POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO

K101026 · Vidacare Corporation · FMI · Jul 27, 2010 · General Hospital

Device Facts

• Record ID: K101026
• Device Name: POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Jul 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours. The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

Device Story

Powered PD-IO and EZ-IO Humeral Head systems provide intraosseous (IO) vascular access for drug and fluid delivery. Device utilizes a powered driver to insert a needle into the bone marrow space (proximal tibia, distal tibia, or humeral head). Used in emergent/urgent clinical settings when IV access is difficult or impossible. Operated by healthcare professionals. Output is established vascular access, allowing clinicians to administer life-saving medications and fluids directly into the systemic circulation. Benefits include rapid, reliable access in pediatric patients where peripheral venous access is challenging.

Clinical Evidence

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

Technological Characteristics

Powered intraosseous infusion system consisting of a driver and needle set. Materials, design, and components are identical to previously cleared predicates. Intended for manual or powered insertion into bone marrow. Sterility and biocompatibility specifications remain unchanged from predicate devices.

Indications for Use

Indicated for pediatric patients (approx. 3kg-39kg) requiring emergent, urgent, or medically necessary vascular access when IV access is difficult or impossible. Provides intraosseous access in the proximal tibia, distal tibia, or humeral head 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

• Powered PD-IO Infusion System (K051992)
• EZ-IO Humeral Head (K052408)
• Powered PD-IO (K063142)
• Vidaport Intraosseous Infusion System (K032885)
• EZ-MIO, EZ-IO, Distal Tibia (K062956)

Submission Summary (Full Text)

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JUL 2 7, 2010

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Image /page/0/Figure/1 description: The image shows the text "5. 510(k) Summary" above the word "vidacare" in a stylized font. The number 5 is followed by a period. The word summary is on the same line as 510(k).

4350 Lockhill Selma Road Shavano Park, TX 78249+2095 210-375-8500 www.Vidacare.com

### SUMMARY

Submitter's name: Address:

Phone: Fax number: Vidacare Corporation 4350 Lockhill Selma Road Shavano Park, TX 78249 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: April 9, 2010

Name of the devices: Powered PD-IO Intraosseous Infusion System; EZ-IO Humeral Head; Powered PD-IO.

| Common or usual name: | Intraosseous Infusion System |
|-----------------------|--------------------------------|
| Classification name: | Hypodermic single lumen needle |
| Class: | Class II |
| CFR Reference number: | 880.5570 |
| Product Code: | FMI |

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

| | 510(k)<br>Number | | Trade or Proprietary or Model Name | | Manufacturer |
|---|------------------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----------------|
| 1 | K051992 | 1 | Powered PD-IO Infusion System | 1 | Vidacare Corp. |
| 2 | K052408 | 2 | EZ-IO Humeral Head | 2 | Vidacare Corp. |
| 3 | K063142 | 3 | Powered PD-IO | 3 | Vidacare Corp. |
| 4 | K091140 | 4 | Vidaport Intraosseous Infusion System<br>(formerly K032885);<br>EZ-IO Humeral Head (formerly K052408;<br>EZ-MIO, EZ-IO, Distal Tibia (formerly<br>K062956). | 4 | Vidacare Corp. |

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

This submission seeks to extend the indications for use for the Powered PD-IO Intraosseous Infusion System (K051992); EZ-IO Humeral Head (K052408) and Powered PD-IO (K063142) for emergent, urgent and medically necessary intraosseous vascular access for the delivery of drugs and fluids to pediatric patients. Vidacare manufactures all of these products. The expansion of indications for these products requires no new technology to facilitate the safe application of the product. There have been no changes to the design or components of the devices cleared under 510(k) K051992, K052408, K063142 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JUL 27 2010

Re: K101026

Trade/Device Name: Powered PD-IO Intraosseous Infusion System; EZ-IO Humeral Head; Powered PD-IO Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 9, 2010 Received: July 13, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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## 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 Turner
Anthony D. Watson, B.S., M.

Anthony D atson, B.S., M.S., M.B.A. 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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# 4. Indications for Use Statement

Indications for Use

510(k) Number (if known): ***_*****_**

Device Name: The Powered PD-IO

The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.

1 27 2018

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Page 1 of 1

Rld C. 7/28/10

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

510(k) Number:

Regulatory Specialists, Inc.

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## 4. Indications for Use Statement

## Indications for Use

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________ EZ-10 Humeral Head

> The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours.

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

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)

Ali C. A 7/28/10

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Contr

Regulatory Specialists, Inc.

510(k) Number:

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## 4. Indications for Use Statement

Indications for Use

JUI 2 7 2010

510(k) Number (if known): _

Device Name: Powered PD-IO Intraosseous Infusion System

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Rid C. Chape 7/27/10

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

ge 1 of 1

510(k) Number: *_*_