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The PAJUNK® Sono-Series Kits SonoLong, SonoLong Sono, PlexoLong Sono, StimuLong Sono, SonoLong NanoLine and SonoLong Curl Sono are intended for delivery of continuous conduction anesthesia and/ or analgesia of peripheral nerves for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. Optionally an electrical stimulus may be applied to assist the physician pinpoint the area of application.

The PAJUNK® Sono-Series Kits are single use sterile and non-pyrogenic kits basically consisting of catheters and cannulas as well as of optional components like Adapter, syringe, filter, filter fixation device and common hospital supply; used to gain entry or puncture the tissue micil inter fination do no continuous regional anesthesia anesthesia and analgesia for pain relief.

An electrical stimulus may be applied to the tip of the cannula/ needle (former PlexoLong series) An Cleunoul caffinale may of the cather (former StimuLong series) via cable and connector to assist the physician pinpoint the area of application.

The Sono-Cannulas/ needles are standard cannulas/ needles (cleared by several PMNsubmissions) equipped with the CornerStone technique in order to significantly enhance ultrasound visibility.

The Sono-catheters are standard anaesthesia conducting catheters equipped with an inner coil (cleared by several PMN-submissions) in order to enhance ultrasound visibility and device stability/ ergonomical features.

This submission of a 510(k) merely is due to new brand names than to introduce new techniques or technologies.

The provided document (K113188 Premarket Notification Submission for Sono-Series Kits) describes the device and its intended use, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, this 510(k) submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices. The core argument for safety and effectiveness is that the Sono-Series Kits are essentially the same as existing devices, with the main change being new brand names and, for some components, enhanced ultrasound visibility features (CornerStone technique for cannulas/needles and an inner coil for catheters).

Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided text. The document explicitly states: "This submission of a 510(k) merely is due to new brand names than to introduce new techniques or technologies."

Here's a breakdown of what is in the document related to substantial equivalence:

1. Device Information:

• Device Name: Sono-Series Kits (needles, catheters)
• Trade Names: SonoLong, SonoLong Sono, SonoLong Curl Sono, StimuLong Sono, PlexoLong Sono, SonoLong NanoLine
• Intended Use: For delivery of continuous conduction anesthesia and/or analgesia of peripheral nerves for up to 72 hours, using a Polyamide indwelling catheter. Optionally, electrical stimulus may be applied.
• Device Description: Single-use, sterile, non-pyrogenic kits consisting of catheters and cannulas, and optional components. The Sono-Cannulas/needles are equipped with the CornerStone technique for enhanced ultrasound visibility. The Sono-catheters have an inner coil for enhanced ultrasound visibility and device stability.

2. Predicate Devices (for establishing substantial equivalence):

• K033018 PAJUNK® StimuLong Plus Catheter sets
• K013041 PAJUNK® PlexoLong Anaesthesia sets
• K111374 PAJUNK® SonoPlex STIM SONO-SERIES CORNERSTONE TECHNIQUE

3. Basis for Substantial Equivalence (instead of performance criteria):
The submission argues that the new Sono-Series Kits are substantially equivalent to the predicate devices because:

• The components are already cleared in the predicate devices' 510(k)s, with new brand names.
• The sterilization process (Ethylene Oxide) and contract sterilizer are identical to those used for all PAJUNK® devices already cleared.
• The CornerStone-technique and catheter coil do not influence sterilization or shelf life.
• Cleaning and sterilization methods, ensuring SAL of 10^-6, compliance with limits for chemical burden, bioburden, pyroburden, and EtO residuals, and shelf life, have been validated and are safe and effective. Shelf-life is set to 5 years, validated for 10 years.
• Biocompatibility: All cannulas comply with ISO 10993-1, 2nd and 3rd edition.
• Technology Characteristics: Shelf life and impact of component arrangement have been proven.
• Conclusion: The comparison to predicate devices, validated sterilization, biocompatibility testing, and bench testing demonstrate that the devices are substantially equivalent (identical) to devices already cleared for market and thus safe and effective. It specifically states: "the safety and efficacy of the CornerStone/Sono-technique is demonstrated for each type of kit" based on clinical evaluation, biocompatibility testing, and bench testing. However, no details about these studies (clinical evaluation, bench testing, what "demonstrated" means in terms of metrics/criteria) are provided in the excerpt.

Therefore, the requested table and study details cannot be provided from the given information. The document primarily serves to explain why the device is considered substantially equivalent to existing devices, rather than presenting a novel performance study against specific acceptance criteria for a new technology or claim.

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