(88 days)
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus continuous is intended for the administration of regional anaesthesia to the peripheral plexus employing continuous technique via catheter, also including optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of regional anaethes ia. Neither needle nor catheter is included.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia is intended for the administration of regional anaesthesia to the peripheral plexus, single-shot or continuous technique, optional localization via electrical stimulus.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia of the peripheral plexus single shot is intended for the administration of regional anaesthesia to the peripheral plexus employing single-shot technique also including optional localization via electrical stimulus.
The convenience tray subject to this submission is compiled by customers from devices either cleared by FDA in former 510(k) submissions or exempt to 510(k) clearance procedure. It may contain each one of PAJUNK®'s devices cleared for use in Anaesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits".
The provided text is for a 510(k) Premarket Notification Submission for PAJUNK®'s Generic Convenience Tray for Regional Anesthesia. This submission focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study to meet specific acceptance criteria in the way a novel medical device might.
Therefore, many of the requested data points (like sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable (N/A) because the submission's purpose is not to demonstrate the performance of a new technology against defined metrics, but to show that a combination of existing, already cleared components, within a convenience tray, is as safe and effective as previous, substantially similar devices.
Here's the breakdown of the information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Material Safety & Biocompatibility: Compliance with ISO 10993-1. | All devices comply with ISO 10993-1, FDA-modified version also. |
| Sterility: Sterilization method ensures a Sterility Assurance Level (SAL) of 10⁻⁶. Validated limits for bioburden, pyroburden (LAL), and EtO-residuals. Shelf life proven for 10 years, set to 5 years. | Sterilization method ensures an SAL of 10⁻⁶; limits for bioburden, pyroburden (LAL), and EtO-residuals and shelf life have been validated and effective. Efficacy of sterile product's lifecycle has been proven for a period of 10 years now. Shelf life is set to 5 years. |
| Functional Equivalence: The convenience tray components are either FDA-cleared or exempt and used in anesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits". | The convenience tray is compiled from devices either cleared by FDA in former 510(k) submissions or exempt. It may contain each one of PAJUNK®'s devices cleared for use in Anaesthesia of the peripheral plexus procedures. The tray complies with FDA's guidance "Sterilized convenience kits". The components are listed in section 11. |
| Substantial Equivalence to Predicate Devices: Device has technological characteristics and indications for use similar to predicate devices (K053283, K013041, K023218, K042979, K033018, K043130, K062900). | The comparison between the predicate devices and the proposed devices in section 12 demonstrates that the proposed devices are substantially equivalent to the predicate devices and safe and effective. |
| Historical Safety & Effectiveness: Components marketed in similar combinations in Europe for over ten years with proven safety and effectiveness. | The tray components are marketed in similar combinations in Europe for more than ten years now and are safe and effective. Efficacy of manufacturing, tray assembly, sterilization, storage and shelf life has been proven. |
Study Details:
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Sample size used for the test set and the data provenance:
- N/A. This submission is not a performance study involving a test set of data. It's a review of existing device characteristics and an assertion of substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No test set or ground truth determination by experts is described in this submission.
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Adjudication method for the test set:
- N/A. No test set requiring adjudication is described.
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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:
- N/A. This is not an AI/software device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/software device. No standalone algorithm performance was assessed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" here is the established safety and effectiveness of the predicate devices and the individual cleared components, and compliance with recognized standards (e.g., ISO 10993-1) for new devices.
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The sample size for the training set:
- N/A. This is not a machine learning device or a performance study with a training set.
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How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set. The "ground truth" for affirming safety and effectiveness relies on regulatory clearances of predicate devices and individual components, and adherence to validated manufacturing and sterilization processes.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).