(70 days)
SonoBlock and SonoBlock II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gam entry and inject local anaesthetics to induce regional anaesthesia.
Warning:
SonoBlock and SonoBlock II Needles are not intended for RF ablation or any other type of ablation procedure.
The subject device, the SonoBlock II nerve block needle is a single-use anaesthesia conducting nerve block needle intended for performing peripheral nerve blocks.
The SonoBlock and SonoBlock II nerve block needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.
The provided document is a 510(k) Summary for the SonoBlock and SonoBlock II needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoPlex II) and primarily addresses changes in manufacturing processes (hub-to-needle bonding), sterilization providers, and packaging materials.
The document does not contain information related to software performance, AI assistance, or human reader effectiveness studies. Therefore, I cannot provide details for criteria 5, 8, and 9, and some parts of other criteria will be marked as "Not Applicable" or "Not Provided."
Here's the breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" against "reported device performance" in the context of device function/efficacy. Instead, it discusses compliance with international standards and the results of various performance tests. The focus is on ensuring that changes to manufacturing and sterilization do not negatively impact the device's physical and material properties.
Here's a compilation of the relevant performance tests and their outcomes:
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance |
|---|---|
| Bending Rigidity (ISO 9626) | "Test successfully passed" (Compliance with standard reported) |
| Breakage (ISO 9626) | "Test successfully passed" (No breakage during visual inspection after 20 complete cycles of reversal of force at 0.5 Hz) |
| Bonding to Hub (ISO 7864) | "Test successfully passed" (Compliance with standard reported, meeting or exceeding minimum force requirements for various item codes. E.g., required 69N, observed average 104.9N and 196.01N) |
| Penetration Force (EN 13097) | "Test successfully passed" (Subject needles comply with defined penetration/insertion forces; objective comparison only, no specific numerical criteria provided). |
| Hub/Connection Performance (ISO 80369-20, ISO 80369-6, ISO 80369-7) | "Test successfully passed" (Compliance with defined requirements for fluid leakage, air leakage, stress cracking, separation axial load, unscrewing, overriding for both NRFit and LUER connectors). |
| Sterility Assurance Level (ISO 11135-1) | SAL = 10^-6 (successfully validated at both Sterigenics and HA2 facilities) |
| Residuals (EO and ECH) (ISO 10993-7) | "In compliance with ISO 10993-7" (Meeting limits of 25ppm for Ethyleneoxide and Ethylene chlorhydrine) |
| Shelf Life for Sterility (5 years) | "found to be sterile after 5 years, the sterile barrier system is efficient." |
| Shelf Life for Device Performance (5 years) | "No decrease in performance after 5 years" (for LUER connection, stability of bonding connections, needle's bending rigidity) |
| Biocompatibility (ISO 10993-1) | "All products comply with ISO 10993-1" |
Study Details
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Sample sizes used for the test set and the data provenance:
- Bending Rigidity & Bonding to Hub: Specific item codes are listed with individual deflection or force values. However, the number of units tested for each item code is not explicitly stated in the summary, nor is the total sample size for these tests.
- Breakage: The number of complete cycles (20) is mentioned, but the number of needles tested is not specified.
- Penetration Force: Not specified.
- Hub/Connection Performance: Not specified.
- Sterilization Validation: Refers to "process most challenging worst case devices" and "1 sublethal cycle, 1 full cycle" for the Overkill Approach, but the specific number of devices tested is not provided.
- Shelf Life: Refers to "process most challenging worst case devices" and "similar characteristics made from the same material," but the specific number of devices tested is not provided.
- Data Provenance: The manufacturing site is PAJUNK GmbH Medizintechnologie, Geisingen, Germany. The sterilization facilities are Sterigenics in Wiesbaden, Germany, and HA2 Medizintechnik in Halberstadt, Germany. The tests appear to be conducted internally or by contract labs associated with the manufacturer, rather than clinical studies with patient data. The studies are prospective in the sense that they are validations performed for regulatory submission, but they are not clinical studies in the traditional sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes engineering performance tests and sterilization/biocompatibility validations, not studies requiring expert review for ground truth in clinical image interpretation or similar contexts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. The tests are governed by international standards (e.g., ISO, EN) which define the test procedures and acceptance criteria objectively.
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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. This device is an anesthesia conduction needle and does not involve AI assistance or human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a medical instrument, not an algorithm. The "standalone" performance refers to the device's physical and material characteristics as tested against international standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests in this document is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 9626, ISO 7864, ISO 80369 series, ISO 11135-1, ISO 10993-7). These standards provide objective and measurable criteria for physical properties, material strength, sterility, and biocompatibility.
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The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).