BONE INJECTION GUN (B.I.G.) DEVICE

K981853 · Waismed, Ltd. · FMI · Nov 17, 1998 · General Hospital

Device Facts

• Record ID: K981853
• Device Name: BONE INJECTION GUN (B.I.G.) DEVICE
• Applicant: Waismed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Nov 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bone Injection Gun (B.I.G.) is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

Device Story

Bone Injection Gun (B.I.G.) provides emergency intraosseous (IO) access; serves as alternative to IV access. Used in proximal tibia. Operated by healthcare professionals in emergency settings. Device facilitates rapid vascular access when IV access is difficult or impossible. Benefits patient by enabling timely administration of fluids and medications during critical care scenarios.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical intraosseous access device. Designed for manual operation to achieve bone penetration. No electronic components, software, or external energy sources.

Indications for Use

Indicated for adult patients requiring intraosseous access in the proximal tibia as an alternative to IV access during emergency situations.

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.

Submission Summary (Full Text)

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NOV 1 7 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ahava Stein Requlatory Affairs Consulting Waismed Limited P.O. Box 454 Ginot Shomron, 44853 ISRAEL

K981853 Re : Bone Injection Gun (B.I.G.) Device Trade Name: Requlatory Class: II Product Code: FMI October 16, 1998 Dated: Received: October 20, 1998

Dear Ms. Stein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Stein

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference fo
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Bone Injection Gun (B.I.G.) Device Name: The Bone Injection Gun (B.I.G.) is intended to provide Indications for use: intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Palacio Cucenti</i> |
|--|------------------------|
| | (Division Sign-Off) |

Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | 1981853 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|-------------------------|----|--------------------------|
| (Per 21 C.F.R. 801.109) | | (Optional Format 1-2-96) |