(103 days)
An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
The Portex® Epidural Filter is a 0.2um (micron) filter used in epidural anesthesia for the filtration of aqueous drugs and is designed to help protect the patient from injected microorganisms or particulate matter. The Filter is comprised of a 0.2 um supported membrane enclosed in a modified acrylic leak proof transparent housing with male Lucr with a rotating Locking Hub and a female Luer Lock.
The filtration area is 5.25 cm², has a flow rate of ≥ 200ml/Min @ 45 psi and can withstand a pressure of ≥ 115 psi during bolus injections.
The priming volume of the filter is 0.8 ml and the hold up volume is 0.45 ml as determined by weight. The filter has a bubble point of ≥46psi. The filter has 100% bacterial retention.
This document describes the Portex® Epidural Filter, a 0.2um filter for epidural anesthesia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical data.
- Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from predicate or general standards) | Reported Performance (Portex® Epidural Filter) |
|---|---|---|
| Filtration Pore Size | 0.22 micron (predicate) | 0.2 micron |
| Filtration Area | Not explicitly stated for predicate in summary | 5.25 cm² |
| Flow Rate | Not explicitly stated for predicate in summary | ≥ 200ml/Min @ 45 psi |
| Pressure Withstand | Not explicitly stated for predicate in summary | ≥ 115 psi (during bolus injections) |
| Priming Volume | Not explicitly stated for predicate in summary | 0.8 ml |
| Hold Up Volume | Not explicitly stated for predicate in summary | 0.45 ml |
| Bubble Point | Not explicitly stated for predicate in summary | ≥ 46 psi |
| Bacterial Retention | Expected to be 100% (implied for filter function) | 100% |
| Material Composition | Hydrophilic membrane in plastic housing (predicate) | Hydrophilic membrane in modified acrylic housing |
| Luer Lock Fittings | Male and female Luer lock fittings | Male Luer with rotating Locking Hub and female Luer Lock |
| ISO 594-1 Testing | Compliant | Data submitted |
| ISO 594-2 Testing | Compliant | Data submitted |
| Dimensional Characteristics | Assumed comparable to predicate | Data submitted |
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Sample Size Used for the Test Set and Data Provenance:
- The document states "Data submitted" for various non-clinical tests (dimensional, flow rate, bubble point, ISO 594-1 and ISO 594-2 testing, bacterial retention).
- Specific sample sizes for each test are not provided in this summary.
- Data Provenance: The nature of these tests (e.g., laboratory testing of device samples) indicates prospective testing performed for the purpose of this submission, likely conducted by the manufacturer, Smiths Medical ASD, Inc., located in Keene, NH, USA. There is no mention of country of origin for the data itself, but it originates from the manufacturer's testing.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a physical filter, and its performance is evaluated through objective, quantitative non-clinical laboratory tests (e.g., flow rate measurement, bacterial retention testing) based on established engineering and medical device standards (e.g., ISO standards). Expert consensus for "ground truth" as typically understood in diagnostic AI/image analysis is not relevant here. The ground truth for these tests is the objective measurement of the filter's physical and functional properties.
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Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is established via objective laboratory measurements, there is no need for expert adjudication.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical medical device (anesthesia conduction filter), not a diagnostic algorithm or image analysis tool, so MRMC studies involving human readers or AI assistance are not relevant. Clinical data was explicitly stated as "Not required."
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The Type of Ground Truth Used:
- The ground truth for the performance was established through objective laboratory testing and measurements based on scientific and engineering principles (e.g., measuring flow rates, bubble points, determining bacterial retention through microbial challenge tests, and adherence to ISO standards for Luer fittings). Comparisons were made against the technological characteristics of a legally marketed predicate device and implied industry standards for filter performance.
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The Sample Size for the Training Set:
- Not applicable. This is a hardware device (filter), not a machine learning algorithm. Therefore, there is no "training set."
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How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for a hardware device, this question is not relevant.
§ 868.5130 Anesthesia conduction filter.
(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).