INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) by INVIRO MEDICAL DEVICES, INC.

The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock 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 Cap - Covers the cannula/needle until the syringe is to be used. The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

AI/ML Overview

The Inviro Medical Luer Lock Syringe (InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes) is a Piston Syringe used to inject medicines and vaccines into, or withdraw fluids from, the body.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates compliance with several international and national standards. The acceptance criteria essentially are successful adherence to the requirements outlined in these standards. The device's reported performance is its claim of successful compliance.

Acceptance Criteria (Applicable Sections of Standards)	Reported Device Performance
ISO 594-1:1986: Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part One: General Requirement	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the general requirements for luer taper connectors as specified in this ISO standard.
ISO 594-2:1986: Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part Two: Locked Connector	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for locked luer taper connectors as specified in this ISO standard.
ISO 7886-1:1993: Single Use Sterile Syringe	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for single-use sterile hypodermic syringes as specified in this ISO standard.
ANSI/AAMI/ISO 11135:2007: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the validation and routine control of ethylene oxide sterilization as specified in this standard. The device is explicitly stated to be "sterilized by Ethylene Oxide Gas."
ISO 11607:2003: Packaging for terminally sterilized medical devices	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for packaging of terminally sterilized medical devices as specified in this ISO standard. The device is supplied in a blister pack and dispenser box, with labeling complying with FDA's Quality System Regulation and Labeling requirements.
ISO 10993-4:2006: Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood	The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for biological evaluation, specifically concerning interactions with blood, as specified in this ISO standard.
Substantial Equivalence to Predicate Device (K081436)	The conclusion states: "The InviroStripe 1, 3, 5, 10, 20, 30 and 10 ml Standard Luer Lock Syringes are substantially equivalent to the InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes in indications for use and technological characteristics." This implies that the new devices perform similar to the previously cleared predicate.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify the exact sample sizes used for the performance tests conducted under the listed ISO/ANSI standards. It simply states that "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." These standards themselves often outline appropriate sample sizes for various tests.

Data Provenance: The document does not explicitly state the country of origin of the data. Given the "Submitter Information" indicates Inviro Medical, Inc. is located in Lawrenceville, GA, USA, it is highly probable that the testing, and thus the data, originated in the United States or was conducted on devices manufactured for the U.S. market. The study appears to be retrospective in the sense that the results of the performance testing are being presented to demonstrate compliance for regulatory approval.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For this type of device (piston syringes), "ground truth" is not established by human experts in the sense of clinical diagnoses or image interpretations. Instead, the "ground truth" is determined by the objective and quantifiable pass/fail criteria defined within the specified international and national standards (ISO, ANSI/AAMI).

Number of Experts: Not applicable in the context of human interpretation.
Qualifications of Experts: Not applicable. The "experts" are the standards themselves and the engineers/technicians who perform the tests according to those standards.

4. Adjudication Method for the Test Set

Not applicable. The performance tests against established standards have objective pass/fail criteria, meaning there is no need for subjective adjudication by multiple experts. The outcome is determined by whether the device's measured properties fall within the specified limits of the standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human performance. The Inviro Medical Luer Lock Syringe is a physical medical device, not a diagnostic AI system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The compliance testing against ISO and ANSI/AAMI standards represents a "standalone" evaluation of the device's physical properties and performance characteristics. This evaluation does not involve a human-in-the-loop scenario, as the device itself is being tested to ensure it meets predefined technical specifications. There is no "algorithm" in the typical AI sense to be evaluated.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on objective, quantifiable specifications and pass/fail criteria defined in recognized international and national standards (e.g., ISO 594-1, ISO 7886-1). This is a form of engineering/performance standard compliance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K101359

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

April 29, 2010 Date prepared:

AUG 2 0 2010

Submitter Information A.

Inviro Medical, Inc. 1755 North Brown Road Suite 150 Lawrenceville, GA 30043

Phone Number: Fax Number: Contact:

949-433-3058 949481-5745 Jim Barley Director of RA/QA

Trade Name:

InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes

B. Device Information

Trade/Proprietary Name:

InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes

Common name of device:

Classification Name:

Product Code:

Regulatory Class:

Classification Number:

Reason for 510(k):

InviroStripe 1, 3, 5, 10, 20, 30
and 60 ml Standard Luer Lock
syringes

Piston Syringe

80 FMF

880.5860

Special 510(k) - Change in packaging, expansion of product line and change of contract manufacturer.

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C. Predicate Device:

InviroStripe 3, 5 and 10 ml Standard Luer Lock syringes

Predicate 510(k) #:

K081436

Predicate product code: FMF

D. Device Description
The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock 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 Cap - Covers the cannula/needle until the syringe is to be used.

The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

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Statement of Indications for Use E.
The InviroStripe Standard Luer Lock Syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.

Comparison of Required Technological Characteristics: F.

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroStripe Standard Luer Lock Syringes and the cited predicate device.

Summary and Conclusion of Nonclinical and Clinical Tests: G.
The intended use of the InviroStripe Standard Luer Lock 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"
ISO 7886-1:1993, "Single Use Sterile Syringe" 3.
ANSI/AAMI/ISO 11135:2007 "Medical Devices -4. Validation and Routine Control of Ethylene Oxide Sterilization
ISO 11607;2003 Packaging for terminally sterilized ડ. medical devices
ISO 10993-4:2006 Biological evaluation of medical 6. devices Part 4: Selection of tests for interactions with blood

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Conclusion:

The InviroStripe 1, 3, 5, 10, 20, 30 and 10 ml Standard Luer Lock Syringes are substantially equivalent to the InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes in indications for use and technological characteristics.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Jim Barley Director of Regulatory Affairs/ Quality Assurance Inviro Medical Devices, Incorporated 1755 North Brown Road, Suite 150 Lawrenceville, Georgia 30043

AUG 20 2010

Re: K101359

Trade/Device Name: Inviro Medical Luer Lock Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 30, 2010 Received: August 03, 2010

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. 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. 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); 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.

Susan Pease

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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Indications For Use

510(k) Number (if known): K101359

Device Name:_Inviro Medical Luer Lock Syringe

Indications For Use:

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

Prescription Use X (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)

Ri C. A

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

K101359 510(k) Number: __

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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).