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The Tuohy NRFit™ cannulas/ needles for anesthesia are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of an epidural catheter.

The device is intended for adult and pediatric patients.

The Tuohy NRFit™ anaesthesia conduction needles are available in different sizes (length and diameter). Optional Accessories are retaining plate and stylet made from plastic or stainless steel as it has been cleared in the predicate device's 510(k)s.

The Tuohy NRFit™ anaesthesia conduction needles can be used for both, epidural anaesthesia and peripheral nerve blocks each equipped with appropriate labelling as the Tuohy needle in general is a commonly used needle with both clinical demands and techniques.

The provided text describes a 510(k) premarket notification for a medical device called "Tuohy NRFit™" anesthesia conduction needles. The manufacturer, PAJUNK GmbH Medizintechnologie, is seeking to demonstrate substantial equivalence to a legally marketed predicate device (K040965, PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES).

The key difference between the subject device and the predicate device is the design of the needle's hub: the predicate devices use a LUER taper connector, while the subject devices use an NRFit connector as described in ISO 80369-6 for neuroaxial devices. The submission argues that all other aspects, including clinical technique, indications for use, technical specifications, materials used, sterility, and biocompatibility, are identical or unaffected by the hub design change.

The document focuses on demonstrating that the new hub design does not compromise the device's safety and effectiveness compared to the predicate.

Here's an analysis of the acceptance criteria and the study presented:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (for direct comparison of subject vs. predicate):
  • Subject Devices: Tuohy NRFit™ in a range from 14G to 22G, and lengths from 90mm to 150mm. Eight specific item numbers were listed for testing.
  • Predicate Devices: Corresponding Tuohy needles (LUER) in a range from 14G to 22G, and lengths from 90mm to 150mm. Eight specific item numbers were listed for testing, matching the subject devices.
  • Data Provenance: The testing was conducted by the manufacturer (PAJUNK GmbH Medizintechnologie) in Germany. The data is prospective for this submission, comparing the new device against the predicate. Both fresh and aged (1 year, 3 years, 5 years accelerated aging) devices were tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This submission focuses on engineering, materials, and performance testing, not diagnostic accuracy or clinical interpretation. Therefore, there is no mention of "experts" in the context of establishing a clinical ground truth for a test set in the way one might see for an AI diagnostic device. The "ground truth" for the performance tests (e.g., pull-off force, bending rigidity) is defined by established international standards (ISO, EN).

4. Adjudication Method for the Test Set:

• Not applicable. The tests are objective, quantitative measurements against established standards. There is no subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is a medical device (anesthesia needle) with a physical design change (hub connector), not an AI-powered diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant or performed for this type of device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, in spirit. While not an "algorithm" in the AI sense, the performance studies (e.g., bending rigidity, bonding to hub, penetration force, sterilization, biocompatibility, shelf life) are tests of the device's inherent physical and material characteristics. They are conducted independently of human interaction during the measurement process, focusing solely on the device's properties. These tests are standalone in that they evaluate the device's technical specifications and compliance with standards.

7. Type of Ground Truth Used:

• The ground truth for this device's acceptance is based on:
  • International Standards: Specific criteria defined in ISO/FDIS 9626:2016, ISO/FDIS 7864:2016, ISO 80369-6, ISO 11135-1, ISO 10993-1, ISO 10993-7, and EN 13097.
  • Established Limits: For chemical residuals, bioburden, and physical forces (e.g., pull-off force).
  • Comparative Equivalence: Demonstrating that the subject device performs identically or equivalently to a legally marketed predicate device for all relevant aspects not affected by the hub change.

8. Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

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