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510(k) Data Aggregation
(209 days)
EchoGlo Needle
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block (PNB) Needle consist of a polycarbonate luer hub, stainless steel cannula and a polyethylene sheath. The needle cannula will be supplied with a bevel tip or a Tuohy tip. The EchoGlo™ PNB Needle will be used for peripheral nerve block under ultrasound guidance. The distal end of the cannula has been engraved with two bands to increase ultrasound visibility by optimally reflecting ultrasound waves. These needles are provided as sterile, nonpyrogenic, single-use disposable devices. The needles may be used for single shot peripheral nerve block or for continuous infusion nerve block. The EchoGlo™ PNB Needle used for a single shot procedure will be supplied in a pouch along with a 24 inch extension set. The extension set will consist of polyvinyl chloride (PVC) tubing and have a Female luer at one end of the tubing and a Male luer at the opposite end of the tubing.
The provided text describes specific medical devices and their non-clinical testing for regulatory approval. It does not contain information about studies involving human readers or comparative effectiveness studies with AI assistance. Hence, acceptance criteria and study details related to human performance, AI, or clinical outcomes are not available in this document.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Non-Clinical Performance Testing" in Table 5-2 that the device was evaluated against. The reported performance for all these tests was that they "met pre-established specifications," demonstrating the device performs as intended. Specific numerical acceptance criteria or performance values are not provided in this summary.
| Category | Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Met pre-established specifications |
| Sensitization | Met pre-established specifications | |
| Acute systemic toxicity | Met pre-established specifications | |
| Material-Mediated Pyrogenicity | Met pre-established specifications | |
| Particulate Matter in Injections | Met pre-established specifications | |
| Exaggerated Leachables | Met pre-established specifications | |
| Hemocompatibility | Met pre-established specifications | |
| Packaging | Packaging integrity (based on ASTM D4169, ASTM F1886, ASTM F2825, ASTM F88, ASTM F2096, ISO 11607-1) | Met pre-established specifications |
| Device Performance | Gauging (T=0, T=6 months accelerated aging (AA)) | Met pre-established specifications |
| Leakage, Air (T=0, T=6 months AA) | Met pre-established specifications | |
| Leakage, Liquid (T=0, T=6 months AA) | Met pre-established specifications | |
| Ease of Assembly (T=0, T=6 months AA) | Met pre-established specifications | |
| Separation Force (T=0, T=6 months AA) | Met pre-established specifications | |
| Resistance to Overriding (T=0, T=6 months AA) | Met pre-established specifications | |
| Unscrewing Torque (T=0, T=6 months AA) | Met pre-established specifications | |
| Stress Cracking (T=0, T=6 months AA) | Met pre-established specifications | |
| Needle Inspections: Bond - Needle and hub (T=0, T=6 months AA), Limits of Acidity/Alkalinity, Patency of Lumen, Limits for Extractable materials | Met pre-established specifications | |
| Needle Stiffness, Resistance to Breakage, Resistance to Corrosion | Met pre-established specifications | |
| Bond Pull - Extension set (T=0, T=6 months AA) | Met pre-established specifications | |
| Demonstration Penetration Force | Met pre-established specifications | |
| Ultrasound Visibility | Ensured equivalence to predicate (qualitative assessment implied by "Summary of Technology Characteristics" on page 4) | |
| Human Factors | Evaluate user interface (based on FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff (3 February 2016)) | Met pre-established specifications |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each non-clinical test. The testing is described as "non-clinical performance testing," which implies laboratory or bench testing rather than studies involving human subjects or real-world clinical data. Therefore, data provenance such as country of origin or retrospective/prospective nature is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes non-clinical performance and engineering tests, not studies that require expert-established ground truth for medical imaging or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical performance and engineering tests, not studies requiring expert adjudication of results.
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
No, an MRMC comparative effectiveness study involving human readers or AI is not discussed in this document. The device is a physical medical needle, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, this question pertains to AI/algorithm performance. The device is a physical medical needle.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference standard would be the established specifications and requirements outlined in the various ISO, ASTM, and USP standards referenced (e.g., ISO 10993 for biocompatibility, ISO 594 for conical fittings, ISO 7864 for hypodermic needles, ASTM D4169 for packaging). The device was tested against these predefined engineering and safety specifications.
8. The Sample Size for the Training Set
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning model.
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