EZ-MIO MANUAL DRIVER

K052195 · Vidacare Corporation · FMI · Nov 2, 2005 · General Hospital

Device Facts

• Record ID: K052195
• Device Name: EZ-MIO MANUAL DRIVER
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PD-IO™ infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg). The EZ-IO™ Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kq)

Device Story

Manual driver device for intraosseous infusion; consists of pentagon shaft attached to ergonomic handle. Used to manually insert needle set (stylet and catheter) into bone cortex to reach marrow. After insertion, driver detaches; stylet removed to leave standard Luer lock catheter in bone. Catheter allows attachment of syringes/IV tubing for fluid/drug administration. Used in emergency settings as alternative to IV access. Benefits patient by providing rapid vascular access when IV access is difficult or impossible.

Clinical Evidence

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

Technological Characteristics

Manual driver with pentagon shaft and ergonomic handle. Accommodates 15g x 25mm (adult) or 15g x 15mm (pediatric) needle sets. Features standard Luer lock interface for fluid administration. Mechanical device; no energy source or software.

Indications for Use

Indicated for intraosseous access in the proximal tibia as an alternative to IV access during emergencies. Pediatric population: birth to 21 years (3-39 kg). Adult population: 22 years or older (>40 kg).

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)
• PD-IO Disposable Intraosseous Infusion Needle (K043490)

Submission Summary (Full Text)

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NOV - 2 2005

Image /page/0/Picture/3 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are black, and the background is white. There is a small circle above the "V" in "VIDACARE", and there is a trademark symbol to the right of the "E" in "VIDACARE".

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: August 7, 2005

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

MIO Reusable Manual Driver MIO Reusable Manual Driver Intraosseous Infusion Needle Hypodermic single lumen needle

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

| Applicant | Device | 510(k) |
|----------------------|-----------------------------------------------|---------|
| VidaCare Corporation | VidaPort Intraosseous Infusion System, * | K032885 |
| VidaCare Corporation | PD-IO Disposable Intraosseous Infusion Needle | K043490 |

Description of the device:

The EZ-MIO. Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The EZ-MIO, Manual Drivers are designed to allow the user to manually insert a needle set consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of

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## ATTACHMENT D - SUMMARY, Page 11

VidaCare Corp. 510(k) Reusable Manual Driver

standard syringes and IV tubing for administration of drugs and fluids (not supplied). There are two size needles that can be used with the EZ-MIO, Manual Driver, an adult size, 15g X 25mm, and pediatric size, 15g X 15mm. A more detailed description, with drawings, can be found in TAB 6 -DESCRIPTION.

Indications for Use:

The PD-IO™ infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg).

The EZ-IO™ Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kq)

Summary of the technological characteristics of the EZ-MIO, Manual Driver

The predicates were compared in the following areas and found to have similar technological characteristics and to be equivalent to the EZ-MIO, Manual Driver.

Anatomical site Biocompatibility Design features Indications for use Needle design Sterility Target population Technique Where used

Regulatory Specialists, Inc.

Page 11

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2005

Vidacare Corporation C/O Mr. Greg Holland Regulatory Consultant to Vidacare Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K052195

Trade/Device Name: EZ-MIO MANUAL DRIVER Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: August 7, 2005 Received: August 12, 2005

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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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 vour 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,

Anitte y. Michael Oria

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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## ATTACHMENT C -Indications For Use Statement

510(k) Number (if known): K052195

Device Name: EZ-MIO Intraosseous Infusion System

Indications For Use:

For pediatric use:

The PD-IO™ infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg).

For adult use:

The EZ-IO™ Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kq)

Prescription Use AND/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)

Anthony V.m

ision of Anesthestology, General Hospital. Intection Control, Dental Devices

510(k) Number:_

Regulatory Specialists, Inc.

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