(77 days)
The EZ-IO 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.
The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired 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 via the humeral head.
The provided text describes the EZ-IO Humeral Head device and its substantial equivalence to a predicate device, the VidaPort Intraosseous Infusion System. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, or detailed ground truth methodologies. The document is primarily a 510(k) premarket notification summary and an FDA clearance letter based on substantial equivalence.
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I can only extract what is available.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a study with reported numerical device performance against such criteria. Instead, it relies on substantial equivalence. The "performance" assessment is qualitative, comparing characteristics to the predicate device.
| Characteristic | EZ-IO Humeral Head | Predicate Device (VidaPort Intraosseous Infusion System) | Comparison Outcome |
|---|---|---|---|
| Indications for Use | Emergency vascular access when standard venous access is not possible; rapid fluid/pharmacological resuscitation required when IV access is not possible. Humeral head IO access. | (Implicitly similar) | Found to have similar technological characteristics and to be equivalent. |
| Target Population | (Implicitly similar) | (Implicitly similar) | Found to have similar technological characteristics and to be equivalent. |
| Drill Design | (Described as a reusable battery-powered driver) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Needle Design | Single-use disposable IO needle assembly | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Technique | Penetrates cortex to desired depth, separates driver, removes stylet, Luer lock for attachment. | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Performance | (Not specified quantitatively) | (Not specified quantitatively) | Found to have similar technological characteristics and to be equivalent. |
| Sterility | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Biocompatibility | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Mechanical Safety | (Implicitly similar or equivalent) | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
| Anatomical Site | Humeral Head | (Implicitly similar or equivalent) | Found to have similar technological characteristics and to be equivalent. |
2. Sample size used for the test set and the data provenance
Not explicitly mentioned in the provided text. The submission is a 510(k) for substantial equivalence, which often relies on comparative analysis rather than new clinical trial data for direct performance measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly mentioned in the provided text.
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 (intraosseous infusion system), not an AI diagnostic tool involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly mentioned in the provided text for establishing performance. The "ground truth" for the submission is the legally marketed predicate device (VidaPort Intraosseous Infusion System), against which the new device (EZ-IO Humeral Head) is compared for "similar technological characteristics and to be equivalent."
8. The sample size for the training set
Not applicable/not mentioned. This is a medical device clearance based on substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable/not mentioned. (See #8)
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NOV 1 7 2005
Image /page/0/Picture/2 description: The image shows the word "VIDACARE" in a bold, sans-serif font. The letters are slightly distressed, giving them a textured appearance. The word is displayed in all capital letters and is horizontally oriented.
722-A Isom Road San Antonio, TX 78216 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
VidaCare Corporation
San Antonio, TX 78216
722-A Isom Road
210-375-8500
210-375-8537
Date the summary was prepared: August 24, 2005
| Name of the device: | EZ-IO |
|---|---|
| Trade or proprietary name: | 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)]:
VidaPort Intraosseous Infusion System (K032885), manufactured by VidaCare.
Description of the device:
The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired 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 via the humeral head.
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Addendum 2 to 510(k), K052408, EZ-IO Humeral Head
Premarket Notification – VidaCare, EZ-IO
Indications:
The EZ-IO 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 predicate VidaPort Intraosseous Infusion System (K032885), and the Humeral Head EZ-IO 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
REGULATORY SPECIALISTS, INC.
REGULATORY SPECIALISTS, INC.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2005
VidaCare Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K052408
Trade/Device Name: EZ-IO Humeral Head Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24, 2005 Received: September 2, 2005
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,
Snyte y. Michie Oms
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
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Indications for Use Statement
Page 1 of 1
020408
510(k) Number (if known):K052408
Device Name: Humeral Head EZ-IO
Indications For Use:
The EZ-IO 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 _ × OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11/17/15 William M. Burdik, Acting B.C. for
Northern Utah
nf Anesthe tiology General Hospital. on Control. Dental Devicess
Number: K052408
§ 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).