(77 days)
Not Found
No
The description focuses on mechanical operation and does not mention any AI/ML components or functions.
No
The device is used to establish vascular access for administration of drugs and fluids, which are the therapeutic agents, but the device itself does not provide therapy.
No
The provided text describes a device used for obtaining vascular access and administering fluids/drugs, not for diagnosing a condition or disease.
No
The device description clearly states it consists of a reusable battery-powered driver and a single-use disposable intraosseous needle assembly, indicating it is a hardware device with mechanical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- EZ-IO Function: The EZ-IO is a device used to gain direct access to the bone marrow within the body (in vivo) for the administration of fluids and medications. It does not analyze or test any bodily specimens.
The description clearly states its purpose is for "emergency vascular access" and "administration of drugs and fluids via the humeral head," which are actions performed directly on the patient's body.
N/A
Intended Use / Indications for Use
The EZ-IO 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.
Product codes
FMI
Device Description
The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle 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 via the humeral head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral head, bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Emergency vascular access
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VidaPort Intraosseous Infusion System (K032885)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
NOV 1 7 2005
Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are slightly distressed, giving them a textured appearance. The word is displayed in all capital letters and is horizontally oriented.
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: 949-262-0411 Fax: 949-552-2821
VidaCare Corporation
San Antonio, TX 78216
722-A Isom Road
210-375-8500
210-375-8537
Date the summary was prepared: August 24, 2005
| Name of the device: | EZ-IO |
|---|---|
| Trade or proprietary name: | EZ-IO |
| 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)]:
VidaPort Intraosseous Infusion System (K032885), manufactured by VidaCare.
Description of the device:
The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle 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 via the humeral head.
1
Addendum 2 to 510(k), K052408, EZ-IO Humeral Head
Premarket Notification – VidaCare, EZ-IO
Indications:
The EZ-IO 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 predicate VidaPort Intraosseous Infusion System (K032885), and the Humeral Head EZ-IO 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.
REGULATORY SPECIALISTS, INC.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2005
VidaCare Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K052408
Trade/Device Name: EZ-IO Humeral Head Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24, 2005 Received: September 2, 2005
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 (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.
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), please contact the Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snyte y. Michie 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
4
Indications for Use Statement
Page 1 of 1
020408
510(k) Number (if known):K052408
Device Name: Humeral Head EZ-IO
Indications For Use:
The EZ-IO 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 _ × OR (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)
11/17/15 William M. Burdik, Acting B.C. for
Northern Utah
nf Anesthe tiology General Hospital. on Control. Dental Devicess
Number: K052408