VIDAPORT INTRAOSSEOUS INFUSION SYSTEM

K032885 · Vidacare Corporation · FMI · Mar 10, 2004 · General Hospital

Device Facts

• Record ID: K032885
• Device Name: VIDAPORT INTRAOSSEOUS INFUSION SYSTEM
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The device is prescription use only per 21 CFR 801.109.

Device Story

VidaPort is a battery-powered, cordless drill-style device used for intraosseous (IO) access. It consists of a reusable driver and a disposable IO needle assembly. The operator activates the drill to penetrate the bone cortex to a preset depth in the marrow. The driver separates from the needle hub, leaving the cannula seated in the bone. The trocar stylet is removed, and the needle assembly's Luer lock allows attachment of standard syringes and IV lines for drug or fluid administration. Used in emergency settings by healthcare providers to establish vascular access when IV access is difficult or unavailable, providing a rapid route for resuscitation.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including electrical safety, electrical emissions, and mechanical testing, as well as animal testing to validate performance and safety.

Technological Characteristics

Battery-powered, cordless drill-style driver with disposable intraosseous needle assembly. Features a trocar stylet and Luer lock interface for standard IV/syringe connection. Class II device (Product Code FMI).

Indications for Use

Indicated for intraosseous access in the proximal tibia as an alternative to IV access during emergencies in adult patients only.

Regulatory Classification

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.

Predicate Devices

• Bone Injection Gun (K981853)

Submission Summary (Full Text)

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K032885

MAR 1 0 2004

## VidaCare Corporation

722-A Isom Road San Antonio, TX 78216 210-375-8500

## SUMMARY

Submitter's name: Address:

Phone:

Fax number:

VidaCare Corporation 722-A Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

Name of contact person:

Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: March 2, 2004

Name of the device: VidaPort Intraosseous Infusion System Trade or proprietary name: VidaPort Intraosseous Infusion System Common or usual name: Bone injection system Classification name: Hypodermic single lumen needle

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

K981853, Bone Injection Gun, manufactured by WaisMed Ltd.

Description of the device:

The VidaPort (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a preset depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.

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Indications:

The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The device is prescription use only per 21 CFR 801.109.

Summary of the technological characteristics of our device compared to the predicate device:

The predicate Bone Injection Gun, K981853 and the VidaPort were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for use Target population Drill Design Needle Design Technique Performance Sterility Biocompatibility Mechanical Safety Anatomical site Where used Standards met

Testing:

Electrical Safety Electrical Emissions Mechanical Animal Body

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

VidaCare Corporation Mr. Greg Holland Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K032885

Trade/Device Name: VidaPort Intraosseous Infusion System Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 18, 2003 Received: December 19, 2003

Dear Mr. Holland:

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. Holland

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 Office of Compliance at [phone]. 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 [phone] cr [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Page l of of

510(k) Number (if known): K0327885

Device Name: VidaPort Intraosseous Infusion System

Indications For Use:

The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Lone Moreau Interim Branch Chief 3/5/04

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

510(k) Number: K032116

REGULATORY SPECIALISTS, INC.