(395 days)
Bact Trap filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side of the ventilator anaesthetic device.
The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose uppassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml.
The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows:
- Pharma Mini™ and Bact-Trap™ Mini 50-900ml
- · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml
- · Bact-HMETM and Bact-Trap™ between 250-1500 ml
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours
The device is a standard breathing circuit bacterial filter used for respiratory management. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. The function of any breathing circuit is to deliver oxygen and anesthetic gases, and eliminate carbon dioxide. These devices can be placed at the following locations on a breathing circuit:
- At the inhalation port of the CO2 absorber of the anesthesia gas machine ●
- At the exhalation port of the CO2 absorber of the anesthesia gas machine
- At the patient end - at the mask or ET tube
- These placements are also common on critical ventilator circuits
The Bact-Trap™ filter is a breathing filter which can be used on the patient's side or on the device side of the ventilator/anesthetic device. It is used as a hygienic measure to decontaminate the breathing circuit.
The Pharma Mini™ HME/Filter , Bact-HME™ HME/Filter and Bact-HME™ Midi HME/Filter is a breathing system filter and a Heat and Moisture Exchanger (HME).
Heat and Moisture Exchangers and HME Filters (HMEF) are designed for patients with a compromised upper airway. HME and HMEFs are used with intubated or tracheostomized patients to collect moisture and heat from the expired gases and return the inhalation cycle. HME and HMEF contain either plastic fibers or open cell polyurethane foam which offer sufficient surface area to mimic or replace the patient's upper airways while intubated. HMEFs have an additional bacterial/viral filter to help prevent the transmission of bacteria and viruses. Bacterial/Viral filter media consists of electrostatically charged fibers and water repellent cover web on both sides. They also work to prevent cross infection to and from the patient during mechanical ventilation of lungs.
The proposed devices listed below are single patient use and should be changed every 24 hours in the environment of use. The patient population applicable to these devices are specified by the tidal volumes for the filter/Heat and Moisture Exchanger.
The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows:
- Pharma Mini™ and Bact-Trap™ Mini 50-900ml
- · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml
- · Bact-HMETM and Bact-Trap™ between 250-1500 ml
The Pharma Mini, Bact-HME Midi and Bact-HME HME Filters and Bact-Trap Mini, Bact-Trap Midi and Bact-Trap filters are offered in several housing configurations, all of which are typical of filters. These configurations include:
- All have standard conical 15 mm / 22 mm fittings for connections ●
- Some models have a port version Female luer lock port for gas sampling for end-tidal . CO2
- Some models have a straight version .
- Some models have an angled version eliminates the need for a mask elbow .
- Straight version packaged with a standard mask elbow for convenience of the user ●
The provided document (K202459) does not describe a study involving an AI/algorithm or human readers in the loop. Instead, it's a 510(k) premarket notification for a breathing circuit bacterial filter and HME (Heat and Moisture Exchanger). The acceptance criteria and the study proving the device meets these criteria relate to the physical and biological performance of the filter/HME devices, not an AI diagnostic tool.
Therefore, many of the requested items (e.g., sample size for test set/training set, expert qualification for ground truth, adjudication methods, MRMC study, standalone algorithm performance, AI effect size) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the acceptance criteria and the non-clinical studies conducted for this device.
Acceptance Criteria & Device Performance (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are based on established international standards and relate to their physical, mechanical, and biological filtration performance. The "performance" column indicates whether the device passed these criteria.
| Test Method | Test Performed | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|---|
| ISO 9360-1 | Gas Leakage and compliance test | No leak @ 1 psi for 2 min | Pass (No leak @ 1 psi for 2 min) |
| ISO 9360-1 | Moisture loss test | Equivalent to Predicate device (performance within acceptable range for HME) | Pass (Equivalent to Predicate device) |
| ISO 10993 | Cytotoxicity test | Non-cytotoxic | Pass (Non-cytotoxic) |
| ISO 10993 | Sensitization test | Non-sensitizer | Pass (Non-sensitizer) |
| ISO 10993 | Irritation test | Non-irritant | Pass (Non-irritant) |
| ISO 18562-2 and -3 | VOC (Volatile Organic Compounds) and Particulate Matter Testing | All test method acceptance criteria met (e.g., levels below specified thresholds) | Pass (All test method acceptance criteria were met) |
| ISO 18562-4 | Leachables evaluation in polar and nonpolar solvents | All test method acceptance criteria met (e.g., leachable substances below specified thresholds) | Pass (All test method acceptance criteria were met) |
| ISO 10993-17 and ISO 10993-18 | Toxicological Risk Assessment | All test method acceptance criteria met (e.g., acceptable safety risk) | Pass (All test method acceptance criteria were met) |
| ASTM 1980-16 | Accelerated Aging | Device meets its performance specification post-conditioning (maintains integrity and function after simulated aging) | Pass (Device meets its performance specification post-conditioning) |
| ASTM F2101 | Viral Filtration Efficiency (VFE) | VFE: >99.99% (as per predicate) | Pass (Filtration efficiency is equivalent to Predicate device >99.99%) |
| ASTM F2101 | Bacterial Filtration Efficiency (BFE) | BFE: >99.999% (as per predicate) | Pass (Filtration efficiency is equivalent to Predicate device >99.999%) |
| EN ISO 23328-2 EN ISO 23323-2 | Pressure Drop | Device meets its performance specification (e.g., pressure drop within clinically acceptable limits for intended use) | Pass (Device meets its performance specification) |
| N/A (Standard Engineering Tests) | Housing Burst Strength | Measured values are sufficient for ensuring safe use (e.g., integrity under pressure) | Pass (The measured values are sufficient for ensuring safe use of the measured devices) |
| ISO 23328-1 | Filtration Performance of Technostat Plus filter media for Bact-Trap bacterial/viral filters and HME filters shelf life confirmation | Measured values are sufficient for ensuring safe use (maintains filtration efficiency over shelf life) | Pass (The measured values are sufficient for ensuring safe use of the measured devices) |
| ISO 9360-1 | Bact-Trap bacterial/viral filters and HME filters shelf life confirmation | Measured values are sufficient for ensuring safe use (maintains HME function over shelf life) | Pass (The measured values are sufficient for ensuring safe use of the measured devices) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each non-clinical test (e.g., how many filters were tested for BFE/VFE or burst strength). It refers to "tests performed" and their summary results.
- Data Provenance: The location of the testing is not explicitly stated, but it's generated by the manufacturer or a contracted lab to support the submission. This is prospective testing designed to demonstrate compliance with standards for the specific device being submitted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
N/A. This information is not relevant as the studies are laboratory-based non-clinical performance tests of a physical device, not an AI model that requires expert human interpretation for establishing ground truth (e.g., for image diagnosis). The "ground truth" here is defined by physical measurements and microbiological testing standards.
4. Adjudication Method for the Test Set
N/A. Adjudication is typically used in human reader studies or to resolve discrepancies in AI model outputs where subjective interpretation is involved. For physical device testing, the results are objectively measured according to specified test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for diagnostic devices (often AI-assisted) to assess reader performance. This submission is for a physical breathing circuit filter device, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical filter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these filters is established through:
- Standardized Test Methods: Adherence to established ISO, ASTM, and EN standards for medical device testing.
- Physical Measurements: Objective measurements of parameters like gas leakage, pressure drop, and burst strength.
- Microbiological Efficiency Testing: Quantitative measurement of bacterial and viral particle removal.
- Chemical/Biological Component Analysis: Ensuring biocompatibility and absence of harmful leachables/VOCs.
8. The Sample Size for the Training Set
N/A. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As above, no training set is involved for this type of device.
§ 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).