The B.I.G. - Bone Injection Gun is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

Device Description

The B.I.G. - Bone Injection Gun consists of a trocar needle held by a piston. The piston is surrounded by a compressed spring. All components are contained in the device's housing. When the device is operated, the compressed spring is released and propels the trocar needle into the bone marrow.

AI/ML Overview

The provided document, K062940, is a 510(k) summary for WaisMed's B.I.G.™ - Bone Injection Gun. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed performance criteria or a study design description that would typically be found in a clinical trial report or a more comprehensive technical document.

Here's an analysis based on the available information:

A table of acceptance criteria and the reported device performance

The document states: "The device was tested for both performance and safety. In all instances, the B.I.G. - Bone Injection Gun functioned as intended."
However, specific quantitative acceptance criteria (e.g., success rate, time to access, specific failure modes and their acceptable limits) and detailed reported device performance metrics are not provided in this summary. It only offers a general statement that the device functioned as intended.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. The document does not describe any specific test set size for performance and safety testing, nor does it mention the provenance of any data used.
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)

This information is not available. The summary does not describe a clinical study involving human experts establishing ground truth. The evaluation appears to be based on functional and safety testing of the device itself rather than an assessment by experts against a reference standard in a clinical context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No description of adjudication methods is present, as there's no mention of a human-reviewed test set requiring such a process.
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

This information is not applicable to this device. The B.I.G. - Bone Injection Gun is an intraosseous infusion device, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable to this device. As a mechanical medical device, the concept of "algorithm only" performance without human-in-the-loop is not relevant. The device requires human operation for its intended use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated as part of a formal study with ground truth. For a mechanical device like the B.I.G., "ground truth" typically relates to its functional performance (e.g., successful insertion, fluid flow rate without leakage, structural integrity). The summary only states that the device "functioned as intended," implying that it met its functional design specifications, which would serve as the de-facto "ground truth" for its performance and safety tests.
The sample size for the training set

This information is not applicable to this device. The B.I.G. - Bone Injection Gun is a mechanical device, not an algorithm that requires a training set.
How the ground truth for the training set was established

This information is not applicable to this device, as it does not involve a training set.

In summary, the provided 510(k) summary for the B.I.G. - Bone Injection Gun states that the device was tested for performance and safety and "functioned as intended." However, it lacks specific details about the acceptance criteria, study design, sample sizes, expert involvement, or any quantitative results that would typically be provided in a comprehensive study report. The premarket notification focuses on demonstrating substantial equivalence to predicate devices (WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) and Vidacare Corporation, Humeral Head EZ-IO (K052408)) based on similar intended uses, indications, technological characteristics, and principles of operation, rather than a detailed presentation of a de novo clinical or performance study with quantified acceptance criteria.

Summary

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K062940

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510(k) SUMMARY

WaisMed's B.I.G.™ - Bone Injection Gun

DEC 2 2 2006

Submitter's Name:	WaisMed, Ltd.
Address:	91 Medinat Hayehudim StreetHerzliyaISRAEL
Telephone Number:	972-9-9550213
Facsimile:	972-9-9516511
Contact Person:	Jonathan S. KahanHogan & Hartson L.L.P.555 13th Street, N.W.Washington, D.C. 20004-1109Phone: (202) 637-5794Fax: (202) 637-5910E-mail: JSKahan@hhlaw.com

Date prepared: September 29, 2006

Name of Device and Name/Address of Sponsor

B.I.G.™ - Bone Injection Gun WaisMed, Ltd. 91 Medinat Hayehudim Street Herzliya ISRAEL

Common or Usual Name

Intraosseous infusion device

Classification Name

Hypodermic single lumen needle

Predicate Devices

WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) Vidacare Corporation, Humeral Head EZ-IO (K052408)

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Kα66940

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Intended Use / Indications for Use

Technological Characteristics

Performance Data

The device was tested for both performance and safety. In all instances, the B.I.G. - Bone Injection Gun functioned as intended.

Substantial Equivalence

The B.I.G. - Bone Injection Gun is as safe and effective as the B.I.G. -Bone Injection Gun for use in the tibia and the Humeral Head EZ-IO. The B.I.G. - Bone Injection Gun has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in indication for use and/or technological characteristics raise no new issues of safety or effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WaisMed, Limited C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson L.L. P. 555 Thirteenth Street, NW Washington, DC 20004

DEC 2 2 2006

Re: K062940

Trade/Device Name: B.I.G. - Bone Injection Gun Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 28, 2006 Received: September 28, 2006

Dear Mr. Kahan:

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 - Mr. Kahan

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/industrv/support/index.html.

Sincerely yours.

Shula R. Murphy, M.D. for Cha. Ken, M.D. 12/22/66

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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Indications for Use Statement

510(k) Number (if known):_

Device Name: B.I.G. - Bone Injection Gun

Indications for Use:

The Bone Injection Gun (BIG) is intended to provide intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K062944

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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).