Who is the manufacturer of Flexicare Heated Wire Breathing Systems?

Flexicare Medical, Ltd. filed the 510(k) submission for Flexicare Heated Wire Breathing Systems (K150900).

What is the FDA product code for Flexicare Heated Wire Breathing Systems?

BZE. It is classified under 21 CFR 868.5270 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Flexicare Heated Wire Breathing Systems?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Flexicare Heated Wire Breathing Systems?

Fisher & Paykel Adult RT380 Heated Breathing Circuit (K122432); Fisher & Paykel MR290 Autofill Humidification chamber (K934140).

Who can help prepare an FDA 510(k) submission like Flexicare Heated Wire Breathing Systems?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Flexicare Heated Wire Breathing Systems

K150900 · Flexicare Medical, Ltd. · BZE · May 15, 2015 · Anesthesiology

Device Facts

Record ID	K150900
Device Name	Flexicare Heated Wire Breathing Systems
Applicant	Flexicare Medical, Ltd.
Product Code	BZE · Anesthesiology
Decision Date	May 15, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5270
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

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. 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

Device consists of sterile, single-patient-use heated wire breathing circuits and autofill humidification chambers; used to connect patient airway to ventilator and external humidifier (Fisher & Paykel MR850). Heated wires within tubing lumen warm inspired gases to reduce condensation. Operated by clinicians in hospital settings. Output is warmed, humidified gas delivered to patient. Benefits include reduced condensation and maintenance of gas temperature (max 37°C).

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspection, internal volume, heated wire resistance, flow resistance, humidifier compatibility, connector strength, leak testing, drop testing, tensile strength, tube compliance, humidification output, shelf life, EMC, electrical safety, and biocompatibility (ISO 10993). All tests passed.

Technological Characteristics

Materials: Low density polyethylene tubing, injection molded/extruded plastics. Design: Heated wire assemblies, 22mm conical connectors (ISO 5356-1:2004). Energy: Passive heating via external humidifier (MR850). Sterilization: Ethylene Oxide. Connectivity: Compatible with standard ventilators and MR850 humidifier. Standards: ISO 5367, ISO 8185, IEC 60601-1, ISO 10993.

Indications for Use

Indicated for adult patients in hospital environments requiring respiratory support or ventilation via a heated humidification system.

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 Adult RT380 Heated Breathing Circuit (K122432)
Fisher & Paykel MR290 Autofill Humidification chamber (K934140)

Related Devices

K110398 — RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS · Respironics, Inc. · Jun 1, 2011
K151303 — AirLife Infant Heated Wire Circuit · Care Fusion · Jan 21, 2016
K153234 — AirLife Adult Heated Wire Circuit · Carefusion, Inc. · Jul 7, 2016
K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM · Flexicare Medical Limited. · Jun 23, 2016
K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit · Vyaire Medical · Sep 14, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name Flexicare Heated Wire Breathing Systems #### Indications for Use (Describe) 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. 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}------------------------------------------------ ## Indications for Use 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) 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." {4}------------------------------------------------ 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 {5}------------------------------------------------ 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: 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. {6}------------------------------------------------ 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. 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. 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. 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 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. | The RT380 and RT385 'Adult Evaqua 2' dual- heated breathing circuits are intended as conduits of breathing gas for ventilation of adult patients, and to maintain the temperature 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 - 1.6m Exp - 1.6m | Ins - 1.6m Exp - 1.6m | | Wire resistance (ohms) | Ins - 18.55 Exp - 25.9 | Ins - 17.5 Exp - 22.6 | | Tube material and designated diameter | Ins - Corrugated 22MM Exp - Smoothbore 22MM | Ins - Corrugated 22MM Exp - 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 Autofill Humidification Chamber. Compatible with F & P MR850 Respiratory Gas Humidifier. | To be used with F & P MR290 Humidification Chamber. Compatible with F & P MR850 Respiratory Gas Humidifier. | | Active controller | No - Humidifier controlled | No - Humidifier controlled | | 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 | 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 37°C | | Sterility Standards Met | Sterile – Ethylene Oxide Gas ISO 5367 ISO 5356 ISO 8185 IEC 60601-1 ISO 10993 BS EN 556 | Non-Sterile ISO 5367 ISO 5356 ISO 8185 IEC 60601-1 ISO 10993 | | Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | | Electrical Safety | IEC 60601-1 compliant IEC 60601-1-2 compliant | IEC 60601-1 compliant IEC 60601-1-2 compliant | | Non-clinical Test 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 Visual inspection/comparison, Dimensional inspection, Internal Volume, Heated wire resistance, resistance to flow, humidifier start up/compatibility, conical connector compliance, connector strength, leaking, drop testing, tensile strength, tube compliance, humidification output, shelf life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent. | | | Conclusion | Flexicare's 038-31-748U Heated Wire Breathing System is considered to be substantially equivalent to the Fisher & Paykel RT380 Breathing Circuit. The comparison of features, performance, materials and intended use demonstrate that Flexicare's 038-31-748U Heated Wire Breathing System is as safe and effective as the predicate device for its intended purpose. | | {9}------------------------------------------------ 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. {10}------------------------------------------------ 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 Device F&P MR290 K: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 = 292 Max = 114.9 | Full = 340 Max = 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 5367 ISO 5356 ISO 8185 IEC 60601-1 ISO 10993 BS EN 556 | ISO 5367 ISO 5356 ISO 8185 IEC 60601-1 ISO 10993 | | Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | | Electrical Safety | IEC 60601-1 compliant IEC 60601-1-2 compliant | IEC 60601-1 compliant IEC 60601-1-2 compliant | {11}------------------------------------------------ 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 Test Results | Verification tests were performed to establish the safety and efficacy of Flexicare's Autofill Humidification Chamber. These Non-clinical tests included 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. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent. | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | Flexicare's Autofill Humidification Chamber is considered to be substantially equivalent to the Fisher & Paykel MR290 Humidification Chamber. The comparison of features, performance, materials and intended use demonstrate that Flexicare's Autofill Humidification Chamber is as safe and effective as the predicate device for its intended purpose. | Summary of performance Testing: Flexicare's Heated Wire Breathing Systems have been evaluated in accordance with standards listed in table: | 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 | | | | Packaging Pouch Integrity | | | | | ASTM F1886-09 ASTM F88-09 ASTM F1929-12 | Pass | | Conical Connector compliance | ISO 5356-1:2004 | Pass | | Leak testing | | | | Drop testing | | | | Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation, Sub-Acute Toxicity | | | | | 10993-10:2010 10993-5:2009 10993-3:2014 10993-6:2009 | 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 | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image is a logo for "flexicare". The logo has the word "flexicare" in blue, with the first letter "f" stylized in red. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. 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.