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510(k) Data Aggregation
(94 days)
The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.
The Filter is a Class II medical device substantially equivalent to the predicate device (K083451, Portex Epidural Filter) as defined in 21 CFR §868.5130, product code BSN. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. The device is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. It has a flat housing, Female Lock and male connector with rotating locking hub, and a Filter membrane. It is available with either NRFit™ Connector according to ISO 80369-6 or LUER-Connector according to ISO 80369-7.
This document is a 510(k) summary for the PAJUNK Epidural MiniFilter NRFit and LUER, an anesthesia conduction filter. It establishes substantial equivalence to a predicate device (Portex Epidural Filter, K083451). The information provided focuses on the comparative performance with a predicate device and performance against recognized standards, rather than a standalone clinical study with acceptance criteria in the context of diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text, with many fields being "Not Applicable" (N/A) due to the nature of this submission (device performance testing against engineering standards instead of a diagnostic AI study):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Internal Protocol) | Reported Device Performance |
|---|---|
| Sterilization | |
| ISO 11135 | Pass |
| Residuals (ISO 10993-7) | Pass |
| Biocompatibility | |
| ISO 10993-1 | Pass |
| Connectivity | |
| Liquid Leakage (ISO 80369-7, 6.1) | Pass |
| Air Leakage (ISO 80369-7, 6.2) | Pass |
| Stress Cracking (ISO 80369-7, 6.3) | Pass |
| Axial Load (ISO 80369-7, 6.4) | Pass |
| Unscrewing torque (ISO 80369-7, 6.5) | Pass |
| Overriding (ISO 80369-7, 6.6) | Pass |
| Liquid Leakage (ISO 80369-6, 6.1) | Pass |
| Air Leakage (ISO 80369-6, 6.2) | Pass |
| Stress Cracking (ISO 80369-6, 6.3) | Pass |
| Axial Load (ISO 80369-6, 6.4) | Pass |
| Unscrewing torque (ISO 80369-6, 6.5) | Pass |
| Overriding (ISO 80369-6, 6.6) | Pass |
| Filter Performance | |
| Burst Pressure (Internal Protocol) | Pass |
| Bubble Point (Internal Protocol) | Pass |
| Leak Tightness (Internal Protocol) | Pass |
| Flow Rate (Internal Protocol) | Pass (≥ 200ml/Min) |
| Shelf Life | |
| Performance maintained after 5 years (real-time & accelerated aging) | Pass (no decrease in performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes performance testing against engineering standards, not a clinical test set with patient data. Therefore, this information is Not Applicable (N/A) in the context of this submission. The testing was conducted to demonstrate compliance with ISO standards and internal protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is Not Applicable (N/A). The device's performance is gauged against established engineering and biocompatibility standards, not against expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable (N/A) as no expert adjudication of clinical data was involved in this type of device submission.
5. 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
This is Not Applicable (N/A). This submission is for a physical medical device (anesthesia conduction filter) and does not involve AI or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable (N/A). This submission is for a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by adherence to recognized international standards (e.g., ISO 80369 series for connectivity, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and internal protocols for specific performance characteristics (Burst Pressure, Bubble Point, Leak Tightness, Flow Rate).
8. The sample size for the training set
This is Not Applicable (N/A). This submission is for a physical medical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is Not Applicable (N/A). No training set for an algorithm was used.
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