PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE

K043490 · Vidacare Corporation · FMI · Feb 18, 2005 · General Hospital

Device Facts

• Record ID: K043490
• Device Name: PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PD-IO Disposable Intraosseous Infusion Needle and Handle provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.

Device Story

PD-IO Disposable Intraosseous Infusion Needle and Handle facilitates emergency vascular access. Device consists of sterile single-use handle with trocar and sterile disposable single-use intraosseous (IO) catheter with standard Luer lock. Operator manually inserts needle through bone cortex into marrow; handle/trocar removed by counter-clockwise rotation, leaving catheter seated. Standard Luer lock allows connection of syringes and IV tubing for fluid/drug administration. Used in clinical/emergency settings by healthcare providers. Provides rapid alternative to IV access in pediatric patients.

Clinical Evidence

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

Technological Characteristics

Single-use manual intraosseous needle and handle. Features include trocar, catheter with standard Luer lock, and manual insertion mechanism. Biocompatible materials. Sterile. Designed for proximal tibia access.

Indications for Use

Indicated for pediatric patients requiring intraosseous access in the proximal tibia as an alternative to IV access during emergencies.

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-IO Intraosseous Infusion System (K032885)
• Cook, Inc., Disposable Intraosseous Infusion Needles (K913258)
• WaisMed BIG for Pediatrics (K022415)

Submission Summary (Full Text)

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FEB 1 8 2005

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K 643490

## SUMMARY

| Submitter's name: | VidaCare Corporation |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Address: | 722-A Isom Road<br>San Antonio, TX 78216 |
| Phone: | 210-375-8500 |
| Fax number: | 210-375-8537 |
| Name of contact person: | Greg Holland |
| | Regulatory Specialists, Inc<br>3722 Ave. Sausalito<br>Irvine, CA 92606<br>Phone: [phone] fax: [phone] |
| Date the summary was prepared: | December 16, 2004 |
| Name of the device: | PD-IO, Disposable Intraosseous Infusion<br>Needle and Handle |
| Trade or proprietary name: | PD-IO, Disposable Intraosseous Infusion<br>Needle and Handle |
| Common or usual name: | Intraosseous Infusion Needle |
| Classification name | Hypodermic single lumen needle |

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

VidaCare Corporation, EZ-IO* Intraosseous Infusion System, K032885 Cook, Inc., Disposable Intraosseous Infusion Needles, K913258 WaisMed BIG for Pediatrics, K022415

Description of the device:

The PD-IO Disposable Intraosseous Infusion Needle and Handle consists of a sterile single use handle with trocar and a sterile disposable single use intraosseous (IO) catheter with standard Luer lock. During use, the PD-IO needle is manually inserted through the cortex of the bone to a desired depth within the bone marrow. The insertion handle with trocar is then separated from the hub of the catheter by turning the handle counter clockwise and then removed

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leaving the catheter securely seated in the bone. The catheter has a standard Luer lock that permits attachment of standard syringes and IV tubing for administration of drugs and fluids.

indications for Use:

The PD-IO Disposable Intraosseous Infusion Needle and Handle THE FD Diopeous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.

Summary of the technological characteristics of the VidaCare PD-10 Disposable Intraosseous Infusion Needle and Handle compared to the predicate devices:

The predicate Cook, Disposable Intraosseous Infusion Needles K913258, VidaCare Corporation EZ-IO K032885 and the WaisMed Ltd BIG Pediatric K022415 were compared in the following areas and found to have similar technological characteristics and to be equivalent to the PD-IO Disposable Intraosseous Infusion Needle.

- Indications for use Design features Needle design Technique Sterility Biocompatibility Anatomical site Where used Standards met Target population Mechanical safety

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

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

Re: K043490

Trade/Device Name: PD-IO Disposable Intraosseous Infusion Needle and Handle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 16, 2004 Received: December 17, 2004

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 releveloca above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the Federal Pova, Drag, Drag, therefore, market the device, subject to the general approvin applivation of the Act. The general controls provisions of the Act include controls provisions or 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 (1 Mr), It may of burgest to fact 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 - Mr. 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 mean that 127 mas and regulations and regulations administered by other Federal agencies. or the For of all , I outh all the Act's requirements, including, but not limited to: registration r our max compry with a 807); labeling (21 CFR Part 801); good manufacturing practice und fisting (21 es read of the quality systems (QS) regulation (21 CFR Part 820); and if requirents as betronic 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), 11 you dontact 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 maj South 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,

Cure

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): k043490

Device Name: PD-IQ Disposable Intraosseous Infusion Needle and Handle ______________________________________________________________________________________________________

Indications For Use:

The PD-IO Disposable Intraosseous Infusion Needle and Handle provides The PD-IO Disposable intraosseous this, as an alternative to IV access during
intraosseous access in the proximal tibia, as an alternative to IV access during
intraosseous ac Intraosseous access in the province in pediatric patients.

Prescription Use__X (Per 21 CFR 801.109) OK

Over-The-Counter Use_ (Optional Format 1-2-96)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Clater V. West

- Lision Sign-Cif) Consion of Anesthesiology, General Hospital. In Schon Control, Dental Devices

3(k) Number. K4424494