(142 days)
The SPROTTE® STANDARD (LUER/ NRFit®) needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.
The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the subarachnoid space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.
The provided text describes a 510(k) premarket notification for a medical device, specifically SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology needles. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (SPROTTE NRFit™, Quincke NRFit™) by validating the addition of an alternative sterilization service provider and an alternative packaging material.
The document does not detail acceptance criteria or study results for AI performance or diagnostic accuracy. Instead, it focuses on the physical and biological characteristics of the needle itself, and the validation of manufacturing processes (sterilization and packaging) to ensure sterility and shelf life.
Therefore, many of the requested items (e.g., AI performance, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission. This is a traditional medical device submission, not an AI/ML-based device.
However, based on the provided text, we can address the applicable criteria:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally implied by adherence to relevant ISO standards and maintaining the same performance characteristics as the predicate device. The "reported device performance" is essentially a "Pass/Fail" determination against these standards.
| Acceptance Criteria (Implied by ISO Standards) | Reported Device Performance |
|---|---|
| ISO 7864 (Anesthesia Conduction Needles) | |
| 4.3 Cleanliness | Passed |
| 4.4 Limits for acidity or alkalinity | Passed |
| 4.5 Limits for extractable metals | Passed |
| 4.10 Needle Tube | Passed |
| 4.11 Needle point | Passed |
| 4.12 Bond between hub and needle tube | Passed |
| 4.13 Patency of lumen | Passed |
| ISO 9626 (Stainless Steel Needle Tubing) | |
| 5.2 Surface finish and visual appearance | Passed |
| 5.3 Cleanliness | Passed |
| 5.4 Limits for acidity and alkalinity | Passed |
| 5.5 Size designation | Passed |
| 5.6 Dimensions | Passed |
| 5.7 Sample size | Passed |
| 5.8 Stiffness | Passed |
| 5.9 Resistance to breakage | Passed |
| 5.10 Resistance to corrosion | Passed |
| ISO 80369-6 (NRFit Connectors) | |
| 6.1 Fluid Leakage | Passed |
| 6.2 Air Leakage | Passed |
| 6.3 Stress Cracking | Passed |
| 6.4 Separation Axial Load | Passed |
| 6.5 Unscrewing | Passed |
| 6.6 Overriding | Passed |
| ISO 80369-7 (LUER Connectors) | |
| 7.1 Fluid Leakage | Passed |
| 7.2 Air Leakage | Passed |
| 7.3 Stress Cracking | Passed |
| 7.4 Separation Axial Load | Passed |
| 7.5 Unscrewing | Passed |
| 7.6 Overriding | Passed |
| Sterilization (ISO 11135-1) | |
| Sterility Assurance Level (SAL) | SAL=10^-6 (Validated) |
| EO and ECH Residuals (ISO 10993-7) | Compliant |
| Shelf Life | |
| Maintain sterility after 60 months | Validated (Found sterile) |
| No decrease in performance after 60 months | Validated |
| Biocompatibility (ISO 10993-1) | Compliant |
| Use of materials | Compliant |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document indicates that for ISO 9626, "5.7 Sample size" was "Passed", implying a specific sample size was used as per the standard, but the exact number is not provided. For sterility and shelf-life testing, "process most challenging worst case devices" were used, but specific numbers are not given.
- Data Provenance: The manufacturing and testing are stated to occur at PAJUNK GmbH Medizintechnologie in Geisingen, Germany, and the contract sterilizers are in Wiesbaden, Germany (Sterigenics) and Halberstadt, Germany (HA2 Medizintechnik). The data is derived from prospective testing conducted to validate the manufacturing and sterilization processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. This submission concerns the physical and biological characteristics of a medical device (anesthesia needle) and the validation of its manufacturing and sterilization processes, not the performance of an AI/ML algorithm or diagnostic accuracy involving expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. No adjudication method for expert reviews or ground truth establishment is mentioned as this is not an AI/ML or diagnostic performance study. Performance is measured against specific ISO standards and validated processes.
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:
This is not applicable. This is not an AI-assisted device; it is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the adherence to established international standards (ISO series) for medical device design, manufacturing, sterilization, and biocompatibility. For instance, sterility is validated to an SAL of 10^-6 (a defined standard), and material properties are tested against specified values in the ISO standards. The performance characteristics of the new device are directly compared to existing predicate devices and their proven specifications, and confirmed by testing against the same engineering and safety standards.
8. The sample size for the training set:
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable.
§ 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).