The syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.

Device Description

The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, insulin (U-100) syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½".
The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, 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.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically associated with medical device performance (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific numerical performance targets for other devices).

The document is an abbreviated 510(k) summary for the Unilife 1mL Unitract® Insulin Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria for the device's primary function in terms of a clinically measured outcome or a specific performance metric.

Here's an breakdown of the types of information that are present, and what is missing for your request:

What is present in the document:

Non-Clinical Performance Data: It mentions that mechanical performance tests were conducted to verify the device meets design specifications based on FDA Consensus Standard ISO 8537:1991 and AS 1077:1992.
Specific Tests Conducted: It lists "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." It also mentions chemical testing (Reducing Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues) and biocompatibility testing (Cytotoxicity and Pyrogens).
Sterilization Validation: Sterilization processes are validated to DIN EN 550:1994 to a sterility assurance level (SAL) of 10^-6.
Manufacturing Process Control: States that functional, chemical, and biological tests are performed on each production lot number.
Conclusion: The device is deemed "substantially equivalent" based on performance testing, intended use, and design principles, and "any differences cited do not raise any new questions of safety and effectiveness."

What is missing from the document (and therefore I cannot provide in the requested format):

A table of acceptance criteria and the reported device performance: While standards are mentioned (ISO 8537, AS 1077, DIN EN 550), the specific numerical acceptance criteria from these standards and the actual numerical results of the device's performance against those criteria are not detailed. For example, it doesn't say "peak activation force must be X-Y Newtons; our device measured Z Newtons."
Sample size used for the test set and the data provenance: Not mentioned for any of the performance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device, not an AI/diagnostic software.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For physical testing, the ground truth would be the objective measurement against the specified standard/design requirement, but the specifics aren't provided.
The sample size for the training set: Not applicable as it's not an AI/algorithm.
How the ground truth for the training set was established: Not applicable.

In essence, this document provides a high-level summary of the types of tests done to support a 510(k) submission, confirming adherence to relevant standards and design specifications, but it does not delve into the detailed quantitative results required to fulfill your request for specific acceptance criteria and reported performance metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K0800877" at the top. Below the text is the logo for "UNILIFE medical solutions". The logo is black and white and features a stylized "U" and a curved arrow.

OCT 21 2008 SECTION 5

Abbreviated 510(k) Summary

This 510(k) summary has been prepared in compliance with 21 CFR 807.92.

Applicant:	Unilife Medical Solutions Limited35 Clarence StreetSydney NSW 2000AustraliaTel: +61 2 8346 6500Fax: +61 2 8346 6511
Contact:	Michelle GowEmail: michelle.gow@unilife.com.au
Date Prepared:	March, 2008
Trade Name:	1mL Unitract® Insulin Syringe
Common Name:	Insulin Syringe
Classification:	Syringe, Piston; 21 CFR 880.5860; FMF; Class II
Predicate Devices:	1cc Insulin SafePro® Safety Syringe (K050134)BD Integra 1mL Syringe (K023752)
Device Description:	The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, insulin (U-100) syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½".The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, 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 syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.

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Image /page/1/Picture/0 description: The image contains the handwritten text "KO8087" at the top. Below that is the logo for "UNILIFE" in a stylized font. Underneath the logo, in smaller letters, is the text "medical solut on:", which appears to be part of the company's tagline or description.

SubstantialEquivalence:	The 1mL Unitract® Insulin Syringe has identical indications for use and similar features to the cited predicate # K050134 which is to infuse insulin subcutaneously; whilst incorporating a sharps injury prevention feature. In addition, the spring based mechanism of the cited predicate # K023752; and how this mechanism is integrated within the design of the 1mL Unitract® Insulin Syringe do not raise new questions of safety and effectiveness.
TechnologicalCharacteristics:	The 1mL Unitract® Insulin Syringe has similar needle retraction mechanisms to the cited predicate # K050134. The syringe is filled; and at the end of the injection stroke once the full dose has been expelled, the plunger engages the needle to allow retraction into the syringe barrel. The cited predicate device relies on manual retraction and plunger fracture, where the 1mL Unitract® Insulin Syringe uses a spring based mechanism to retract the needle. The auto disable feature of the 1mL Unitract® Insulin 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® Insulin Syringe spring based mechanism are similar to the technology of the cited predicate # K023752. The spring mechanism of this predicate device is located at the distal end of the syringe which facilitates the retraction of the needle into the plunger. The 1mL Unitract® Insulin Syringe spring mechanism is located on the proximal end of the syringe to allow retraction into the barrel. The design of the 1mL Unitract® Insulin Syringe integrates the technological design characteristics of the cited predicates, and having similar operating procedures for filling and mixing insulin, aspiration and injection, has been demonstrated to have no significant differences.
	The syringe components are manufactured from USP Class VI materials and stainless steel.
Non ClinicalPerformance Data:	Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard ISO 8537:1991 Sterile single-use syringes, with or without needle, for insulin and the voluntary standard AS 1077:1992, Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U- 100). 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.

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Image /page/2/Picture/0 description: The image shows the logo for Unilife medical solutions. The logo is in black and white and features the word "Unilife" in a stylized font. Below the word "Unilife" is the phrase "medical solutions" in a smaller font. To the right of the word "Unilife" is a graphic element that appears to be a stylized letter "C".

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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 108.

Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number.

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Conclusion: The 1mL Unitract® Insulin Syringe with 27G x ½" and 29G x ½" needles submitted in this 510(k) is determined as substantially equivalent to the cited predicate devices based on performance testing, intended use and design principles of operation and technology, used for the subcutaneous infusion of insulin. Any differences cited do not raise any new questions of safety and effectiveness.

[INTENTIONALLY LEFT BLANK BELOW LINE]

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Image /page/3/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 eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2008

Ms. Michelle Gow Quality and Regulatory Affairs Director Unilife Medical Solutions Limited Level 5, 35 Clarence Street Sydney, NSW AUSTRALIA 2000

Re: K080877

Trade/Device Name: 1mL Unitract® Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 4, 2008 Received: September 8, 2008

Dear Ms. Gow:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Gow

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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SECTION 4

Indications for Use

510(k) Number (if known):

Unknown

Device Name:

1mL Unitract® Insulin Syringe

Indications for Use:

The syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), intended to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K080877

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).