral needle. The syringe incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed.
The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the NMT Safety Syringe, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Device Function: Injection of Medication	Safe and reliable method of injecting medication into a patient.	Functions as a conventional hypodermic syringe for injecting medication. Explicitly deemed "safe and reliable" for this purpose by the manufacturer.
Device Function: Protection from Needlesticks	Protects the user from potential needlesticks.	The contaminated needle is automatically withdrawn inside the syringe immediately after the completion of patient injection, activated by complete delivery of syringe contents. This protects the user from accidental needlesticks that occur between removing the needle from the patient and disposing of the syringe.
Equivalence to Predicate Device	Either equivalent to, or exceeds the performance of the VanishPoint™ syringe (K946219) across key operations.	Bench testing was conducted to evaluate: - Dead space in the device - Graduated capacity - Forces involved with the operation of the retraction mechanism - Pressure rating of the devices under worst-case static loading. In all cases, the NMT Safety Syringe was either equivalent to, or exceeded the performance of the VanishPoint™ syringe.
One-handed Operation	Designed for one-handed operation.	The NMT Safety Syringe is stated to be designed for one-handed operation, similar to the predicate device.
Retraction Mechanism	Utilizes springs to retract the needle when the plunger is fully depressed.	The device incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed. It utilizes springs for this mechanism, similar to the predicate device. Complete delivery of syringe contents activates the retraction mechanism.
Intended Use	Subcutaneous and intramuscular use.	Explicitly stated in the "Indications for Use" section for "subcutaneous and intramuscular use."

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

Test Set Sample Size: The document does not specify a numerical sample size for the bench testing. It only states that "Bench testing has been conducted to examine the key operations."
Data Provenance: The bench testing appears to be conducted by the manufacturer, New Medical Technology Ltd. The contact details for the submitter are "New Medical Technology Ltd., Oakbank Park, Livingston, Scotland, EH53 OTH, UK." This suggests the testing was performed in the UK and is prospective in nature, as it was conducted specifically to demonstrate equivalence for this 510(k) submission.

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

This information is not provided in the document. The study described is bench testing, which typically does not involve human expert adjudication in the same way clinical studies with diagnostic devices do. The "ground truth" for the performance metrics (e.g., dead space, forces, pressure rating) would be established through engineering measurements and adherence to design specifications and industry standards.

4. Adjudication method for the test set

This information is not applicable as the described study is bench testing, not a clinical study requiring adjudication of expert interpretations.

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. This device is a physical medical device (safety syringe), not an AI-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable as the NMT Safety Syringe is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench testing would be engineering measurements and objective performance metrics compared against predefined design specifications, industry standards, and the performance of the predicate device (VanishPoint™ syringe). For example, dead space would be measured, retraction forces would be quantified, and pressure resistance would be tested.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

Summary

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510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 8: NMT SAFETY SYRINGE RÉLEASEABLE 510(K) SUMI

K982431

NMT Safety Syringe Releaseable 510(k) Summary.

This summary regarding 510(k)-safety and effectiveness information is being Hils Sunmary Togal Che requirements of SMDA 1990 and 21 CFR 807.92.

1) Date of Summary:	July 10th, 1998.
CONTACT NAME:	Richard Young
TELEPHONE:	(44) 1506 445000
FACSIMILE:	(44) 1506 430444
SUBMITTERS CONTACT DETAILS:	New Medical Technology Ltd.New Medical HouseOakbank ParkLivingstonScotlandEH53 OTHUK

2)

Device Name: Common Name: Classification name: 3)

NMT Safety Syringe Safety Syringe Piston Syringe

Image /page/0/Picture/12 description: The image shows the word "DRAFT" in bold, outlined letters. The letters are slightly slanted to the right. The font is simple and blocky, with thick lines forming each letter.

Substantailly Equivalent Device: VanishPoint™ Syringe K946219 510(k) Number:

General

The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.

5)

The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.

The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from

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510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 8: NMT SAFETY SYRINGE RELEASEABLE 510(k) SUMMARY

accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The NMT Safety Syringe is substantially equivalent to the previously marketed VanishPoint™ syringe. Technologically, both devices are standard piston syringes which utilize springs to retract the needle when the plunger is fully depressed. Both devices are designed for one-handed operation and have the same intended use. Bench testing has been conducted to examine the key operations associated with the use of both devices. This has included evaluation of the dead space in the device, the graduated capacity, the forces involved with the operation of the retraction mechanism and the pressure rating of the devices under worst case static loading. In all cases the NMT Safety Syringe was either equivalent to, or exceeded the performance of the VanishPoint™ syringe.

Tahn Campbell by M.C. Skovsak

John Campbell, Ph.D., M.B.A Chief Executive Officer

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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 & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

New Medical Technology Limited C/O John Campbell, Ph.D., M.B.A. Chief Executive Officer New Medical Technology 1500 West Oak street, Suite 200 P.O. Box 317 Zionsville, Indiana 46077

K982431 Re : NMT Safety Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: October 5, 1998 Received: October 7, 1998

Dear Dr. Campbell:

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, 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Campbell

This letter will allow you to beqin 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

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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510(k) PREMARKET NOTIFICATION NMT Safety Syringe APPENDIX 10: INDICATIONS FOR USE SHEET

INDICATION FOR USE

510(k) Number (if known): Unknown

NMT Safety Syringe Device Name:

For subcutaneous and intramuscular use. Indications for Use

The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.

The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign Off) Diveston of Section Control, Infection Control, and General Hospital Devices

510(k) Number 198247

Prescription Use X

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).