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The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics.

The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space (optional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example Stimul.ong and Stimulong Tsui-Method.

Pajunks Injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.

Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.

Pajunk GmbH Medizintechnologie is submitting this 510(k) for the Pajunk StimuLong Tsui Method Set. The Tsui-Test is a well known technique in epidural anesthesia. It combines the advantages of epidural anestesia and stimulation via catheter in order to verify the area anesthesia is applied to. The Tsui test makes epidural anesthesia much more safe and effective as demonstrated and proven in several studies and articles published since the 1990 % (see section 20 of this submission. Physicians until now had to combine different devices in order to get a "self-made set acc. Tsui". Dr. Tsui combined Pajunks StimuLong set and technique deared for perifical use and Prayinks Epilong set and technique for epidural use to have a striking safe and effective alternative to "selfmade in-house devices". The devices for epidural Anesthesia (EpiLong) and peripheral Anesthesia employing stimulation via catheter (StimuLong) are already cleared for market seperately without claiming specific patient populations. The basis of this submission in the indications for use of this two cleared device: peripheral and epidural stimulation guided anesthesia. The components which are part of the subject device kit have already gained market clearance. They are combined under a new indication on customers demands. The predicate devices are Pajunks own products cleared for a non specified population, i.e. for use with adult patients. In order to demonstrate safety and effectiveness Pajunk provides clinical lieterature from Dr. Tsui as well as a clinical evaluation. Pajunks StimuLong Tsul Method Set are single use, sterile, non-pyrogenic and latex free medical device kits. They are intended for continuous peripheral or epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. An electrical stimulus may be applied via catheter in order to precisely identify the area anesthesia is intended to be applied to.

The Pajunks StimuLong Tsui Method Set provides a coated Tuohy cannula, a StimuLong catheter, StimuLong adaptor, valve, adaptor cables, injection hose, filter, LOR-syringe, catheter fixation device, FixoLong and tightning adaptors. The coating on the cannula is laqueur or NanoLine coating, which has been cleared in K053283. The catheter comes with a catheter container, steel stylett and introductory aid for better handling and shape security. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylett. There is no change in components compared to the StimuLong and EpiLong set already cleared for market. All components are available seperately. Within the indications for use and the components cleared for market the StimuLong Tsui method set is customizable.

This document is a 510(k) Premarket Notification Submission for Pajunks StimuLong Tsui Method Set. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Summary of Acceptance Criteria and Device Performance:

The primary acceptance criterion for this submission is demonstrating substantial equivalence to existing predicate devices already cleared for market. The study proving this involves a comparison of technology characteristics and a review of clinical literature.

Study Details:

The submission does not describe a traditional clinical study with a test set, ground truth experts, or formal adjudication. Instead, it relies on a literature review and comparison to predicate devices to demonstrate substantial equivalence.

1. Sample size used for the test set and data provenance:

   • No explicit "test set" in the sense of patient data is described. The evaluation relies on a comparison with predicate devices and existing clinical literature.
   • Data provenance is primarily from "clinical literature from Dr. Tsui" and "several studies and articles published since the 1990's" (referred to in Section 20 of the submission, though not provided in the excerpt) related to the Tsui-Test technique and the predicate devices. The country of origin for the studies is not specified in the provided text. The submission itself is from a German manufacturer (Pajunk GmbH Medizintechnologie).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • No direct ground truth establishment by experts for a novel test set is described. The efficacy and safety are inferred from the existing body of clinical literature and the established use of the technique (Tsui-Test) and the predicate devices. The clinical literature cited refers to Dr. Tsui, implying his expertise underpins the technique.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • No adjudication method is relevant or described, as there isn't a new test set requiring expert review and consensus.

4. 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 MRMC study was conducted. This device is a medical instrument (catheter set) and not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is a medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for the device's safety and effectiveness is established through:
     • Clinical literature review: Citing published studies and articles (e.g., from Dr. Tsui) supporting the safety and effectiveness of the "Tsui-Test" technique and the use of stimulation via catheter for precise application of anesthesia.
     • Predicate device history: The components and the general techniques (epidural and peripheral anesthesia with stimulation) are already cleared and established through the predicate devices (Pajunks StimuLong Set and Pajunks EpiLong Set).

7. The sample size for the training set:

   • Not applicable. This is a medical device submission, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable.

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