EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO

K091140 · Vidacare Corporation · FMI · Oct 14, 2009 · General Hospital

Device Facts

• Record ID: K091140
• Device Name: EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Oct 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only. EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Device Story

Intraosseous (IO) access system comprising manual/power drivers and needles; provides vascular access in distal tibia, proximal tibia, or humeral head. Used in emergent, urgent, or medically necessary clinical settings when IV access is unattainable. Operates by inserting needle into bone marrow space to facilitate fluid/medication delivery. Intended for adult patients; duration of use up to 24 hours. Healthcare providers use device to establish life-saving access; output is established IO route. Benefits include rapid, reliable access for resuscitation or therapy when peripheral veins are inaccessible.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and design to predicate devices.

Technological Characteristics

Hypodermic single lumen needle system. Includes manual and power-driven insertion mechanisms. Materials, design, and biocompatibility are identical to previously cleared predicates. Device is intended for short-term (up to 24 hours) intraosseous access.

Indications for Use

Indicated for adult patients requiring intraosseous access in the distal tibia, proximal tibia, or humeral head when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

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

• EZ-MIO, EZ-IO, Distal Tibia (K062956)
• Vidaport Intraosseous Infusion System (K032885)
• EZ-IO, Humeral Head (K052408)

Submission Summary (Full Text)

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# 5. 510(k) Summary

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722 Isom Road. San Antonio, TX 78216 Tel [phone] Fax [phone] Toll Free (within US) 866 479 8500 www.vidacare.com

OCT 1 4 2009

### SUMMARY

722 Isom Road

210-375-8500

VidaCare Corporation

San Antonio, TX 78216

Submitter's name: Address:

Phone: Fax number:

Name of contact person:

210-375-8537 Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone]

Fax: [phone]

| Date the summary was prepared: | Original, April 17, 2009<br>Revised, October 10, 2009 |
|--------------------------------|-------------------------------------------------------|
|--------------------------------|-------------------------------------------------------|

EZ-MIO Distal Tibia, EZ-IO Distal Tibia Name of the devices: Vidaport Intraosseous Infusions System EZ-IO, Humeral Head

Intraosseous Infusion System Common or usual name: Hypodermic single lumen needle Classification name:

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

| | 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---------------|---------------------------------------|----------------|
| 1 | K062956 | EZ-MIO, EZ-IO, Distal Tibia | Vidacare Corp. |
| 2 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corp. |
| 3 | K052408 | EZ-IO, Humeral Head | Vidacare Corp. |

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Indications for Use:

## EZ-MIO and EZ-IO:

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

## Vidaport Intraosseous Infusion System:

The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

## EZ-IO Humeral Head:

The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

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

This submission extends the indications for use to include usage in emergent, urgent, or medically necessary cases for up to 24 hours. There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical.

Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Where Used

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an emblem that features a stylized representation of an eagle with its wings spread. The eagle is facing to the right and has three lines extending from its wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-0609 Silver Spring, MD 20993-0002

Vidacare Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606

## OCT 1 4 2009

Re: K091140

Trade/Device Name: Vidacare® Needle for EZ-M10 and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head

Regulation Number: 21 CFR 880.5570

Regulation Name: Hypodermic Single Lumen Needle

Regulatory Class: II

Product Code: FMI

Dated: September 25, 2009

Received: September 28, 2009

Dear Ms. 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 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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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 (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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Lanier

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### 4. Indications for Use Statement

#### Indications for Use

. 199

510(k) Number (if known): K091140

### Device Name: Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head

Indications for Use:

#### EZ-MIO and EZ-IO:

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

#### Vidaport Intraosseous Infusion System:

The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

#### EZ-IO Humeral Head:

The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

X Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Arata

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

510(k) Number:

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