(279 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a plastic cannula, with no mention of AI or ML.
No.
The device is described as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums, designed to replace hypodermic needles for withdrawal or injection of medication. It does not actively treat or diagnose a disease or condition.
No.
The device is described as an "additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites." Its function is to facilitate the transfer of medication, not to diagnose a condition.
No
The device description clearly states it is a "Plastic Cannula" and describes physical characteristics and performance related to material properties and mechanical function, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums. This describes a device used for administering or withdrawing substances from the body or containers, not for performing tests on biological samples in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics and function of a cannula designed to replace hypodermic needles for accessing vials and injection sites. This aligns with a medical device used for drug delivery or withdrawal, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical and functional aspects of the cannula itself (penetration force, flow rate, interface security), not on the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is a "Single Dose Dispensing Pin," which is also a device used for accessing vials and dispensing medication, not an IVD.
In summary, the InviroLink and InviroLink w/EZ Wings Plastic Cannulas are medical devices used for drug administration and withdrawal, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
80 LHI
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 2.
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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/EZ
Wings 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 |
1
| 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.
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 2.
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.
- 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.
2
-
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.
3
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.
4
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
5
Indications For Use
510(k) Number (if known): K071301
Device Name:
Indications For Use:
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.
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:
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