Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.

Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Device Description

Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.

Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source.

The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.

Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for Flexicare Heated Wire Breathing Systems and Autofill Humidification Chambers.

It's important to note that this document is a 510(k) summary for a medical device cleared in 2015. It focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a de novo application with extensive clinical trials. Therefore, the information provided is geared towards proving equivalence through performance testing against established standards and predicate device characteristics, rather than detailing a study that "proves the device meets the acceptance criteria" in the sense of a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Device 1: Flexicare Heated Wire Breathing Systems

Characteristic compared (Acceptance Criteria)	Flexicare Adult Heated Wire Breathing Systems (Reported Performance)
Intended use	Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size. (Matches Predicate Device's intended use)
Target population	Adult (Matches Predicate Device)
Environment used	Hospital (Matches Predicate Device)
Volume (ml)	926 (Predicate: 1090) - Difference acknowledged, but deemed substantially equivalent
Tube length (m)	Ins - 1.6m; Exp - 1.6m (Matches Predicate Device)
Wire resistance (ohms)	Ins - 18.55; Exp - 25.9 (Predicate: Ins - 17.5, Exp - 22.6) - Differences acknowledged, but outcomes of heat dispersal and temperature not exceeding 37ºC maintained
Tube material and designated diameter	Ins - Corrugated 22MM; Exp - Smoothbore 22MM (Predicate: Ins - Corrugated 22MM, Exp - Smoothbore 22MM) - The summary later clarifies a difference: Flexicare has corrugated inspiratory and smoothbore expiratory, while F&P has corrugated for both. This difference is discussed as not impacting substantial equivalence.
Rated Flow	40L.min (Matches Predicate Device)
Compliance (ml/Kpa)	7.68ML/kPa (Predicate: 8.93ML/kPa) - Difference acknowledged, but deemed substantially equivalent
Resistance to flow @ 30 lpm (mb)	0.3 (Predicate: 0.2) - Difference acknowledged, but deemed substantially equivalent
Compatibility with environment and other devices	To be used with Flexicare Autofill Humidification Chamber. Compatible with F & P MR850 Respiratory Gas Humidifier. (Matches Predicate Device's compatibility with F&P MR290 and MR850)
Active controller	No - Humidifier controlled (Matches Predicate Device)
Energy used and/or delivered	Due to the wire resistance, heat is dispersed into the breathing tube lumen. As a result, the air passing through the tubing is warmed whilst travelling to patient, reducing the water condensation in the breathing System. The raising of the gas temperature does not exceed 37ºC. (Matches Predicate Device)
Sterility Standards Met	Sterile – Ethylene Oxide Gas (Predicate: Non-Sterile) - Difference in sterility presented, but likely mitigated by device classification and subsequent testing ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 (Predicate met similar standards, but not BS EN 556)
Biocompatibility	ISO 10993 compliant (Matches Predicate Device)
Electrical Safety	IEC 60601-1 compliant, IEC 60601-1-2 compliant (Matches Predicate Device)
Non-clinical Test Results (various performance tests)	All tests listed below are reported as "Pass" against "Pre-Determined Acceptance Criteria" or relevant ISO/ASTM/IEC standards: Visual inspection, Dimensional inspection, System internal volume, Wire resistance, Tubing resistance to flow, MR850 start-up test/system compatibility check, Means of connection (ISO 5367:2000), Tubing resistance to flow, Increase in flow with bending, Leakage, Compliance, Packaging Pouch Integrity (ASTM F1886-09, ASTM F88-09, ASTM F1929-12), Conical Connector compliance (ISO 5356-1:2004), Leak testing, Drop testing, Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation, Sub-Acute Toxicity (ISO 10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009), Testing to ISO 5367, temp probe tensile testing, temp port leaking (ISO 8185:2007), Electromagnetic capability & Electrical safety testing (BS EN 60601-1:2006, BS EN 60601-1-2:2007, IEC 60601-1:2005 +CORR.1:2006 CORR. 2:2007).

Device 2: Flexicare Autofill Humidification Chamber

Characteristic compared (Acceptance Criteria)	Flexicare Autofill Humidification Chamber (Reported Performance)
Intended use	Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment. (Slightly broader than predicate, but still within scope of humidification)
Target population	Any patient using a heated humidifier (Matches Predicate Device)
Environment used	Hospital (Matches Predicate Device)
Fill Volume (ml)	Full = 292; Max = 114.9 (Predicate: Full = 340; Max = 83.9) - Differences acknowledged, but deemed substantially equivalent
Weight (g)	124 (Predicate: 109.5) - Difference acknowledged, but deemed substantially equivalent
Leakage (ml/min)	No leakage (Matches Predicate Device)
Compliance at empty (ml/Kpa)	5.5 (Matches Predicate Device)
Resistance to flow @ 60 lpm (mb)	0.1 (Predicate: 0.3) - Difference acknowledged, indicating potentially better performance, but deemed substantially equivalent
Moisture output (mg/l) at 10lpm	46.6 (Predicate: 53.9) - Difference acknowledged, but deemed substantially equivalent. This is a performance parameter and the difference may be material depending on exact requirements, but the submission claims substantial equivalence.
Compatibility with environment and other devices	To be used with Flexicare's Heated Wire Breathing Systems and F & P MR850 Respiratory Gas Humidifier. (Matches Predicate Device's compatibility with F&P Heated Wire Breathing Systems and MR850)
Energy used and/or delivered	Electrical energy within heater unit is used to raise the temperature and humidity of the gas delivered to the patient. (Matches Predicate Device)
Sterility Standards Met	Sterile - Ethylene Oxide Gas (Predicate: Non-Sterile) - Difference in sterility presented, but likely mitigated by device classification and subsequent testing ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556 (Predicate met similar standards, but not BS EN 556)
Biocompatibility	ISO 10993 compliant (Matches Predicate Device)
Electrical Safety	IEC 60601-1 compliant, IEC 60601-1-2 compliant (Matches Predicate Device)
Non-clinical Test Results (various performance tests)	All tests listed below are reported as "Pass" against "Pre-Determined Acceptance Criteria" or relevant ISO/ASTM/IEC standards: Visual inspection/comparison, Dimensional inspection, Internal Volume, resistance to flow, conical connector compliance, connector strength, leaking, tensile strength, compliance, humidification output, shelf life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility.

Study Information (Based on provided 510(k) Summary)

The document describes non-clinical performance testing rather than a clinical study as would be typical for proving effectiveness for new technology. The primary study presented is a substantial equivalence comparison with predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a numerical count of individual units for each test, but it refers to "All Samples" passing performance testing. The provenance is internal company testing (Flexicare Medical Limited, UK). The tests are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance.
Data Provenance: The testing was conducted by Flexicare Medical Limited, located in the United Kingdom.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the "ground truth" for these tests are objective, measurable physical properties and compliance with engineering standards (e.g., resistance values, leakage rates, dimensional properties). These are not subjective interpretations requiring human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and comparisons against pre-defined acceptance criteria or industry standards. There is no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a technical device and not an AI or diagnostic imaging device that would typically involve human readers for interpretation. Therefore, a MRMC study is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense. The performance tests ("Non-clinical Test Results") are standalone evaluations of the device's physical and functional properties against predefined criteria and standards. There is no "human-in-the-loop" component in evaluating the device's technical specifications. The devices themselves do not incorporate AI or complex algorithms requiring such evaluation.

7. Type of Ground Truth Used

The "ground truth" for these tests is based on:
- Objective physical measurements: (e.g., volume, length, resistance, weight, flow rates).
- Compliance with international standards: (e.g., ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, ISO 10993, ASTM F1886, ASTM F88, ASTM F1929, BS EN 556).
- Comparison to a legally marketed predicate device: The characteristics and performance of the predicate device (Fisher & Paykel RT380 and MR290) serve as a benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this device does not involve AI/ML, there is no training set or associated ground truth for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 15, 2015

Flexicare Medical Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K150900

Trade/Device Name: Flexicare Heated Wire Breathing Systems Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE, BTT Dated: April 30, 2015 Received: May 1, 2015

Dear Mr. 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.

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Page 2 - Mark Job

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

Device Name

Flexicare Heated Wire Breathing Systems

Indications for Use (Describe)

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."

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Indications for Use

510(k) Number (if known)

Device Name

Flexicare Autofill Humidification Chamber

Indications for Use (Describe)

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.

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."

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Image /page/4/Picture/0 description: The image is a logo for Flexicare. The logo has the word "flexicare" in blue and red, with the "flexi" in blue and the "care" in red. To the left of the word is a stylized "f" in red and blue. Below the word is the phrase "TOTAL QUALITY - TOTAL CARE" in red.

SECTION 4

510(k) Summary

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Image /page/5/Picture/0 description: The image shows the 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. Above the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. The logo is simple and modern, and it conveys a sense of quality and care.

Cynon Valley Business Park, Mountain Ash, Mid Glamorgan. CF45 4ER UK. Tel: +44 (0)1443 474647 Fax: +44 (0)1443 474222 Customer Services: +44 (0)1443 471580 Purchasing Fax: +44 (0)1443 476332 Email: enquiries@flexicare.com www.flexicare.com

510(k) Summary

510(k) Sponsor, Contact Person and Date Summary Prepared:

Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom

Joel Biddle Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222

Summary prepared on: May 2015

Device Name:

Trade Name: Flexicare Heated Wire Breathing Systems

Common/Usual Name: Heated Breathing System

Classification Name: Breathing System Heater: 21 CFR 868.5270

Product Codes: BZE (breathing system heater) and BTT (respiratory gas humidifier).

Legally Marketed Equivalent Device:

Flexicare's Adult Heated Wire Breathing Systems are substantially equivalent to Fisher & Paykel's Adult RT380 Heated Breathing Circuit cleared under K122432.

Flexicare's Autofill Humidification Chamber is substantially equivalent to Fisher & Paykel's MR290 Autofill Humidification chamber cleared under K934140.

Device Description:

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Image /page/6/Picture/0 description: The image is a logo for "flexicare". The logo has the word "flexicare" in blue and red letters. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red letters.

The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.

Intended Use:

Humidification Chambers are intended for use to hold water reguired to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Substantial Equivalence:

Flexicare's Heated Wire Breathing Systems have the same intended use as the predicate device.

Flexicare's Heated Wire Breathing Systems and the Predicate device are single patient use devices. Supplied in Adult sizes.

Neither manufacturer's devices are life supporting or life sustaining.

Patient Contact -

Skin Contact & Externally Communicating - Prolonged duration <30days (for max 7 days use)

Neither Flexicare's Heated Wire Breathing Systems nor the predicate device by Fisher & Paykel require software to operate/function.

Flexicare's Heated Wire Breathing Systems & the predicate device require connection to an electronically powered Fisher & Paykel MR850 Respiratory Gas Humidifier.

Flexicare's Heated Wire Breathing Systems are supplied sterile in individual EO permeable pouches. Fisher & Paykel's devices are supplied non-sterile in sealed Polybags.

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Both devices are able to be used with industry standard devices such as ventilators and catheter mounts.

Both Flexicare's Heated Wire Breathing Systems & the predicate device are designed for the same intended use in the same intended conditions.

Both designs consist of components made from injection molded & extruded plastics. During comparison testing it was determined that there were no invasive components in either of the manufacturer's devices.

The gas delivering tubing of both the Flexicare and predicate device are manufactured from Low density Polyethylene. Both manufacturers' device's feature an inspiratory limb angled 22mm female connector with temperature port. Both manufacturers' device's also feature a Y-piece connector with temperature port at the patient end.

All connectors on both Flexicare and Predicate devices are conical connectors compliant with ISO 5356-1:2004.

Flexicare Heated Wire Breathing System tubes are blue and/or colorless with all connectors blue in color except for the angled machine-end connectors which are colorless. The Fisher and Paykel Heated Wire Breathing System tubes are blue and/or colorless with colorless connectors.

Any differences in color/shade between the Flexicare devices and the predicate devices is by manufacturer's choice/ branding, and is not related to sizing, intended use, gender of patient or performance of device.

Both manufacturer's devices are supplied with an automatically filling humidification chamber.

Both Flexicare Heated Wire Breathing Systems and Predicate device have 1,6m breathing tube length.

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Image /page/8/Picture/0 description: The image is a logo for "flexicare". The logo is made up of the word "flexicare" in blue and red, with the "f" in "flexi" being stylized with two curved lines, one red and one blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller blue letters.

Substantial equivalence comparison table - Adult Heated Wire Breathing Systems

Flexicare's Heated Wire Breathing Systems are substantially equivalent to RT380 Heated Wire Breathing System manufactured by Fisher & Paykel (510(k) K122432) The Table below shows the similarities and differences between the Flexicare Medical Adult Heated Wire Breathing Systems and Fisher & Paykel predicate device.

Characteristic compared	Flexicare Adult Heated Wire Breathing Systems	Predicate Device F&P RT380
510K	K: Unknown	K:122432
Intended use	Flexicare Heated Wire Breathing Systems areintended for use to connect a patient's airwayto a Ventilator and Humidification Chamber aspart of a complete system to provide warmedand humidified inspired respiratory gases toventilated patients and those receivingrespiratory support. Intended for Adultpatients within a hospital environment.Compatible with Fisher & Paykel MR850Respiratory Gas Humidifier. Available in Adult(038-31-748U) size.	The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended asconduits of breathing gas for ventilation ofadult patients, and to maintain thetemperature of humidified inspired gas.Source: K122432 SE letter from FDA
Target population	Adult	Adult
Indications for use	Instruction leaflet	Instruction leaflet
Environment used	Hospital	Hospital
Product labelling	Heated Wire Breathing System	Heated Wire Breathing System
Volume (ml)	926	1090
Tube length (m)	Ins - 1.6mExp - 1.6m	Ins - 1.6mExp - 1.6m
Wire resistance (ohms)	Ins - 18.55Exp - 25.9	Ins - 17.5Exp - 22.6
Tube material and designated diameter	Ins - Corrugated 22MMExp - Smoothbore 22MM	Ins - Corrugated 22MMExp - Smoothbore 22MM
Rated Flow	40L.min	40L.min
Compliance (ml/Kpa)	7.68ML/kPa	8.93ML/kPa
Resistance to flow @ 30 lpm (mb)	0.3	0.2
Compatibility with the environment and other devices.	To be used with Flexicare AutofillHumidification Chamber. Compatible with F &P MR850 Respiratory Gas Humidifier.	To be used with F & P MR290 HumidificationChamber. Compatible with F & P MR850Respiratory Gas Humidifier.
Activecontroller	No - Humidifier controlled	No - Humidifier controlled
Energy usedand ordelivered	Due to the wire resistance, heat is dispersedinto the breathing tube lumen. As a result, theair passing through the tubing is warmedwhilst travelling to patient, reducing the watercondensation in the breathing System. Theraising of the gas temperature does notexceed 37ºC	Due to the wire resistance, heat is dispersedinto the breathing tube lumen. As a result, theair passing through the tubing is warmedwhilst travelling to patient, reducing the watercondensation in the breathing System. Theraising of the gas temperature does notexceed 37°C
SterilityStandards Met	Sterile – Ethylene Oxide GasISO 5367ISO 5356ISO 8185IEC 60601-1ISO 10993BS EN 556	Non-SterileISO 5367ISO 5356ISO 8185IEC 60601-1ISO 10993
Biocompatibility	ISO 10993 compliant	ISO 10993 compliant
Electrical Safety	IEC 60601-1 compliantIEC 60601-1-2 compliant	IEC 60601-1 compliantIEC 60601-1-2 compliant
Non-clinicalTest Results	Verification tests were performed to establish the safety and efficacy of Flexicare's 038-31-748U Heated Wire Breathing System. These Non-clinical tests included Visualinspection/comparison, Dimensional inspection, Internal Volume, Heated wire resistance,resistance to flow, humidifier start up/compatibility, conical connector compliance, connectorstrength, leaking, drop testing, tensile strength, tube compliance, humidification output, shelflife verification, Electromagnetic Capability, Electrical Safety and Biocompatibility. Testingdemonstrated that the relevant features, design and performance of each manufacturer'sdevice are substantially equivalent.
Conclusion	Flexicare's 038-31-748U Heated Wire Breathing System is considered to be substantiallyequivalent to the Fisher & Paykel RT380 Breathing Circuit. The comparison of features,performance, materials and intended use demonstrate that Flexicare's 038-31-748U HeatedWire Breathing System is as safe and effective as the predicate device for its intended purpose.

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Image /page/9/Picture/0 description: The image is a logo for a company called "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 tagline "TOTAL QUALITY - TOTAL CARE", which is written in red. The logo is simple and modern, and it conveys a sense of quality and care.

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Image /page/10/Picture/0 description: The image is a logo for "flexicare". The logo is made up of the word "flexicare" in blue and red, with the "f" in "flexi" being stylized with two curved lines, one red and one blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller blue letters.

Substantial equivalence comparison table - Autofill Humidification Chamber

Flexicare's Autofill Humidification Chamber is substantially equivalent to MR290 Autofill Humidification Chamber manufactured by Fisher & Paykel (510(k) K934140) The Table below shows the similarities and differences between the Flexicare Medical Autofill Humidification chamber and Fisher & Paykel predicate device.

Characteristic compared	Flexicare Autofill Humidification Chamber	Predicate DeviceF&P MR290K:934140
510K
Intended use	Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.	Humidification chambers are intended for use to hold water required to humidify the air being delivered to patients.
Target population	Any patient using a heated humidifier	Any patient using a heated humidifier
Indications for use	Instruction leaflet	Instruction leaflet
Environment used	Hospital	Hospital
Product labelling	Autofill Humidification chamber	Autofill Humidification chamber
Fill Volume (ml)	Full = 292Max = 114.9	Full = 340Max = 83.9
Weight (g)	124	109.5
Leakage (ml/min)	No leakage	No leakage
Compliance at empty (ml/Kpa)	5.5	5.5
Resistance to flow @ 60 lpm (mb)	0.1	0.3
Moisture output (mg/l) at 10lpm	46.6	53.9
Compatibility with the environment and other devices.	To be used with Flexicare's Heated Wire Breathing Systems and F & P MR850 Respiratory Gas Humidifier.	To be used with F & P Heated Wire Breathing Systems and F & P MR850 Respiratory Gas Humidifier.
Energy used and or delivered	Electrical energy within heater unit is used to raise the temperature and humidity of the gas delivered to the patient	Electrical energy within heater unit is used to raise the temperature and humidity of the gas delivered to the patient
Sterility	Sterile - Ethylene Oxide Gas	Non-Sterile
Standards Met	ISO 5367ISO 5356ISO 8185IEC 60601-1ISO 10993BS EN 556	ISO 5367ISO 5356ISO 8185IEC 60601-1ISO 10993
Biocompatibility	ISO 10993 compliant	ISO 10993 compliant
Electrical Safety	IEC 60601-1 compliantIEC 60601-1-2 compliant	IEC 60601-1 compliantIEC 60601-1-2 compliant

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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 letters in blue. Above the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. The logo is simple and modern, and it conveys a sense of quality and care.

Non-clinical TestResults	Verification tests were performed to establish the safety and efficacy of Flexicare's AutofillHumidification Chamber. These Non-clinical tests included Visual inspection/comparison,Dimensional inspection, Internal Volume, resistance to flow, conical connectorcompliance, connector strength, leaking, tensile strength, compliance, humidificationoutput, shelf life verification, Electromagnetic Capability, Electrical Safety andBiocompatibility. Testing demonstrated that the relevant features, design andperformance of each manufacturer's device are substantially equivalent.
Conclusion	Flexicare's Autofill Humidification Chamber is considered to be substantially equivalent tothe Fisher & Paykel MR290 Humidification Chamber. The comparison of features,performance, materials and intended use demonstrate that Flexicare's AutofillHumidification Chamber is as safe and effective as the predicate device for its intendedpurpose.

Non-clinical TestResults

Verification tests were performed to establish the safety and efficacy of Flexicare's AutofillHumidification Chamber. These Non-clinical tests included Visual inspection/comparison,Dimensional inspection, Internal Volume, resistance to flow, conical connectorcompliance, connector strength, leaking, tensile strength, compliance, humidificationoutput, shelf life verification, Electromagnetic Capability, Electrical Safety andBiocompatibility. Testing demonstrated that the relevant features, design andperformance of each manufacturer's device are substantially equivalent.

Conclusion

Flexicare's Autofill Humidification Chamber is considered to be substantially equivalent tothe Fisher & Paykel MR290 Humidification Chamber. The comparison of features,performance, materials and intended use demonstrate that Flexicare's AutofillHumidification Chamber is as safe and effective as the predicate device for its intendedpurpose.

Summary of performance Testing: Flexicare's Heated Wire Breathing Systems have been evaluated in accordance with standards listed in table:

Test	Standard / Pre-DeterminedAcceptance Criteria	Outcome
Visual inspection	Pre-Determined Acceptance Criteria	Pass
Dimensional inspection	Pre-Determined Acceptance Criteria	Pass
System internal volume	Pre-Determined Acceptance Criteria	Pass
Wire resistance	Pre-Determined Acceptance Criteria	Pass
Tubing resistance to flow	Pre-Determined Acceptance Criteria	Pass
MR850 start-up test/ system compatibility check	Pre-Determined Acceptance Criteria	Pass
Means of connection	ISO 5367:2000	Pass
Tubing resistance to flow
Increase in flow with bending
Leakage
Compliance
Packaging Pouch Integrity
	ASTM F1886-09ASTM F88-09ASTM F1929-12	Pass
Conical Connector compliance	ISO 5356-1:2004	Pass
Leak testing
Drop testing
Cytotoxicity, Irritation, Sensitization, SystemicToxicity, Genotoxicity, Implantation, Sub-AcuteToxicity
	10993-10:201010993-5:200910993-3:201410993-6:2009	Pass
Testing to ISO 5367, temp probe tensile testing,temp port leaking	ISO 8185:2007	Pass
Electromagnetic capability & Electrical safetytesting	BS EN 60601-1:2006BS EN 60601-1-2:2007IEC 60601-1:2005 +CORR.1:2006CORR. 2:2007	Pass

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All Samples 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 Heated Wire Breathing Systems pass all performance tests and performs at least as well as the marketed predicate devices.

Although very similar in design and function there are some differences, as described below, between the Flexicare Heated Wire Breathing Systems and the predicate devices from Fisher & Paykel.

The Flexicare Heated Wire Breathing System has a corrugated inspiratory limb and a smoothbore expiratory limb whilst the Fisher and Paykel device has corrugated limbs for both inspiratory and expiratory.

Another difference between Flexicare's device and its predicate device from Fisher & Paykel is the colour of tubing, connectors and accessories. However, these differences in colour are only due to individual company branding/marketing.

The overall conclusion from the comparison testing is that Flexicare's Heated Wire Breathing Systems are considered to be substantially equivalent to that of the predicate devices.

Regulation Number and Section

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).