The EZ-MIO Sternal is very similar to the EZ-MIO, manual driver, previously cleared under 510(k) K052195. The two minor differences between the devices are in the driver and addition of a collar to the needle set. The predicate EZ-MIO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed reusable driver. The EZ-MIO Sternal is single use and has a smaller driver permanently attached to the needle set. The second difference is the EZ-MIO Sternal has a permanently attached collar added to the same needle set used by the EZ-MIO. The collar is used to control depth of penetration. Both products utilize the same needle set and are designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of a bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set, both systems function identically by allowing the user to remove a stylet from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). The needle set size used in the sternum is the identical needle set used by the predicate EZ-MIO (15G X 25mm). The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission requests an indication for use of the EZ-MIO Sternal in the sternum location already established by the predicate device Pyng F.A.S.T.1 (K970380).

AI/ML Overview

This Premarket Notification [510(k)] for the Vidacare EZ-MIO Sternal device does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) summary submitted to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not include:

Acceptance criteria: Specific performance metrics with defined thresholds.
Study details: Information about a clinical or other performance study designed to demonstrate the device meets acceptance criteria.
Sample sizes (test, training): There's no mention of a test set or training set.
Data provenance, ground truth establishment, expert qualifications, adjudication methods: These are all related to performance studies, which are not described here.
MRMC comparative effectiveness study or standalone algorithm performance: These concepts are relevant to AI/algorithm-driven devices, which the EZ-MIO Sternal (an intraosseous infusion system) is not.

The document states: "The EZ-MIO Sternal has the exact same technology as the EZ-MIO cleared under 510(k) K052195. There have been no major changes to the design or components and therefore the comparison of technological characteristics such as target population, needle design, technique, sterility, biocompatibility and where it is used is identical."

This indicates that the submission relies on the established safety and effectiveness of the predicate devices rather than new performance studies specifically for the EZ-MIO Sternal. The primary purpose of this 510(k) is to extend the indications for use of an existing device concept to a new anatomical location (sternum) based on equivalence to another device already cleared for that location (PYNG Medical Corp. F.A.S.T. 1).

Summary

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Premarket Notification [510(k)], Vidacare, EZ-Mi

5. 510(k) Summary

JAN 2 6 2007

Image /page/0/Picture/3 description: The image shows the word "vidacare" in a stylized, sans-serif font. The letters are bold and black, with a slightly futuristic or technical appearance. The font has rounded corners and a uniform stroke width, giving it a clean and modern look.

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

SUMMARY

Submitter's name: Address:

Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

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

Date the summary was prepared: November 3, 2006

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

EZ-MIO Sternal EZ-MIO Sternal Intraosseous Infusion System Hypodermic single lumen needle

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

510(k)Number	Trade or Proprietary orModel Name	Manufacturer
K052195	EZ-MIO Manual Driver	Vidacare Corp.
K970380	F.A.S.T. 1 IntraosseousInfusion System (powered)	PYNG Medical Corp.

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Description of the device:

Indications:

Sternal IO access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies

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

The EZ-MIO Sternal has the exact same technology as the EZ-MIO cleared under 510(k) K052195. There have been no major changes to the design or components and therefore the comparison of technological characteristics such as target

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population, needle design, technique, sterility, biocompatibility and where it is used is identical.

Vidacare also wishes to use as a predicate F.A.S.T. 1 Intraosseous Infusion System, K970380, by PYNG Medical Corp., as this system has been cleared for use in the sternal location for which we are applying.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three abstract human profiles facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 2 6 2007

Re: K063567

Trade/Device Name: EZ-MIO Sternal Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 24, 2006 Received: November 28, 2006

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.

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Page 2 - Ms. Holland

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissamed on that your device complies with other requirements meall mat ITDA nas made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must comply with an the Het Free Progations (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 807), labolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality broken (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) This icter will anow you to begin mainent of substantial equivalence of your device to a premarket notification. - The PDF Inish is 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), If you desire spocitio actrice to: Joine 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 may outmit our. Echerariational 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,

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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4. Indications for Use Statement Indications for Use

510(k) Number (if known):

Device Name: EZ-MIO Sternal

Sternal IO access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies

Prescription Use
(Part 21 CFR 801 Subpart D) X

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)

Am 0. m

Anesthesiology, Chinanol Murq. Tal. nrol, Dental Devices

REGULATORY SPECIALISTS, INC.

Regulation Number and Section

§ 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).