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 ●

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2021

Pharma System AB % Scott Blood Director of Regulatory Affairs MEDIcept Inc. 200 Homer Ave Ashland, Massachusetts 01721

Re: K202459

Trade/Device Name: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: August 19, 2021 Received: August 23, 2021

Dear Scott Blood:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202459

Device Name

Bact-Trap™ Filter, Bact-Trap™ Mini Filter, Bact-Trap™ Midi Filter, Pharma Mini™ HME/Filter , Bact-HME™ HME/Filter and Bact-HME™ Midi HME/Filter

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in bold, dark blue letters, while "CEPT" is in a purple, cursive font. Below the logo is the text "Trusted Solutions, Rapid Response," with "Trusted Solutions" in purple and "Rapid Response" in gray.

1. 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the content of this 510(k) summary is provided for the Pharma Systems Bact-Trap™ Filter, Bact-Trap™Mini Filter, Bact-Trap™ Midi Filter, Pharma Mini™ HME/Filter, Bact-HME™ HME/Filter, and Bact-HME™ Midi HME/Filter.

1.1. Submitter's Information

Pharma Systems AB Name: Address: Rubanksgatan 9, 741 71 Knivsta, SWEDEN

+46 18 349500 Phone: +46 18 349530 Fax: Contact: MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 Scott Blood sblood@medicept.com 978.729.5978

Date Prepared: August 18, 2021

1.2. Device Name

Device Name: Bact-Trap™ Filter Bact-Trap™ Mini Filter Bact-Trap™ Midi Filter Pharma Mini™ HME/Filter Bact-HME™ HME/Filter Bact-HME™ Midi HME/Filter Common Name: Breathing Circuit Bacterial Filter Classification Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II per 21 CFR §868.5260 Product Code: CAH - Breathing Circuit bacterial filter and HME

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Image /page/4/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, and the word "CEPT" is in large, bold, purple letters. Below the logo is the phrase "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in gray and "Rapid Response" in purple.

Legally Marketed Predicate Device 1.3.

The following are the identified Predicate Devices:

Pharma Systems K903056 Bact Trap filters .
- Intended Use: o
  - Isolation of patients from bacterial and viral contamination, prevention of cross contamination
  - Protection of ventilators, resuscitators, measuring devices, etc. from contamination.
Pharma Systems K903058 Bact HME ●
- Intended Use: O
  - Protection of patients from excessive heat and moisture loss.
  - Isolation of patients from bacterial and viral contamination, prevention of cross contamination (HMEF)

The following is the identified Reference Device:

ARC Medical, Inc K090738- FilterFloFilter, ThermoFlo Filter/HME ●
- o Intended Use: FilterFloTM 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 anesthetic or ventilator breathing systems.

The FilterFloTM filter may either be used on the patient side or on the device side of the ventilator anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.

The TherrmoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The TherrnoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.

The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.

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Image /page/5/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, and the word "CEPT" is in a stylized purple font. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller, gray font.

The predicates referenced above have not been subject to a design-related recall.

Device Description 1.4.

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 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).

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

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Image /page/6/Picture/0 description: The image is a logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, and the word "CEPT" is in a stylized, purple font. Below the words is the phrase "Trusted Solutions, Rapid Response" in a smaller, gray font. The logo is simple and professional, and the colors are eye-catching.

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 ●

1.4.1. Environment of Use

Hospital, sub-acute institutions, and pre-hospital

Principles of Operation 1.4.2.

There are two principles of operation with the subject devices:

. Filtration is via the principle of electrostatic charges that attract and capture the microbes in the polypropylene media.
Passive humidification is the use of a "treated" media (paper or foam) which absorbs the patient's exhaled heat and moisture and upon inhales the retained heat and humidity is released to the dry inhalation gases.

1.4.3. Materials of Use

The proposed devices contain the following biocompatible materials:

The Bacterial/viral filters Bact-Trap, Bact-Trap Midi, Bact-Trap Mini, Bact-Trap Gas Return 7010, 7011, 7015, 7050, 7054, 7055, 7061, 7110, 7120 are composed of the following biocompatible materials:
- . SBC
- . Polypropylene
- Acrylic and Polypropylene fibers .
- . Polyethylene
The Heat- and Moisture Exchange Filters Bact-HME, Bact-HME Midi, Pharma Mini 6000, 6020, 6100, 6120, 6121, 6130. 6310, 6320 are composed of the following biocompatible materials:
- . SBC

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Image /page/7/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI", is in large, bold, dark blue letters. The second part of the logo, "CEPT", is in a cursive, purple font. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller, gray font.

. Polypropylene
Acrylic and Polypropylene fibers .
. Polyethylene
Cross linkable acrylic polymer .
. Silicone antifoam emulsion
. Polyethylene
Thermally bound Polyester(Polyethylene Terephthalate) .

Duration and Type of Contact:

The proposed devices are intended for limited or less than 24 hours of use. When in use, the devices come in indirect contact with the human body (i.e Mucosal membrane of mouth and nose).

1.5. Indications for Use

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 Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The Bact HME/Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml.

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Image /page/8/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in bold, dark blue letters, while "CEPT" is in a lighter purple color. Below the logo is the text "Trusted Solutions, Rapid Response", with "Trusted Solutions" in purple and "Rapid Response" in gray.

Technological Characteristics Comparison with the Predicate 1.6. Devices

DeviceFeature	Proposed Device: Bact-Trap, Pharma Mini,Bact-HME, Backt-HME Filter andHME/FilterK202459	PrimaryPredicate:PharmaSystemsK903056 - BactTrap filters	PrimaryPredicate:PharmaSystemsK903058 -Bact HME	Reference Predicate:ARC MedicalK090738-ThermoFlo™
Indicationsfor Use	Bact Trap filter is abreathing system filterwhich is designed toreduce possible airborneor liquid-borne crosscontamination withmicro-organisms andparticulate matter viaanaestheticor ventilator breathingsystems.The Bact Trap filter mayeither be used on thepatient side or on thedevice side of theventilator anaestheticdevice.The Bact HME/Bact-HME Midi/Pharma Miniis a breathing systemfilter and a Heat andMoisture Exchanger.The combination of afilter and a Heat andMoisture Exchangeroffer the benefit of bothproduct features. Heatand MoistureExchangers are used as aconditioning system formechanically ventilatedpatients whose upperairways are bypassed. Inalmost all cases ofmechanical ventilationthey are a fully validalternative to heated	Isolation ofpatients frombacterial andviralcontamination,prevention ofcrosscontamination.Protection ofventilators,resuscitators,measuringdevices, fromcontamination.	Protection ofpatients fromexcessive heatand moistureloss.Isolation ofpatients frombacterial andviralcontaminationprevention ofcross-contamination(HMEF)	FilterFlo™ filter is abreathing system filterwhich is designed toreduce possibleairborne or liquid-borne crosscontamination withmicro-organisms andparticulate matter viaanaesthetic orventilator breathingsystems.The FilterFlo™ filtermay either be used onthe patient side or onthe device side of theventilator/anaesthetic device andis used as a hygienicmeasure alternativelyto decontamination ofbreathing system and /or breathing gasconveying parts of theventilator.The ThermoFlo™filter/HME is abreathing system filterand a Heat andMoisture Exchanger.The combination of afilter and a Heat andMoisture Exchangeroffer the benefit ofboth product features.Heat and MoistureExchangers are usedas a conditioningsystem formechanically
DeviceFeature	Proposed Device: Bact-Trap, Pharma Mini,Bact-HME, Backt-HME Filter andHME/Filter	PrimaryPredicate:PharmaSystemsK903056 - BactTrap filters	PrimaryPredicate:PharmaSystemsK903058 –Bact HME	Reference Predicate:ARC MedicalK090738-ThermoFlo™
	humidifiers. The BactHME/Bact-HME Midi/Pharma Mini should beused with patients whohave a Tidal Volumebetween 50 - 1500 ml.			ventilated patientswhose upper airwaysare bypassed. Inalmost all cases ofmechanical ventilationthey are a fully validalternative to heatedhumidifiers. Theproduct is the onlyconditioningopportunity ofbreathing gases incases of emergencyventilation or duringtransport since heatedhumidified are almostimpossible to use. TheThermoFlo™filter/HME should beused with patients whohave a Tidal Volumebetween 250 - 1500ml.
Classification	II	Same	Same	Same
TargetPopulation	Adult Tidal Volume50-1500 ml	Same	Same	Tidal Volume 250-1500ml
ClinicalSetting	Hospital, sub-acute,pre-hospital andhome	Same	Same	Same
Principle ofOperation	Filtration via theprinciple ofelectrostatic chargesin the media.Passive	Same	Same	Same
DeviceFeature	Proposed Device: Bact-Trap, Pharma Mini,Bact-HME, Backt-HME Filter andHME/Filter	PrimaryPredicate:PharmaSystemsK903056 - BactTrap filters	PrimaryPredicate:PharmaSystemsK903058 -Bact HME	Reference Predicate:ARC MedicalK090738-ThermoFlo™
	functioning as heatand moistureexchangers.
CompatibilitywithEnvironmentof Use	Intended for usewith ventilators,anesthesia gasmachines	Same	Same	Same
Prescriptive	Yes	Yes	Yes	Yes
Sterile/Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
Single PatientUse	Yes	Yes	Yes	Yes
MaximumUse	24 hours	Same	Same	Same
Shelf-Life	3 years	Same	Same	Unknown
FiltrationEfficiency	BFE: >99.999%VFE: >99.99%	Same	Same	Unknown

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Image /page/9/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI" is in large, bold, blue letters. The second part of the logo, "CEPT" is in a stylized purple font. Underneath the logo is the text "Trusted Solutions, Rapid Response" in a smaller font.

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Image /page/10/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the name, "MEDI", is in bold, dark blue letters. The second part of the name, "CEPT", is in a cursive, purple font. Below the name is the phrase "Trusted Solutions, Rapid Response" in a smaller font.

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Image /page/11/Picture/0 description: The image shows the logo for MEDI-CEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a stylized purple font. Below the company name is the tagline "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.

1.7. Summary of Non-Clinical Testing

Test Method	Test Performed	Summary	Results(pass/fail)
ISO 9360-1	Gas Leakage and compliance testMoisture loss test	No leak @ 1 psi for 2 minEquivalent to Predicate device	Pass
ISO 10993	Cytotoxicity testSensitization testIrritation test	Non-cytotoxicNon-sensitizerNon-irritant	Pass
ISO 18562-2 and-3	VOC and Particulate MatterTesting	All test method acceptancecriteria were met.	Pass
ISO 18562-4	Leachables evaluation in polar andnonpolar solvents	All test method acceptancecriteria were met.	Pass
ISO 10993-17and ISO 10993-18	Toxicological Risk Assessment	All test method acceptancecriteria were met.	Pass
ASTM 1980-16	Accelerated Aging	Device meets its performancespecification post-conditioning	Pass
ASTM F2101	Viral Filtration EfficiencyBacterial Filtration Efficiency	Filtration efficiency isequivalent to Predicate deviceFiltration efficiency isequivalent to Predicate device	Pass
EN ISO 23328-2EN ISO 23323-2	Pressure Drop	Device meets its performancespecification	Pass
N/A	Housing Burst Strength	The measured values aresufficient for ensuring safeuse of the measured devices.	Pass
ISO 23328-1	Filtration Performance ofTechnostat Plus filter media forBact-Trap bacterial/viral filters andHME filters shelf life confirmation	The measured values aresufficient for ensuring safeuse of the measured devices.	Pass
ISO 9360-1	Bact-Trap bacterial/viral filters andHME filters shelf life confirmation	The measured values aresufficient for ensuring safeuse of the measured devices.	Pass

1.8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device (Bact-Trap, Pharma Mini, Bact-HME, Bact-HME Filter and HME/Filter) is as safe, as effective, and performs as well as or better than the legally marketed device

Regulation Number and Section

§ 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).