Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical features for safety and reuse prevention, with no mention of AI or ML.

Therapeutic

No.
The device is described as being used to administer medication, which is a delivery mechanism, not a therapeutic action in itself.

Diagnostic

No
The device is described as a syringe used to administer medication, not to diagnose a condition. Its function is to facilitate the delivery of substances into the body rather than to detect or identify a disease or medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical syringe with a barrel, plunger, and needle, incorporating mechanical features for safety and reuse prevention. There is no mention of software as a component or the primary function of the device.

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 "administer (infuse) medication subcutaneous, intramuscular, or intradermal." This describes a device used for delivering substances into the body, which is a therapeutic or procedural function, not a diagnostic one.
Device Description: The description focuses on the mechanical aspects of a syringe, including the barrel, plunger, needle, and safety features. It does not mention any components or functions related to analyzing samples from the body to diagnose conditions.
Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Unitract Tuberculin Syringe, as supplied, is a device with a small barrel, plunger, and fixed needle, calibrated in milliliters (0.01 increments) to be used to administer (infuse) medication subcutaneous, intramuscular, or intradermal. It incorporates features that include reuse prevention (auto-disable) and sharps injury prevention (automatic needle retraction).

Product codes

FMF

Device Description

The 1mL Unitract® Tuberculin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied as 27G x 1/2". The devices function in a manner similar to standard syringes, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature. The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.

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

Not Found

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)

Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard and the voluntary standards.
Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature.
Chemical testing included Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues (EO Sterilisation).
Biocompatibility testing of the finished devices included Cytotoxicity and Pyrogens; with all materials in the fluid path meeting USP Class VI requirements.
Sterilisation processes are validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to a sterility assurance level (SAL) of 10⁻⁶.
Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number.

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

Not Found

Predicate Device(s)

K093400, K023752

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K100998

medical solutions

SECTION 6

This 510(k) summary has been prepared in compliance with 21 CFR 807.92. AUG
Applicant:	Unilife Medical Solutions Limited
633 Lowther Rd
Lewisberry, PA 17339

The devices function in a manner similar to standard syringes, but
also incorporates a sharps injury prevention (automatic needle
retraction) and reuse prevention (auto disable) feature.

The sharps injury prevention feature allows for automatic and full
retraction of the needle into the syringe barrel immediately after the
full dose has been expelled; where the rate of retraction may be
controlled by the user. The reuse prevention feature also engages
immediately after retraction, which prevents further movement of
the plunger in either direction. |
| Indications for Use: | The Unitract Tuberculin Syringe, as supplied, is a device with a
small barrel, plunger, and fixed needle, calibrated in milliliters (0.01
increments) to be used to administer (infuse) medication
subcutaneous, intramuscular, or intradermal. It incorporates features
that include reuse prevention (auto-disable) and sharps injury
prevention (automatic needle retraction). |
| Substantial Equivalence: | The 1mL Unitract® Tuberculin Syringe has similar indications for
use to the cited predicates # K093400 and # K023752 which is to
infuse drugs; whilst incorporating a sharps injury prevention feature. |

Traditional 510(k) Summary

ﻣ

AUG 3 0 2010

ない。
"

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Image /page/1/Picture/0 description: The image shows the logo for Unilife medical solutions. The logo is in black and white. The word "UNILIFE" is in a stylized font, and the words "medical solutions" are in a smaller font below the word "UNILIFE".

The device design and technology is identical to K093400. The design of the ImL Unitract® Tuberculin Syringe does not raise new
questions of safety and effectiveness based on its similarities to the cited predicates in terms of design and intended use.

Technological Characteristics:	The ImL Unitract® Tuberculin Syringe has identical needle retraction mechanisms to the cited predicate # K093400. The syringe is filled and at the end of the injection stroke as the full dose has been expelled, the plunger engages the needle to allow retraction into the syringe barrel. The auto disable feature of the 1mL Unitract® Tuberculin Syringe is integrated within the plunger design, where after full retraction, the plunger engages with the collar outer to prevent movement of the plunger in either direction. This feature requires no secondary action by the user to disable the syringe. The characteristics of the 1mL Unitract® Tuberculin Syringe spring based mechanism are identical to the technology of the cited predicate # K093400. The 1mL Unitract® Tuberculin Syringe spring mechanism is located on the proximal end of the syringe to allow retraction into the barrel. The design of the ImL Unitract Tuberculin Syringe integrates the technological design characteristics of the cited predicate, and having similar operating procedures for aspiration and injection, has
	been demonstrated to have no significant differences. The syringe components are manufactured from biocompatible materials and stainless steel.
Non Clinical Performance Data:	Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard and the voluntary standards.
	Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature.
	Chemical testing included Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues (EO Sterilisation).
	Biocompatibility testing of the finished devices included Cytotoxicity and Pyrogens; with all materials in the fluid path meeting USP Class VI requirements.
	Sterilisation processes are validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to a sterility assurance level (SAL) of 10⁻⁶.
	Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number.
Conclusion:	The 1mL Unitract® Tuberculin Syringe with 27G x 1/2" needle submitted in this 510(k) is determined as substantially equivalent to the cited predicate device based on performance testing, intended use and design principles of operation and technology,. Any differences cited do not raise any new questions of safety and effectiveness.

[INTENTIONALLY LEFT BLANK BELOW LINE]

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of three stylized human figures standing side-by-side, with their arms raised. The figures are black and are set against a white background. The text "DEPARTMENT OF HEALTH &" is written vertically along the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Melissa L. DeHass Senior Manager, Regulatory Affairs Unilife Medical Solutions Limited 633 Lowther Road Lewisberry, Pennsylvania 17339

AUG 30 2010

Re: K100998

Trade/Device Name: 1mL Unitract® Tuberculin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 26, 2010 Received: July 28, 2010

Dear Ms. DeHass:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Mr. DeHass

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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm,

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for "UNILIFE medical solutions". The logo is in black and white and features a stylized font. Below the logo is the number "100998" written in what appears to be handwriting.

SECTION 5 Indications for Use

510(k) Number (if known):

This submission

Device Name:

1 mL Unitract® Tuberculin Syringe

Indications for Use:

The Unitract Tuberculin Syringe, as supplied, is a device with a small barrel, plunger, and fixed needle, calibrated in milliliters (0.01 increments) to be used to administer (infuse) medication subcutaneous, intramuscular, or intradermal. It incorporates features that include reuse prevention (auto-disable) and sharps injury prevention (automatic needle retraction).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

p

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number: K100998