EZ-IO

K052408 · Vidacare Corporation · FMI · Nov 17, 2005 · General Hospital

Device Facts

• Record ID: K052408
• Device Name: EZ-IO
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EZ-IO is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

Device Story

EZ-IO is a battery-powered, handheld intraosseous infusion system. It consists of a reusable driver and a single-use disposable needle assembly. The driver drills the needle through the bone cortex into the marrow of the humeral head. Once seated, the driver is detached, the trocar/stylet is removed, and the remaining cannula provides a Luer lock connection for standard IV lines or syringes. Used in emergency settings for rapid resuscitation when venous access fails. Benefits include immediate vascular access for life-saving drug and fluid delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons.

Technological Characteristics

Battery-powered handheld driver; single-use disposable IO needle assembly with Luer lock; cannula-based access; mechanical drilling mechanism; manual operation.

Indications for Use

Indicated for patients requiring emergency vascular access for fluid or pharmacological resuscitation when standard intravenous access is not possible.

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

• VidaPort Intraosseous Infusion System (K032885)

Submission Summary (Full Text)

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## NOV 1 7 2005

Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are slightly distressed, giving them a textured appearance. The word is displayed in all capital letters and is horizontally oriented.

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

## SUMMARY

Submitter's name: Address:

Phone: Fax number:

Name of contact person:

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

VidaCare Corporation

San Antonio, TX 78216

722-A Isom Road

210-375-8500

210-375-8537

Date the summary was prepared: August 24, 2005

| Name of the device: | EZ-IO |
|----------------------------|--------------------------------|
| Trade or proprietary name: | EZ-IO |
| Common or usual name: | Intraosseous Infusion System |
| Classification name: | Hypodermic single lumen needle |

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

VidaPort Intraosseous Infusion System (K032885), manufactured by VidaCare.

Description of the device:

The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired 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 via the humeral head.

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Addendum 2 to 510(k), K052408, EZ-IO Humeral Head

Premarket Notification – VidaCare, EZ-IO

Indications:

The EZ-IO is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

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

The predicate VidaPort Intraosseous Infusion System (K032885), and the Humeral Head EZ-IO 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

REGULATORY SPECIALISTS, INC.

REGULATORY SPECIALISTS, INC.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2005

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

Re: K052408

Trade/Device Name: EZ-IO Humeral Head Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24, 2005 Received: September 2, 2005

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 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 - Ms. 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 (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 [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] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snyte y. Michie Oms

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

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Indications for Use Statement

Page 1 of 1

020408

510(k) Number (if known):K052408

Device Name: Humeral Head EZ-IO

Indications For Use:

The EZ-IO is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

Prescription Use _ × OR (Part 21 CFR 801 Subpart D)

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)

11/17/15 William M. Burdik, Acting B.C. for
Northern Utah

nf Anesthe tiology General Hospital. on Control. Dental Devicess

Number: K052408