(177 days)
EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.
EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.
The provided text is a 510(k) summary for the Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head. This document does not contain information about acceptance criteria or a study proving device performance in the manner requested. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.
The key points from the document are:
- Device: Intraosseous infusion systems (needles and drivers) for providing access in the distal tibia, proximal tibia, or humeral head.
- Purpose of Submission: Extends the indications for use to include usage for up to 24 hours.
- Method of Equivalence: The submission states, "There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical." This means the product's performance is assumed to be equivalent to the predicate devices because its design and components are unchanged.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies because the provided text does not contain that information. The document is a regulatory submission focused on substantial equivalence, not a detailed performance study report.
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5. 510(k) Summary
Image /page/0/Picture/2 description: The image contains two lines of text. The first line appears to be handwritten and reads "KO91140". The second line is a stylized, block-lettered word "vidacare". The font used for "vidacare" has a unique, almost circuit-like appearance.
722 Isom Road. San Antonio, TX 78216 Tel (210) 375 8500 Fax (210) 375 8537 Toll Free (within US) 866 479 8500 www.vidacare.com
OCT 1 4 2009
SUMMARY
722 Isom Road
210-375-8500
VidaCare Corporation
San Antonio, TX 78216
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
210-375-8537 Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411
Fax: 949-552-2821
| Date the summary was prepared: | Original, April 17, 2009Revised, October 10, 2009 |
|---|---|
| -------------------------------- | ------------------------------------------------------- |
EZ-MIO Distal Tibia, EZ-IO Distal Tibia Name of the devices: Vidaport Intraosseous Infusions System EZ-IO, Humeral Head
Intraosseous Infusion System Common or usual name: Hypodermic single lumen needle Classification name:
The legally marketed devices to which we are claiming equivalence [807.92(a) (3)]:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer | |
|---|---|---|---|
| 1 | K062956 | EZ-MIO, EZ-IO, Distal Tibia | Vidacare Corp. |
| 2 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corp. |
| 3 | K052408 | EZ-IO, Humeral Head | Vidacare Corp. |
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Indications for Use:
EZ-MIO and EZ-IO:
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Vidaport Intraosseous Infusion System:
The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.
EZ-IO Humeral Head:
The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Summary of the technological characteristics of our device compared to the predicate devices:
This submission extends the indications for use to include usage in emergent, urgent, or medically necessary cases for up to 24 hours. There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, 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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an emblem that features a stylized representation of an eagle with its wings spread. The eagle is facing to the right and has three lines extending from its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-0609 Silver Spring, MD 20993-0002
Vidacare Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
OCT 1 4 2009
Re: K091140
Trade/Device Name: Vidacare® Needle for EZ-M10 and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: II
Product Code: FMI
Dated: September 25, 2009
Received: September 28, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Lanier
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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4. Indications for Use Statement
Indications for Use
. 199
510(k) Number (if known): K091140
Device Name: Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head
Indications for Use:
EZ-MIO and EZ-IO:
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Vidaport Intraosseous Infusion System:
The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.
EZ-IO Humeral Head:
The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
X Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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. Arata
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
REGULATORY SPECIALISTS, INC
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).