(111 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml.
May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.
The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm.
The filter functions by electrostatic capture.
The acceptance criteria and study proving the device meets these criteria for the Bact-Trap™ HEPA Midi are detailed below.
This device is a bacterial/viral filter, and the studies performed are primarily performance tests against established standards and metrics for such filters, rather than clinical studies involving human patients or ground truth from expert readings in a diagnostic context.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to flow | 99.97% (based on DOE 3020-97 and ASTM D2986 - 95a DOP) | >99.97% |
| Dead Space (ml) | Not explicitly stated as acceptance criteria, but based on predicate device | 46 ml for straight, 48 ml for angled |
| Standard 15/22 mm connectors | Yes (ISO 5356-1) | Yes |
| Gas sampling port | Yes | Yes |
| Housing material | Polystyrene | Polystyrene |
| Filter media | Electrostatic | Electrostatic |
| Weight (gm) | Not explicitly stated as acceptance criteria | 32 gm |
| Indications for use (To filter inspired and/or expired gases) | Yes | Yes |
| Intended for single patient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population (> 150 ml tidal volume) | Yes | Yes |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes | Yes |
| Compliance to ISO 5356-1 Conical 15/22 | Yes | Yes |
| Compliance to ISO 594-2 Luer Fittings | Yes | Yes |
| Compliance to DOE 3020-97 and ASTM D2986 - 95a DOP | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each performance criterion. However, the data provenance for the bacterial and viral filtration efficiency (BFE and VFE) is stated as Nelson Lab. This indicates the testing was conducted by an external laboratory specializing in such evaluations. The filtration performance (HEPA, BFE, VFE) and resistance to flow are typical engineering performance tests that would involve a specific number of devices tested under controlled laboratory conditions. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance. The country of origin for the data is presumably where Nelson Lab is located (typically USA) and potentially Sweden for other internal testing by Pharma Systems AB.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For this type of medical device (bacterial/viral filter), the "ground truth" is established through physical and engineering performance measurements against established standards (e.g., DOE 3020-97, ASTM D2986 - 95a DOP, ISO standards) and laboratory testing protocols to determine filtration efficiency and resistance. There are no human experts establishing a "ground truth" through interpretation of data in the way radiologists or pathologists would for diagnostic devices. The experts involved would be the laboratory technicians and scientists performing the tests and verifying the methodologies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "truth" is determined by direct physical/engineering measurements using standardized testing methods, not by expert consensus or adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with or without AI assistance. The Bact-Trap™ HEPA Midi is a filter for breathing circuits, not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense, a "standalone" performance evaluation was conducted. The device's performance was measured intrinsically against established physical and engineering standards (e.g., filtration efficacy, resistance to flow). These measurements are inherent to the device's design and materials and do not involve a "human-in-the-loop" for its function, nor an algorithm in the traditional sense of AI. The device operates mechanically/physically without software control or human intervention for its primary filtration function.
7. Type of Ground Truth Used
The "ground truth" used is based on:
- Physical and Engineering Standards: Compliance with established international and national standards such as ISO 5356-1, ISO 594-2, DOE 3020-97, and ASTM D2986 - 95a DOP.
- Laboratory Performance Measurements: Direct measurements of physical properties (e.g., dead space, weight) and functional performance (e.g., resistance to flow, bacterial and viral filtration efficiency) obtained from controlled laboratory tests. These are objective, quantifiable results.
8. Sample Size for the Training Set
Not applicable. The Bact-Trap™ HEPA Midi does not utilize an algorithm or AI that requires a "training set" of data. Its function is based on physical filtration principles and material properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).