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510(k) Data Aggregation
(130 days)
SonoTAP and SonoTAP II
The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.
The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoTAP and SonoTAP II cannulas are not for intrathecal use.
The provided text is a 510(k) Summary for the SonoTAP and SonoTAP II anesthesia conduction needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoTAP, K113207) primarily by addressing changes related to sterilization facilities and packaging materials.
The document does not describe a study involving an AI/human reader comparative effectiveness study, nor does it provide a standalone algorithm performance study data, nor does it typically include details on ground truth establishment for a diagnostic AI study. This submission is for a medical device (anesthesia conduction needles), not an AI-powered diagnostic device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test set sample sizes in the context of AI are not applicable to the scope of this regulatory submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the needle itself, validating manufacturing processes and material changes, rather than a clinical performance study involving human interpretation of diagnostic images or AI output.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance:
The document lists various sections of ISO standards as "sections tested" and reports "Pass / Fail" for them. This indicates that the tests successfully met the acceptance criteria defined by those standards. However, specific numerical performance results against acceptance thresholds are only given for one specific test:
| Section/Characteristic | Acceptance Criteria (from standard) | Reported Device Performance (with numbers where available) |
|---|---|---|
| ISO 7864 – 4.3 Cleanliness | (Implied by "Passed") | Passed |
| ISO 7864 – 4.4 Limits for acidity or alkalinity | (Implied by "Passed") | Passed |
| ISO 7864 – 4.5 Limits for extractable metals | (Implied by "Passed") | Passed |
| ISO 7864 – 4.10 Needle Tube | (Implied by "Passed") | Passed |
| ISO 7864 – 4.11 Needle point | (Implied by "Passed") | Passed |
| ISO 7864 – 4.12 Bond between hub and needle tube | 69 N (required by standard) | Average of 104.9 N and 196.01 N met in result. |
| ISO 7864 – 4.13 Patency of lumen | (Implied by "Passed") | Passed |
| ISO 9626 – 5.2 Surface finish and visual appearance | (Implied by "Passed") | Passed |
| ISO 9626 – 5.3 Cleanliness | (Implied by "Passed") | Passed |
| ISO 9626 – 5.4 Limits for acidity and alkalinity | (Implied by "Passed") | Passed |
| ISO 9626 – 5.5 Size designation | (Implied by "Passed") | Passed |
| ISO 9626 – 5.6 Dimensions | (Implied by "Passed") | Passed |
| ISO 9626 – 5.7 Sample size | (Implied by "Passed") | Passed (Note: This refers to whether the sample size for the test met the standard's requirement, not the overall study sample size for the submission.) |
| ISO 9626 – 5.8 Stiffness | (Implied by "Passed") | Passed |
| ISO 9626 – 5.9 Resistance to breakage | (Implied by "Passed") | Passed |
| ISO 9626 – 5.10 Resistance to corrosion | (Implied by "Passed") | Passed |
| ISO 80369-6 (Neuraxial connectors) | (Implied by "Tested") | Fluid Leakage, Air Leakage, Stress Cracking, Separation Axial Load, Unscrewing, Overriding (All sections were tested, implying successful compliance to the standard as part of substantial equivalence for the NRFit connector). |
| ISO 80369-7 (Intravascular/Hypodermic connectors) | (Implied by "Tested") | Fluid Leakage, Air Leakage, Stress Cracking, Separation Axial Load, Unscrewing, Overriding (All sections were tested, implying successful compliance to the standard for the LUER connector). |
| Sterility Assurance Level | SAL=10^-6 | SAL=10^-6 successfully validated at both facilities. |
| Shelf Life | 60 months from sterilization | Validated and verified to maintain sterility for 60 months. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes for each mechanical and sterility test, only that "worst case needles" were subjected to testing for hub-to-needle bonding strength and that "sample size" for ISO 9626 was "Passed," implying it met the standard's requirements. For sterility validation, ISO 11135 dictates specific sample sizes based on the method (e.g., overkill, half-cycle approach), which would have been followed but are not explicitly reported in quantitative terms in this summary.
- Data Provenance: The tests were conducted internally by PAJUNK GmbH Medizintechnologie (Germany) or by their contract sterilizers (Sterigenics Germany GmbH and HA2 MEDIZINTECHNIK GMBH, Germany). The data is generated from prospective testing of manufactured devices and packaging.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a diagnostic AI device requiring expert ground truth for image interpretation. The "ground truth" here is the physical measurement results from standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study assessing subjective interpretation (e.g., radiological reads). Quality control and engineering tests have defined pass/fail criteria.
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:
Not applicable. This is a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used for these tests are objective, measurable physical and chemical properties and performance characteristics defined by international standards (e.g., force in Newtons for bonding strength, presence/absence of leakage, sterility assurance level).
8. The sample size for the training set:
Not applicable. As this is not an AI/ML device, there are no training sets.
9. How the ground truth for the training set was established:
Not applicable.
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