INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 by INVIRO MEDICAL DEVICES, INC.

The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.

Device Description

The InviroLink/InviroTip Plastic Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.

The family of InviroLink Plastic Cannulas are 18 gauge equivalent plastic cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroLink Plastic Cannulas:

InviroLink, Model # 130001
InviroLink with EZ wings, Model # 130501

The InviroLink Plastic Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.

AI/ML Overview

This looks like a 510(k) summary for a medical device called InviroLink/InviroLink w/EZ Wings Plastic Cannula.
The summary does not contain information about an AI/ML device, therefore, the following information is not available:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

However, it does provide acceptance criteria and a summary of the nonclinical and clinical tests performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Product/Performance Requirements)	Reported Device Performance
Visual Inspection:
- Smooth surface	Met requirement
- Without oil contamination	Met requirement
- Without extraneous matter	Met requirement
- Without other defects	Met requirement
- Invisible lubricant on cannula	Met requirement
- Free of flash and burrs	Met requirement
Color:
- Color of each cannula and cap meets product requirement	Met requirement
Dimensional:
- All components met dimensional requirements	Met requirement
Functional:
- Cap Pull off Force	Met requirement
- InviroLink/Syringe interface	Met requirement
- Penetration	Met requirement
- Bending	Met requirement
- Tip breaking Forces	Met requirement
- Flow rate	Met requirement
Interface:
- Secure interface between InviroLink and medicine vial stopper	Able to withstand 330 kPa for 30 seconds without leakage
- Secure interface between InviroLink and syringe luer lock fitting	Able to withstand 330 kPa for 30 seconds without leakage

2. Study that Proves the Device Meets the Acceptance Criteria:

The document states: "The InviroLink/InviroLink w/EZ Wings Plastic Cannulas met the following product/performance requirements: A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs."

The study described is a series of nonclinical performance tests conducted by Inviro Medical. The details provided are a direct summary of the outcomes of these tests, confirming that the device achieved the established product/functional requirements. There is no specific study name or reference provided beyond this summary.

Breakdown of the Nonclinical Tests:

Visual Inspection: This involved physical examination to ensure the device's surface quality (smoothness, absence of contaminants, defects, flash, burrs) and the visibility of lubricant.
Color Check: Verification that the cannula and cap colors conformed to product specifications.
Dimensional Testing: Measurement of all components of the InviroLink and InviroLink w/EZ Wings to ensure they met the specified dimensional requirements outlined in the part/assembly drawings.
Functional Testing: This encompassed several specific tests:
- Cap Pull off Force: Measuring the force required to remove the cap.
- InviroLink/Syringe interface: Assessing the integrity and fit of the connection to the syringe.
- Penetration: Evaluating the ease and effectiveness of penetrating rubber-stoppered vials or septums.
- Bending: Testing the device's resistance to bending.
- Tip breaking Forces: Determining the force at which the tip would break.
- Flow rate: Measuring the rate at which fluids can be dispensed through the cannula.
Interface Testing: This focused on the security and integrity of the critical connections:
- Medicine Vial Stopper Interface: Testing the seal between the cannula and a medicine vial stopper.
- Syringe Luer Lock Fitting Interface: Testing the seal between the cannula and the syringe luer lock.
- Both interfaces were tested to withstand 330 kPa of pressure for 30 seconds without leakage.

The document presents the outcomes of these tests as conclusive proof that the device met all listed product/performance requirements. There's no mention of a traditional "study" in the sense of a published clinical trial or a detailed methodology report beyond this summary of successful outcomes.

Summary

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FEB 1 2 2008

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

A. Submitter Information
Inviro Medical 1755 North Brown Road Suite 150 Lawrenceville, GA 30043

Phone Number: Fax Number: Contact:

678-405-4031 678-405-4044 Jim Barley Director RA/QA

Trade Name:

InviroLink/InviroLink w/EZ Wings Cannula

Device Information B.

Trade/Proprietary Name:	InviroLink/InviroLink w/EZWings Plastic Cannula
Common name of device:	Syringe Cannula
Classification Name:	Set, I.V. Fluid Transfer
Product Code:	80 LHI
Regulatory Class:	II
Classification Number:	880.5440
Reason for 510(k):	New Device

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C.	Predicate Device:	Alaris Medical Systems, Inc.Single Dose Dispensing Pin
	Predicate 510(k) #:	K013087
	Predicate product code:	LHI

D. Device Description
The InviroLink/InviroTip Plastic Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.

1. InviroLink, Model # 130001
InviroLink with EZ wings, Model # 130501 2.

Statement of Indications for Use E.
The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.

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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 InviroLink and InviroLink w/EZ Wings Plastic cannulas and the cited predicate device.
G. Summary and Conclusion of Nonclinical and Clinical Tests:
The InviroLink/InviroLink w/EZ Wings Plastic Cannulas met the following product/performance requirements:

A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs.

The color of each cannula and cap met the product requirement.

Dimensional - All components of the Invirolink and InviroLink w/EZ Wings met the dimensional, visual and functional requirements listed on the part/assembly drawing.

Functional – The InviroLink and InviroLink w/EZ Wings met the requirements for Cap Pull off Force, InviroLink/Syringe interface, penetration, bending and tip breaking Forces and flow rate.

Interface - The interfaces between the InviroLink and the medicine vial stopper and the Invirolink and the syringe luer lock fitting were secure and able to withstand 330 kPa of pressure for 30 seconds without leakage.

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

FEB 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Barley Director, of Regulatory Affairs/Quality Assurance Inviro Medical Devices, Incorporated 3235 Satellite Boulevard Building 400, Suite 300 Duluth, Georgia 30096

Re: K071307

Trade/Device Name: InviroLink and InviroLink w/EZ Wings Plastic Cannula Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: January 17, 2008 Received: February 5, 2008

Dear Mr. James 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. James 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address. http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih-Liang, Ph.D.

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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Indications For Use

510(k) Number (if known): K071301

Device Name:

Indications For Use:

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)

Anthem Vm

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

510(k) Number:

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).