(90 days)
The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The ZIEN IO Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the ZIEN IO Needle Set) that connects to a reusable manually powered drill (the ZIEN IO Driver). Upon manual activation, the Driver penetrates through the cortex of the bone to a desired depth within the bone marrow by means of rotary cutting action along with force applied axially by the operator. The Driver can then be separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The stylet containing the driver connection is then removed. The needle insertion can also be performed by hand, without the use of the Driver, as per the user's discretion. A standard Luer lock (part of the needle assembly) permits attachment of standard syringes and IV lines for administration of drugs and fluids.
The ZIEN IO Intraosseous Access System is a medical device designed to provide intraosseous access when intravenous access is difficult or impossible. The provided document, a 510(k) premarket notification, indicates that no clinical testing was performed for this submission. The substantial equivalence to a predicate device (SAM IO™ Intraosseous Access System, K191488) was established through non-clinical bench and simulated use testing.
Therefore, information regarding acceptance criteria and performance derived from a study involving human subjects or AI effectiveness studies is not available in the provided text. The following sections will address the available information based on the non-clinical testing detailed in the document.
1. A table of acceptance criteria and the reported device performance
The document primarily refers to "applicable design and performance requirements" and "conformity to applicable standards" as the acceptance criteria for non-clinical testing. The device's performance is reported as "Fulfilled" or "Passed-Fulfilled" against these standards.
| Acceptance Criteria (Standard ID # and Title) | Reported Device Performance |
|---|---|
| ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Fulfilled |
| ISO 23908 (1st edition 2011-06-11) Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling | Passed-Fulfilled |
| ISO 7864 (4th edition 2016-08-01) Sterile hypodermic needles for single use - Requirements and test methods | Passed-Fulfilled |
| ISO 9626 (2nd edition 2016-08-01) Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods | Passed-Fulfilled |
| ISO 10555-1 (2nd Edition 2013-06-15) Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements | Fulfilled |
| ASTM A632-19 (2029) Standard specification for Seamless and Welded Austenitic Stainless Steel Tubing (small-diameter) for general service | Fulfilled |
| ASTM A313-13 (2013) Standard Specification for Stainless Steel Spring Wire | Fulfilled |
| ZIEN Medical Technologies, Inc. conducted a risk analysis on the proposed system in accordance with ISO 14971. All identified risks have been addressed through device design, verification/validation or through documentation. | Fulfilled |
| ISO 11135:2014 Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control of a Sterilization Process for Medical Devices | Passed-Fulfilled |
| ISO 10993-7:2008/Amd 2019 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals | Fulfilled |
| ISO 11607-2: 2019 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes | Passed-Fulfilled |
| ASTM F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | Passed-Fulfilled |
| ASTM F88/F88-23 Standard Test Method for Seal Strength of Flexible Barrier Materials | Passed-Fulfilled |
| ASTM F2096-11:2019 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | Passed-Fulfilled |
| ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Passed-Fulfilled |
| ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems | Passed-Fulfilled |
| ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process | Fulfilled |
| Demonstrated ability for the ZIEN IO Intraosseous Access System to establish IO access in in-vitro model. | Less than 10 seconds |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical bench testing or simulated use testing. It also does not provide details on the data provenance such as the country of origin or whether the data was retrospective or prospective, as these terms are typically relevant for clinical studies, which were not performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided in the document. The testing was non-clinical (bench and simulated use) and did not involve expert establishment of ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing was non-clinical and did not involve human-based assessment requiring adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an intraosseous access system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The ZIEN IO Intraosseous Access System is a physical medical device, not an algorithm, and therefore does not have "standalone" algorithm performance in the sense of AI. Its performance was tested as a standalone physical system in bench and simulated use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was established by conformity to established international and industry standards (e.g., ISO, ASTM) and the successful completion of specified performance tests. For instance, mechanical properties were tested against standard specifications, and sterility against validated sterilization processes. The "simulated use" testing implies a simulated environment, rather than a clinical ground truth.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical device and does not involve a "training set" for AI.
§ 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).