BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST

K022415 · Waismed, Ltd. · FMI · Oct 11, 2002 · General Hospital

Device Facts

• Record ID: K022415
• Device Name: BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
• Applicant: Waismed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The B.I.GTM- Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

Device Story

B.I.G. (Bone Injection Gun) for Pediatrics is a spring-loaded, handheld mechanical device designed for rapid intraosseous (IO) access. Used in emergency settings by healthcare providers, it provides an alternative to intravenous (IV) access. The device features a housing with a spring-loaded mechanism that automatically injects a trocar needle into the patient's proximal tibia bone marrow. Once access is established, the device allows for the connection of a syringe or standard intravascular administration set for fluid or medication delivery. The device is purely mechanical; it does not utilize electronic sensors, software, or algorithms. It facilitates life-saving therapy by enabling rapid vascular access in pediatric patients where traditional IV access may be difficult or time-consuming to obtain.

Clinical Evidence

The submission includes supportive data consisting of in vitro studies, clinical data, and a literature survey to demonstrate substantial equivalence. No specific performance metrics (e.g., success rates, sensitivity) are detailed in the provided text.

Technological Characteristics

Mechanical spring-loaded injection device. Comprises a housing and a trocar needle. Designed for manual operation. No electronic components, software, or external energy sources. Sterile, single-use device.

Indications for Use

Indicated for pediatric patients up to 12 years of age requiring intraosseous access in the proximal tibia as an alternative to IV access during emergencies.

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

• The Bone Injection Gun Device (Waismed Ltd.) (K981853)
• The Intraosseous Access Needles (Cook Inc.) (K915409, K913258)

Submission Summary (Full Text)

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K022415

## 510(K) SUMMARY

# WaisMed LTD. B.I.GTM- Bone injection Gun for Pediatrics

WaisMed Ltd. Applicant: P.O. Box 3582 Industrial Zone Caesarea, 38900 ISRAEL Tel: [phone] Fax: [phone] E-Mail: [e-mail]

## Contact Persons:

Dorit Winitz, Ph.D. Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

Trade Name:

B.I.GTM- Bone Injection Gun for Pediatrics

Classification Name:

Needle, Hypodermic, Single Lumen

### Predicate Devices

- The Bone Injection Gun Device (Waismed Ltd.), cleared . under K981853
- The Intraosseous Access Needles (Cook Inc.), cleared . under K915409, K913258

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#### Intended Use:

The B.I.GTM- Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

#### Device Description:

The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.

#### Performance Data & Substantial Equivalence:

The B.I.GTM. Bone injection Gun for Pediatrics, like both its predicates; the Adults' Model of the B.I.G.TM device and the Cook intraosseous Access Needles, is intended to provide intraosseous access as an alternative to intravascular access during emergencies. As the adult's model of the B.I.G.TM device it is limited for use in the proximal tibia and similarly to the Cook intraosseous Access Needles, the B.I.G.TM device is intended for use in the pediatric population.

The B.I.G™. Bone injection Gun for Pediatrics has the same technological features and principles of operation as the predicate Adults' B.I.G.TM device. Any minor differences in these aspects between the systems do not raise new types of safety or effectiveness issues as demonstrated by a supportive data including in vitro studies, clinical data and literature survey.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles or faces, stacked one above the other, with flowing lines suggesting movement or connection.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WaisMed Limited C/O Dr. Dorit Winitz Push-med Limited 117 Ahuzah Street Ra' anana 43373 ISRAEL

Re: K022415

Trade/Device Name: Bone Injection ( B.I.G.) for Pediatrics Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 21, 2002 Received: July 24, 2002

Dear Dr. Winitz:

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.

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.

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Page 2 - Dr. Winitz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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 to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy J. Ulatowski

Timothy A. Ulatowski 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: K022415

Device Name:

B.I.GTM. Bone injection Gun for Pediatrics

Indications for Use:

The B.I.G™. Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

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510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use _ ﮯ (Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Patricia Cucenta

Division of Anesthesiology, General Hos Infection Control, Dental Dev

510(k) Number: K022415

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