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The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.

The device is intended for adult and pediatric patients.

The SPROTTE® Special NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia. The device is available in a range from 18G to 24G at a range of length from 90mm to 100mm. It is a disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/medical device manufacturers. The materials used include Stainless Steel 1.4301 (X5CrNi18-10), AISI 304 (V2A) for the needle/cannula, introducer tubing, stylet tubing, and haemostylet. Polycarbonate PC is used for the needle hub, ramp in tip, introducer hub, stylet knob, and retaining plate. Epoxy resin is used for optional glue.

This document describes the 510(k) premarket notification for the PAJUNK® SPROTTE® Special NRFit™ anesthesia conduction needle. The submission aims to demonstrate substantial equivalence to a predicate device (K911221 ATRAUMATIC SPECIAL SPROTTE NEEDLE). The key differences highlighted are the material of the hub and the stylet's knob, which are deemed non-significant due to either historical changes with new material being tested, or no patient contact for the knob.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For the subject devices, 5 types of SPROTTE® Special NRFit™ needles were tested, ranging from 18G to 24G in gauge and 90mm to 100mm in length.
  • For the predicate devices, 5 types of SPROTTE® Special needles were tested, with the same range of gauge and length.
  • Each of these device types was tested after sterilization and after accelerated aging (1 year, 3 years, 5 years). The specific number of individual units tested per type is not explicitly stated beyond these categorical breakdowns.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is a German company (PAJUNK® GmbH Medizintechnologie) and the studies involve physical testing of medical devices, the data is likely generated in a laboratory setting, presumably by or on behalf of the manufacturer, and would be considered prospective for the purpose of this submission.

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

This submission does not involve clinical studies with human "ground truth" derived from expert consensus. The "ground truth" or acceptance criteria are based on recognized international standards for medical devices (e.g., ISO 9626, ISO 7864, ISO 80369-6, ISO 11135-1, ISO 10993-1/5/10), which define physical and material properties, performance characteristics, and safety aspects. Therefore, no human experts were used to establish "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of diagnostic outcomes. Performance is measured against engineering and safety standards.

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

Not applicable. This is a premarket notification for a physical medical device (anesthesia conduction needle), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance and safety assessments is primarily engineering and safety standards (e.g., ISO 9626, ISO 7864, ISO 80369-6, ISO 11135-1, ISO 10993-1/5/10) and the physical and material characteristics of the predicate device. For tests like bonding strength and bending rigidity, the "ground truth" is adherence to predefined force thresholds or established methodologies in the standards. For biocompatibility, it's compliance with ISO standards through a series of conducted tests.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm. The "training" for this device's performance comes from historical data, design validation, and manufacturing processes perfected over time, as implied by the use of an already cleared predicate device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing is established through compliance with established medical device regulations, design controls, and international standards. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.

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