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510(k) Data Aggregation
K Number
K202459Device Name
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
Manufacturer
Pharma System AB
Date Cleared
2021-09-26
(395 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
Pharma System AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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
Device Description
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 ●
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