(81 days)
Not Found
No
The device description and intended use clearly describe a purely mechanical device for manual insertion of a needle. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No.
This device is a manual driver used to insert a needle set for emergency vascular access, which facilitates the infusion of fluids. It is a tool for drug/fluid delivery, not a therapeutic device that provides therapy itself.
No
The device is described as a tool for emergency vascular access to administer fluids and drugs, not for diagnosing a medical condition.
No
The device description clearly outlines a physical, manual driver with a handle and shaft designed to insert a needle set into bone, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Humeral Head, Manual Driver is a device used to physically insert a needle into bone for vascular access. It is a tool for administering fluids and medications directly into the bone marrow, not for analyzing biological samples.
- Intended Use: The intended use is for "emergency vascular access" and "rapid fluid or pharmacological resuscitation," which are therapeutic and procedural actions, not diagnostic testing.
The device description clearly outlines a mechanical process for inserting a needle and facilitating infusion, which is entirely outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Humeral Head, Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The Humeral Head, Manual Drivers are designed to allow the user to manually insert a needle set consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). The size needle that can be used with the Humeral Head, Manual Driver, is 15g X 25mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral head
Indicated Patient Age Range
Not Found
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)
Not Found
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
5. 510(k) Summary
Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are black, and there is a small, circular design above the "V". To the right of the word "VIDACARE" is the trademark symbol. The overall impression is that this is a logo or brand name.
NOV - 7 2006
722-A Isom Road San Antonio, TX 78216 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number: VidaCare Corporation 722-A Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
Date the summary was prepared: August 7, 2006
| Name of the device: | Humeral Head, Manual Driver |
|---|---|
| Trade or proprietary name: | Humeral Head, Manual Driver |
| Common or usual name: | Intraosseous Infusion System |
| Classification name: | Hypodermic single lumen needle |
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k)
Number | Trade or Proprietary or
Model Name | Manufacturer |
|------------------|---------------------------------------|------------------|
| 1 K052195 | 1 EZ-MIO Manual Driver | 1 VidaCare Corp. |
| 2 K052408 | 2 EZ-IO Humeral Head | 2 VidaCare Corp. |
Description of the device:
The Humeral Head, Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The Humeral Head, Manual Drivers are designed to allow the user to manually insert a needle set
1
consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). The size needle that can be used with the Humeral Head, Manual Driver, is 15g X 25mm.
Indications:
The Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
Summary of the technological characteristics of our device compared to the predicate device:
The Humeral Head, Manual Driver has the exact same indications for use as the EZ-IO Humeral Head (K052408) with the exact same technology as the EZ MIO Manual Driver (K052195). The Humeral Head, Manual Driver is for Humeral head IO access with a manual driver instead of the powered driver.
The predicates and the Humeral Head, Manual Driver were compared in the following areas and found to have similar technological characteristics and to be equivalent.
- Indications For Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Anatomical Sites Where Used
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 eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2006
VidaCare Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K062422
Trade/Device Name: Humeral Head, Manual Driver Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 7, 2006 Received: August 18, 2006
Dear Ms. Holland:
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 - Ms. Holland
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 (OS) 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 vour 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/industry/support/index.html.
Sincerely vours,
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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4. Indications for Use Statement Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
The Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.
Prescription Use
(Part 21 CFR 801 Subpart D)
X
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) "=============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D, 2
sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Number: K9662422
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