FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

K160540 · Flexicare Medical Limited. · BZE · Jun 23, 2016 · Anesthesiology

Device Facts

• Record ID: K160540
• Device Name: FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
• Applicant: Flexicare Medical Limited.
• Product Code: BZE · Anesthesiology
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Indications for Use

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 Story

System connects patient airway to ventilator and humidification chamber; delivers warmed, humidified respiratory gases. Comprised of disposable tubing, connectors, and heated wire assemblies. Heated wire within tube lumen reduces condensation and water build-up. Autofill chamber holds water and connects to heater unit for automatic filling. Used in hospital settings by clinicians. Output is warmed, humidified gas; affects clinical decision-making by maintaining patient airway moisture and temperature. Benefits patient by preventing airway drying and reducing condensation-related complications.

Clinical Evidence

Bench testing only. Evaluated against ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, and ISO 10993. Tests included visual/dimensional inspection, internal volume, wire resistance, flow resistance, humidifier compatibility, connector strength, leak testing, drop testing, tensile strength, tube compliance, humidification output, shelf life, EMC, and electrical safety. All tests passed.

Technological Characteristics

Materials: injection molded and extruded plastics. Sensing/Actuation: heated wire resistance for gas warming. Form factor: neonatal breathing circuit with corrugated/smoothbore tubing. Connectivity: compatible with Fisher & Paykel MR850 humidifier. Sterilization: Ethylene Oxide (EO) gas. Standards: ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556.

Indications for Use

Indicated for neonatal patients in a hospital environment requiring respiratory support and active humidification via a ventilator and humidification chamber. Compatible with flow rates >4L/min.

Regulatory Classification

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.

Predicate Devices

• Fisher & Paykel Neonatal RT235 Heated Breathing Circuit (K034026)
• Fisher & Paykel MR290 Autofill Humidification chamber (K934140)

Submission Summary (Full Text)

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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 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.

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 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)

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.

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 [e-mail]

"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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### 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)

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.

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 [e-mail]

"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 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: [phone] Fax: [phone]

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:

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.

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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.

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.

### 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

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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 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.

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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.

| Characteristic<br>compared | Flexicare Neonatal Heated Wire Breathing<br>Systems | Predicate Device<br>F&P RT235 |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K:160540 | K:034026 |
| Intended use | Flexicare Neonatal Heated Wire Breathing<br>Systems are intended for use to connect a<br>patient's airway to a Ventilator and<br>Humidification Chamber as part of a complete<br>system to provide warmed and humidified<br>inspired respiratory gases to ventilated<br>patients and those receiving respiratory<br>support. Intended for Neonatal patients<br>within a hospital environment. Compatible<br>with Fisher & Paykel MR850 Respiratory Gas<br>Humidifier. Available in Neonatal (038-33-<br>201U) size. For flow rates >4L/min. | The dual-heated breathing circuits are<br>intended as conduits of breathing gas for<br>ventilation of patients, and to maintain<br>the temperature of humidified inspired<br>gas.<br>The RT236 is used for flow rates between<br>0.3 and 4 L/min, and the RT235 is for flow<br>rates greater than 4 L/min, for infant patients.<br>Source: K034026 SE letter from FDA |
| Target<br>population | Neonatal | Neonatal |
| Indications for<br>use | Instruction leaflet | Instruction leaflet |
| Environment<br>used | Hospital | Hospital |
| Product<br>labelling | Heated Wire Breathing System | Heated Wire Breathing System |
| Volume (ml) | 500 | 375 |
| Tube length (m) | Ins – 1.1m + 300mm extension<br>Exp - 1.66m | Ins – 1.1m + 360mm extension<br>Exp - 1.65m |
| Wire resistance<br>(ohms) | Ins – 21.6<br>Exp - 19.2 | Ins – 21.8<br>Exp - 22.9 |
| Tube material<br>and designated<br>diameter | Ins - Corrugated 15mm<br>Exp - Smoothbore 15mm | Ins - Corrugated 15mm<br>Exp - Corrugated 15mm |
| Rated Flow | >4L.min | >4L.min |
| Compliance<br>(ml/Kpa) | 5.18ML/kPa | 3.64ML/kPa |
| Resistance to<br>flow @ 30 lpm<br>(mb) | 2.7 | 2.1 |
| Compatibility<br>with the<br>environment<br>and other<br>devices | To be used with Flexicare Autofill<br>Humidification Chamber. Compatible with F &<br>P MR850 Respiratory Gas Humidifier. | To be used with F & P MR290 Humidification<br>Chamber. Compatible with F & P MR850<br>Respiratory Gas Humidifier. |
| Active<br>controller | No - Humidifier controlled | No - Humidifier controlled |
| Energy used<br>and or<br>delivered | Due to the wire resistance, heat is dispersed<br>into the breathing tube lumen. As a result, the<br>air passing through the tubing is warmed<br>whilst travelling to patient, reducing the water<br>condensation in the breathing System. The<br>raising of the gas temperature does not<br>exceed 37°C | Due to the wire resistance, heat is dispersed<br>into the breathing tube lumen. As a result, the<br>air passing through the tubing is warmed<br>whilst travelling to patient, reducing the water<br>condensation in the breathing System. The<br>raising of the gas temperature does not<br>exceed 37°C |
| Sterility | Sterile - Ethylene Oxide Gas | Non-Sterile |
| Standards Met | ISO 5367<br>ISO 5356<br>ISO 8185<br>IEC 60601-1<br>ISO 10993<br>BS EN 556 | ISO 5367<br>ISO 5356<br>ISO 8185<br>IEC 60601-1<br>ISO 10993 |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant |
| Electrical Safety | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant |
| Non-clinical<br>Test Results | Verification tests were performed to establish the safety and efficacy of Flexicare's 038-33-<br>201U Neonatal Heated Wire Breathing System. These Non-clinical tests included Visual<br>inspection/comparison, Dimensional inspection, Internal Volume, Heated wire resistance,<br>resistance to flow, humidifier start up/compatibility, conical connector compliance, connector<br>strength, leaking, drop testing, tensile strength, tube compliance, humidification output, shelf<br>life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility.<br>Testing demonstrated that the relevant features, design and performance of each<br>manufacturer's device are substantially equivalent. | |
| Conclusion | Flexicare's 038-33-201U Neonatal Heated Wire Breathing System is considered to be<br>substantially equivalent to the Fisher & Paykel RT235 Breathing Circuit. The comparison of<br>features, performance, materials and intended use demonstrate that Flexicare's 038-33-201U<br>Neonatal Heated Wire Breathing System is as safe and effective as the predicate device for its<br>intended purpose | |

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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.

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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 for<br>use to hold water required to humidify the<br>air being delivered to patients. Intended<br>for any patient requiring active<br>humidification within a hospital<br>environment. | Humidification chambers are intended for<br>use to hold water required to humidify the<br>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 = 292<br>Max = 114.9 | Full = 340<br>Max = 83.9 | |
| Weight (g) | 124 | 109.5 | |
| Leakage (ml/min) | No leakage | No leakage | |
| Compliance at empty<br>(ml/Kpa) | 5.5 | 5.5 | |
| Resistance to flow @<br>60 lpm (mb) | 0.1 | 0.3 | |
| Moisture output<br>(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 or<br>delivered | Electrical energy within heater unit is used<br>to raise the temperature and humidity of<br>the gas delivered to the patient | Electrical energy within heater unit is used<br>to raise the temperature and humidity of the<br>gas delivered to the patient | |
| Sterility | Sterile - Ethylene Oxide Gas | Non-Sterile | |
| Standards Met | ISO 5367<br>ISO 5356<br>ISO 8185<br>IEC 60601-1<br>ISO 10993<br>BS EN 556 | ISO 5367<br>ISO 5356<br>ISO 8185<br>IEC 60601-1<br>ISO 10993 | |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | |
| Electrical Safety | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | |
| Non-clinical Test<br>Results | Verification tests were performed to establish the safety and efficacy of Flexicare's Autofill<br>Humidification Chamber. These Non-clinical tests included Visual inspection/comparison,<br>Dimensional inspection, Internal Volume, resistance to flow, conical connector | | |

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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, humidification<br>output, shelf life verification, Electromagnetic Capability, Electrical Safety and<br>Biocompatibility. Testing demonstrated that the relevant features, design and<br>performance of each manufacturer's device are substantially equivalent. |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Flexicare's Autofill Humidification Chamber is considered to be substantially equivalent to<br>the Fisher & Paykel MR290 Humidification Chamber. The comparison of features,<br>performance, materials and intended use demonstrate that Flexicare's Autofill<br>Humidification Chamber is as safe and effective as the predicate device for its intended<br>purpose. |

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

| Test | Standard / Pre-Determined<br>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 | | |
| Packaging Pouch Integrity | ASTM F1886-09<br>ASTM F88-09<br>ASTM F1929-12 | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | | |
| Drop testing | | |
| Cytotoxicity, Irritation, Sensitization, Systemic<br>Toxicity, Genotoxicity, Implantation, Sub-Acute<br>Toxicity, Extractables & Leachables testing. | 10993-10:2010<br>10993-5:2009<br>10993-3:2014<br>10993-6:2009<br>10993-17:2009 | Pass |
| Testing to ISO 5367, temp probe tensile testing,<br>temp port leaking | ISO 8185:2007 | Pass |
| Electromagnetic capability & Electrical safety<br>testing | BS EN 60601-1:2006<br>BS EN 60601-1-2:2007<br>IEC 60601-1:2005 +CORR.1:2006<br>CORR. 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.

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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.