EZ SYRINGE

• K Number: K011951
• Device Name: EZ SYRINGE
• Manufacturer: OWEN MUMFORD, LTD.
• Date Cleared: 2001-08-02 ( 42 days)
• Product Code: FMF
• Regulation Number: 880.5860

Intended Use

The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.

Device Description

The EZ Syringe O.T.C is a hand held, non-sterile manual device using 1 ml BD Hypak disposable glass pre-filled syringe. The devices are designed for use with the 1 ml BD Hypak disposable glass syringe, and to accommodate self- use in the home by the patient or caregiver. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe. The device contains a number of features which adds to its safety and effectiveness, these are as follows :- - Parking Action of Boot Remover. - Drop Test. - Environmental .

Predicate Devices

K872233

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical features and manual operation, with no mention of AI/ML terms or data processing.

Therapeutic

No

Explanation: The device is intended to aid in the self-administration of drugs by enhancing grip and removing the needle shield, not to treat or diagnose a medical condition itself.

Diagnostic

No

Explanation: The device is described as a handheld, non-sterile manual device intended to aid in the self-administration of drugs from a prefilled syringe. Its features focus on facilitating gripping and removing the needle shield. There is no mention of the device collecting, analyzing, or interpreting any physiological data to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is described as a "hand held, non-sterile manual device" with physical components like "enlarged wings" and a "semi-automatic feature to remove the needle shield." It is clearly a physical hardware device designed to aid in drug administration.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to aid in the self-administration of drugs from a prefilled syringe. This is a device used for delivering a substance into the body, not for testing a sample from the body to diagnose a condition.
• Device Description: The description focuses on the mechanical features that facilitate gripping and needle shield removal for injection. It does not mention any components or processes related to analyzing biological samples.
• Lack of IVD Characteristics: The summary lacks any mention of:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing diagnostic information
  • Reagents or assays

The device is clearly designed to assist with the physical act of injecting a pre-filled syringe, which falls under the category of a drug delivery or administration device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.

Product codes (comma separated list FDA assigned to the subject device)

FMF

Device Description

The EZ Syringe O.T.C is a hand held, non-sterile manual device using 1 ml BD Hypak disposable glass pre-filled syringe.
The devices are designed for use with the 1 ml BD Hypak disposable glass syringe, and to accommodate self- use in the home by the patient or caregiver. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.
The device contains a number of features which adds to its safety and effectiveness, these are as follows :-

• Front twisting body with wings which easily removes the soft needle shield from the . syringe.
• Large finger grip engineered to aid in the handling of the device.
• Allows the pre-filled syringe to be loaded and unloaded.
• Requires one turn to remove the needle shield.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home by the patient or caregiver.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A number of tests have been performed proving the correct action of a wide range of functions for the EZ Syringe, they are:-

• · Parking Action of Boot Remover.
• · Drop Test.
• Environmental .

The performance testing completed under section 6 of this 510(K) submission indicates that the device performs within the agreed specification and is safe and reliable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K872233

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

510(K) SUMMARY.

Submitted by:

Mr. Robert Shaw. Vice President. Owen Mumford Incorporated. 1755 - A West Oak Commons Court. Marietta. Georgia 30062. USA.

770-977-2226. Tel: Fax: [phone].

Device Name: Classification Name: Predicate Device:

EZ Syringe. Piston Syringe, Accessory, Inject-Ease (K872233).

Owen Mumford Limited has been successfully marketing syringe needle introducers throughout the world since 1986.

These products provide a safe and simple way to aid the patient in the home with a recommended treatment regime via a self-administered manual injection.

DEVICE DESCRIPTION.

The EZ Syringe O.T.C is a hand held, non-sterile manual device using 1 ml BD Hypak disposable glass pre-filled syringe.

The devices are designed for use with the 1 ml BD Hypak disposable glass syringe, and to accommodate self- use in the home by the patient or caregiver. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.

The device contains a number of features which adds to its safety and effectiveness, these are as follows :-

• Front twisting body with wings which easily removes the soft needle shield from the . syringe.
• Large finger grip engineered to aid in the handling of the device. �
• Allows the pre-filled syringe to be loaded and unloaded. �
• Requires one turn to remove the needle shield. �

510(K) Submission EZ Syringe. June 2001 -

1

INTENDED USE.

The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.

OPERATIONAL.

The design concepts of the EZ Syringe submitted in this application are such that it makes the principal quite basic in its function to aid the patient in the home to support a manual injection.

PERFORMANCE.

A number of tests have been performed proving the correct action of a wide range of functions for the EZ Syringe, they are:-

• · Parking Action of Boot Remover.
• · Drop Test.
• Environmental .

The performance testing completed under section 6 of this 510(K) submission indicates that the device performs within the agreed specification and is safe and reliable.

USER TRIAL.

The correspondence included in section 9 of this over - the - counter submission clearly indicates the success of the device for patient or carer preference for carrying out a manual injection.

510(K) Submission. EZ Syringe. June 2001.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. The text is in all caps and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 2001

Mr. Robert Shaw Vice President Owen Mumford, Limited 1755 A West Oak Commons Court Marietta, Georgia 30062

Re : K011951 Trade/Device Name: EZ Syringe 880.5860 Requlation Number: Regulatory Class: II Product Code: FMF Dated: June 21, 2001 Received: June 21, 2001

Dear Mr. Shaw:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beoced above and we have determined the market the device forline.com (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholobars, e commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment acco on reclassified in accordance with the devices that have Federal Food, Drug, and Cosmetic Act (Act), provisions of the reachar room, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ing 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 (Special Concrois) additional controls. Existing major be subject to bacting your device can be found in the Code of Fegulations arrooms, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with Subscuncially Squarenting Practice requirements, as set ene Current Souality System Regulation (QS) for Medical Forch in the gas gaint (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodre go mapleverify such assumptions. Failure to nomiliberation of regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

3

Page 2 - Mr. Shaw

this response to your premarket notification submission does this response to your premazio got have under sections 531 not afrect any obligation you mees under the Electronic through 542 of the net 102 xevisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as This lecter will arrow yourse researce notification. The FDA described in your 510(x) providence of your device to a legally I inding of substancial equice in a classification for your marketed predicate device robated in the market.

If you desire specific advice for your device on our labeling II you desire bpccirie and additionally 809.10 for in regulation (ar endevices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at (501) 5927 5927 device, please contact the Dromocion and adversions [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from the bivibies. [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely Yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

(Unknown). 510(K) Number:

EZ - Syringe O. T. C. Device Name:

Indications for Use:

The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates entarged wings
filled BD Hypak 1 ml disposable glass syringe. The device incorporated wings Inted BD Hypak I ini disposure grass by ago ago remove the needle shield of the Hypak syringe.

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

Concurrence of the CDRA, Office of Evaluation (ODE)

Prescription Use: ............................................................................................................................................................ (Per 21 CFR 801.109)

Over-The-Counter Use:....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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Laura Cucciariale

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

510(k) Number

510(K) Submission. EZ Syringe. June 2001.