Who is the manufacturer of F&P 950 Respiratory Humidifier?

Fisher & Paykel Healthcare filed the 510(k) submission for F&P 950 Respiratory Humidifier (K220703).

What is the FDA product code for F&P 950 Respiratory Humidifier?

BTT. It is classified under 21 CFR 868.5450 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for F&P 950 Respiratory Humidifier?

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

What are the predicate devices for F&P 950 Respiratory Humidifier?

F&P MR850 Respiratory Humidifier (K110019); Adult Evaqua 2 (RT380/RT385) (K122432); F&P AirSpiral Heated Breathing Tube (K162553); F&P Infant Evaqua 2 (RT265/266) (K103767); F&P 850 AirSpiral Adult NIV And NHF Circuit Kit (850A61) (K212031); Neonatal Breathing Circuits (RT130/RT131) (K020332).

Who can help prepare an FDA 510(k) submission like F&P 950 Respiratory Humidifier?

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.

F&P 950 Respiratory Humidifier

K220703 · Fisher & Paykel Healthcare · BTT · Jun 16, 2023 · Anesthesiology

Device Facts

Record ID	K220703
Device Name	F&P 950 Respiratory Humidifier
Applicant	Fisher & Paykel Healthcare
Product Code	BTT · Anesthesiology
Decision Date	Jun 16, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5450
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

F&P 950 Respiratory Humidifier: The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. F&P 950 Breathing Circuit Kits: 950A80J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950P81J, 950P40J: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N40J: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

Device Story

The F&P 950 Respiratory Humidifier warms and humidifies respiratory gases for delivery to patients via heated breathing circuits. The system comprises a heaterbase, sensor cartridge, and expiratory heater wire adapter. It accepts gas from an external flow source; sensors monitor gas temperature at the chamber exit and within the delivery tube to regulate humidity and minimize condensate. The device is operated by healthcare professionals in hospitals or long-term care facilities. Output is displayed to the clinician, who uses the device to support respiratory therapy (invasive/non-invasive ventilation, nasal high flow). By maintaining optimal gas temperature and humidity, the device helps prevent airway drying and associated complications, benefiting patients requiring respiratory support.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including humidification output, thermal overshoot, surface temperature (ISO 80601-2-74), resistance to flow, compliance, gas leak testing (ISO 5367), and human factors/usability validation.

Technological Characteristics

Programmable electrical medical device (Class II, double insulated). Components: heaterbase, sensor cartridge, expiratory heater wire adapter, breathing circuit kits. Sensing: temperature monitoring at chamber exit and delivery tube. Connectivity: standalone. Software: Class B (IEC 62304). Sterilization: not specified (single-use accessories). Standards: ISO 80601-2-74, ISO 5367, IEC 60601-1, IEC 60601-1-8.

Indications for Use

Indicated for providing heat and humidity to respiratory gases for neonatal, infant, child, adolescent, and adult patients in hospital or long-term care facilities. Used by health professionals for invasive ventilation, non-invasive ventilation, and nasal high flow therapy.

Regulatory Classification

Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Predicate Devices

F&P MR850 Respiratory Humidifier (K110019)
Adult Evaqua 2 (RT380/RT385) (K122432)
F&P AirSpiral Heated Breathing Tube (K162553)
F&P Infant Evaqua 2 (RT265/266) (K103767)
F&P 850 AirSpiral Adult NIV And NHF Circuit Kit (850A61) (K212031)
Neonatal Breathing Circuits (RT130/RT131) (K020332)

Reference Devices

F&P RT019 Inspiratory/Expiratory Filter (K050927)
F&P OJR215 Pressure Relief Manifold NHF (K173770)
F&P AIRVO 2 (K131895)
F&P Optiflow™ Oxygen Kit (K211096)
Philips Disposable Exhalation Port (K982454)
Infant Flow SiPAP (K031745)
Instrumentation Industries RTC 24-V Metered Dose Inhaler (K091111)
F&P RT016 Inspiratory Filter (K133666)

Related Devices

K223684 — F&P 820 Humidification System · Fisher & Paykel Healthcare, Ltd. · Sep 5, 2023
K251448 — FL-10000U Respiratory Humidifier · Flexicare Medical Limited. · Jan 16, 2026
K133766 — HUMICARE D900 · Gruendler GmbH · Nov 24, 2014
K122705 — HUMICARE D900 · Grundler GmbH · May 21, 2013
K030090 — H2 HEATED HUMIDIFIER · Respironics, Inc. · Jan 24, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 16, 2023 Fisher & Paykel Healthcare Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place Auckland. 2013 New Zealand Re: K220703 Trade/Device Name: F&P 950 Respiratory Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: May 17, 2023 Received: May 17, 2023 Dear Reena Daken: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/5 description: The image shows the name "Ethan L. Nyberg -S" in a large, clear font. The text is horizontally aligned and appears to be part of a document or presentation. The background is plain, ensuring the name is easily readable. for James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220703 Device Name F&P 950 Respiratory Humidifier ### Indications for Use (Describe) F&P 950 Respiratory Humidifier The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. #### F&P 950 Breathing Circuit Kits: 950P81J, 950P40J The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications. Type of Use (Select one or both, as applicable) | <svg height="1em" width="1em"><path d="M2 0h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2a2 2 0 0 1 2-2z" fill="none" stroke="currentColor"></path><path d="M3.75 8.03l2.27-2.27a.75.75 0 0 1 1.06 1.06l-2.27 2.27 4.27 4.27a.75.75 0 0 1-1.06 1.06l-4.27-4.27z" fill="currentColor"></path></svg> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="1em" width="1em"><path d="M2 0h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2a2 2 0 0 1 2-2z" fill="none" stroke="currentColor"></path></svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ # 510(k) Summary As required by 21 CFR 807.92 # I. SUBMITTER | Company Name and Address | Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place East Tamaki Auckland 2013, New Zealand Telephone: +64 9 574 0100 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Prepared and Submitted by | Nicholas Yap Regulatory Affairs Specialist | | Contact Person | Reena Daken Regulatory Affairs Manager Telephone: +64 9 574 0100 Email: reena.daken@fphcare.co.nz | | Date Prepared | 15 June 2023 | # II. DEVICE | Name of Device | F&P 950 Respiratory Humidifier | |----------------------------------------|--------------------------------| | Common/Usual Name | Respiratory Humidifier | | Classification Name | Respiratory Gas Humidifier | | Regulatory Class | Class II | | Primary Classification Product Code | BTT (21 CFR §868.5450) | | Secondary Product Code | BZE | {4}------------------------------------------------ # III. PREDICATE DEVICE - Primary Predicate device: . | 510(k) Number | Device Name | |---------------|----------------------------------| | K110019 | F&P MR850 Respiratory Humidifier | - Secondary Predicate devices: . | 510(k) Number | Device Name | Reason for secondary predicate | |------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | K122432 | Adult Evaqua 2 (RT380/RT385) | Used as a predicate for the 950A80J, 950A81J, and 950A82J accessory breathing circuit kits. | | K162553 | F&P AirSpiral Heated Breathing Tube | Used as a predicate for the 950A40J, 950N40J, 950P40J, and AA451SU accessory breathing circuit kits. | | K103767 | F&P Infant Evaqua 2 (RT265/266) | Used as a predicate for the 950N80J, 950N81J, and 950P81J accessory breathing circuit kits. | | K212031 | F&P 850 AirSpiral Adult NIV And NHF Circuit Kit (850A61) | Used as a predicate for the 950A60J, and 950A61J accessory breathing circuit kits. | | K020332 | Neonatal Breathing Circuits (RT130/RT131) | Used as a predicate for the 950N61J accessory breathing circuit kit. | #### . Reference device(s): | 510(k) Number | Device Name | Reason for reference | |------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K050927 | F&P RT019 Inspiratory/Expiratory Filter | Used to address the technological differences between the subject and predicate device and support claims of safety and effectiveness with respect to breathing circuit kit design - identical component(s) contained within subject device breathing circuit kit(s). | | K173770 | F&P OJR215 Pressure Relief Manifold NHF | Used to address the technological differences between the subject and predicate device and support claims of safety and effectiveness with respect to breathing circuit kit design - identical component(s) contained within subject device breathing circuit kit(s). | | K131895 | F&P AIRVO 2 | Used to address the technological differences between the subject and predicate device and support claims of safety and effectiveness with respect to the adjustable temperature set points and flow rates for nasal high flow therapy in the subject device's Optiflow mode. | | K211096 | F&P Optiflow™ Oxygen Kit | Used to address the technological differences between the subject and predicate device and support claims of safety and effectiveness with respect to the flow rates for nasal high flow therapy up to 70 L/min. | {5}------------------------------------------------ | K982454 | Philips Disposable Exhalation Port | Used to compare performance of DEP within F&P 950 accessory breathing circuit kits | |---------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K031745 | Infant Flow SiPAP | Used to verify performance in accuracy of pressure delivery of the F&P 950 accessory breathing circuit kits. | | K091111 | Instrumentation Industries RTC 24-V Metered Dose Inhaler | Used to compare performance of MDI with the F&P 950 accessory breathing circuit kits | | K133666 | F&P RT016 Inspiratory Filter | Used to address the technological differences between the subject and predicate device and support claims of safety and effectiveness with respect to breathing circuit kit design - identical component(s) contained within subject device breathing circuit kit(s). | #### DEVICE DESCRIPTION IV. The F&P 950 Respiratory Humidifier is designed to warm and humidify air after it leaves a commercially available flow source and to maintain the air in a warmed and humidified condition to the point of delivery into the patient via heated tubing. The F&P 950 Respiratory Humidifier is made up of a heaterbase, sensor cartridge and expiratory heater wire adapter with breathing circuit kits to support the use with adult, pediatric and neonatal patients. Breathing circuit kits enable the use of the F&P 950 Respiratory Humidifier with clinical procedures such as invasive ventilation and nasal high flow. The device is a programmable electrical medical device that uses sensors throughout the system to humidify the gas. Gas travels through the chamber where it is humidity is requlated through monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate. # V. INDICATIONS FOR USE STATEMENT F&P 950 Respiratory Humidifier: The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. F&P 950 Breathing Circuit Kits: 950A80J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950P81J, 950P40J: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N40J: The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications. {6}------------------------------------------------ # VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Design/technological characteristic for comparison | Subject Device F&P 950 Respiratory Humidifier | Primary Predicate Device F&P MR850 Respiratory Humidifier (K110019) | Comments | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | To provide heat and humidity to respiratory gases | To provide heat and humidity to respiratory gases | Identical | | Indications for use | The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. | The Fisher & Paykel Healthcare MR850 humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases. | Equivalent The subject and primary predicate devices have equivalent indications for use. Both devices are indicated to provide heat and humidity to respiratory gases delivered to patients. | | Patient population | Patients requiring respiratory gases | Patients requiring mechanical ventilation or positive pressure breathing assistance, via face non-invasive or invasive | Identical The relevant patient populations are described in the relevant breathing circuit kits. | | Intended use environment | Hospital or long-term care facility | Hospital | Equivalent The intended use environments are equivalent. | | Intended user group | Health professional | Hospital use by trained personnel | Equivalent The intended user groups are equivalent. | | Delivered humidity level | Bypassed airway: >33mg/L for flow < 60 L/min Non-bypassed airway: >12mg/L for flow < 120 L/min | Bypassed airway: >33mg/L for flow < 60 L/min Non-bypassed airway: >10mg/L for flow < 120 L/min | Equivalent The subject device meets the humidity output requirements of ISO 80601-2-74:2017 while the primary predicate device meets the humidity output requirements of ISO 8185:2007. | | | Breathing circuit kits have specified flow ranges based on patient population. | Breathing circuit kits have specified flow ranges based on patient population. | | | Time to reach set temperature | <30min | <30 min | Identical | | Operating principle | Gas travels through the chamber where it is humidified. The humidity is regulated through | Gas travels through the chamber where it is humidified. The humidity is regulated through | Identical | | Design/technological characteristic for comparison | Subject Device F&P 950 Respiratory Humidifier | Primary Predicate Device F&P MR850 Respiratory Humidifier (K110019) | Comments | | | monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate. | monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate. | | | Ambient operating conditions | 18-26°C (Adult) 20-26°C (Neonatal and Pediatric) | 18-26°C | Equivalent The subject device falls within the primary predicate device operating conditions. | | Device operating modes | Bypassed airway: • Invasive mode • Neonatal mode Non-bypassed airway: • Mask mode (adult and pediatric) • CPAP NIV mode (neonatal) • Optiflow™ mode | Bypassed airway: • Invasive mode Non-bypassed airway: • Non-invasive (Mask) mode | Equivalent The subject device includes five modes compared to the predicate device's modes. However, these modes are subsets of equivalent humidity levels and flow rates as described in rows above. The additional modes do not introduce new questions of safety or effectiveness as the specified flow ranges are tested in the performance testing and the humidity levels conform to the current recognized standards. | | Alarms | Alarms exceed 45 dbA @1m Auditory alarm pause: 120 seconds Conforms to IEC 60601-1-8: 2006 + A1: 2012 | Alarms exceed 50 dbA @1m Auditory alarm pause: 120 seconds Conforms to IEC 60601-1-8: 2003 | Equivalent The subject and primary predicate devices conform with applicable standards at the time of release. | | Storage conditions (Hardware) | -20°C - 60°C | -10°C - 50°C | Equivalent The subject device has broader storage conditions than the primary predicate device. This has been verified in the transport and storage testing included in performance testing. | | Service life (Hardware) | 7 years | 7 years | Identical | | IEC 60601-1 classification | Class II | Class I | Equivalent | | Design/technological characteristic for comparison | Subject Device F&P 950 Respiratory Humidifier | Primary Predicate Device F&P MR850 Respiratory Humidifier (K110019) | Comments | | | | | The subject device is double insulated with a functional earth, making it a Class II device. | | IEC 62304 software classification | Class B | Class B | Identical | #### Table 1: Subject Device and Primary Predicate Comparison Table {7}------------------------------------------------ {8}------------------------------------------------ ### Table 2: 950A80J – Adult / Pediatric Ventilator Circuit Kit to Secondary Predicate Comparison Table | Characteristic for comparison | Subject Device 950A80J | Secondary Predicate Device F&P RT380 (K122432) | Comments | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical | | Indications for Use | The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. | 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. | Equivalent Both the subject and secondary predicate device are indicated to provide heat and humidity to respiratory gases delivered to patients. | | Operating Principle | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | Identical Both the subject device and the secondary predicate device contain the components that connect together to create a closed circuit that allows for invasive or noninvasive ventilation. | | Patient Population | Adult, adolescent and child patients with tidal volume above 200 mL. | Adult patients. | Different The subject device is compliant to the pneumatic requirements of ISO 5367 for the indicated patient populations. | | Intended Interface | Invasive ventilation: Endotracheal tube (ETT) or tracheostomy interface Noninvasive ventilation: Non-vented mask with standard elbow | Invasive ventilation: Endotracheal tube (ETT) or tracheostomy interface Noninvasive ventilation: Non-vented mask with standard elbow | Identical | {9}------------------------------------------------ | Specified Flow Range | Invasive mode: 5 - 60 L/min | Up to 60 L/min in Invasive mode as per the MR850 user instructions | ldentical | |----------------------|-----------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | | Mask mode: 5 – 120 L/min | Up to 120 L/min in Noninvasive mode as per the MR850 user instructions | | | Duration of Use | 14 Days | 14 Days | ldentical | | Reusability | Single Use | Single Use | ldentical | | Shelf Life | 3 years | 5 years | Equivalent | | | | | The subject device falls within the secondary predicate device shelf life duration. | | Storage conditions | -10°C — 50°C | -30°C — 50°C | Equivalent | | | | | The subject device falls within the secondary | | | | | predicate device storage condition range. | #### Table 3: 950A81J – Adult / Pediatric Ventilator Circuit Kit (with Filter) to Secondary Predicate Comparison Table | Characteristic for comparison | Subject Device 950A81J | Secondary Predicate Device F&P RT380 (K122432) | Comments | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical | | Indications for Use | The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. | 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. | Equivalent Both the subject and secondary predicate device are indicated to provide heat and humidity to respiratory gases delivered to patients. | | Operating Principle | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | Identical Both the subject device and the secondary predicate device contain the components that connect together to create a closed circuit that allows for invasive or noninvasive ventilation. | | Patient Population | Adult, adolescent and child patients with tidal volume above 200 mL. | Adult patients. | Different The subject device is compliant to the pneumatic requirements of ISO 5367 for the indicated patient populations. | | Intended Interface | Invasive ventilation: | Invasive ventilation: | Identical | {10}------------------------------------------------ | Characteristic for comparison | Subject Device 950A81J | Secondary Predicate Device F&P RT380 (K122432) | Comments | |----------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | | Endotracheal tube (ETT) or tracheostomy interface | Endotracheal tube (ETT) or tracheostomy interface | | | | Noninvasive ventilation: Non-vented mask with standard elbow | Noninvasive ventilation: Non-vented mask with standard elbow | | | Specified Flow Range | Invasive mode: 5 – 60 L/min | Up to 60 L/min in Invasive mode as per the MR850 user instructions | Identical | | | Mask mode: 5 – 120 L/min | Up to 120 L/min in Noninvasive mode as per the MR850 user instructions | | | Duration of Use | 14 Days | 14 Days | Identical | | Reusability | Single Use | Single Use | Identical | | Shelf Life | 3 years | 5 years | Equivalent The subject device falls within the secondary predicate device shelf life duration. | | Storage conditions | -10°C – 50°C | -30°C – 50°C | Equivalent The subject device falls within the secondary predicate device storage condition range. | | Filter | RT019 Inspiratory / Expiratory Filter | RT019 Inspiratory / Expiratory Filter | Identical | #### Table 4: 950A82J - Adult / Pediatric Ventilator Circuit Kit (with Filter and Pressure line) to Secondary Predicate Comparison Table | Characteristic for comparison | Subject Device 950A82J | Secondary Predicate Device F&P RT385 (K122432) | Comments | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical | | Indications for Use | The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. | 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. | Equivalent Both the subject and secondary predicate device are indicated to provide heat and humidity to respiratory gases delivered to patients. | | Operating Principle | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and | Breathing circuit kit contains a dryline, humidification chamber, inspiratory limb, and | Identical | | Characteristic for | Subject Device | Secondary Predicate Device | Comments | | comparison | 950A82J | F&P RT385 (K122432) | | | | expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | expiratory limb to create a closed circuit that allows for invasive or noninvasive ventilation. | Both the subject device and the secondary predicate device contain the components that connect together to create a closed circuit that allows for invasive or noninvasive ventilation. | | Patient Population | Adult, adolescent and child patients with tidal volume above 200 mL. | Adult patients. | Different The subject device is compliant to the pneumatic requirements of ISO 5367 for the indicated patient populations. | | Intended Interface | Invasive ventilation: Endotracheal tube (ETT) or tracheostomy interface Noninvasive ventilation: Non-vented mask with standard elbow | Invasive ventilation: Endotracheal tube (ETT) or tracheostomy interface Noninvasive ventilation: Non-vented mask with standard elbow | Identical | | Specified Flow Range | Invasive mode: 5 - 60 L/min Mask mode: 5 – 120 L/min | Up to 60 L/min in Invasive mode as per the MR850 user instructions Up to 120 L/min in Noninvasive mode as per the MR850 user instructions | Identical | | Duration of Use | 14 Days | 14 Days | Identical | | Reusability | Single Use | Single Use | Identical | | Shelf Life | 3 years | 5 years | Equivalent The subject device falls within the secondary predicate device shelf life duration. | | Storage conditions | -10°C - 50°C | -30°C - 50°C | Equivalent The subject device falls within the secondary predicate device storage condition range. | | Filter | RT019 Inspiratory / Expiratory Filter | RT019 Inspiratory / Expiratory Filter | Identical | | Pressure Line | 498042178 Pressure Line with 693040748 Elbow | 498042178 Pressure Line with 693040748 Elbow | Identical | | Characteristic for comparison | Subject Device 950A40J | Secondary Predicate Device F&P AirSpiral™ Heated Breathing Circuit (K162553) | Comments | | Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical | | Indications for Use | The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. | Heated breathing tube for delivery of humidified respiratory gases. For use with AIRVO and AIRVO2 Series humidifiers in hospitals and long-term care facilities. For use at flows from 2 to 60 L.min-1 depending on the patient interface. | Equivalent Both the subject and secondary predicate device are indicated to provide heat and humidity to respiratory gases delivered to patients. | | Operating Principle | Breathing circuit kit contains a dryline, humidification chamber, and inspiratory limb to create a single limb for the delivery of high flow therapy. | Breathing circuit kit contains a humidification chamber and inspiratory limb to create a single limb for the delivery of high flow therapy. | Identical Both the subject device and the secondary predicate device contain the components that connect together to create a single limb for delivery of high flow. | | Patient Population | Adult, adolescent and child patients weighing above 10 kg. | Spontaneously breathing patient requiring flows between 2 –60 L/min. | Different The predicate is not indicated for a specific population but for a flow range. This includes both the adult and pediatric patient populations. | | Intended Interface | High flow nasal cannula and tracheostomy high flow interface | High flow nasal cannula and tracheostomy high flow interface | Identical | | Specified Flow Range | 5 – 70 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | Different The subject device has the same specified flow range of 5 - 70 L/min as the AA403 Optiflow™ Oxygen Kit (K211096) reference device, also designed for use with high flow therapy. | | Duration of Use | 14 Days | 14 Days | Identical | | Reusability | Single Use | Single Use | Identical | | Shelf Life | 3 years | 5 years | Equivalent The subject device falls within the secondary predicate device shelf life duration. | | Storage conditions | 10°C – 50°C | 10°C – 50°C | Identical | | Characteristic for | Subject Device | Secondary Predicate Device | Comments | | comparison | 950N80J…