ThermoShield HME Filter

K163300 · Flexicare Medical Limited. · CAH · Mar 22, 2017 · Anesthesiology

Device Facts

• Record ID: K163300
• Device Name: ThermoShield HME Filter
• Applicant: Flexicare Medical Limited.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device. Flexicare's ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes. Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel. Expert clinical judgment must be used in assessing patient humidification requirements.

Device Story

ThermoShield HME Filter is a single-use, disposable device placed at the patient end of a breathing circuit between the Y-piece and airway device. It incorporates HME media and an electrostatic filter pad to reduce bacterial/viral transmission and maintain respiratory moisture, preventing mucosal drying and ETT occlusion. The device features a female luer-lock port with a tethered cap for CO2 monitoring. It is operated by trained personnel in pre-hospital, hospital, and homecare settings. The healthcare provider connects the device to the breathing circuit and monitors CO2 via the luer port. By providing humidification and filtration, the device supports respiratory function and reduces contamination risks during assisted ventilation.

Clinical Evidence

Bench testing only. Performance verified against ISO 9360-1, ISO 5356-1, ISO 594-1/2, and ASTM F2101. Testing included visual inspection, CO2 monitoring function, moisture output/loss, pressure drop, gas leakage, conical connector compliance, and biocompatibility (ISO 10993). Results demonstrated performance comparable to predicate devices.

Technological Characteristics

Materials: Polypropylene housing, filter pad, and HME paper; PVC tethered luer cap; LDPE shrink sleeve. Sensing: Electrostatic filtration and HME moisture exchange. Connectivity: Standardized 22/15mm conical connectors (ISO 5356-1) and luer-lock port (ISO 594-2). Form factor: Adult and Mini (pediatric) sizes. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring anesthesia, artificial respiration, or assisted ventilation. Available in Adult and Mini (pediatric) sizes for use in pre-hospital, hospital, and homecare environments by trained personnel.

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

• Gibeck Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight (K964382)
• Gibeck Humid-Vent Filter Pedi (K952084)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2017

Flexicare Medical Limited % Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313

Re: K163300

Trade/Device Name: ThermoShield HME Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: March 08, 2017 Received: March 15, 2017

Dear Mr. Mark Job:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163300

Device Name

ThermoShield HME Filter

Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.

Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.

Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel.

Expert clinical judgment must be used in assessing patient humidification requirements.

Type of Use (Select one or both, as applicable)

2 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 Flexicare. The logo has the word "flexicare" in blue and red, with the first two letters stylized as a single graphic. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller, red letters.

### 510(k) Summary

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]

Summary prepared on: March 18th, 2017.

Device Name:

| Trade Name: | ThermoShield HME Filters |
|----------------------|-------------------------------------------------------|
| Common/Usual Name: | Breathing System Bacterial / Viral filter with HME |
| Classification Name: | Filter, Bacterial, Breathing-Circuit. 21 CFR 868.5260 |
| Product Code: | CAH |
| Classification: | Class 2 |

There have been no prior submissions for the devices included within this submission.

#### Legally Marketed Equivalent Device:

Flexicare's ThermoShield HME Filters are substantially equivalent to:

- Gibeck "Humid-Vent Filter Compact angled/ Humid-Vent ● Filter Compact Straight" which was cleared for marketing by 510(k) No K964382 for adult population.
And,

- Gibeck "Humid-Vent Filter Pedi" which was cleared for marketing by 510(k) K952084 for pediatric population.

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Image /page/4/Picture/0 description: The image is a logo for "flexicare". The word "flexicare" is written in a stylized font, with the "f" and "care" in red and the "lexi" in blue. Above the word is a red and blue graphic that resembles a stylized "f". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in blue.

### Device Description:

Flexicare's ThermoShield HME Filters are designed to prevent the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration

Flexicare's ThermoShield HME Filters include a HME (Heat and Moisture Exchanger) Media in addition to a filter. The Inclusion of HME media is intended to help prevent complications due to drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT) occlusion. This is achieved by the HME media preventing a large amount of the water vapor from passing through the device.

Flexicare's ThermoShield HME Filters consist of a top/bottom housing, filter pad, HME media and a luer port cap. The Female luer-lock port allows 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 ThermoShield HME Filters feature a 22mm Male and a 15mm Female conical connector. The machine side features a 22mm Female and a 15mm Male conical connector.

All conical connectors comply with dimensions stated within BS EN ISO 5356-1: 2004

Flexicare's ThermoShield HME Fitters have rounded housing with no sharp edges. This reduces the risk of pressure marks on the patient.

Flexicare's ThermoShield HME Fitters are available in Adult and Mini (Pediatric) sizes.

Flexicare's ThermoShield HME Filters are supplied non sterile in individually sealed polybags.

Intended Use:

Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

An HMEF is normally positioned at the patient end of the breathing system between the circuit Ypiece and the catheter mount or patient airway device.Flexicare's ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.

Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel.

Expert clinical judqment must be used in assessing patient humidification requirements.

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Image /page/5/Picture/0 description: The image shows the logo for "flexicare". The "f" in flexicare is stylized with two curved lines, one red and one blue. The rest of the word "lexicare" is in blue, with a small blue dot above the "i". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".

### Substantial Equivalence

Flexicare's ThermoShield HME Filters have the same intended use as the predicate devices. The indication for use are slightly different and do not affect substantial equivalence. Flexicare's ThermoShield HME Filters, Gibeck "Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight" and the Gibeck "Humid-Vent Filter Pedi" are single use devices. Supplied in Adult and Pediatric sizes. None of the devices are life supporting or life sustaining.

Patient Contact -

Skin contact (intact skin) & Externally Communicating - limited Duration (<24hrs)

Both manufacturer's filters are designed for a single patient use.

None of the devices are life supporting or life sustaining, nor are they implanted.

None of the filters use software or are electronically driven. None of the filters are sterile.

Both manufacturer's filters are intended to be used in conjunction with other devices such as catheter mounts and industry standardized conical connectors.

Both manufacturer's filters are designed for the same intended use in the same intended conditions. Both manufacturer's filters consist of 4-5 components made from injection molded plastics, coiled paper & stamped polymer weave.

Neither manufacturer's devices are in vitro diagnostic devices.

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Image /page/6/Picture/0 description: The image is a logo for "flexicare". The word "flexicare" is written in a stylized font, with the "f" being a stylized design in red and blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.

# Substantial equivalence comparison table - Adult filters

| | Flexicare's ThermoShield HME Filters - Adult<br>K: 163300 | Gibeck Humid-vent Filter Compact<br>K: 964382 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Filter housing top<br>Filter housing bottom<br>Filter pad<br>HME paper<br>Tethered luer port cap<br>Outer shrink sleeve | Filter housing top<br>Filter housing bottom<br>Filter pad<br>HME paper<br>Luer port cap<br>Outer sticker |
| Materials | Filter housing top - Polypropylene<br>Filter housing bottom - Polypropylene<br>Filter pad - Polypropylene<br>HME paper - Paper<br>Tethered luer port cap - PVC<br>Outer shrink sleeve - LDPE | Filter housing top - ABS<br>Filter housing bottom - Polypropylene<br>Filter pad - Polypropylene<br>HME paper - Paper<br>luer port cap - ABS<br>Outer sticker - Paper |
| Assembly Method | Snap Fit casing | Snap Fit casing |
| Patient population | Adult | Adult |
| Emergency use | Yes | Yes |
| Environment of use | Pre-hospital, Hospital & Homecare | Pre-hospital, Hospital & Homecare |
| Patient use/Duration of use | Single use, disposable, <24hrs | Single use, disposable, <24hrs |
| Supplied sterile | No | No |
| Indications for use | Flexicare's ThermoShield HME (Heat and<br>Moisture Exchange) Filters are intended to<br>reduce the transmission of bacteria and<br>viruses to/from a patient, and to maintain<br>moisture levels in the patient's respiratory<br>tract during anesthesia, artificial respiration<br>and other types of assisted ventilation.<br>An HMEF is normally positioned at the patient<br>end of the breathing system between the<br>circuit Y-piece and the catheter mount or<br>patient airway device.<br>Flexicare's ThermoShield HME Filters are<br>single use devices for use on a single patient<br>for up to 24hrs and are available in Adult and<br>Mini (pediatric) sizes.<br>Flexicare's ThermoShield HME Filters are<br>designed to be used in pre-hospital, hospital<br>and homecare environments by trained<br>personnel.<br>Expert clinical judgment must be used in<br>assessing patient humidification<br>requirements. | Humid-vent filter (HMEF) are combined<br>Heat and Moisture Exchanger (HME) and<br>Bacterial/Viral Filter for humidification<br>and bacterial/viral filtration during<br>anesthesia and ventilator care.<br>Expert clinical judgment must be used in<br>assessing the patients humidification<br>requirements.<br>Source: Gibeck Humid-Vent Filter<br>Compact IFU. |
| Colours | Clear/colorless, Blue | Clear/colorless, Blue, White |

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Image /page/7/Picture/0 description: The image is a logo for Flexicare. The logo has the word "flexicare" in blue and red, with the "f" being a stylized design in both colors. Below the word is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.

| 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>594-2 | Yes | Yes |
| Configurations | Straight with luer port | Straight with luer port |
| Filtration Method | Electrostatic | Electrostatic |
| Placement within circuit | Patient side | Patient side |
| Weight (g) | Straight with luer port<br>38g | Straight with luer port<br>31g |
| Internal Volume/dead<br>space as per ISO 9360-1 | Straight with luer port<br>46ml | Straight with luer port<br>35ml |
| Bacterial/ Viral Filtration<br>efficiency/ filter integrity<br>(Fresh) | BFE - 99.999%<br>VFE - 99.99% | BFE - 99.9999%<br>VFE - 99.999% |
| Salt Method filtration<br>efficiency | 98.90% | Not stated |
| Moisture output (mg/L) | Vt 500 - 30.4mg H2O/L air | Vt 500 - 29.2mg H2O/L air |
| Moisture loss (mg/L) | Vt 500 - 6.8 mg H2O/L air | Vt 500 – 7.8mg H2O/L air |
| Tidal Volume range (ml) | 138-800ml | 150-1000ml |
| Pressure Drop/ Flow<br>resistance | Straight filters<br>1.71cmH2O @ 30LPM<br>4.31cmH2O @ 60LPM<br>7.82cmH2O @ 90LPM | Straight filters<br>1.25cmH2O @ 30LPM<br>2.96cmH2O @ 60LPM<br>5.21cmH2O @ 90LPM |
| Housing Burst strength | >101kPa | >101kPa |
| Leakage per ISO 9360-1 6.4 | No leak at 101kPa | No leak at 101kPa |
| Compliance per ISO 9360-1<br>6.5 | Straight filters<br>14ml/kPa | Straight filters<br>13ml/kPa |
| Reuse, Cleaning &<br>Disinfection | N/A – Single use | N/A – Single use |
| Shelf Life | 4 years | 5 years |
| Packaging | Non-sterile Polybag | Non-sterile Polybag |
| Temp/humidity req's | None stated | None stated |
| Non-clinical<br>Test Results | Verification tests were performed on Flexicare's Adult ThermoShield HME Filter. These<br>Non-clinical tests included Visual inspection/comparison, HME moisture output, HME<br>moisture loss, Compliance testing, Pressure drop, Conical connector compliance testing,<br>Luer lock compliance testing, shelf life verification, Biocompatibility and Filtration<br>efficiency. Testing demonstrated that the relevant features, design and performance of<br>each manufacturer's device are substantially equivalent. | |
| Conclusion | Flexicare's Adult ThermoShield HME Filter is considered to be substantially equivalent the<br>Gibeck Humid-vent Filter Compact. The comparison of each devices features, performance,<br>materials, intended use and intended purpose demonstrate this. | |
| | Flexicare's ThermoShield HME Filters - Mini<br>K: 163300 | Gibeck Humid-vent Filter Pedi<br>K:952084 |
| Components | Filter housing top<br>Filter housing bottom<br>Filter pad<br>HME paper<br>Tethered luer port cap<br>Outer shrink sleeve | Filter housing top<br>Filter housing bottom<br>Filter pad<br>HME paper<br>Luer port cap<br>Outer sticker |
| Materials | Filter housing top - Polypropylene<br>Filter housing bottom - Polypropylene<br>Filter pad - Polypropylene<br>HME paper - Paper<br>Tethered luer port cap - PVC<br>Outer shrink sleeve - LDPE | Filter housing top - ABS<br>Filter housing bottom - Polypropylene<br>Filter pad - Polypropylene<br>HME paper - Paper<br>luer port cap - ABS<br>Outer sticker - Paper |
| Assembly Method | Snap Fit casing | Snap Fit casing |
| Patient population | Pedi | Pedi |
| Emergency use | Yes | Yes |
| Environment of use | Pre-hospital, Hospital & Homecare | Pre-hospital, Hospital & Homecare |
| Patient use/Duration of use | Single use, disposable, <24hrs | Single use, disposable, <24hrs |
| Supplied sterile | No | No |
| Indications for use | Flexicare's ThermoShield HME (Heat and<br>Moisture Exchange) Filters are intended to<br>reduce the transmission of bacteria and<br>viruses to/from a patient, and to maintain<br>moisture levels in the patient's respiratory<br>tract during anesthesia, artificial respiration<br>and other types of assisted ventilation.<br>An HMEF is normally positioned at the patient<br>end of the breathing system between the<br>circuit Y-piece and the catheter mount or<br>patient airway device.<br>Flexicare's ThermoShield HME Filters are<br>single use devices for use on a single patient<br>for up to 24hrs and are available in Adult and<br>Mini (pediatric) sizes.<br>Flexicare's ThermoShield HME Filters are<br>designed to be used in pre-hospital, hospital<br>and homecare environments by trained<br>personnel.<br>Expert clinical judgment must be used in<br>assessing patient humidification<br>requirements. | Humid-Vent Filter Pedi is a combined<br>heat and moisture exchanger (HME) and<br>bacterial/viral filter for humidification<br>and bacterial/viral filtration during<br>anesthesia and intensive care. With luer<br>lock port for ETCO2, anesthetic agent or<br>pressure monitoring Vt50-250ml. It<br>reduces hypothermia and post-operative<br>shivering as well as the risk of<br>bacterial/viral contamination.<br><br>Source: Gibeck Humid-Vent Filter Pedi<br>IFU. |
| Colours | Clear/ colorless, Blue | Clear/ colorless, Blue, White |
| Standard 22/15mm<br>connections in compliance<br>with ISO 5356.1 | Yes | Yes |
| | |…