POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM

K051992 · Vidacare Corporation · FMI · Oct 20, 2005 · General Hospital

Device Facts

• Record ID: K051992
• Device Name: POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
• Applicant: Vidacare Corporation
• Product Code: FMI · General Hospital
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).

Device Story

Powered PD-IO Intraosseous Infusion System functions as a cordless, battery-powered drill; used to gain emergency vascular access. Device consists of a reusable driver and a disposable intraosseous needle assembly. Operator activates driver to drill through bone cortex into marrow; driver detaches from needle hub; trocar/stylet removed; cannula remains seated. Standard Luer lock on needle hub allows connection of syringes and IV lines for drug/fluid administration. Used in emergency settings; operated by healthcare professionals. Benefits patient by providing rapid, reliable vascular access when IV access is difficult or impossible.

Clinical Evidence

bench testing only

Technological Characteristics

Battery-powered handheld driver; disposable intraosseous needle assembly with trocar/stylet and Luer lock connector. Mechanical drilling principle. Class II device.

Indications for Use

Indicated for pediatric patients (birth to 21 years, approx. 3-39 kg) requiring emergency intraosseous access in the proximal tibia as an alternative to IV access.

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

• PD-IO Disposable Intraosseous Infusion Needle (K043490)
• VidaPort Intraosseous Infusion System (K032885)

Submission Summary (Full Text)

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4051992

## 307 8 0 2005

VIDACARE

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: July 19, 2005

| Name of the device: | Powered PD-IO Intraosseous Infusion System |
|----------------------------|--------------------------------------------|
| Trade or proprietary name: | Powered PD-IO Intraosseous Infusion System |
| 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)]:

PD-IO Disposable Intraosseous Infusion Needle (K043490), manufactured by VidaCare. manufactured by Thusion System (K032885), manufactured by VidaCare.

Description of the device:

The Powered PD-IO Intraosseous Infusion System (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a cordloos anil) conclusions (IO) needle assembly. Upon activation, single ass aloposable most the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle

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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.

Indications:

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).

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

The predicates PD-IO Disposable Intraosseous Infusion Needle (K043490), VidaPort Intraosseous Infusion System (K032885), and the Powered PD-IO Intraosseous Infusion System 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.

Page 11

REGULATORY SPECIALISTS, INC.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2005

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

Re: K051992

Trade/Device Name: POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen necdle Regulatory Class: II Product Code: FMI Dated: July 19, 2005 Received: July 22, 2005

Dear Ms. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to commerce prof to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mar nave been require approval of a premarket approval application (PMA). and Cosmetic Act (710c) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel after a Act include requirements for annual registration, listing of general controls provincial ground of the ling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0070).
may be subject to such additional controls. Existing major regulations affective can may be subject to suerit additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Gode seements concerning your device in the Federal Register.

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## Page 2 - Ms. Holland

Please be advised that I·DA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 DTT is issumts a sour device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally it cach statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN Fart 607, laboring (21 OFR Part 820); and if applicable, the electronic forth in the quant) by bections (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro necess (sveting your device as described in your Section 510(k) This letter will and in your o organ finding of substantial equivalence of your device to a legally prematics noticate 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 If you ucare specific advice for your as [phone]. Also, please note the regulation entitled, Contact the Office or Society of Court (21CFR Part 807.97). You may obtain Misoranding of reference to promosibilities under the Act from the Division of Small other general involmation of your responser 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,

Sligte Y. Michiels 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

Enclosure

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510(k) Addendum K051992, Powered PD-IO

## Indications For Use Statement

510(k) Number (if known):___K051992

Device Name: Powered PD-IO Intraosseous Infusion System

Indications For Use:

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).

× AND/OR Prescription Use (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

Avision Sig Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: