(217 days)
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.
This is a 510(k) premarket notification for the "IO Needle Safety Sheath (IOSS)", a device intended to assist in the safe removal of intraosseous needles. The information provided heavily focuses on proving substantial equivalence to a predicate device (EZ-IO Intraosseous Vascular Access System) and includes non-clinical performance data.
Here's an analysis of the acceptance criteria and the study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity per ISO 10993 series. | Pass. Final, finished devices tested for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity. All tests confirmed the suitability of IOSS. |
| **Verification of Product | ||
| Specification** | IOSS must meet all product specifications after exposure to ambient, high temperature/humidity, and low temperature environmental conditions. | Pass. Confirmed that the IO Needle Safety Sheath (IOSS) met all product specifications high temperature/humidity, and low temperature environmental conditions. |
| Usability | The intended user population can use IOSS without encountering a needle stick, serious use errors, or problems for the intended use and expected use environment. | Pass. Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems. |
| Distribution | IOSS must meet all product specifications and acceptance criteria after being exposed to shipping and transportation conditions (ISTA 3A 2018). | Pass. Distribution testing conforming to ISTA 3A 2018 (FDA Recognition Number 5-126) confirmed that IOSS met all product specifications and acceptance criteria after being exposed to shipping and transportation conditions. |
| Accelerated Shelf Life | IOSS must meet all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of up to 5 years. | Pass. Confirmed that IOSS met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of one (1), three (3), and five (5) years. |
| Shelf Life (Real-Time) | IOSS must meet all product specifications following real-time ambient condition exposure for one (1), three (3), and five (5) years. | Test on-going. |
| Prevention of Needle Stick | Implicit within the usability acceptance criteria. The device should prevent accidental needle sticks. | Pass. "Usability Testing: Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems." (This is inferential, as a specific quantitative criterion for needle stick prevention isn't explicitly stated but is the core function of a "safety sheath"). |
| Irreversible Capture | Implicit within the device description: "It irreversibly captures the IO needle within the device upon removal from the patient." | Confirmed during product specification testing and usability testing, as the device passed all specifications and was used safely and effectively. (Specific data on the mechanism of irreversible capture or its success rate is not explicitly detailed in the summary, but implied by the "Pass" for usability and product specifications). |
| Tactile and Visual Confirmation of Safe Mode | Implicit in device description: "There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode." | Confirmed during product specification testing and usability testing. (No specific data points on tactile/visual confirmation success rates are provided, but its functionality is implied to be met). |
2. Sample Size Used for the Test Set and Data Provenance
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Usability Testing:
- Sample Size: 500 uses by thirty (30) users.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, human factors validation testing typically involves prospective studies with enrolled participants.
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Other tests (Biocompatibility, Product Specifications, Distribution, Accelerated Shelf Life): These involve device units, not human subjects, so "test set" and "data provenance" as typically applied to clinical studies are not directly applicable. These are conducted in a laboratory setting. The "final, finished devices" were tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
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Usability Testing: The document refers to "thirty (30) Users" to assess usability. It does not specify if these were "experts" in the sense of establishing ground truth for the device's functional performance, but rather participants for evaluating user experience and safety.
- Ground Truth: The "ground truth" for usability testing is whether these users encountered needle sticks, serious use errors, or problems. This is established by direct observation and feedback from the users themselves, evaluated against predefined safety and effectiveness criteria.
- Qualifications: The qualifications of these 30 users are not detailed beyond "intended user population." They likely represent healthcare professionals who would typically use such a device. There is no mention of "experts" specifically establishing a ground truth for the test set.
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Other tests: Ground truth for these bench tests is established by industry standards (e.g., ISO 10993, ISTA 3A) and internal product specifications, which are typically developed by engineers and quality assurance personnel. No external experts are mentioned for validating these specific test outcomes.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1 or 3+1 consensus) is mentioned for any of the tests.
- For Usability Testing, the results would typically be analyzed by human factors engineers against predefined pass/fail criteria for safety and effectiveness (e.g., zero needle sticks, minimal serious use errors). This is more of a data analysis and evaluation process than an adjudication by multiple, independent experts as seen in, for example, image interpretation studies.
- For Bench Performance Testing, results are typically compared directly to quantitative specifications and pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done.
- This device is a physical accessory (safety sheath) for an existing medical needle. The studies focus on its physical performance, safety features (preventing needle sticks), and usability, rather than diagnostic interpretation effectiveness that would necessitate an MRMC study.
- Therefore, there is no effect size of human readers improving with AI vs. without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
- No, a standalone algorithm-only study was not applicable or performed.
- This device is a mechanical accessory; it does not involve algorithms or AI. Its core function is to be used with a human operator and an existing IO needle.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993 series) and specific laboratory test parameters designed to detect cytotoxic, sensitization, irritation, acute systemic toxicity, and pyrogenicity responses.
- Verification of Product Specifications, Distribution, Accelerated Shelf Life, Shelf Life: Ground truth is established by the device meeting its predefined engineering and product specifications and demonstrating performance in accordance with recognized industry standards (e.g., ISTA 3A).
- Usability: Ground truth is established by direct observation of user interaction, user feedback, and analysis of adverse events (e.g., needle sticks) or serious use errors during simulated use scenarios, evaluated against predefined safety and effectiveness criteria.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical safety accessory, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device itself is designed, manufactured, and tested, not "trained."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).