(70 days)
For Bone Marrow Aspiration of the Iliac Crest.
The Powered EZ-IO Bone Marrow Aspiration System 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 desired depth within the bone marrow. The driver then is separated 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 syringe for aspiration. The needle is 15 gauge and 60mm long.
This document is a 510(k) summary for the Powered EZ-IO Bone Marrow Aspiration System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full study to establish performance against acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or specific acceptance criteria performance) is not typically found in these types of submissions.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing their "technological characteristics." The "performance" is implied through this equivalence, suggesting the device performs comparably to already approved devices.
| Characteristic Compared | Predicate Devices (VidaPort Intraosseous Infusion System, Manan Biopsy Set) | Powered EZ-IO Bone Marrow Aspiration System | Equivalence Status |
|---|---|---|---|
| Indications for Use | Yes | For Bone Marrow Aspiration of the Iliac Crest. | Equivalent |
| Target Population | Yes | Yes | Equivalent |
| Driver Design Features | Yes | Reusable battery powered driver | Equivalent |
| Needle Design | Yes | Disposable intraosseous (IO) needle assembly, 15 gauge, 60mm long | Equivalent |
| Technique | Yes | Upon activation, drill penetrates through cortex to desired depth; driver separated, cannula seated, trocar/stylet removed, Luer lock permits aspiration. | Equivalent |
| Sterility | Yes | Yes | Equivalent |
| Biocompatibility | Yes | Yes | Equivalent |
| Anatomical Sites Where Used | Yes | Iliac Crest | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a performance "test set" in the traditional sense involving human subjects or patient data. The evaluation is based on comparing design characteristics and intended use with predicate devices. Therefore, there is no information provided on sample size or data provenance for a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical or performance "test set" is described, there's no mention of experts establishing ground truth. The substantial equivalence assessment is typically conducted by the manufacturer and reviewed by regulatory bodies (like the FDA).
4. Adjudication Method for the Test Set:
Not applicable, as no test set or clinical study requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, there is no mention of an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context does not apply. The performance is assessed based on its functional design and equivalence to existing devices.
7. The Type of Ground Truth Used:
Ground truth, in the context of substantial equivalence for a physical device like this, refers to the established safety and effectiveness of the predicate devices. The "ground truth" is that these predicate devices are already legally marketed and considered safe and effective for their intended use. The new device is then compared to this established "truth." No specific "pathology" or "outcomes data" is referenced for the comparison, but rather the functional and design characteristics.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (aspiration system), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.