(85 days)
Not Found
No
The device description and intended use describe a purely mechanical device for intraosseous access. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used to facilitate intraosseous access, which is a procedure for administering fluids or medications, but the device itself does not provide a therapeutic effect.
No
The device is used to provide intraosseous access for fluid or pharmacological resuscitation, which is a treatment or intervention, not a diagnostic procedure.
No
The device description clearly outlines physical components (trocar needle, piston, spring, housing) and a mechanical mechanism of action, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide intraosseous access for fluid or pharmacological resuscitation. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a mechanical tool for inserting a needle into bone. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in these samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The B.I.G. - Bone Injection Gun is a device used to deliver treatment (fluids/pharmacology) directly into the bone marrow.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral head, tibia (for predicate device)
Indicated Patient Age Range
Adult patients only.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for both performance and safety. In all instances, the B.I.G. - Bone Injection Gun functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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 |
| Herzliya | |
| ISRAEL | |
| Telephone Number: | 972-9-9550213 |
| Facsimile: | 972-9-9516511 |
| Contact Person: | Jonathan S. Kahan |
| Hogan & Hartson L.L.P. | |
| 555 13th Street, N.W. | |
| Washington, D.C. 20004-1109 | |
| Phone: (202) 637-5794 | |
| Fax: (202) 637-5910 | |
| E-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)
1
Kα66940
2 of 2
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.
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
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.
3
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
4
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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)
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