HUMERAL HEAD, MANUAL DRIVER

K062422 · Vidacare Corporation · FMI · Nov 7, 2006 · General Hospital

Device Facts

• Record ID: K062422
• Device Name: HUMERAL HEAD, MANUAL DRIVER
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Nov 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humeral Head, Manual Driver 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

Manual intraosseous (IO) infusion system consisting of a pentagon shaft attached to an ergonomic handle. Used by clinicians for emergency vascular access in the humeral head. Device facilitates manual insertion of a 15g x 25mm needle set (stylet and catheter) into the bone cortex. Upon reaching the marrow, the manual driver is detached; the stylet is removed, leaving a standard Luer lock catheter seated in the bone. The Luer lock allows connection of standard syringes or IV tubing for fluid/drug administration. Provides an alternative to powered drivers for rapid resuscitation when IV access is unattainable.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to legally marketed predicate devices.

Technological Characteristics

Manual intraosseous infusion system. Components: pentagon shaft, ergonomic handle, 15g x 25mm needle set (stylet and catheter). Features standard Luer lock interface for fluid administration. Non-powered, manual operation. Sterility and biocompatibility maintained consistent with predicate devices.

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

• EZ-MIO Manual Driver (K052195)
• EZ-IO Humeral Head (K052408)

Submission Summary (Full Text)

{0}------------------------------------------------

## 5. 510(k) Summary

Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are black, and there is a small, circular design above the "V". To the right of the word "VIDACARE" is the trademark symbol. The overall impression is that this is a logo or brand name.

NOV - 7 2006

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:

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

Date the summary was prepared: August 7, 2006

| Name of the device: | Humeral Head, Manual Driver |
|----------------------------|--------------------------------|
| Trade or proprietary name: | Humeral Head, Manual Driver |
| 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)]:

| 510(k)<br>Number | Trade or Proprietary or<br>Model Name | Manufacturer |
|------------------|---------------------------------------|------------------|
| 1 K052195 | 1 EZ-MIO Manual Driver | 1 VidaCare Corp. |
| 2 K052408 | 2 EZ-IO Humeral Head | 2 VidaCare Corp. |

Description of the device:

The Humeral Head, Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The Humeral Head, Manual Drivers are designed to allow the user to manually insert a needle set

{1}------------------------------------------------

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 standard syringes and IV tubing for administration of drugs and fluids (not supplied). The size needle that can be used with the Humeral Head, Manual Driver, is 15g X 25mm.

## Indications:

The Humeral Head, Manual Driver 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 Humeral Head, Manual Driver has the exact same indications for use as the EZ-IO Humeral Head (K052408) with the exact same technology as the EZ MIO Manual Driver (K052195). The Humeral Head, Manual Driver is for Humeral head IO access with a manual driver instead of the powered driver.

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

- Indications For Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Anatomical Sites Where Used

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2006

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

Re: K062422

Trade/Device Name: Humeral Head, Manual Driver Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 7, 2006 Received: August 18, 2006

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.

{3}------------------------------------------------

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 (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 vour 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 vours,

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

{4}------------------------------------------------

## 4. Indications for Use Statement Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

The Humeral Head, Manual Driver 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
(Part 21 CFR 801 Subpart D)

X

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D, 2

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

Number: K9662422

Page 1 of 1