(67 days)
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults as an alternative to IV access during emergencies.
The EZ-MIO manual driver, previously cleared under 510(k) K052195, consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through 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 in the distal tibia utilizing the MIO manual driver is identical to the predicate 15q X 25mm. The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission extends the indication for use of the manual device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K052195.
The EZ-IO powered driver, previously cleared under 510(k) K032885 for adult use, consists of a reusable battery powered driver connected to a single use disposable intraosseous (IQ) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power 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 EZ-IO powered driver is identical to the predicate 15g X 25mm. The EZ-IO powered intraosseous system is cleared for use in the proximal tibia under 510(k) K032885. This submission extends the indication for use of the powered device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K032885.
This document is a 510(k) summary for the EZ-MIO and EZ-IO Intraosseous Infusion Systems, seeking to extend their indications for use to include the distal tibia in adults. The submission primarily relies on equivalence to previously cleared devices (K052195 and K032885) and does not describe a new study with specific acceptance criteria or performance metrics directly comparable to a table.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert qualifications, and ground truth establishment for a new study validating the extended indication are not present in this summary. The submission argues that since there are "no changes to the design or components," the devices are substantially equivalent to their predicates for the new anatomical site based on existing technology.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or present a new study with specific performance metrics for the distal tibia insertion that would traditionally be reported in such a table. The argument for expanded indication is based on the devices being identical to their cleared predicates and the technique being similar.
Inferred Acceptance Criteria:
- Substantial Equivalence: The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate devices (EZ-MIO, K052195; EZ-IO, K032885) for the new indication (distal tibia in adults). This implies that the device performs similarly in terms of safety and effectiveness as demonstrated by the predicate devices for their cleared indications.
- No Design Changes: The device must have no changes to its design or components compared to the cleared predicate devices.
- Same Technique: The insertion technique for the distal tibia must be the same as the technique cleared for the proximal tibia.
Reported Device Performance (Inferred from Substantial Equivalence):
Since no new performance data for the distal tibia is presented, the "reported device performance" is essentially that the EZ-MIO and EZ-IO systems, when used in the distal tibia with the specified 15g x 25mm needle, are expected to perform comparably to their performance in the proximal tibia, which was deemed safe and effective in their original 510(k) clearances. This includes:
- Successfully facilitating the infusion of desired fluids.
- Firmly seating the stylet and cannula in the bone.
- Allowing separation and removal of the stylet, leaving a standard Luer lock catheter.
2. Sample size used for the test set and the data provenance
The document does not describe a new "test set" or a new clinical study to evaluate performance in the distal tibia. The submission is based on the technological characteristics being identical to the predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not applicable to this specific submission for an expanded indication. The "data provenance" would refer to the original studies conducted for the predicate devices, which are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new test set or ground truth establishment for an expanded indication study is described in this summary.
4. Adjudication method for the test set
Not applicable, as no new test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for intraosseous infusion, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this particular 510(k) expanding the indication, the "ground truth" is implied to be the established safety and effectiveness of the predicate devices for their original indications, and the argument that the same principles apply due to identical device characteristics and technique. No new empirical "ground truth" for the distal tibia is presented.
8. The sample size for the training set
Not applicable, as no new training set or new study is described.
9. How the ground truth for the training set was established
Not applicable, as no new training set or new study is described. The relevant "ground truth" in this submission pertains to the established performance of the predicate devices.
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5. 510(k) Summary
Image /page/0/Picture/2 description: The image contains a stylized word that appears to be "viclace". The font is blocky and futuristic, with rounded corners and a uniform line thickness. The letters are connected, giving the word a continuous, almost circuit-like appearance. The overall impression is modern and technological.
DEC - 6 2006
722 Isom Road, San Antonio, TX 78216 Tel (210) 375 8500 Fax (210) 375 8537 Toll Free (within US) 866 479 8500 www.vidacare.com
SUMMARY
Submitter's name: Address:
Phone:
Fax number:
Vidacare Corporation 722 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: September 28, 2006
| Name of the device: | EZ-MIO and EZ-IO |
|---|---|
| Trade or proprietary name: | EZ-MIO and EZ-IO |
| 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 orModel Name | Manufacturer |
|---|---|---|
| 1 K052195 | 1 EZ-MIO Manual Driver | 1 Vidacare Corp. |
| 2 K032885 | 2 VidaPort IntraosseousSystem (powered) | 2 Vidacare Corp. |
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2 cf 2
Description of the device:
The EZ-MIO. manual driver, previously cleared under 510(k) K052195, consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through 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 in the distal tibia utilizing the MIO manual driver is identical to the predicate 15q X 25mm. The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission extends the indication for use of the manual device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K052195.
The EZ-IO powered driver, previously cleared under 510(k) K032885 for adult use, consists of a reusable battery powered driver connected to a single use disposable intraosseous (IQ) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power 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 EZ-IO powered driver is identical to the predicate 15g X 25mm. The EZ-IO powered intraosseous system is cleared for use in the proximal tibia under 510(k) K032885. This submission extends the indication for use of the powered device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K032885.
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Indications:
The EZ-MIO and EZ-IO intraosseous system provides intraosseous access in the distal tibia of adults as an alternative to IV access during emergencies.
Summary of the technological characteristics of our device compared to the predicate device:
This submission extends the indication for use to include the distal tibia site in adults of the EZ-MIO manual and the EZ-IO powered intraosseous systems. There have been no changes to the design or components of the EZ-MIO or EZ-IO cleared under 510(k) K052195 and K032885 and therefore the comparison of technological characteristics listed below are identical.
Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Where Used
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vidacare Corporation C/O Ms. Grace Holland Regulatory Consultant Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
DEC - 5 2006
Re: K062956
Trade/Device Name: EZ-MIO, EZ-IO Distal Tibia Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: September 28, 2006 Received: September 29, 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.
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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 (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/industry/support/index.html.
Sincerely yours.
Syndite y. Michau Omd.
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: EZ-MIO and EZ-IO
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults as an alternative to IV access during emergencies.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) u============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Number K06295-4
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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).