INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES by INVIRO MEDICAL DEVICES, INC.

1 Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe.
3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
4 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
5 Cap - Covers the cannula/needle until the syringe is to be used.

The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

AI/ML Overview

This is an analysis of a 510(k) premarket notification for a medical device, specifically hypodermic syringes. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information elements related to AI performance, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this document. This submission is for a physical medical device (syringes), not a diagnostic algorithm.

However, I can extract the acceptance criteria based on voluntary standards and the reported device performance as stated.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are compliance with established international and national standards for medical devices, and the "reported device performance" is the claim of compliance to these standards.

Acceptance Criterion (Voluntary Standard)	Reported Device Performance
ISO 594-1:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part One: General Requirement"	Compliance demonstrated
ISO 594-2:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part Two: Locked Connector"	Compliance demonstrated
ISO 7886-1:1993, "Single Use Sterile Syringe"	Compliance demonstrated
ANSI/AAMI/ISO 11135, "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization"	Compliance demonstrated
ISO 11607:2003, "Packaging for terminally sterilized medical devices"	Compliance demonstrated
ISO 10993-4:2006, "Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood"	Compliance demonstrated (Biocompatibility considered)

The study proving the device meets these criteria is referred to as "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." The conclusion of the submission is that the device is "substantially equivalent" to its predicate based on these tests and technological characteristics.

Non-Applicable Information for this Device (Hypodermic Syringes)

The following points are not applicable to the provided 510(k) summary for the InviroStripe hypodermic syringes, as this is a physical medical device and not an AI/diagnostic algorithm:

Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical devices typically involves engineering tests, material testing, and sterilization validation, not data sets in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI is not relevant here. Device performance is assessed against technical specifications and standard requirements.
Adjudication method for the test set: Not applicable. Adjudication relates to expert human review of data, which is not part of physical device testing.
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. This is for AI-assisted diagnostic devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical syringe. The "ground truth" for this device's performance would be its adherence to the physical and functional specifications defined by the voluntary standards.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable. There is no AI model to train.

Summary

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K081434

1 of 3

510(k) Summary (As required by 21 CFR 807.92(a))

OCT 2 2 2008

Submitter Information A.
BMDI Pty Ltd. 63-79 Parramatta Road Suite 306 Silverwater, Australia NSW 2128

Phone Number:	949-433-3058
Fax Number:	949481-5745
Contact:	Jim BarleyUS Agent

Trade Name:

InviroStripe Standard 3, 5 and 10 ml hypodermic syringes

B. Device Information

Trade/Proprietary Name:	InviroStripe Standard 3, 5 and10 ml hypodermic syringes
Common name of device:	Piston Syringe
Classification Name:	Piston Syringe
Product Code:	80 FMF
Regulatory Class:	II
Classification Number:	880.5860
Reason for 510(k):	New Device
Predicate Device:	Yi Xin Sterile Syringe for Single Use
Predicate 510(k) #:	K050999

Predicate product code: FMF

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K051436
2 of 3

D. Device Description
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.

The piston syringe is a plastic disposable htpodermic syringe made of the following components:

1 Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe.
3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
4 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
5 Cap - Covers the cannula/needle until the syringe is to be used.

Statement of Indications for Use E.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.

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F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroStripe Standard 3, 5 and 10 ml hypodermic syringes and the cited predicate device.
G. Summary and Conclusion of Nonclinical and Clinical Tests:
The intended use of the InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

Performance testing consisted of compliance to the applicable sections of the following voluntary standards:

ISO 594-1:1986, "Syringe, Syringe Needle and Other 1. Medical Apparatus 6% (Lu-Er) Taper Connector -Part One: General Requirement"
ISO 594-2:1986, "Syringe, Syringe Needle and Other 2. Medical Apparatus 6% (Lu-Er) Taper Connector -Part Two: Locked Connector"
1. ISO 7886-1:1993. "Single Use Sterile Syringe"
1. ANSI/AAMI/ISO 11135 - "Medical Devices -Validation and Routine Control of Ethylene Oxide 、 Sterilization
ISO 11607;2003 Packaging for terminally sterilized న. medical devices
1. ISO 10993-4:2006 - Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

Conclusion:

The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are substantially equivalent to the Yi Xin Sterile Syringe for Single Use in indications for use and technological characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

BMDI Pty Limited C/O Mr. James Barley James Barley 33572 Sea Wind Court Dana Point, California 92629

Re: K081436

Trade/Device Name: InviroStripe 3,5 and 10 ml Luer Lock Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 1, 2008 Received: October 6, 2008

Dear Mr. Barley:

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 - Mr. Barley

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 (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.

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,

Chris S. Lim, Ph.D.

Chiu S. Lin, Ph. D Division 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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Indication For Use

510(k) Number (if known): K081436

Device Name: InviroStripe 3, 5 and 10 ml Luer Lock Syringes

Indication For Use:

The InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes are used to inject medicines into, or withdraw fluids from the body.

Prescription Use
(Part 21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Brown for ADW

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

510(k) Number: K081434 Page 1 of 1

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).