(250 days)
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.
The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
The provided text describes the acceptance criteria and study results for the Flexicare HepaShield Bacterial Viral Breathing System Filter, which is a medical device.
1. Table of acceptance criteria and the reported device performance:
| Test | Standard / Pre-Determined Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Visual Inspection | Product packaging must remain sealed & undamaged. All components of devices must be free of flash, cracking, warping, discoloration or contamination. | Pass |
| Compliance testing (Internal Volume/dead space) | BS EN ISO 9360: 2009 (Methodology only, no pass criteria) | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (47ml vs 35ml for predicate) |
| Pressure drop | BS EN ISO 23328-2 (Refers to: BS EN ISO 9360: 2009) - Methodology only, no pass criteria | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (1.70 cmH2O @ 30LPM; 3.92 cmH2O @ 60LPM; 6.56 cmH2O @ 90LPM) |
| Gas Leakage (for comparison only, HME aspects not applicable) | Pre-determined Acceptance Criteria* (implies visual inspection criteria for gas leakage if unspecified) | methodology only, no pass criteria |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass |
| Leak testing | Not explicitly stated (likely internal specification) | Pass |
| Drop testing | Not explicitly stated (likely internal specification) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Material Mediated | BS EN ISO 10993-10:2010, BS EN ISO 10993-5:2009 | Pass |
| Pyrogenicity | BS EN ISO 10993-11:2009 | Pass |
| Bacterial Endotoxin | (USP) guidelines <161> and <85>, ANSI/AAMI ST72:2011 | Pass |
| Particulate emissions (gas pathway) | EN ISO 18562-2:12017 | Pass |
| VOC emissions (gas pathway) | EN ISO 18562-3:2017 | Pass |
| Gauging tests on luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Liquid leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Air leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer separation force | BS EN ISO 80369-7:2016 | Pass |
| Luer unscrewing torque | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer ease of assembly | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer resistance to overriding | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer testing for stress cracking | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Shelf life testing | Standards included within this table (implying all relevant performance criteria are met over shelf life) | Pass |
| Filter integrity | Based on ASTM F2101 (Nelson Labs Protocol), BS EN ISO 23328-1 (2008) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported BFE - 99.99999%, VFE - 99.9999%, Salt Method filtration efficiency - 99.89%) |
| Pressure Drop (as part of Filter integrity or separate measurement) | BS EN ISO 23328-2 (2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported <2 ml/min) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to non-clinical bench testing and adherence to consensus standards. It does not provide specific sample sizes for each test beyond stating that the device "passed all performance tests." The data provenance is from laboratory testing performed by Flexicare, likely at their facilities in the UK or a contracted lab. This is prospective testing as it's part of the premarket notification process for a new device.
The document implicitly indicates that testing was done in accordance with international standards (e.g., ISO, EN ISO, ASTM, USP), which are globally recognized, but the specific country of origin for the data generation would be the UK or the location of any contracted testing laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a medical device (filter), not an AI or diagnostic imaging device. Therefore, the "ground truth" is established through objective physical and biological measurements in a laboratory setting based on recognized international standards. There are no human experts "establishing ground truth" in the same way as for diagnostic image interpretation. The expertise lies in the engineers and technicians performing the tests and interpreting the results against the defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The tests are objective measurements against defined criteria in standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (filter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (filter), not an algorithm. The testing described is for the standalone performance of the filter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective, quantifiable physical and biological measurements as defined by recognized international standards (e.g., ISO, ASTM, EN ISO, USP) for filtration efficiency, pressure drop, biocompatibility, connector compliance, and mechanical integrity.
8. The sample size for the training set
Not applicable. There is no AI component or "training set" for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI component or "training set" for this physical device.
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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.
March 23, 2020
Flexicare Medical Limited Joel Biddle Regulatory Manager Cynon Vallev Business Park Mountain Ash, cf45 4er UK
Re: K191909
Trade/Device Name: HepaShield Bacterial Viral Breathing System Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: February 19, 2020 Received: February 24, 2020
Dear Joel Biddle:
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.
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
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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 medical devices and radiation-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,
Elizabeth Claverie, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191909
Device Name HepaShield Bacterial Viral Breathing System Filter
Indications for Use (Describe)
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Type of Use (Select one or both, as applicable)
[X] 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 is a logo for "flexicare". The logo is in blue and consists of a stylized letter "f" with three curved lines above it. Below the word "flexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font size. The logo is clean and modern, and the blue color gives it a sense of trustworthiness and reliability.
510(k) Summary
K191909
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. CF45 4ER. United Kingdom
Joel Biddle Senior Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222
Summary prepared on: March 16th, 2020. Device Name:
Trade Name: HepaShield Bacterial Viral Breathing System Filter
Common/Usual Name: Breathing circuit bacterial filter.
Classification Name: Breathing circuit bacterial filter: 21 CFR 868.5260
Product Codes: CAH (Breathing circuit bacterial filter)
Predicate Device:
Pall's Ultipor 25 Bacterial Viral Breathing System Filter (K013093)
Device Description:
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.
The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
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Image /page/4/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "F" followed by the word "lexicare." Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE." The logo is clean and professional, and the blue color gives it a sense of trustworthiness.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
Indications For Use:
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult size. Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Technoloqical Characteristic Comparison Table:
The table below shows the similarities and differences between the Flexicare's HepaShield Bacterial Viral Breathing System Filter and the predicate device manufactured by Pall.
| Flexicare's HepaShield Breathing SystemFilter | Pall's Ultipor 25 Breathing System Filter | |
|---|---|---|
| 510(k) | K191909 | K013093 |
| Components | Filter housing topFilter housing bottomFilter Media packTethered luer port capOuter shrink sleeve | Filter housing topFilter housing bottomFilter Media packTethered luer port cap |
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded housing |
| Target population | Adult | Adult |
| Emergency use | Yes | Yes |
| Environment of use | Hospital | Hospital |
| Patient use/Duration of use | Single use, disposable, <24hrs | Single use, disposable, <24hrs |
| Contraindications | - DO NOT place the HepaShieldBacterial Viral Breathing SystemFilter between a humidificationdevice or nebulizing device and thepatient.- Single Use. Do not reuse.- DO NOT attempt to decontaminatethis product in any way. Thisincludes rinsing, washing ordecontamination using gas, heat,steam, or boiling water.- When used in conjunction with a | - Do not install the filter in eitherpositions A or B in conjunction withheater water-bath humidifiers ornebulizers.- Do not Reuse.- Do not Soak, rinse, wash, sterilize ortreat with liquid disinfectants.- Note: This Product is free of naturalrubber latex. |
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Image /page/5/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" with three curved lines above it. The word "flexicare" is written in a sans-serif font to the right of the "f". Below the word "flexicare" is the tagline "TOTAL QUALITY - TOTAL CARE".
| humidified breathing system, theHepaShield Bacterial Viral BreathingSystem Filter is contraindicated foruse at the patient end. | ||
|---|---|---|
| Supplied sterile | Both Non-sterile & sterile variants | Non-sterile |
| Product labelling | HepaShield Bacterial Viral Breathing SystemFilter | PALL Ultipor BREATHING SYSTEM FILTER |
| Indications for use | Flexicare's HepaShield Bacterial ViralBreathing System Filters are intended toreduce the transmission of bacteria andviruses to/from a patient during anesthesia.For use with ventilators, anesthesiamachines and open flow systems wherefiltration of inspired and/or expired gases isdesired.Flexicare's HepaShield Bacterial ViralBreathing System Filters are single usedevices for use on a single patient for up to24hrs and are available in Adult size.Flexicare's HepaShield Bacterial Viral | The Pall Ultipor Anesthesia Breathing CircuitSystem with a Breathing System Filter("BSF") is intended for use in theadministration of medical gases duringanesthesia. The circuit connects theanesthesia gas machine to the patient, bymeans of an oronasal facemask or by aconnection to an artificial airway, such as anendotracheal tube or laryngeal mask. ThePall Ultipor 25 BSF minimizes viral andbacterial contamination of the inspiratoryand expiratory limbs of the circuit with aminimum efficiency of 99.999%. |
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Image /page/6/Picture/0 description: The image is a logo for "flexicare". The logo is in blue and consists of a stylized "f" followed by the word "lexicare" in a sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller sans-serif font. The logo is clean and modern, and the blue color gives it a sense of trustworthiness and reliability.
| Breathing System Filters are designed to beused in hospital environments by trainedpersonnel. | Source: K013093 510(k) summary | |
|---|---|---|
| Intended use | Instruction leaflet | Instruction leaflet |
| Patient connection | ET tube, Laryngeal Mask Airway, Cathetermount, Breathing circuit | ET tube, Laryngeal Mask Airway, Cathetermount, Breathing circuit |
| Standard 22/15mmconnections in compliancewith ISO 5356-1 | Yes | Yes |
| Luer port for gas samplingin compliance with ISO80369-7 | Yes | Yes |
| Configurations | Straight with luer port | Straight with luer port |
| Filtration Method | Mechanical | Mechanical |
| Placement within circuit | Patient sideMachine side | Patient sideMachine side |
| Weight (g) | 42g | 26g |
| Internal Volume/deadspace as per ISO 9360-1 | 47ml | 35ml |
| Bacterial/ Viral Filtrationefficiency/ filter integrity(Fresh) | BFE - 99.99999%VFE - 99.9999% | BFE - 99.999% |
| Salt Method filtrationefficiency | 99.89% | Not stated |
| Tidal Volume range (ml) | 141ml-800ml | Not stated |
| Pressure Drop/ Flowresistance per BS EN ISO23328-2/ BS EN ISO 9360-1 | 1.70 cmH2O @ 30LPM3.92 cmH2O @ 60LPM6.56 cmH2O @ 90LPM | 1.43 cmH2O @ 30LPM3.10 cmH2O @ 60LPM4.96 cmH2O @ 90LPM |
| Leakage per BS EN ISO23328-2/ BS EN ISO 9360-1 | <2 ml/min | <2 ml/min |
| Compliance per BS EN ISO9360-1 | 0.057 ml/cmH2O | 0.029 ml/cmH2O |
| Reuse, Cleaning &Disinfection | N/A - Single use (max 24hrs) | N/A - Single use (max 24hrs) |
| Shelf Life | 5 years | 5 years |
| Packaging | Polybag | Polybag |
| Temp/humidity req's | Not stated | Not stated |
| Standards met | ISO 5356-1ISO 10993-1BS EN ISO 23328-1BS EN ISO 80369-7 | 510(K) Summary does not specify |
| Biocompatibility | ISO 10993 compliantEN ISO 18562 compliant | Not stated |
Summary of Nonclinical Testing: Flexicare's HepaShield Bacterial Viral Breathing System Filter has been evaluated in accordance with standards listed in table:
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Image /page/7/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" with three curved lines above it. To the right of the "f" is the word "lexicare" in a sans-serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
| Test | Standard / Pre Determined AcceptanceCriteria | Results |
|---|---|---|
| Visual Inspection | Pre-determined Acceptance Criteria* | Pass |
| Compliance testing | BS EN ISO 9360: 2009 | Methodology only, no passcriteria - Comparableperformance outcome betweenFlexicare's new devices andthe predicate devices |
| Pressure drop | BS EN ISO 23328-2 (Refers to: BS EN ISO9360: 2009) - Methodology only, no pass criteria | Methodology only, no passcriteria - Comparable |
| Gas Leakage | - for comparison only.HME aspects not applicable. | performance outcome betweenFlexicare's new devices andthe predicate devices |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass |
| Leak testing | Pass | |
| Drop testing | Pass | |
| Cytotoxicity, Irritation, Sensitization,Systemic toxicity, Material Mediated | BS EN ISO 10993-10:2010BS EN ISO 10993-5:2009 | Pass |
| Pyrogenicity, | BS EN ISO 10993-11:2009 | Pass |
| Bacterial Endotoxin | (USP) guidelines <161> and <85>.ANSI/AAMI ST72:2011, | Pass |
| Particulate emissions (gaspathway) | EN ISO 18562-2:12017 | Pass |
| VOC emissions (gas pathway) | EN ISO 18562-3:2017 | Pass |
| Gauging tests on luer | Pass | |
| Liquid leakage from luer | Pass | |
| Air leakage from luer | Pass | |
| Luer separation force | BS EN ISO 80369-7:2016 | Pass |
| Luer unscrewing torque | Pass | |
| Luer ease of assembly | Pass | |
| Luer resistance to overriding | Pass | |
| Luer testing for stress cracking | Pass | |
| Shelf life testing | Standards included within this table | Pass |
| Filter integrity | Based on ASTM F2101 (Nelson Labs Protocol) | Methodology only, no passcriteria within standard. |
| BS EN ISO 23328-1 (2008) | Methodology only, no passcriteria within standard. | |
| Pressure Drop | BS EN ISO 23328-2 (2009) | Methodology only, no passcriteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) | Methodology only, no passcriteria within standard |
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Image /page/8/Picture/0 description: The image shows the logo for "flexicare" in blue. The logo features a stylized "f" with three curved lines above the word "flexicare". Below the word "flexicare" is the text "TOTAL QUALITY - TOTAL CARE".
* Pre-determined Acceptance Criteria - Visual inspection
Criteria: Product packaging must remain sealed & undamaged. All components of devices must be free of flash, cracking, warping, discoloration or contamination.
Methodology: Visual inspection under normal or corrected vision of device packaging (inspection of panels, seams and welds for unsealed areas/openings, pint quality, tares) and assembled device (inspection of device for cracking, warping, discolouration, cosmetic defects, flash and contamination within material).
Flexicare's HepaShield Bacterial Viral Breathing System Filter passed the performance testing when tested against methods and criteria from both pre-determined acceptance criteria methods and relevant FDA Recognized standards.
The results of this testing show that Flexicare's HepaShield Bacterial Viral Breathing System Filter passes all performance tests and perform at least as well as the marketed predicate device.
Consensus Standards
The recognized consensus standard for devices classified through FDA product code CAH are:
- ISO 5356-1: 2004 Anaesthetic And Respiratory Equipment Conical Connectors: ● Part 1: Cones And Sockets.
- EN ISO 18652: 2017 Biocompatibility Evaluation Of Breathing Gas Pathways In ● Healthcare Applications
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Image /page/9/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "F" with three curved lines. The word "Flexicare" is written in a sans-serif font to the right of the "F". Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrates that the Flexicare HepaShield Bacterial Viral Breathing System Filter device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Pall's Ultipor 25 Bacterial Viral Breathing System Filter (K013093). .
§ 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).