BONE INJECTION GUN (B.I.G.)

K062940 · Waismed, Ltd. · FMI · Dec 22, 2006 · General Hospital

Device Facts

• Record ID: K062940
• Device Name: BONE INJECTION GUN (B.I.G.)
• Applicant: Waismed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

B.I.G. (Bone Injection Gun) is a mechanical intraosseous infusion device; used in emergency settings for adult patients. Device consists of a trocar needle, piston, and compressed spring within a housing. Operation involves releasing the compressed spring to propel the trocar needle into the bone marrow. Provides rapid access for fluid or pharmacological resuscitation when IV access is not possible. Operated by healthcare providers.

Clinical Evidence

Bench testing only. Performance and safety testing demonstrated the device functions as intended.

Technological Characteristics

Mechanical intraosseous infusion device. Consists of a trocar needle, piston, and compressed spring housed in a plastic/mechanical assembly. Operates via spring-loaded mechanical propulsion of the needle into bone marrow. No software or electronic components.

Indications for Use

Indicated for adult patients requiring intraosseous access as an alternative to IV access during emergencies, specifically for humeral head access when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 Street<br>Herzliya<br>ISRAEL |
| Telephone Number: | 972-9-9550213 |
| Facsimile: | 972-9-9516511 |
| Contact Person: | Jonathan S. Kahan<br>Hogan & Hartson L.L.P.<br>555 13th Street, N.W.<br>Washington, D.C. 20004-1109<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

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

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.

### Technological Characteristics

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.

### 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 [phone]. 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 [phone] or [phone] 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)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

K062944

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