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.

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.

AI/ML Overview

This document describes the acceptance criteria and the studies performed to demonstrate substantial equivalence for the Flexicare ThermoShield HME Filter (Adult and Mini/Pediatric sizes) to their respective predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document presents separate comparison tables for the Adult and Mini (Pediatric) filters against their respective predicate devices. The "Non-clinical Test Results" section summarizes the primary studies conducted to meet acceptance criteria.

Adult Filters:

Acceptance Criteria / Test	Standard / Pre-determined Acceptance Criteria	Reported Device Performance (Flexicare ThermoShield HME Filters - Adult)	Predicate Device Performance (Gibeck Humid-vent Filter Compact)
Components	Same components	Filter housing top, Filter housing bottom, Filter pad, HME paper, Tethered luer port cap, Outer shrink sleeve	Filter housing top, Filter housing bottom, Filter pad, HME paper, Luer port cap, Outer sticker
Materials	Comparable materials	Polypropylene (housing, filter pad), Paper (HME paper), PVC (luer cap), LDPE (shrink sleeve)	ABS (housing top, luer cap), Polypropylene (housing bottom, filter pad), Paper (HME paper, sticker)
Assembly Method	Same method	Snap Fit casing	Snap Fit casing
Patient population	Same population	Adult	Adult
Emergency use	Same use	Yes	Yes
Environment of use	Same environments	Pre-hospital, Hospital & Homecare	Pre-hospital, Hospital & Homecare
Patient use/Duration of use	Same use context	Single use, disposable, <24hrs	Single use, disposable, <24hrs
Supplied sterile	Same sterility status	No	No
Indications for use	Same intended use	Reduce bacteria/viruses, maintain moisture during anesthesia/ventilation. Positioned at patient end. Single use <24hrs. Adult & Mini sizes. Pre-hospital/hospital/homecare environments. Expert clinical judgment for humidification.	Humidification and bacterial/viral filtration during anesthesia and ventilator care. Expert clinical judgment for humidification.
Colours	Comparable colors	Clear/colorless, Blue	Clear/colorless, Blue, White
Standard 22/15mm connections compliance with ISO 5356-1	ISO 5356-1: 2004	Yes	Yes
Luer port for gas sampling compliance with ISO 594-2	ISO 594-2	Yes	Yes
Configurations	Same configurations	Straight with luer port	Straight with luer port
Filtration Method	Same method	Electrostatic	Electrostatic
Placement within circuit	Same placement	Patient side	Patient side
Weight (g)	Comparable	Straight with luer port: 38g	Straight with luer port: 31g
Internal Volume/dead space as per ISO 9360-1	Comparable	Straight with luer port: 46ml	Straight with luer port: 35ml
Bacterial/Viral Filtration efficiency/filter integrity (Fresh)	Acceptable levels (ASTM F2101, BS EN ISO 23328-1)	BFE - 99.999%, VFE - 99.99%	BFE - 99.9999%, VFE - 99.999%
Salt Method filtration efficiency	Not explicitly stated for acceptance, for comparison	98.90%	Not stated
Moisture output (mg/L)	Comparable (ISO 9360-1 methodology)	Vt 500 - 30.4mg H2O/L air	Vt 500 - 29.2mg H2O/L air
Moisture loss (mg/L)	Comparable (ISO 9360-1 methodology)	Vt 500 - 6.8 mg H2O/L air	Vt 500 – 7.8mg H2O/L air
Tidal Volume range (ml)	Comparable	138-800ml	150-1000ml
Pressure Drop/Flow resistance	Comparable (ISO 9360-1 methodology)	Straight: 1.71cmH2O@30LPM, 4.31cmH2O@60LPM, 7.82cmH2O@90LPM	Straight: 1.25cmH2O@30LPM, 2.96cmH2O@60LPM, 5.21cmH2O@90LPM
Housing Burst strength	>101kPa	>101kPa	>101kPa
Leakage per ISO 9360-1 6.4	No leak at 101kPa	No leak at 101kPa	No leak at 101kPa
Compliance per ISO 9360-1 6.5	Comparable	Straight: 14ml/kPa	Straight: 13ml/kPa
Reuse, Cleaning & Disinfection	Same usage	N/A – Single use	N/A – Single use
Shelf Life	Comparable	4 years	5 years
Packaging	Same packaging type	Non-sterile Polybag	Non-sterile Polybag
Temp/humidity req's	Same	None stated	None stated
Visual Inspection	Pre-determined Acceptance Criteria*	Pass	N/A (Internal test for Flexicare device)
CO2 monitoring function test	Pre-determined Acceptance Criteria **	Pass	N/A (Internal test for Flexicare device)
Conical Connector compliance	BS EN ISO 5356-1 2004	Pass	N/A (Internal test for Flexicare device)
Luer lock compliance (Dimensional, Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, Stress cracking)	ISO 594-1, ISO 594-2 (BS EN 1707:1997)	Pass	N/A (Internal test for Flexicare device)
Shelf life testing	All standards included in table	Pass	N/A (Internal test for Flexicare device)
Filter integrity	BS EN ISO 23328-1 (2008)	Methodology only, no pass criteria within standard.	N/A (Internal test for Flexicare device)
Biocompatibility (Cytotoxicity, Implant, Sensitization, Genotoxicity)	BS EN ISO 10993-10:2010, -5:2009, -3:2014, -6:2009	Pass	N/A (Internal test for Flexicare device)

Mini (Pediatric) Filters:

Acceptance Criteria / Test	Standard / Pre-determined Acceptance Criteria	Reported Device Performance (Flexicare ThermoShield HME Filters - Mini)	Predicate Device Performance (Gibeck Humid-vent Filter Pedi)
Components	Same components	Filter housing top, Filter housing bottom, Filter pad, HME paper, Tethered luer port cap, Outer shrink sleeve	Filter housing top, Filter housing bottom, Filter pad, HME paper, Luer port cap, Outer sticker
Materials	Comparable materials	Polypropylene (housing, filter pad), Paper (HME paper), PVC (luer cap), LDPE (shrink sleeve)	ABS (housing top/bottom, luer cap), Polypropylene (filter pad), Paper (HME paper, sticker)
Assembly Method	Same method	Snap Fit casing	Snap Fit casing
Patient population	Same population	Pedi	Pedi
Emergency use	Same use	Yes	Yes
Environment of use	Same environments	Pre-hospital, Hospital & Homecare	Pre-hospital, Hospital & Homecare
Patient use/Duration of use	Same use context	Single use, disposable, <24hrs	Single use, disposable, <24hrs
Supplied sterile	Same sterility status	No	No
Indications for use	Same intended use	Reduce bacteria/viruses, maintain moisture during anesthesia/ventilation. Positioned at patient end. Single use <24hrs. Adult & Mini sizes. Pre-hospital/hospital/homecare environments. Expert clinical judgment for humidification.	Humidification and bacterial/viral filtration during anesthesia and intensive care. With luer lock port for ETCO2, etc. Reduces hypothermia and shivering. Risk reduction for bacterial/viral contamination.
Colours	Comparable colors	Clear/colorless, Blue	Clear/colorless, Blue, White
Standard 22/15mm connections compliance with ISO 5356.1	ISO 5356-1: 2004	Yes	Yes
Luer port for gas sampling compliance with ISO 594-2	ISO 594-2	Yes	Yes
Configurations	Same configurations	Straight with luer port	Straight with luer port
Filtration Method	Same method	Electrostatic	Electrostatic
Placement of device within circuit	Same placement	Patient end	Patient end
Weight (g)	Comparable	Straight with luer port: 25g	Straight with luer port: 14.5g
Internal Volume/dead space as per ISO 9360-1	Comparable	Straight with luer port: 25ml	Straight with luer port: 12ml
Bacterial/Viral Filtration efficiency/filter integrity (Fresh)	Acceptable levels (ASTM F2101, BS EN ISO 23328-1)	BFE - 99.99%, VFE - 99.9%	BFE - 99.9999%, VFE - 99.9%
Salt Method filtration efficiency	Not explicitly stated for acceptance, for comparison	97.71%	Not stated
Moisture output (mg/L)	Comparable (ISO 9360-1 methodology)	Vt 200 - 30.3mg H2O/L air	Vt 200 - 30.4mg H2O/L air
Moisture loss (mg/L)	Comparable (ISO 9360-1 methodology)	Vt 200 - 6.9 mg H2O/L air	Vt 200 - 6.9mg H2O/L air
Tidal Volume Range (ml)	Comparable	75-600ml	50-250ml
Pressure Drop/Flow resistance	Comparable (ISO 9360-1 methodology)	Straight: 2.02cmH2O@30LPM, 4.86cmH2O@60LPM, 8.61cmH2O@90LPM	Straight: 1.90cmH2O@30LPM, 4.72cmH2O@60LPM, 7.98cmH2O@90LPM
Housing Burst strength	>101kPa	>101kPa	>101kPa
Leakage per ISO 9360-1 6.4	No leak at 101kPa	No leak at 101kPa	No leak at 101kPa
Compliance per ISO 9360-1 6.5	Comparable	Straight: 10ml/kPa	Straight: 10ml/kPa
Reuse, Cleaning & Disinfection	Same usage	N/A – Single use	N/A – Single use
Shelf Life	Comparable	4 years	5 years
Packaging	Same packaging type	Non-sterile Polybag	Non-sterile Polybag
Temp/humidity req's	Same	None stated	None stated
Visual Inspection	Pre-determined Acceptance Criteria*	Pass	N/A (Internal test for Flexicare device)
CO2 monitoring function test	Pre-determined Acceptance Criteria **	Pass	N/A (Internal test for Flexicare device)
Conical Connector compliance	BS EN ISO 5356-1 2004	Pass	N/A (Internal test for Flexicare device)
Luer lock compliance (Dimensional, Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, Stress cracking)	ISO 594-1, ISO 594-2 (BS EN 1707:1997)	Pass	N/A (Internal test for Flexicare device)
Shelf life testing	All standards included in table	Pass	N/A (Internal test for Flexicare device)
Filter integrity	BS EN ISO 23328-1 (2008)	Methodology only, no pass criteria within standard.	N/A (Internal test for Flexicare device)
Biocompatibility (Cytotoxicity, Implant, Sensitization, Genotoxicity)	BS EN ISO 10993-10:2010, -5:2009, -3:2014, -6:2009	Pass	N/A (Internal test for Flexicare device)

2. Sample sizes used for the test set and the data provenance:

The document summarizes "non-clinical tests" performed on the Flexicare ThermoShield HME Filter (Adult and Mini sizes). The specific sample sizes for each test are not explicitly stated within the provided text. However, the tests are identified as "Verification tests were performed on Flexicare's Adult/Mini ThermoShield HME Filter." and the results are presented as "All Samples passed the performance testing." This implies that a sufficient number of devices were tested to draw the stated conclusions.

The data provenance is internal to Flexicare Medical Limited, as the studies are described as "Flexicare's ThermoShield HME Filters have been evaluated..." and conducted "against methods and criteria from predetermined acceptance criteria in-house test methods and relevant BS EN & ISO FDA recognized standards." This indicates the data is retrospective internal testing to demonstrate substantial equivalence to previously marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a technical device (breathing circuit filter); therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological images) is not directly applicable. The "ground truth" for the performance characteristics of the device (such as filtration efficiency, moisture output, pressure drop) is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and predefined engineering specifications. The implication is that the tests were conducted by qualified personnel in a laboratory setting, not by "experts" rendering opinions on cases.

4. Adjudication method for the test set:

Not applicable. As described above, this is a technical device evaluated against objective performance criteria and standards, not a diagnostic device requiring expert adjudication of results.

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 device is a mechanical filter (breathing circuit bacterial filter) and does not involve AI or human readers for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical filter and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established via objective, quantitative measurements against recognized international standards (e.g., ISO, BS EN, ASTM) and predefined internal acceptance criteria. For example:

Filtration efficiency: Measured experimentally using a challenge organism/material.
Moisture output/loss: Measured experimentally under controlled conditions.
Pressure drop: Measured experimentally at various flow rates.
Biocompatibility: Evaluated through standard in-vitro and in-vivo tests.
Dimensional compliance: Measured against ISO standard specifications.

These are empirical measurements, not expert consensus or pathological findings.

8. The sample size for the training set:

Not applicable. This device is a mechanical product and does not involve a training set for an algorithm.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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: 00 44 1443 474 647

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:

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:

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 - AdultK: 163300	Gibeck Humid-vent Filter CompactK: 964382
Components	Filter housing topFilter housing bottomFilter padHME paperTethered luer port capOuter shrink sleeve	Filter housing topFilter housing bottomFilter padHME paperLuer port capOuter sticker
Materials	Filter housing top - PolypropyleneFilter housing bottom - PolypropyleneFilter pad - PolypropyleneHME paper - PaperTethered luer port cap - PVCOuter shrink sleeve - LDPE	Filter housing top - ABSFilter housing bottom - PolypropyleneFilter pad - PolypropyleneHME paper - Paperluer port cap - ABSOuter 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 andMoisture Exchange) Filters are intended toreduce the transmission of bacteria andviruses to/from a patient, and to maintainmoisture levels in the patient's respiratorytract during anesthesia, artificial respirationand other types of assisted ventilation.An HMEF is normally positioned at the patientend of the breathing system between thecircuit Y-piece and the catheter mount orpatient airway device.Flexicare's ThermoShield HME Filters aresingle use devices for use on a single patientfor up to 24hrs and are available in Adult andMini (pediatric) sizes.Flexicare's ThermoShield HME Filters aredesigned to be used in pre-hospital, hospitaland homecare environments by trainedpersonnel.Expert clinical judgment must be used inassessing patient humidificationrequirements.	Humid-vent filter (HMEF) are combinedHeat and Moisture Exchanger (HME) andBacterial/Viral Filter for humidificationand bacterial/viral filtration duringanesthesia and ventilator care.Expert clinical judgment must be used inassessing the patients humidificationrequirements.Source: Gibeck Humid-Vent FilterCompact 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 22/15mmconnections in compliancewith ISO 5356-1	Yes	Yes
Luer port for gas samplingin compliance with ISO594-2	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 port38g	Straight with luer port31g
Internal Volume/deadspace as per ISO 9360-1	Straight with luer port46ml	Straight with luer port35ml
Bacterial/ Viral Filtrationefficiency/ filter integrity(Fresh)	BFE - 99.999%VFE - 99.99%	BFE - 99.9999%VFE - 99.999%
Salt Method filtrationefficiency	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/ Flowresistance	Straight filters1.71cmH2O @ 30LPM4.31cmH2O @ 60LPM7.82cmH2O @ 90LPM	Straight filters1.25cmH2O @ 30LPM2.96cmH2O @ 60LPM5.21cmH2O @ 90LPM
Housing Burst strength	>101kPa	>101kPa
Leakage per ISO 9360-1 6.4	No leak at 101kPa	No leak at 101kPa
Compliance per ISO 9360-16.5	Straight filters14ml/kPa	Straight filters13ml/kPa
Reuse, Cleaning &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-clinicalTest Results	Verification tests were performed on Flexicare's Adult ThermoShield HME Filter. TheseNon-clinical tests included Visual inspection/comparison, HME moisture output, HMEmoisture loss, Compliance testing, Pressure drop, Conical connector compliance testing,Luer lock compliance testing, shelf life verification, Biocompatibility and Filtrationefficiency. Testing demonstrated that the relevant features, design and performance ofeach manufacturer's device are substantially equivalent.
Conclusion	Flexicare's Adult ThermoShield HME Filter is considered to be substantially equivalent theGibeck Humid-vent Filter Compact. The comparison of each devices features, performance,materials, intended use and intended purpose demonstrate this.
	Flexicare's ThermoShield HME Filters - MiniK: 163300	Gibeck Humid-vent Filter PediK:952084
Components	Filter housing topFilter housing bottomFilter padHME paperTethered luer port capOuter shrink sleeve	Filter housing topFilter housing bottomFilter padHME paperLuer port capOuter sticker
Materials	Filter housing top - PolypropyleneFilter housing bottom - PolypropyleneFilter pad - PolypropyleneHME paper - PaperTethered luer port cap - PVCOuter shrink sleeve - LDPE	Filter housing top - ABSFilter housing bottom - PolypropyleneFilter pad - PolypropyleneHME paper - Paperluer port cap - ABSOuter 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 andMoisture Exchange) Filters are intended toreduce the transmission of bacteria andviruses to/from a patient, and to maintainmoisture levels in the patient's respiratorytract during anesthesia, artificial respirationand other types of assisted ventilation.An HMEF is normally positioned at the patientend of the breathing system between thecircuit Y-piece and the catheter mount orpatient airway device.Flexicare's ThermoShield HME Filters aresingle use devices for use on a single patientfor up to 24hrs and are available in Adult andMini (pediatric) sizes.Flexicare's ThermoShield HME Filters aredesigned to be used in pre-hospital, hospitaland homecare environments by trainedpersonnel.Expert clinical judgment must be used inassessing patient humidificationrequirements.	Humid-Vent Filter Pedi is a combinedheat and moisture exchanger (HME) andbacterial/viral filter for humidificationand bacterial/viral filtration duringanesthesia and intensive care. With luerlock port for ETCO2, anesthetic agent orpressure monitoring Vt50-250ml. Itreduces hypothermia and post-operativeshivering as well as the risk ofbacterial/viral contamination.Source: Gibeck Humid-Vent Filter PediIFU.
Colours	Clear/ colorless, Blue	Clear/ colorless, Blue, White
Standard 22/15mmconnections in compliancewith ISO 5356.1	Yes	Yes

Luer port for gas samplingin compliance with ISO594-2	Yes	Yes
Configurations	Straight with luer port	Straight with luer port
Filtration Method	Electrostatic	Electrostatic
Placement of device withincircuit	Patient end	Patient end
Weight (g)	Straight with luer port25g	Straight with luer port14.5g
Internal Volume/deadspace as per ISO 9360-1	Straight with luer port25ml	Straight with luer port12ml
Bacterial/ Viral Filtrationefficiency/ filter integrity(Fresh)	BFE - 99.99VFE - 99.9	BFE - 99.9999VFE - 99.9
Salt Method filtrationefficiency	97.71%	Not stated
Moisture output (mg/L)	Vt 200 - 30.3mg H2O/L air	Vt 200 - 30.4mg H2O/L air
Moisture loss (mg/L)	Vt 200 - 6.9 mg H2O/L air	Vt 200 - 6.9mg H2O/L air
Tidal Volume Range (ml)	75-600ml	50-250ml
Pressure Drop/ Flowresistance	Straight filters2.02cmH2O @ 30LPM4.86cmH2O @ 60LPM8.61cmH2O @ 90LPM	Straight filters1.90cmH2O @ 30LPM4.72cmH2O @ 60LPM7.98cmH2O @ 90LPM
Housing Burst strength	>101kPa	>101kPa
Leakage per ISO 9360-1 6.4	No leak at 101kPa	No leak at 101kPa
Compliance per ISO 9360-16.5	Straight filters10ml/kPa	Straight filters10ml/kPa
Reuse, Cleaning &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-clinicalTest Results	Verification tests were performed on Flexicare's Mini ThermoShield HME Filter. TheseNon-clinical tests included Visual inspection/comparison, HME moisture output, HMEmoisture loss, Compliance testing, Pressure drop, Conical connector compliance testing,Luer lock compliance testing, shelf life verification, Biocompatibility and Filtrationefficiency. Testing demonstrated that the relevant features, design and performance ofeach manufacturer's device are substantially equivalent.
Conclusion	Flexicare's Mini ThermoShield HME Filter is considered to be substantially equivalent theGibeck Humid-vent Filter Pedi. The comparison of each devices features, performance,materials, intended use and intended purpose demonstrate this.

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Substantial equivalence comparison table - Mini filters

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Although very similar in design and function, there are some differences (described below) between Flexicare's ThermoShield HME Filters and the predicate devices manufactured by Gibeck. However, these differences do not raise new safety or effectiveness issues.

One difference between manufacturers HME filters in both adult and pediatric sizes is the luer cap. Flexicare's ThermoShield HME Filters in both adult and pediatric size (with a luer port) feature a tethered flexible PVC cap that pushes onto and plugs the luer port. Gibeck's adult and pediatric HME Filters (with a luer port) feature an ABS screw on luer cap which plugs the luer port.

Flexicare's ThermoShield HME Filters also differ from the Gibeck predicate devices in their housing materials.

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Image /page/10/Picture/0 description: The image shows the logo for Flexicare. The logo is in blue and red, with the word "flexicare" in blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. The logo is simple and modern.

Flexicare's ThermoShield HME Filters (both adult and pediatric) housing is manufactured from Polypropylene (both top and bottom parts), whilst Gibeck's adult filter housing consists of an ABS top half and a Polypropylene bottom half. Gibeck's Pediatric filter consists of ABS top & bottom halves.

Summary of testing:

Flexicare's ThermoShield HME Filters have been evaluated in accordance with standards listed in Table below:

Test	Standard / Pre Determined AcceptanceCriteria	Outcome
Visual Inspection	Pre-determined Acceptance Criteria*	Pass
Co2 monitoring function test	Pre-determined Acceptance Criteria **	Pass
HME moisture outputHME moisture loss	BS EN ISO 9360: 2009 - Methodology only, nopass criteria - for comparison only.	Methodology only, no passcriteria - Comparableperformance outcome betweenFlexicare's new devices andthe predicate devices
Compliance testing
Pressure drop
Gas Leakage
Conical Connector compliance	BS EN ISO 5356-1 2004	Pass
Leak testing		Pass
Drop testing		Pass
Cytotoxicity, Implant, Sensitization,Genotoxicity	BS EN ISO 10993-10:2010BS EN ISO 10993-5:2009BS EN ISO 10993-3: 2014BS EN ISO 10993-6:2009	Pass
Dimensional inspection of luer	ISO 594-1	Pass
Gauging tests on luer		Pass
Liquid leakage from luer		Pass
Air leakage from luer		Pass
Luer separation force		Pass
Luer unscrewing torque	ISO 594-2 (BS EN 1707:1997)	Pass
Luer ease of assembly		Pass
Luer resistance to overriding		Pass
Luer testing for stress cracking		Pass
Shelf life testing	All standards included within this table	Pass
Filter integrity	Based on ASTM F2101 (Nelson Labs Protocol)BS EN ISO 23328-1 (2008)	Methodology only, no passcriteria within standard.Methodology only, no passcriteria within standard.

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).

** Pre-determined Acceptance Criteria - Co2 monitoring function test

Criteria: Flexicare's HME Filters with monitoring ports must provide a positive consistent CO2 reading when connected to a Capnograph CO2 analyzing machine via a monitoring line.

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Image /page/11/Picture/0 description: The image is a logo for "flexicare". The word "flexicare" is written in a stylized font, with the "f" in red and the rest of the word in blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller blue letters. The logo is simple and modern, and the use of color is eye-catching.

Methodology: Test subject device is connected to a Capnograph CO2 analyzing machine via a monitoring line with BS EN 1707:1997 compliant luer lock connectors. A test volunteer is required to breathe through the patient side steadly over a 1-minute period. Test conductor to note whether a positive, consistent CO2 reading has been achieved.

All Samples passed the performance testing when tested against methods and criteria from predetermined acceptance criteria in-house test methods and relevant BS EN & ISO FDA recognized standards.

The results of this testing show that Flexicare's ThermoShield HME Filters pass all performance tests and performs at least as well as marketed predicate devices "Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight" and "Humid-Vent Filter Pedi" by Gibeck.

The conclusions drawn from the nonclinical performance testing demonstrate that Flexicare's ThermoShield HME Filters are as safe, as effective, as the legally marketed predicate devices "Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight" and "Humid-Vent Filter Pedi" by Gibeck.

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).