(395 days)
No
The device description and performance studies focus on the physical filtration and heat/moisture exchange properties of the device, with no mention of AI or ML.
Yes
The device, which includes filters and heat and moisture exchangers (HMEs), is used to manage and condition breathing gases for mechanically ventilated patients and to prevent cross-contamination, directly contributing to the treatment and mitigation of compromised respiratory function.
No.
The device is a breathing system filter and heat and moisture exchanger that filters airborne and liquid-borne contaminants and conditions air for mechanically ventilated patients. Its function is therapeutic and preventative, not diagnostic.
No
The device description clearly details physical components like filters, housings, and ports, and the performance studies focus on physical properties and biological compatibility, not software functionality.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The described devices (Bact Trap filters, Bact HME/Bact-HME Midi/Pharma Mini) are breathing system filters and Heat and Moisture Exchangers. Their primary function is to filter air and condition the air being breathed by a patient during mechanical ventilation or anesthesia. They are used in vivo (within the body's breathing circuit), not in vitro (outside the body, examining specimens).
- Intended Use: The intended use is to reduce cross-contamination and condition inhaled air within a breathing system. This is a therapeutic and supportive function related to respiratory management, not diagnostic testing of biological samples.
- Device Description: The description focuses on the physical characteristics and placement within a breathing circuit, consistent with a respiratory support device.
- Performance Studies: The performance studies listed (filtration efficiency, pressure drop, biocompatibility, etc.) are relevant to the function of a breathing filter and HME, not to the performance of an IVD test.
Therefore, the device falls under the category of a respiratory support device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 or on the device 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 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 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
Product codes (comma separated list FDA assigned to the subject device)
CAH
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mucosal membrane of mouth and nose (indirect contact)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospital, sub-acute institutions, and pre-hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Method: ISO 9360-1
Test Performed: Gas Leakage and compliance test, Moisture loss test
Summary: No leak @ 1 psi for 2 min, Equivalent to Predicate device
Results: Pass
Test Method: ISO 10993
Test Performed: Cytotoxicity test, Sensitization test, Irritation test
Summary: Non-cytotoxic, Non-sensitizer, Non-irritant
Results: Pass
Test Method: ISO 18562-2 and -3
Test Performed: VOC and Particulate Matter Testing
Summary: All test method acceptance criteria were met.
Results: Pass
Test Method: ISO 18562-4
Test Performed: Leachables evaluation in polar and nonpolar solvents
Summary: All test method acceptance criteria were met.
Results: Pass
Test Method: ISO 10993-17 and ISO 10993-18
Test Performed: Toxicological Risk Assessment
Summary: All test method acceptance criteria were met.
Results: Pass
Test Method: ASTM 1980-16
Test Performed: Accelerated Aging
Summary: Device meets its performance specification post-conditioning
Results: Pass
Test Method: ASTM F2101
Test Performed: Viral Filtration Efficiency, Bacterial Filtration Efficiency
Summary: Filtration efficiency is equivalent to Predicate device, Filtration efficiency is equivalent to Predicate device
Results: Pass
Test Method: EN ISO 23328-2 EN ISO 23323-2
Test Performed: Pressure Drop
Summary: Device meets its performance specification
Results: Pass
Test Method: N/A
Test Performed: Housing Burst Strength
Summary: The measured values are sufficient for ensuring safe use of the measured devices.
Results: Pass
Test Method: ISO 23328-1
Test Performed: Filtration Performance of Technostat Plus filter media for Bact-Trap bacterial/viral filters and HME filters shelf life confirmation
Summary: The measured values are sufficient for ensuring safe use of the measured devices.
Results: Pass
Test Method: ISO 9360-1
Test Performed: Bact-Trap bacterial/viral filters and HME filters shelf life confirmation
Summary: The measured values are sufficient for ensuring safe use of the measured devices.
Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency (BFE): >99.999%
Viral Filtration Efficiency (VFE): >99.99%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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
2
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)
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
| 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.
- Intended Use: o
- 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)
- Intended Use: O
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.
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
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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.
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 ●
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
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 or on the device 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 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
| Device
Feature | Proposed Device: Bact-
Trap, Pharma Mini,
Bact-HME, Backt-
HME Filter and
HME/Filter
K202459 | Primary
Predicate:
Pharma
Systems
K903056 - Bact
Trap filters | Primary
Predicate:
Pharma
Systems
K903058 -
Bact HME | Reference Predicate:
ARC Medical
K090738-
ThermoFlo™ |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for 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 or on the
device 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 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 | Isolation of
patients from
bacterial and
viral
contamination,
prevention of
cross
contamination.
Protection of
ventilators,
resuscitators,
measuring
devices, from
contamination. | Protection of
patients from
excessive heat
and moisture
loss.
Isolation of
patients from
bacterial and
viral
contamination
prevention of
cross-
contamination
(HMEF) | FilterFlo™ 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 FilterFlo™ filter
may either be used on
the patient side or on
the device side of the
ventilator/
anaesthetic device and
is used as a hygienic
measure alternatively
to decontamination of
breathing system and /
or breathing gas
conveying parts of the
ventilator.
The ThermoFlo™
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 |
| Device
Feature | Proposed Device: Bact-
Trap, Pharma Mini,
Bact-HME, Backt-
HME Filter and
HME/Filter | Primary
Predicate:
Pharma
Systems
K903056 - Bact
Trap filters | Primary
Predicate:
Pharma
Systems
K903058 –
Bact HME | Reference Predicate:
ARC Medical
K090738-
ThermoFlo™ |
| | humidifiers. The Bact
HME/Bact-HME Midi/
Pharma Mini should be
used with patients who
have a Tidal Volume
between 50 - 1500 ml. | | | 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
ThermoFlo™
filter/HME should be
used with patients who
have a Tidal Volume
between 250 - 1500
ml. |
| Classification | II | Same | Same | Same |
| Target
Population | Adult Tidal Volume
50-1500 ml | Same | Same | Tidal Volume 250-
1500ml |
| Clinical
Setting | Hospital, sub-acute,
pre-hospital and
home | Same | Same | Same |
| Principle of
Operation | Filtration via the
principle of
electrostatic charges
in the media.
Passive | Same | Same | Same |
| Device
Feature | Proposed Device: Bact-
Trap, Pharma Mini,
Bact-HME, Backt-
HME Filter and
HME/Filter | Primary
Predicate:
Pharma
Systems
K903056 - Bact
Trap filters | Primary
Predicate:
Pharma
Systems
K903058 -
Bact HME | Reference Predicate:
ARC Medical
K090738-
ThermoFlo™ |
| | functioning as heat
and moisture
exchangers. | | | |
| Compatibility
with
Environment
of Use | Intended for use
with ventilators,
anesthesia gas
machines | Same | Same | Same |
| Prescriptive | Yes | Yes | Yes | Yes |
| Sterile/Non-
Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Patient
Use | Yes | Yes | Yes | Yes |
| Maximum
Use | 24 hours | Same | Same | Same |
| Shelf-Life | 3 years | Same | Same | Unknown |
| Filtration
Efficiency | BFE: >99.999%
VFE: >99.99% | Same | Same | Unknown |
9
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.
10
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.
11
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 test
Moisture loss test | No leak @ 1 psi for 2 min
Equivalent to Predicate device | Pass |
| ISO 10993 | Cytotoxicity test
Sensitization test
Irritation test | Non-cytotoxic
Non-sensitizer
Non-irritant | Pass |
| ISO 18562-2 and
-3 | VOC and Particulate Matter
Testing | All test method acceptance
criteria were met. | Pass |
| ISO 18562-4 | Leachables evaluation in polar and
nonpolar solvents | All test method acceptance
criteria were met. | Pass |
| ISO 10993-17
and ISO 10993-
18 | Toxicological Risk Assessment | All test method acceptance
criteria were met. | Pass |
| ASTM 1980-16 | Accelerated Aging | Device meets its performance
specification post-
conditioning | Pass |
| ASTM F2101 | Viral Filtration Efficiency
Bacterial Filtration Efficiency | Filtration efficiency is
equivalent to Predicate device
Filtration efficiency is
equivalent to Predicate device | Pass |
| EN ISO 23328-2
EN ISO 23323-2 | Pressure Drop | Device meets its performance
specification | Pass |
| N/A | Housing Burst Strength | The measured values are
sufficient for ensuring safe
use of the measured devices. | Pass |
| ISO 23328-1 | Filtration Performance of
Technostat Plus filter media for
Bact-Trap bacterial/viral filters and
HME filters shelf life confirmation | The measured values are
sufficient for ensuring safe
use of the measured devices. | Pass |
| ISO 9360-1 | Bact-Trap bacterial/viral filters and
HME filters shelf life confirmation | The measured values are
sufficient for ensuring safe
use 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