HUMERAL HEAD, MANUAL DRIVER by VIDACARE CORPORATION

The Humeral Head, Manual Driver 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.

Device Description

The Humeral Head, Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The Humeral Head, Manual Drivers are designed to allow the user to manually insert a needle set consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed 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 size needle that can be used with the Humeral Head, Manual Driver, is 15g X 25mm.

AI/ML Overview

This document is a 510(k) summary for the Humeral Head, Manual Driver device, submitted by VidaCare Corporation in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with acceptance criteria and performance metrics for a novel medical device. Therefore, much of the requested information regarding acceptance criteria and study details demonstrating performance for a new algorithm/AI device is not available in the provided text.

The device described is a physical medical instrument (a manual driver for intraosseous infusion), not a digital or AI-powered diagnostic/treatment system. As such, the concept of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, or reader improvement with AI assistance, as typically applied to AI/ML devices, is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) submission for this type of device revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable or not explicitly stated:

Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Provided Text)

1. A table of acceptance criteria and the reported device performance

For this 510(k) submission, the "acceptance criteria" are implied by the regulatory standard for substantial equivalence, which requires demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise new questions of safety or effectiveness. The "performance" is implicitly deemed acceptable if substantial equivalence is established.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Same Indications for Use as predicate devices	The Humeral Head, Manual Driver has the exact same indications for use as the EZ-IO Humeral Head (K052408).
Similar Technological Characteristics to predicate devices (e.g., Target Population, Driver Design Features, Needle Design, Technique, Sterility, Biocompatibility, Anatomical Sites Where Used)	"The predicates and the Humeral Head, Manual Driver were compared in the following areas and found to have similar technological characteristics and to be equivalent." (List includes: Indications For Use, Target Population, Driver Design Features, Needle Design, Technique, Sterility, Biocompatibility, Anatomical Sites Where Used).
Does not raise new questions of safety or effectiveness	Implied by the FDA's granting of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not explicitly stated. This device is a physical instrument for medical procedures, not a diagnostic algorithm that processes data. Therefore, there's no "test set" of data in the sense of patient images or clinical records for an algorithm's performance evaluation. The submission relies on comparison to predicate devices, not on a new clinical study with a specific data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As above, there is no "test set" driven by expert ground truth for this type of device submission. The substantial equivalence relies on regulatory review and engineering/design comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a MRMC comparative effectiveness study was not done. This device is an intraosseous infusion system and does not involve "human readers" or "AI assistance" in the context of interpretation of medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market experience. The new device is deemed acceptable if it is substantially equivalent to these already accepted devices.

8. The sample size for the training set

Not applicable. There is no "training set" for an algorithm associated with this device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned.

Summary

{0}------------------------------------------------

5. 510(k) Summary

Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are black, and there is a small, circular design above the "V". To the right of the word "VIDACARE" is the trademark symbol. The overall impression is that this is a logo or brand name.

NOV - 7 2006

722-A Isom Road San Antonio, TX 78216 210-375-8500

SUMMARY

Submitter's name: Address:

Phone: Fax number: VidaCare Corporation 722-A Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

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: August 7, 2006

Name of the device:	Humeral Head, Manual Driver
Trade or proprietary name:	Humeral Head, Manual Driver
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)]:

510(k)Number	Trade or Proprietary orModel Name	Manufacturer
1 K052195	1 EZ-MIO Manual Driver	1 VidaCare Corp.
2 K052408	2 EZ-IO Humeral Head	2 VidaCare Corp.

Description of the device:

{1}------------------------------------------------

consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed 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 size needle that can be used with the Humeral Head, Manual Driver, is 15g X 25mm.

Indications:

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

The Humeral Head, Manual Driver has the exact same indications for use as the EZ-IO Humeral Head (K052408) with the exact same technology as the EZ MIO Manual Driver (K052195). The Humeral Head, Manual Driver is for Humeral head IO access with a manual driver instead of the powered driver.

The predicates and the Humeral Head, Manual Driver were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications For Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Anatomical Sites Where Used

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2006

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

Re: K062422

Trade/Device Name: Humeral Head, Manual Driver Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 7, 2006 Received: August 18, 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.

{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 (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.

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 vour 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 vours,

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

{4}------------------------------------------------

4. Indications for Use Statement Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

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)

Anthony D, 2

sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

Number: K9662422

Page 1 of 1

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).