(176 days)
The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.
The VidaPort (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a preset depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
The provided text is a 510(k) premarket notification for the VidaPort Intraosseous Infusion System. It describes the device, its indications for use, and a comparison to a predicate device (Bone Injection Gun, K981853). However, it does not contain information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or expert involvement as typically found in clinical trials or performance studies for AI/software devices.
This document is a regulatory submission for a simple mechanical device and focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous standalone study. The "Testing" section mentions various types of testing (Electrical Safety, Electrical Emissions, Mechanical, Animal Body) but doesn't provide the details needed to fill out the requested table and study information.
Therefore, I cannot extract the requested information from the provided text. The document is not structured to provide these details for the following reasons:
- Type of Device: The VidaPort is a mechanical intraosseous infusion system (like a drill) for emergency access, not a diagnostic AI or imaging device. The types of performance metrics and studies required are vastly different.
- Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This often involves comparing technological characteristics and showing that the new device does not raise new questions of safety or effectiveness. It does not typically require a standalone clinical trial with detailed performance metrics and ground truth establishment in the same way an AI diagnostic tool would.
- Content Focus: The document focuses on describing the device, its indications, and a high-level comparison to the predicate device, asserting "similar technological characteristics" and equivalence across several domains. It mentions "Testing" but provides no specifics on methodologies, acceptance criteria, or results.
To answer your request, if this were an AI or software device, the required information would typically be found in a well-documented performance study, clinical trial report, or validation report that would be part of a more comprehensive regulatory submission (e.g., a PMA or a more detailed 510(k) for an AI device).
Given the provided text, I can only state that the document does not contain the specific information required to complete the table and answer the study-related questions. It indicates that various tests (Electrical Safety, Electrical Emissions, Mechanical, Animal Body) were performed to demonstrate equivalence, but it does not detail their methods, acceptance criteria, or results.
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MAR 1 0 2004
VidaCare Corporation
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:
Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
Date the summary was prepared: March 2, 2004
Name of the device: VidaPort Intraosseous Infusion System Trade or proprietary name: VidaPort Intraosseous Infusion System Common or usual name: Bone injection system Classification name: Hypodermic single lumen needle
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
K981853, Bone Injection Gun, manufactured by WaisMed Ltd.
Description of the device:
The VidaPort (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a preset depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
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Indications:
The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The device is prescription use only per 21 CFR 801.109.
Summary of the technological characteristics of our device compared to the predicate device:
The predicate Bone Injection Gun, K981853 and the VidaPort were compared in the following areas and found to have similar technological characteristics and to be equivalent.
Indications for use Target population Drill Design Needle Design Technique Performance Sterility Biocompatibility Mechanical Safety Anatomical site Where used Standards met
Testing:
Electrical Safety Electrical Emissions Mechanical Animal Body
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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
VidaCare Corporation Mr. Greg Holland Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K032885
Trade/Device Name: VidaPort Intraosseous Infusion System Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 18, 2003 Received: December 19, 2003
Dear Mr. 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.
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Page 2 - Mr. 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 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 (301) 594-4618. 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 cr (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
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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Page l of of
510(k) Number (if known): K0327885
Device Name: VidaPort Intraosseous Infusion System
Indications For Use:
The VidaPort provides 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)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Lone Moreau Interim Branch Chief 3/5/04
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Device
510(k) Number: K032116
REGULATORY SPECIALISTS, INC.
§ 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).