HepaShield Bacterial Viral Breathing System Filter

K191909 · Flexicare Medical Limited. · CAH · Mar 23, 2020 · Anesthesiology

Device Facts

• Record ID: K191909
• Device Name: HepaShield Bacterial Viral Breathing System Filter
• Applicant: Flexicare Medical Limited.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended 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 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.

Device Story

HepaShield is a mechanical bacterial/viral breathing system filter; used in hospital settings by trained personnel during anesthesia or assisted ventilation. Device consists of a housing (top/bottom), pleated paper filter pack, and a tethered luer port cap for CO2 monitoring. Input is inspired/expired breathing gases; filter media mechanically traps pathogens; output is filtered gas. Device connects to standard 22mm/15mm conical connectors (ISO 5356-1). Single-use, disposable (max 24 hours). Benefits include reduced cross-contamination risk for patients and equipment. Healthcare providers integrate it into the breathing circuit to maintain sterility of the gas pathway.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated against ISO 9360-1, ISO 23328-2, ISO 5356-1, ISO 10993, and EN ISO 18562. Metrics included BFE (99.99999%), VFE (99.9999%), pressure drop, gas leakage, and biocompatibility. All tests passed.

Technological Characteristics

Mechanical filtration via pleated paper filter pack. Housing: ultrasonic welded. Connectors: 22mm/15mm conical (ISO 5356-1). Luer port: ISO 80369-7. Biocompatibility: ISO 10993, EN ISO 18562. Shelf life: 5 years. Sterile and non-sterile variants available.

Indications for Use

Indicated for adult patients requiring anesthesia, artificial respiration, or assisted respiration in hospital environments to reduce bacterial/viral transmission during gas filtration. Contraindicated for use between a humidification/nebulizing device and the patient, or at the patient end when used with a humidified breathing system.

Regulatory Classification

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.

Predicate Devices

• Pall's Ultipor 25 Bacterial Viral Breathing System Filter (K013093)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

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 System<br>Filter | Pall's Ultipor 25 Breathing System Filter |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K191909 | K013093 |
| Components | Filter housing top<br>Filter housing bottom<br>Filter Media pack<br>Tethered luer port cap<br>Outer shrink sleeve | Filter housing top<br>Filter housing bottom<br>Filter Media pack<br>Tethered 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 HepaShield<br>Bacterial Viral Breathing System<br>Filter between a humidification<br>device or nebulizing device and the<br>patient.<br><br>- Single Use. Do not reuse.<br><br>- DO NOT attempt to decontaminate<br>this product in any way. This<br>includes rinsing, washing or<br>decontamination using gas, heat,<br>steam, or boiling water.<br><br>- When used in conjunction with a | - Do not install the filter in either<br>positions A or B in conjunction with<br>heater water-bath humidifiers or<br>nebulizers.<br><br>- Do not Reuse.<br><br>- Do not Soak, rinse, wash, sterilize or<br>treat with liquid disinfectants.<br><br>- Note: This Product is free of natural<br>rubber 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, the<br>HepaShield Bacterial Viral Breathing<br>System Filter is contraindicated for<br>use at the patient end. | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Supplied sterile | Both Non-sterile & sterile variants | Non-sterile |
| Product labelling | HepaShield Bacterial Viral Breathing System<br>Filter | PALL Ultipor BREATHING SYSTEM FILTER |
| Indications for use | Flexicare's HepaShield Bacterial Viral<br>Breathing System Filters are intended to<br>reduce the transmission of bacteria and<br>viruses to/from a patient during anesthesia.<br>For use with ventilators, anesthesia<br>machines and open flow systems where<br>filtration of inspired and/or expired gases is<br>desired.<br>Flexicare's HepaShield Bacterial Viral<br>Breathing System Filters are single use<br>devices for use on a single patient for up to<br>24hrs and are available in Adult size.<br>Flexicare's HepaShield Bacterial Viral | The Pall Ultipor Anesthesia Breathing Circuit<br>System with a Breathing System Filter<br>("BSF") is intended for use in the<br>administration of medical gases during<br>anesthesia. The circuit connects the<br>anesthesia gas machine to the patient, by<br>means of an oronasal facemask or by a<br>connection to an artificial airway, such as an<br>endotracheal tube or laryngeal mask. The<br>Pall Ultipor 25 BSF minimizes viral and<br>bacterial contamination of the inspiratory<br>and expiratory limbs of the circuit with a<br>minimum 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 be<br>used in hospital environments by trained<br>personnel. | Source: K013093 510(k) summary |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended use | Instruction leaflet | Instruction leaflet |
| Patient connection | ET tube, Laryngeal Mask Airway, Catheter<br>mount, Breathing circuit | ET tube, Laryngeal Mask Airway, Catheter<br>mount, Breathing circuit |
| Standard 22/15mm<br>connections in compliance<br>with ISO 5356-1 | Yes | Yes |
| Luer port for gas sampling<br>in compliance with ISO<br>80369-7 | Yes | Yes |
| Configurations | Straight with luer port | Straight with luer port |
| Filtration Method | Mechanical | Mechanical |
| Placement within circuit | Patient side<br>Machine side | Patient side<br>Machine side |
| Weight (g) | 42g | 26g |
| Internal Volume/dead<br>space as per ISO 9360-1 | 47ml | 35ml |
| Bacterial/ Viral Filtration<br>efficiency/ filter integrity<br>(Fresh) | BFE - 99.99999%<br>VFE - 99.9999% | BFE - 99.999% |
| Salt Method filtration<br>efficiency | 99.89% | Not stated |
| Tidal Volume range (ml) | 141ml-800ml | Not stated |
| Pressure Drop/ Flow<br>resistance per BS EN ISO<br>23328-2/ BS EN ISO 9360-1 | 1.70 cmH2O @ 30LPM<br>3.92 cmH2O @ 60LPM<br>6.56 cmH2O @ 90LPM | 1.43 cmH2O @ 30LPM<br>3.10 cmH2O @ 60LPM<br>4.96 cmH2O @ 90LPM |
| Leakage per BS EN ISO<br>23328-2/ BS EN ISO 9360-1 | <2 ml/min | <2 ml/min |
| Compliance per BS EN ISO<br>9360-1 | 0.057 ml/cmH2O | 0.029 ml/cmH2O |
| Reuse, Cleaning &<br>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 5356-1<br>ISO 10993-1<br>BS EN ISO 23328-1<br>BS EN ISO 80369-7 | 510(K) Summary does not specify |
| Biocompatibility | ISO 10993 compliant<br>EN 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 Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Visual Inspection | Pre-determined Acceptance Criteria* | Pass |
| Compliance testing | BS EN ISO 9360: 2009 | Methodology only, no pass<br>criteria - Comparable<br>performance outcome between<br>Flexicare's new devices and<br>the predicate devices |
| Pressure drop | BS EN ISO 23328-2 (Refers to: BS EN ISO<br>9360: 2009) - Methodology only, no pass criteria | Methodology only, no pass<br>criteria - Comparable |
| Gas Leakage | - for comparison only.<br>HME aspects not applicable. | performance outcome between<br>Flexicare's new devices and<br>the predicate devices |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass |
| Leak testing | | Pass |
| Drop testing | | Pass |
| Cytotoxicity, Irritation, Sensitization,<br>Systemic toxicity, Material Mediated | BS EN ISO 10993-10:2010<br>BS EN ISO 10993-5:2009 | Pass |
| Pyrogenicity, | BS EN ISO 10993-11:2009 | Pass |
| Bacterial Endotoxin | (USP) guidelines <161> and <85>.<br>ANSI/AAMI ST72:2011, | Pass |
| Particulate emissions (gas<br>pathway) | 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 pass<br>criteria within standard. |
| | BS EN ISO 23328-1 (2008) | Methodology only, no pass<br>criteria within standard. |
| Pressure Drop | BS EN ISO 23328-2 (2009) | Methodology only, no pass<br>criteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) | Methodology only, no pass<br>criteria 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). .