(175 days)
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No
The summary describes a mechanical device for intraosseous access and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used to access a site for emergency purposes, rather than directly treating a condition itself.
No
Explanation: The device is intended to provide intraosseous access as an alternative to IV access during emergencies, which is a therapeutic or interventional function, not a diagnostic one. It does not identify or investigate a disease or condition.
No
The device description clearly states "Bone Injection Gun (B.I.G.)", which is a physical device used for intraosseous access. There is no mention of software as the primary or sole component.
Based on the provided information, the Bone Injection Gun (B.I.G.) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- B.I.G. Intended Use: The B.I.G. is used to provide intraosseous access directly into the bone (proximal tibia) as an alternative to IV access. This is a procedure performed on the patient's body, not a test of a specimen taken from the body.
Therefore, the B.I.G. is a medical device used for a procedural intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
proximal tibia
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines forming its body and wings. The eagle is facing to the right.
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.
1
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
Indications for Use Statement
Page 1 of 1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Palacio Cucenti | |
|---|---|
| (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) |