Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway 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 Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.

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 Neonatal 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 Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification 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 Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.

AI/ML Overview

The provided text describes the Flexicare Neonatal Heated Wire Breathing Systems and Autofill Humidification Chamber seeking clearance via a 510(k) pathway, asserting substantial equivalence to predicate devices (Fisher & Paykel RT235 Heated Breathing Circuit and MR290 Autofill Humidification Chamber).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

Substantial Equivalence Study: The entire document is a 510(k) summary, which is a submission to the FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. The "study" here is thus a comprehensive comparison and verification testing program, often referred to as non-clinical performance testing.
No AI Component: The devices described (heated wire breathing systems and humidification chambers) are hardware-based medical devices. There is no mention of algorithms, artificial intelligence (AI), machine learning (ML), or software with diagnostic or therapeutic capabilities. Therefore, questions related to expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable.
Ground Truth for Testing: The "ground truth" for the non-clinical tests is based on established engineering principles, recognized international standards (ISO, ASTM, IEC, BS EN), and pre-determined acceptance criteria derived from the predicate device's performance or general medical device safety and efficacy requirements.

1. Table of Acceptance Criteria and the Reported Device Performance

The document provides two comparison tables (one for the breathing system and one for the humidification chamber) listing characteristics between the Flexicare device and its predicate. Additionally, a "Summary of performance Testing" table (page 10) outlines specific tests, their standards/acceptance criteria, and the outcome.

Flexicare Neonatal Heated Wire Breathing Systems

Characteristic Compared	Flexicare Neonatal Heated Wire Breathing Systems	Predicate Device F&P RT235 (K034026)	Acceptance Criteria/Standard	Flexicare Performance (Outcome)
Intended Use	Connect patient airway to Ventilator and Humidification Chamber for warmed/humidified inspired gases. Neonatal patients, hospital environment. Compatible with F&P MR850. Flow rates >4L/min.	Conduits of breathing gas for ventilation, maintain temperature of humidified inspired gas. RT235 for flow rates >4L/min, infant patients.	The Flexicare device has the "same intended use as the predicate device" (page 5).	Substantially equivalent
Target Population	Neonatal	Neonatal	Matching target population.	Equivalent
Volume (ml)	500	375	No explicit acceptance criterion given for this difference, but overall conclusion states substantial equivalence. Differences in volume, while noted, were deemed not to affect substantial equivalence.	Not directly applicable for pass/fail
Wire Resistance (ohms)	Ins – 21.6, Exp - 19.2	Ins – 21.8, Exp - 22.9	No explicit acceptance criterion given for this difference, but overall conclusion states substantial equivalence.	Not directly applicable for pass/fail
Tube Material/Diameter	Ins - Corrugated 15mm, Exp - Smoothbore 15mm	Ins - Corrugated 15mm, Exp - Corrugated 15mm	No explicit acceptance criterion for the smoothbore vs corrugated expiratory limb difference, but overall deemed to not affect safety/efficacy upon testing (page 11 mentions this difference and concludes it does not affect safety/effectiveness).	Not directly applicable for pass/fail
Rated Flow	>4L/min	>4L/min	Matching rated flow. Equivalent
Compliance (ml/Kpa)	5.18 ml/kPa	3.64 ml/kPa	No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence.	Not directly applicable for pass/fail
Resistance to Flow @ 30 Lpm	2.7 mb	2.1 mb	No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence.	Not directly applicable for pass/fail
Compatibility	Flexicare Autofill Humidification Chamber, F&P MR850 Resp Gas Humidifier	F&P MR290 Humidification Chamber, F&P MR850 Resp Gas Humidifier	The Flexicare device is compatible with the required humidifier predicate (F&P MR850).	Compatible
Sterility	Sterile - Ethylene Oxide Gas	Non-Sterile	Standards for sterility were met (BS EN 556 listed). This difference is noted but not deemed to preclude substantial equivalence.	Passed sterility standard
Standards Met	ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556	ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993	Compliance with relevant recognized international standards is a core acceptance criterion.	All standards passed
Biocompatibility	ISO 10993 compliant	ISO 10993 compliant	ISO 10993 compliance.	Compliant
Electrical Safety	IEC 60601-1 compliant, IEC 60601-1-2 compliant	IEC 60601-1 compliant, IEC 60601-1-2 compliant	IEC 60601-1 and 60601-1-2 compliance.	Compliant

Flexicare Autofill Humidification Chamber

Characteristic Compared	Flexicare Autofill Humidification Chamber	Predicate Device F&P MR290 (K934140)	Acceptance Criteria/Standard	Flexicare Performance (Outcome)
Intended Use	Hold water to humidify air delivered to patients. Any patient, hospital environment.	Hold water to humidify air delivered to patients.	The Flexicare device has the "same intended use as the predicate device" (page 9).	Substantially equivalent
Fill Volume (ml)	Full = 292, Max = 114.9	Full = 340, Max = 83.9	No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence.	Not directly applicable for pass/fail
Weight (g)	124	109.5	No explicit acceptance criterion for this difference, but overall conclusion states substantial equivalence.	Not directly applicable for pass/fail
Leakage (ml/min)	No leakage	No leakage	No leakage.	Passed
Compliance at empty (ml/Kpa)	5.5	5.5	Matching compliance.	Equivalent
Resistance to Flow @ 60 lpm (mb)	0.1	0.3	Lower resistance to flow than predicate, which is a positive performance characteristic.	Passed
Moisture Output (mg/l) at 10 lpm	46.6	53.9	The moisture output is slightly lower than the predicate (46.6 vs 53.9). However, no specific acceptance criterion is stated for this. The overall conclusion still asserts substantial equivalence, implying this difference was acceptable within the context of the device's intended use and overall performance profile.	Not directly applicable for pass/fail
Compatibility	Flexicare's Heated Wire Breathing Systems, F&P MR850 Respiratory Gas Humidifier	F&P Heated Wire Breathing Systems, F&P MR850 Respiratory Gas Humidifier	The Flexicare device is compatible with the required humidifier predicate (F&P MR850).	Compatible
Sterility	Sterile - Ethylene Oxide Gas	Non-Sterile	Standards for sterility were met (BS EN 556 listed). This difference is noted but not deemed to preclude substantial equivalence.	Passed sterility standard
Standards Met	ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556	ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993	Compliance with relevant recognized international standards is a core acceptance criterion.	All standards passed
Biocompatibility	ISO 10993 compliant	ISO 10993 compliant	ISO 10993 compliance.	Compliant
Electrical Safety	IEC 60601-1 compliant, IEC 60601-1-2 compliant	IEC 60601-1 compliant, IEC 60601-1-2 compliant	IEC 60601-1 and 60601-1-2 compliance.	Compliant

Performance Testing Summary (Page 10)

Test	Standard / Pre-Determined Acceptance 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	(These are listed separately without explicit standards, assumed under Pre-Determined Acceptance Criteria or relevant ISO standards)	Pass
Packaging Pouch Integrity	ASTM F1886-09, ASTM F88-09, ASTM F1929-12	Pass
Conical Connector compliance	ISO 5356-1:2004	Pass
Leak testing	(Assumed under Pre-Determined Acceptance Criteria)	Pass
Drop testing	(Assumed under Pre-Determined Acceptance Criteria)	Pass
Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation, Sub-Acute Toxicity, Extractables & Leachables testing.	10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009, 10993-17:2009	Pass
Testing to ISO 5367, temp probe tensile testing, temp port leaking	ISO 8185:2007	Pass
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	Pass

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

Sample Size for Test Set: The document does not specify the exact number of units/samples used for each non-clinical test (e.g., how many systems were visually inspected, or how many were subjected to drop testing). It generally states "Verification tests were performed" or "Testing demonstrated."
Data Provenance: The tests are explicitly referred to as "Non-clinical Test Results" and "Verification tests." These are laboratory-based engineering and performance tests conducted on the physical devices. The country of origin for the data is implicitly the UK, where Flexicare Medical Limited is located. The nature of testing is prospective in the sense that the new Flexicare devices were manufactured and then specifically tested against established standards and in comparison to a predicate device.

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

Not Applicable. This is a non-clinical device clearance, not an AI/clinical diagnostic study. The "ground truth" for the test set is determined by the specifications in recognized international standards (ISO, ASTM, IEC, BS EN) and the pre-determined acceptance criteria established by the manufacturer, which are based on engineering requirements and predicate device performance. There are no "experts" establishing a clinical "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical device testing, there is no need for adjudication as typically understood in clinical or AI performance studies involving human readers. Test results are objectively measured against predefined criteria.

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. The device is not an AI-powered diagnostic tool, and no human-reader study was conducted or is relevant for this type of device clearance.

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

Not Applicable. The device is a physical medical device (breathing systems and humidification chambers), not an algorithm or software. No standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on:
- Recognized International Standards: Such as ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556, ASTM F1886-09, ASTM F88-09, ASTM F1929-12. These standards define the expected performance metrics, safety requirements, and test methodologies for medical devices of this type.
- Predicate Device Performance: Direct comparison to the Fisher & Paykel RT235 and MR290 devices forms a key basis for establishing substantial equivalence.
- Pre-Determined Acceptance Criteria: For tests not covered by specific standards, Flexicare established internal "Pre-Determined Acceptance Criteria" based on engineering specifications and ensuring safety and effectiveness comparable to the predicate.

8. The Sample Size for the Training Set

Not Applicable. This refers to machine learning models, which are not part of this submission. There is no "training set" in the context of this traditional medical device clearance. The development of the device itself would involve engineering design and iterative prototyping, but not a dataset for training an algorithm.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are the most prominent element of the logo.

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

June 23, 2016

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

Re: K160540

Trade/Device Name: Flexicare Neonatal Heated Wire Breathing Systems Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE, BTT Dated: May 27, 2016 Received: June 8, 2016

Dear 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.

{1}------------------------------------------------

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 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/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 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.

Sincerely,

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K160540

Device Name

Flexicare Neonatal 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."

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

Device Name

Flexicare Autofill Humidification Chamber

Indications for Use (Describe)

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

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.2

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 estimale 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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for "flexicare". The word "flexicare" is written in blue and red letters, with the first two letters in red and the rest in blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red letters. The logo is simple and modern, and it is likely used to represent a company or organization that provides flexible care services.

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 Senior Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222

Summary prepared on: May 27th, 2016

Device Name:

Trade Name: Flexicare Neonatal 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 Neonatal Heated Wire Breathing Systems are substantially equivalent to Fisher & Paykel's Neonatal RT235 Heated Breathing Circuit cleared under K034026.

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

Device Description:

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for "flexicare". The logo has the word "flexicare" in a stylized font, with the "f" in red and blue, and the rest of the word in blue and red. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in blue. The logo is simple and modern, and it conveys a sense of quality and care.

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

Intended Use:

Flexicare Neonatal 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 Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.

Substantial Equivalence:

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

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

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

Patient Contact

Externally Communicating - Tissue contact of permanent duration.

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

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

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

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

Both Flexicare's Neonatal 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 qas delivering tubing of both the Flexicare and predicate device are manufactured from Low density Polyethylene. Both manufacturers' device's feature an inspiratory limb angled

{6}------------------------------------------------

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 red and blue swoosh. The rest of the word is written in blue and red. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller, red letters.

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 Neonatal 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 Neonatal Heated Wire Breathing Systems and Predicate device have 1.6m expiratory tube length breathing tube length.

Flexicare's Neonatal Heated Wire Breathing Systems Inspiratory tube is 1100mm + 300mm in length.

Fisher & Paykel predicate device Inspiratory tube is 1100mm + 360mm in length.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for "flexicare". The "f" in flexicare is stylized with a red and blue line that curves around the word. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".

Substantial equivalence comparison table - Neonatal Heated Wire Breathing Systems

Flexicare's Neonatal Heated Wire Breathing Systems are substantially equivalent to RT235 Heated Wire Breathing System manufactured by Fisher & Paykel (510(k) K034026) The Table below shows the similarities and differences between the Flexicare Medical Neonatal Heated Wire Breathing Systems and Fisher & Paykel predicate device.

Characteristiccompared	Flexicare Neonatal Heated Wire BreathingSystems	Predicate DeviceF&P RT235
510K	K:160540	K:034026
Intended use	Flexicare Neonatal Heated Wire BreathingSystems are intended for use to connect apatient's airway to a Ventilator andHumidification Chamber as part of a completesystem to provide warmed and humidifiedinspired respiratory gases to ventilatedpatients and those receiving respiratorysupport. Intended for Neonatal patientswithin a hospital environment. Compatiblewith Fisher & Paykel MR850 Respiratory GasHumidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.	The dual-heated breathing circuits areintended as conduits of breathing gas forventilation of patients, and to maintainthe temperature of humidified inspiredgas.The RT236 is used for flow rates between0.3 and 4 L/min, and the RT235 is for flowrates greater than 4 L/min, for infant patients.Source: K034026 SE letter from FDA
Targetpopulation	Neonatal	Neonatal
Indications foruse	Instruction leaflet	Instruction leaflet
Environmentused	Hospital	Hospital
Productlabelling	Heated Wire Breathing System	Heated Wire Breathing System
Volume (ml)	500	375
Tube length (m)	Ins – 1.1m + 300mm extensionExp - 1.66m	Ins – 1.1m + 360mm extensionExp - 1.65m
Wire resistance(ohms)	Ins – 21.6Exp - 19.2	Ins – 21.8Exp - 22.9
Tube materialand designateddiameter	Ins - Corrugated 15mmExp - Smoothbore 15mm	Ins - Corrugated 15mmExp - Corrugated 15mm
Rated Flow	>4L.min	>4L.min
Compliance(ml/Kpa)	5.18ML/kPa	3.64ML/kPa
Resistance toflow @ 30 lpm(mb)	2.7	2.1
Compatibilitywith theenvironmentand otherdevices	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 37°C	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
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
Non-clinicalTest Results	Verification tests were performed to establish the safety and efficacy of Flexicare's 038-33-201U Neonatal 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.Testing demonstrated that the relevant features, design and performance of eachmanufacturer's device are substantially equivalent.
Conclusion	Flexicare's 038-33-201U Neonatal Heated Wire Breathing System is considered to besubstantially equivalent to the Fisher & Paykel RT235 Breathing Circuit. The comparison offeatures, performance, materials and intended use demonstrate that Flexicare's 038-33-201UNeonatal Heated Wire Breathing System is as safe and effective as the predicate device for itsintended purpose

{8}------------------------------------------------

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

{9}------------------------------------------------

Image /page/9/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 a stylized font. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller blue letters. The logo is simple and modern, and it is likely used to represent a company that provides flexible care services.

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	Flexicare Autofill Humidification Chamber	Predicate Device
compared		F&P MR290
510K	K:160540	K:934140
Intended use	Humidification Chambers are intended foruse to hold water required to humidify theair being delivered to patients. Intendedfor any patient requiring activehumidification within a hospitalenvironment.	Humidification chambers are intended foruse to hold water required to humidify theair 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	To be used with Flexicare's Heated Wire	To be used with F & P Heated Wire
environment and	Breathing Systems and F & P MR850	Breathing Systems and F & P MR850
other devices.	Respiratory Gas Humidifier.	Respiratory Gas Humidifier.
Energy used and ordelivered	Electrical energy within heater unit is usedto raise the temperature and humidity ofthe gas delivered to the patient	Electrical energy within heater unit is usedto raise the temperature and humidity of thegas 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
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 connector

{10}------------------------------------------------

Image /page/10/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. Above the word "flexicare" is a red and blue graphic that looks like a stylized "f". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".

	compliance, 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 Neonatal 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, Extractables & Leachables testing.	10993-10:201010993-5:200910993-3:201410993-6:200910993-17:2009	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

Device Design Differences:

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

The Flexicare Neonatal 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.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image is a logo for "flexicare". The logo has a stylized "f" in red and blue, with the rest of the word "lexicare" in blue and red. Below the word is the phrase "TOTAL QUALITY - TOTAL CARE" in blue.

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 do not affect the safety and/or effectiveness of either manufacturer's devices and are due to individual company branding/marketing.

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

Testing carried out to evaluate substantial equivalence between Flexicare's devices and the predicate devices captured within K160540 was undertaken in accordance to relevant ISO, ASTM. IEC and BS EN FDA recognized standards.

These standards have been developed and created in conjunction with various committees and requlatory bodies worldwide, and set criteria for the critical elements of a device in terms of function, performance, safety and regulatory compliance.

The testing captured within the summary of testing table above supported the determination of substantial equivalence. This was determined as these tests are mandatory requirements of the standards related to the devices in question, and are the baseline of tests that should be carried out to evaluate the safety of a both a new device of this nature and/or evaluate substantial equivalence against a marketed device.

When tested to methods specified within the listed standards Flexicare's Neonatal Heated Wire Breathing Systems performed passed all testing, and performed at least as well as the marketed predicate devices. This demonstrated not only the compliance of Flexicare's device with relevant standards, but also the similarity of design, function, performance, safety between Flexicare's Neonatal Heated Wire Breathing Systems and the marketed predicate devices.

A number of "non-standard" tests were also contribute toward the determination of substantial equivalence between Flexicare's Neonatal Heated Wire Breathing Systems and the marketed predicate devices. Being "non-standard", these tests are marked as "Pre-Determined Acceptance Criteria" within the table above and have no set criteria. This testing was conducted to further illustrate similarities between devices that may not have been required to identify within the relevant standards.

Conclusion

Flexicare's 038-33-201U Neonatal Heated Wire Breathing System & Autofill Humidification Chamber are considered to be substantially equivalent to the Fisher & Paykel RT235 Breathing Circuit & MR290 Humidification Chamber. The comparison of features performance, materials and intended use (illustrated within tables included in this summary document), and evaluation of devices including safety, performance, function, compatibility, biological safety, electrical safety, electromagnetic compatibility (EMC) in accordance with relevant FDA recognized standards demonstrates that Flexicare's 038-33-201U Neonatal Heated Wire Breathing System is as safe and effective as the predicate device for its intended purpose.

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).