(463 days)
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.
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.
The document is a 510(k) Summary for the F&P 950 Respiratory Humidifier and its accessory breathing circuit kits. It outlines the device's indications for use and compares its technological characteristics to a primary predicate device (F&P MR850 Respiratory Humidifier) and several secondary predicate devices for the various breathing circuit kits. The summary also details the non-clinical tests performed to demonstrate substantial equivalence.
Here's the requested information based on the provided text, focusing on acceptance criteria and supporting studies:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Delivered humidity level (Bypassed airway) >33mg/L for flow < 60 L/min Delivered humidity level (Non-bypassed airway) >12mg/L for flow < 120 L/min Time to reach set temperature <30min Alarms (auditory) Exceed 45 dbA @1m Auditory alarm pause 120 seconds Ambient operating conditions (Adult) 18-26°C Ambient operating conditions (Neonatal and Pediatric) 20-26°C Storage conditions (Hardware) -20°C - 60°C Service life (Hardware) 7 years shelf life for circuit kits 3 years (Note: some predicate devices had 5 years; for the subject device, this is stated as "Equivalent - The subject device falls within the secondary predicate device shelf life duration," implying 3 years meets the criteria for substantial equivalence, though less than some predicates). Storage conditions for circuit kits -10°C – 50°C (Note: some predicate devices had -30°C – 50°C; for the subject device, this is stated as "Equivalent - The subject device falls within the secondary predicate device storage condition range.") -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for specific performance tests (e.g., number of devices tested, number of runs for humidification accuracy). It refers to testing being "in line with" or conforming to various ISO and ASTM standards, which would define appropriate sample sizes for those tests. The data provenance (country of origin, retrospective/prospective) is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable to the type of device and studies described. The studies are non-clinical (bench/performance testing, biocompatibility, electrical safety, software verification, human factors), not clinical studies involving expert interpretation of data like imaging.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the studies described are non-clinical performance and safety tests, not clinical studies involving expert adjudication of findings.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices, often those incorporating AI, and is not applicable to a respiratory humidifier.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Not applicable. The F&P 950 Respiratory Humidifier is a hardware device with embedded software, not an AI algorithm intended for standalone performance evaluation in the context of interpretation tasks. Performance testing was done on the device as a whole system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance tests, "ground truth" is established by adherence to recognized standards:
- Humidification output, thermal overshoot, surface temperature: ISO 80601-2-74:2017
- Resistance to flow, compliance, gas leak: ISO 5367:2014
- Electrical safety: ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
- EMC: IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23
- Alarms: IEC 60601-1-8:2006 and A1:2012
- Biocompatibility: ISO 10993-1:2018 and ISO 18562-1:2017
- Software verification and validation: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Human Factors Testing: FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices."
The "ground truth" is essentially the specified requirements and acceptance criteria outlined in these internationally recognized standards and guidance documents.
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The sample size for the training set:
Not applicable. This device does not appear to involve machine learning or AI algorithms that require a "training set" in the conventional sense of supervised learning. The software verification and validation is for embedded software controlling the device's functions.
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How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for this type of device.
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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
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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,
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
As required by 21 CFR 807.92
I. SUBMITTER
| Company Name andAddress | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Nicholas YapRegulatory Affairs Specialist |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: 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 ClassificationProduct Code | BTT (21 CFR §868.5450) |
| Secondary ProductCode | BZE |
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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 BreathingTube | Used as a predicate for the 950A40J, 950N40J,950P40J, and AA451SU accessory breathingcircuit 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 AndNHF Circuit Kit (850A61) | Used as a predicate for the 950A60J, and950A61J accessory breathing circuit kits. |
| K020332 | Neonatal Breathing Circuits(RT130/RT131) | Used as a predicate for the 950N61J accessorybreathing circuit kit. |
. Reference device(s):
| 510(k)Number | Device Name | Reason for reference |
|---|---|---|
| K050927 | F&P RT019 Inspiratory/ExpiratoryFilter | Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to breathing circuit kit design - identicalcomponent(s) contained within subject devicebreathing circuit kit(s). |
| K173770 | F&P OJR215 Pressure ReliefManifold NHF | Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to breathing circuit kit design - identicalcomponent(s) contained within subject devicebreathing circuit kit(s). |
| K131895 | F&P AIRVO 2 | Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to the adjustable temperature set pointsand flow rates for nasal high flow therapy in thesubject device's Optiflow mode. |
| K211096 | F&P Optiflow™ Oxygen Kit | Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to the flow rates for nasal high flowtherapy up to 70 L/min. |
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| K982454 | Philips Disposable Exhalation Port | Used to compare performance of DEP withinF&P 950 accessory breathing circuit kits |
|---|---|---|
| K031745 | Infant Flow SiPAP | Used to verify performance in accuracy ofpressure delivery of the F&P 950 accessorybreathing circuit kits. |
| K091111 | Instrumentation Industries RTC24-V Metered Dose Inhaler | Used to compare performance of MDI with theF&P 950 accessory breathing circuit kits |
| K133666 | F&P RT016 Inspiratory Filter | Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to breathing circuit kit design - identicalcomponent(s) contained within subject devicebreathing 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.
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VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Design/technologicalcharacteristic forcomparison | Subject DeviceF&P 950 Respiratory Humidifier | Primary Predicate DeviceF&P MR850 Respiratory Humidifier (K110019) | Comments |
|---|---|---|---|
| Intended use | To provide heat and humidity to respiratorygases | To provide heat and humidity to respiratory gases | Identical |
| Indications for use | The F&P 950 Respiratory Humidifier isintended to provide heat and humidity torespiratory gases delivered to patients. It is foruse in a hospital or long-term care facility by ahealth professional. | The Fisher & Paykel Healthcare MR850 humidifieris intended to be used to warm and add humidityto gases delivered to patients requiring mechanicalventilation or positive pressure breathingassistance or general medical gases. | EquivalentThe subject and primary predicate deviceshave equivalent indications for use.Both devices are indicated to provide heatand humidity to respiratory gases deliveredto patients. |
| Patient population | Patients requiring respiratory gases | Patients requiring mechanical ventilation orpositive pressure breathing assistance, via facenon-invasive or invasive | IdenticalThe relevant patient populations aredescribed in the relevant breathing circuitkits. |
| Intended use environment | Hospital or long-term care facility | Hospital | EquivalentThe intended use environments areequivalent. |
| Intended user group | Health professional | Hospital use by trained personnel | EquivalentThe intended user groups are equivalent. |
| Delivered humidity level | Bypassed airway: >33mg/Lfor flow < 60 L/minNon-bypassed airway: >12mg/Lfor flow < 120 L/min | Bypassed airway: >33mg/Lfor flow < 60 L/minNon-bypassed airway: >10mg/Lfor flow < 120 L/min | EquivalentThe subject device meets the humidityoutput requirements of ISO 80601-2-74:2017while the primary predicate device meets thehumidity output requirements ofISO 8185:2007. |
| Breathing circuit kits have specified flowranges based on patient population. | Breathing circuit kits have specified flow rangesbased on patient population. | ||
| Time to reach settemperature | <30min | <30 min | Identical |
| Operating principle | Gas travels through the chamber where it ishumidified. The humidity is regulated through | Gas travels through the chamber where it ishumidified. The humidity is regulated through | Identical |
| Design/technologicalcharacteristic forcomparison | Subject DeviceF&P 950 Respiratory Humidifier | Primary Predicate DeviceF&P MR850 Respiratory Humidifier (K110019) | Comments |
| monitoring the gas temperature exiting thechamber to achieve the target humidity level.The gas is then transported to the patientthrough a heated delivery tube. The gastemperature exiting the heated delivery tube ismonitored to minimize the formation ofcondensate. | monitoring the gas temperature exiting thechamber to achieve the target humidity level. Thegas is then transported to the patient through aheated delivery tube. The gas temperature exitingthe heated delivery tube is monitored to minimizethe formation of condensate. | ||
| Ambient operatingconditions | 18-26°C (Adult)20-26°C (Neonatal and Pediatric) | 18-26°C | EquivalentThe subject device falls within the primarypredicate device operating conditions. |
| Device operating modes | Bypassed airway:• Invasive mode• Neonatal modeNon-bypassed airway:• Mask mode (adult and pediatric)• CPAP NIV mode (neonatal)• Optiflow™ mode | Bypassed airway:• Invasive modeNon-bypassed airway:• Non-invasive (Mask) mode | EquivalentThe subject device includes five modescompared to the predicate device's modes.However, these modes are subsets ofequivalent humidity levels and flow rates asdescribed in rows above. The additionalmodes do not introduce new questions ofsafety or effectiveness as the specified flowranges are tested in the performance testingand the humidity levels conform to thecurrent recognized standards. |
| Alarms | Alarms exceed 45 dbA @1mAuditory alarm pause: 120 secondsConforms to IEC 60601-1-8: 2006 + A1: 2012 | Alarms exceed 50 dbA @1mAuditory alarm pause: 120 secondsConforms to IEC 60601-1-8: 2003 | EquivalentThe subject and primary predicate devicesconform with applicable standards at thetime of release. |
| Storage conditions(Hardware) | -20°C - 60°C | -10°C - 50°C | EquivalentThe subject device has broader storageconditions than the primary predicate device.This has been verified in the transport andstorage testing included in performancetesting. |
| Service life (Hardware) | 7 years | 7 years | Identical |
| IEC 60601-1 classification | Class II | Class I | Equivalent |
| Design/technologicalcharacteristic forcomparison | Subject DeviceF&P 950 Respiratory Humidifier | Primary Predicate DeviceF&P MR850 Respiratory Humidifier (K110019) | Comments |
| The subject device is double insulated with afunctional earth, making it a Class II device. | |||
| IEC 62304 softwareclassification | Class B | Class B | Identical |
Table 1: Subject Device and Primary Predicate Comparison Table
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Table 2: 950A80J – Adult / Pediatric Ventilator Circuit Kit to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950A80J | Secondary Predicate DeviceF&P RT380 (K122432) | Comments |
|---|---|---|---|
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to adult, adolescent and child patients,within the limits of its stated technicalspecifications. | The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended asconduits of breathing gas for ventilation ofadult patients, and to maintain thetemperature of humidified inspired gas. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | IdenticalBoth the subject device and the secondary predicatedevice contain the components that connect togetherto create a closed circuit that allows for invasive ornoninvasive ventilation. |
| Patient Population | Adult, adolescent and child patients with tidalvolume above 200 mL. | Adult patients. | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Non-vented mask with standard elbow | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Non-vented mask with standard elbow | Identical |
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| Specified Flow Range | Invasive mode: 5 - 60 L/min | Up to 60 L/min in Invasive mode as per theMR850 user instructions | ldentical |
|---|---|---|---|
| Mask mode: 5 – 120 L/min | Up to 120 L/min in Noninvasive mode as perthe 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 secondarypredicate 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 forcomparison | Subject Device950A81J | Secondary Predicate DeviceF&P RT380 (K122432) | Comments |
|---|---|---|---|
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to adult, adolescent and child patients,within the limits of its stated technicalspecifications. | The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended asconduits of breathing gas for ventilation ofadult patients, and to maintain thetemperature of humidified inspired gas. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | IdenticalBoth the subject device and the secondary predicatedevice contain the components that connect togetherto create a closed circuit that allows for invasive ornoninvasive ventilation. |
| Patient Population | Adult, adolescent and child patients with tidalvolume above 200 mL. | Adult patients. | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Invasive ventilation: | Invasive ventilation: | Identical |
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| Characteristic forcomparison | Subject Device950A81J | Secondary Predicate DeviceF&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 theMR850 user instructions | Identical |
| Mask mode: 5 – 120 L/min | Up to 120 L/min in Noninvasive mode as perthe MR850 user instructions | ||
| Duration of Use | 14 Days | 14 Days | Identical |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -30°C – 50°C | EquivalentThe subject device falls within the secondarypredicate 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 Device950A82J | Secondary Predicate DeviceF&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 theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to adult, adolescent and child patients,within the limits of its stated technicalspecifications. | The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended asconduits of breathing gas for ventilation ofadult patients, and to maintain thetemperature of humidified inspired gas. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases 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 thatallows for invasive or noninvasive ventilation. | expiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | Both the subject device and the secondary predicatedevice contain the components that connect togetherto create a closed circuit that allows for invasive ornoninvasive ventilation. | |
| Patient Population | Adult, adolescent and child patients with tidalvolume above 200 mL. | Adult patients. | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Non-vented mask with standard elbow | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Non-vented mask with standard elbow | Identical |
| Specified Flow Range | Invasive mode: 5 - 60 L/minMask mode: 5 – 120 L/min | Up to 60 L/min in Invasive mode as per theMR850 user instructionsUp to 120 L/min in Noninvasive mode as perthe MR850 user instructions | Identical |
| Duration of Use | 14 Days | 14 Days | Identical |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C - 50°C | -30°C - 50°C | EquivalentThe subject device falls within the secondarypredicate device storage condition range. |
| Filter | RT019 Inspiratory / Expiratory Filter | RT019 Inspiratory / Expiratory Filter | Identical |
| Pressure Line | 498042178 Pressure Line with 693040748Elbow | 498042178 Pressure Line with 693040748Elbow | Identical |
| Characteristic forcomparison | Subject Device950A40J | Secondary Predicate DeviceF&P AirSpiral™ Heated BreathingCircuit (K162553) | Comments |
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It isintended for delivery of heated humidifiedrespiratory gases to adult, adolescent andchild patients, within the limits of its statedtechnical specifications. | Heated breathing tube for delivery ofhumidified respiratory gases.For use with AIRVO and AIRVO2 Serieshumidifiers in hospitals and long-term carefacilities.For use at flows from 2 to 60 L.min-1depending on the patient interface. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, and inspiratory limbto create a single limb for the delivery of highflow therapy. | Breathing circuit kit contains a humidificationchamber and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | IdenticalBoth the subject device and the secondary predicatedevice contain the components that connect togetherto create a single limb for delivery of high flow. |
| Patient Population | Adult, adolescent and child patients weighingabove 10 kg. | Spontaneously breathing patient requiringflows between 2 –60 L/min. | DifferentThe predicate is not indicated for a specificpopulation but for a flow range. This includes boththe adult and pediatric patient populations. |
| Intended Interface | High flow nasal cannula and tracheostomyhigh flow interface | High flow nasal cannula and tracheostomyhigh flow interface | Identical |
| Specified Flow Range | 5 – 70 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | DifferentThe subject device has the same specified flowrange of 5 - 70 L/min as the AA403 Optiflow™Oxygen Kit (K211096) reference device, alsodesigned 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 | EquivalentThe subject device falls within the secondarypredicate 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 | F&P RT265 / RT266 (K103767) | |
| Intended Use | Deliver heated and humidified respiratory | Deliver heated and humidified respiratory | Identical |
| gases. | gases. | ||
| Indications for Use | The breathing set is an accessory to the | The dual-heated breathing circuits are | Equivalent |
| F&P 950 Respiratory Humidifier. It is intended | intended as conduits of breathing gas for | Both the subject and secondary predicate device are | |
| for delivery of heated humidified respiratory | ventilation of infant patients, and to maintain | indicated to provide heat and humidity to respiratory | |
| gases to neonatal, infant and child patients, | the temperature of humidified inspired gas. | gases delivered to patients. | |
| within the limits of its stated technical | The RT265 is used for flow rates greater than | ||
| specifications. | 4 L/min, and the RT266 is for flow rates | ||
| between 0.3 and 4 L/min. | |||
| Operating Principle | Breathing circuit kit contains a dryline, | Breathing circuit kit contains a dryline, | Identical |
| humidification chamber, inspiratory limb, and | humidification chamber, inspiratory limb, and | Both the subject device and the secondary predicate | |
| expiratory limb to create a closed circuit that | expiratory limb to create a closed circuit that | device contain the components that connect together | |
| allows for invasive or noninvasive ventilation. | allows for invasive or noninvasive ventilation. | to create a closed circuit that allows for invasive or | |
| noninvasive ventilation. | |||
| Patient Population | For neonatal patients with tidal volume below | Infant | Different |
| 50 mL | The subject device is compliant to the pneumatic | ||
| For infant and child patients with tidal volume | requirements of ISO 5367 for the indicated patient | ||
| 50 mL - 300 mL | populations. | ||
| Intended Interface | Invasive ventilation: | Invasive ventilation: | Identical |
| Endotracheal tube (ETT) or tracheostomy | Endotracheal tube (ETT) or tracheostomy | ||
| interface | interface | ||
| Noninvasive ventilation: | Noninvasive ventilation: | ||
| Midline or lateral CPAP interface with nasal | Midline or lateral CPAP interface with nasal | ||
| prongs or a nasal mask | prongs or a nasal mask | ||
| Specified Flow Range | 0.5 — 40 L/min | RT266 | Equivalent |
| 0.3 — 4 L/min | The subject device covers an equivalent flow range | ||
| to the two secondary predicate devices. The | |||
| RT265 | AirSpiral™ technology in the F&P 950 inspiratory | ||
| >4 L/min | limb removes the need for separate low flow and | ||
| high flow inspiratory limbs. | |||
| Duration of Use | 14 Days | 7 days | Different |
| The subject device has the same duration of use as | |||
| the RT380/RT385 secondary predicate device | |||
| (K122432). | |||
| Characteristic forcomparison | Subject Device950N80J | Secondary Predicate DeviceF&P RT265 / RT266 (K103767) | Comments |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
{11}------------------------------------------------
Table 5: 950A40J – Optiflow™ Circuit Kit to Secondary Predicate Comparison Table
{12}------------------------------------------------
Table 6: 950N80J – Neonatal / Pediatric Ventilator Circuit Kit to Secondary Predicate Comparison Table
{13}------------------------------------------------
{14}------------------------------------------------
Table 7: 950N81J – Neonatal / Pediatric Ventilator Circuit Kit (with Pressure line) to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950N81J | Secondary Predicate DeviceF&P RT265 / RT266 (K103767) | Comments |
|---|---|---|---|
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to neonatal, infant and child patients,within the limits of its stated technicalspecifications. | The dual-heated breathing circuits areintended as conduits of breathing gas forventilation of infant patients, and to maintainthe temperature of humidified inspired gas.The RT265 is used for flow rates greater than4 L/min, and the RT266 is for flow ratesbetween 0.3 and 4 L/min. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | IdenticalBoth the subject device and the secondary predicatedevice contain the components that connect togetherto create a closed circuit that allows for invasive ornoninvasive ventilation. |
| Patient Population | For neonatal patients with tidal volume below50 mLFor infant and child patients with tidal volume50 mL - 300 mL | Infant | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation: | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation: | Identical |
{15}------------------------------------------------
| Characteristic forcomparison | Subject Device950N81J | Secondary Predicate DeviceF&P RT265 / RT266 (K103767) | Comments |
|---|---|---|---|
| Midline or lateral CPAP interface with nasalprongs or a nasal mask | Midline or lateral CPAP interface with nasalprongs or a nasal mask | ||
| Specified Flow Range | $0.5 - 40$ L/min | RT266$0.3 - 4$ L/minRT265$>4$ L/min | EquivalentThe subject device covers an equivalent flow rangeto the secondary predicate device. The AirSpiral™technology in the F&P 950 inspiratory limb removesthe need for separate low flow and high flowinspiratory limbs. |
| Duration of Use | 14 Days | 7 days | DifferentThe subject device has the same duration of use asthe RT380/RT385 secondary predicate device(K122432). |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
| Pressure Line | 498042167 Pressure Line with 693040108Elbow | 498042167 Pressure Line with 693040108Elbow | Identical |
Table 8: 950N40J – Optiflow™ Junior Circuit Kit to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950N40J | Secondary Predicate DeviceF&P AirSpiral™ Heated BreathingCircuit (K162553) | Comments |
|---|---|---|---|
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to neonatal, infant and child patients,within the limits of its stated technical | Heated breathing tube for delivery ofhumidified respiratory gases.For use with AIRVO and AIRVO2 Serieshumidifiers in hospitals and long-term carefacilities. | EquivalentBoth the subject and secondary predicate device areindicated to provide heat and humidity to respiratorygases delivered to patients. |
{16}------------------------------------------------
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
|---|---|---|---|
| comparison | 950N40J | F&P AirSpiral™ Heated BreathingCircuit (K162553) | |
| specifications. | For use at flows from 2 to 60 L.min-1depending on the patient interface. | ||
| Operating Principle | Breathing circuit kit contains a humidificationchamber, and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | Breathing circuit kit contains a humidificationchamber and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | IdenticalBoth the subject device and the secondary predicatedevice contain the components that connect togetherto create a single limb for delivery of high flow. |
| Patient Population | Neonatal, infant and child patients | Spontaneously breathing patient requiringflows between 2 -60 L/min. | DifferentThe predicate is not indicated for a specificpopulation but for a flow range. This includespediatric patient populations. |
| Intended Interface | High flow nasal cannula and tracheostomyhigh flow interface | High flow nasal cannula and tracheostomyhigh flow interface | Identical |
| Specified Flow Range | 0.5 – 36 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | DifferentThe 950N40J flow range has been aligned directlywith the specified flow range (0.5 – 36 L/min) of thepreviously cleared F&P OJR215 Pressure ReliefManifold NHF (K173770) that is contained within thekit. |
| Duration of Use | 14 Days | 14 Days | Identical |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 9: 950P81J – Pediatric Ventilator Circuit Kit (with Pressure line) to Secondary Predicate Comparison Table
| Characteristic for comparison | Subject Device 950P81J | Secondary Predicate Device F&P RT265 / RT266 (K103767) | Comments |
|---|---|---|---|
| Classification Product Code | BZE | BZE | Identical |
| Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical |
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
| comparison | 950P81J | F&P RT265 / RT266 (K103767) | |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to neonatal, infant, child andadolescent patients, within the limits of itsstated technical specifications. | The dual-heated breathing circuits areintended as conduits of breathing gas forventilation of infant patients, and to maintainthe temperature of humidified inspired gas.The RT265 is used for flow rates greater than4 L/min, and the RT266 is for flow ratesbetween 0.3 and 4 L/min. | EquivalentBoth the subject and secondary predicate deviceare indicated to provide heat and humidity torespiratory gases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to create a closed circuit thatallows for invasive or noninvasive ventilation. | IdenticalBoth the subject device and the secondarypredicate device contain the components thatconnect together to create a closed circuit thatallows for invasive or noninvasive ventilation. |
| Patient Population | For neonatal patients with tidal volume below50 mLFor infant, child and adolescent patients withtidal volume 50 mL - 300 mL | Infant | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Midline or lateral nasal CPAP interface, ornon-vented mask with standard elbow | Invasive ventilation:Endotracheal tube (ETT) or tracheostomyinterfaceNoninvasive ventilation:Midline or lateral nasal CPAP interface, ornon-vented mask with standard elbow | Identical |
| Specified Flow Range | 1 — 60 L/min | RT2660.3 — 4 L/minRT265>4 L/min | EquivalentThe subject device covers an equivalent flow rangeto the secondary predicate device. The AirSpiral™technology in the F&P 950 inspiratory limbremoves the need for separate low flow and highflow inspiratory limbs. |
| Duration of Use | 14 Days | 7 days | DifferentThe subject device has the same duration of useas the RT380/RT385 secondary predicate device(K122432). |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | Equivalent |
| Characteristic forcomparison | Subject Device950P40J | Secondary Predicate DeviceF&P AirSpiral™ Heated BreathingCircuit (K162553) | Comments |
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to neonatal, infant, child andadolescent patients, within the limits of itsstated technical specifications. | Heated breathing tube for delivery ofhumidified respiratory gases.For use with AIRVO and AIRVO2 Serieshumidifiers in hospitals and long-term carefacilities.For use at flows from 2 to 60 L.min-1depending on the patient interface. | EquivalentBoth the subject and secondary predicate deviceare indicated to provide heat and humidity torespiratory gases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a humidificationchamber, and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | Breathing circuit kit contains a humidificationchamber and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | IdenticalBoth the subject device and the secondarypredicate device contain the components thatconnect together to create a single limb for deliveryof high flow. |
| Patient Population | Neonatal, infant, child and adolescent patients | Spontaneously breathing patient requiringflows between 2 -60 L/min. | DifferentThe predicate is not indicated for a specificpopulation but for a flow range. This includespediatric patient populations. |
| Intended Interface | High flow nasal cannula and tracheostomyhigh flow interface | High flow nasal cannula and tracheostomyhigh flow interface | Identical |
| Specified Flow Range | 1 - 60 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | EquivalentThe subject and secondary predicate devices haveequivalent flow ranges. |
| Duration of Use | 14 Days | 14 Days | Identical |
{17}------------------------------------------------
{18}------------------------------------------------
| Characteristic for comparison | |||
|---|---|---|---|
| Subject Device 950P81J | |||
| Secondary Predicate Device F&P RT265 / RT266 (K103767) | |||
| Comments | The subject device falls within the secondary predicate device shelf life duration. | ||
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 10: 950P40J – Pediatric Optiflow™ Circuit Kit to Secondary Predicate Comparison Table
{19}------------------------------------------------
| Characteristic forcomparison | Subject Device950P40J | Secondary Predicate DeviceF&P AirSpiral™ Heated BreathingCircuit (K162553) | Comments |
|---|---|---|---|
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 11: AA451SU – Optiflow™ Oxygen Kit to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject DeviceAA451SU | Secondary Predicate DeviceF&P AirSpiral™ Heated BreathingCircuit (K162553) | Comments |
|---|---|---|---|
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to adult, adolescent and child patients,within the limits of its stated technicalspecifications. | Heated breathing tube for delivery ofhumidified respiratory gases.For use with AIRVO and AIRVO2 Serieshumidifiers in hospitals and long-term carefacilities.For use at flows from 2 to 60 L.min-1depending on the patient interface. | EquivalentBoth the subject and secondary predicate deviceare indicated to provide heat and humidity torespiratory gases delivered to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, and inspiratory limbto create a single limb for the delivery of highflow therapy. | Breathing circuit kit contains a humidificationchamber and inspiratory limb to create asingle limb for the delivery of high flowtherapy. | IdenticalBoth the subject device and the secondarypredicate device contain the components thatconnect together to create a single limb for deliveryof high flow. |
| Patient Population | Adult, adolescent and child patients weighingabove 10 kg | Spontaneously breathing patient requiringflows between 2 -60 L/min. | DifferentThe predicate is not indicated for a specificpopulation but for a flow range. This includes boththe adult and pediatric patient populations. |
| Interface Connections | Patient end connector is designed with Fisher& Paykel secure connector features | Patient end connector is designed with Fisher& Paykel secure connector features | Equivalent |
{20}------------------------------------------------
| Characteristic forcomparison | Subject DeviceAA451SU | Secondary Predicate DeviceF&P AirSpiralTM Heated BreathingCircuit (K162553) | Comments |
|---|---|---|---|
| Specified Flow Range | 5 – 70 L/min | 10 - 60 L/min on the F&P AIRVO 2(K131895). | DifferentThe subject device has the same specified flowrange of 5 - 70 L/min as the AA403 OptiflowTMOxygen Kit (K211096) reference device, alsodesigned 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 | EquivalentThe subject device falls within the secondarypredicate device shelf life duration. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 12: 950A60J – Bi-Level / CPAP Single Limb Circuit Kit to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950A60J | Secondary Predicate DeviceF&P 850 AirSpiral Adult NIV And NHFCircuit Kit (K212031) | Comments |
|---|---|---|---|
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases | Heated breathing tube for delivery ofhumidified respiratory gases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to adult, adolescent and child patients,within the limits of its stated technicalspecifications. | For the delivery of heated, humidifiedbreathing gases to spontaneously breathingadult patients. This breathing set is suitablefor use with Fisher & Paykel HealthcareMR850 Humidifiers in hospital and long-termcare environments. | EquivalentBoth the subject and secondary predicate deviceare indicated to deliver heated and humidifiedrespiratory gases to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, anddisposable exhalation port to create a singlelimb with intentional leak for delivery ofnoninvasive ventilation. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, anddisposable exhalation port to create a singlelimb with intentional leak for delivery ofnoninvasive ventilation. | IdenticalBoth the subject device and the secondarypredicate device contain the components thatconnect together to allow for noninvasiveventilation. |
| Patient Population | Adult, adolescent and child patients weighingabove 10 kg. | Spontaneously breathing adult patientsrequiring flows between 10 – 120 L/min | Different |
{21}------------------------------------------------
| Characteristic forcomparison | Subject Device950A60J | Secondary Predicate DeviceF&P 850 AirSpiral Adult NIV And NHFCircuit Kit (K212031) | Comments |
|---|---|---|---|
| depending on the required therapy and patientinterface. | The subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. | ||
| Intended Interface | Non-vented mask (used with DEP) andvented mask | Non-vented mask (used with DEP) andvented mask | Identical |
| Specified Flow Range | 5 – 120 L/min | 10 - 120 L/min | Equivalent |
| Ambient operatingconditions | 18°C – 26°C | 20°C – 26°C | Equivalent |
| Reusability | Single Use | Single Use | Identical |
| Duration of Use | 14 Days | 14 days | Identical |
| Shelf Life | 3 years | 2 years | EquivalentThe subject device meets a 3 year shelf life. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 13: 950A61J – Bi-Level / CPAP Single Limb Circuit Kit (with filter) to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950A61J | Secondary Predicate DeviceF&P 850 AirSpiral Adult NIV And NHFCircuit Kit (K212031) | Comments |
|---|---|---|---|
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases. | Heated breathing tube for delivery ofhumidified respiratory gases. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It isintended for delivery of heated humidifiedrespiratory gases to adult, adolescent andchild patients, within the limits of its statedtechnical specifications. | For the delivery of heated, humidifiedbreathing gases to spontaneously breathingadult patients. This breathing set is suitablefor use with Fisher & Paykel HealthcareMR850 Humidifiers in hospital and long-termcare environments. | EquivalentBoth the subject and secondary predicate device areindicated to deliver heated and humidified respiratorygases to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, anddisposable exhalation port to create a single | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, anddisposable exhalation port to create a single | Equivalent |
{22}------------------------------------------------
| Characteristic forcomparison | Subject Device950A61J | Secondary Predicate DeviceF&P 850 AirSpiral Adult NIV And NHFCircuit Kit (K212031) | Comments |
|---|---|---|---|
| limb with intentional leak for delivery ofnoninvasive ventilation. | limb with intentional leak for delivery ofnoninvasive ventilation. | Both the subject device and the secondary predicatedevice contain the components that connect togetherto allow for noninvasive ventilation | |
| Patient Population | Adult, adolescent and child patientsweighing above 10 kg. | Spontaneously breathing adult patientsrequiring flows between 10 – 120 L/mindepending on the required therapy andpatient interface. | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | Non-vented mask (used with DEP) andvented mask | Non-vented mask (used with DEP) andvented mask | Identical |
| Specified Flow Range | 5 – 120 L/min | 10 – 120 L/min | Equivalent |
| Ambient operatingconditions | 18°C – 26°C | 20°C – 26°C | Equivalent |
| Reusability | Single Use | Single Use | Identical |
| Duration of Use | 14 Days | 14 days | Identical |
| Shelf Life | 3 years | 2 years | EquivalentThe subject device meets a 3 year shelf life. |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
| Filter | RT016 Inspiratory Filter | RT016 Inspiratory Filter | Identical |
Table 14: 950N61J – Nasal CPAP Flow Driver Circuit Kit to Secondary Predicate Comparison Table
| Characteristic forcomparison | Subject Device950N61J | Secondary Predicate DeviceF&P RT130 / RT131 (K020332) | Comments |
|---|---|---|---|
| Classification ProductCode | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratorygases. | Deliver heated and humidified respiratorygases for mechanical ventilation or support. | Identical |
| Indications for Use | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It is intendedfor delivery of heated humidified respiratorygases to neonatal, infant and child patients, | The heated-wire breathing circuits areintended as conduits of breathing gas forventilation of patients, and to maintain thetemperature of humidified inspired gas, toreduce condensation. They are accessories | EquivalentBoth the subject and secondary predicate device areindicated to deliver heated and humidified respiratorygases to patients. |
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
| comparison | 950N61J | F&P RT130 / RT131 (K020332) | |
| within the limits of its stated technicalspecifications. | for the Fisher & Paykel Healthcare MR850Respiratory Gas Humidifier. The RT130 isused for flow rates between 0.3 and 4 L/min,and the RT131 is for flow rates greater than 4L/min, for neonatal patients. | ||
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andadapters to allow for delivery of Nasal CPAP. | Breathing circuit kit contains a dryline,humidification chamber, inspiratory limb, andexpiratory limb to allow for the delivery ofNasal CPAP. | EquivalentBoth the subject device and the secondary predicatedevice contain the components that connect togetherto allow for Nasal CPAP. |
| Patient Population | Neonatal, infant and child patients. | Infant patients. | DifferentThe subject device is compliant to the pneumaticrequirements of ISO 5367 for the indicated patientpopulations. |
| Intended Interface | CPAP Generator assembly with nasalinterface (prongs or mask) | Nasal CPAP interface with nasal prongs ornasal mask | Equivalent |
| Specified Flow Range | 0.5 – 40 L/min | RT1300.3 – 4 L/minRT131>4 L/min | EquivalentThe subject device covers an equivalent flow rangeto the two secondary predicate devices. TheAirSpiral™ technology in the F&P 950 inspiratorylimb removes the need for separate low flow andhigh flow inspiratory limbs. |
| Ambient operatingconditions | 20°C – 26°C | 20°C – 26°C | Identical |
| Reusability | Single Use | Single Use | Identical |
| Duration of Use | 14 Days | 7 Days | DifferentThe subject device has a different duration of use tothe RT130/RT131 secondary predicate (K020332).However, the duration of use is the same as theRT380/RT385 (K122432). |
| Shelf Life | 3 years | 5 years | Equivalent |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
{23}------------------------------------------------
{24}------------------------------------------------
VII. PERFORMANCE DATA
Summary of non-clinical tests
The F&P 950 Respiratory Humidifier has been tested to the applicable requirements of the following standards:
| Standards | Title |
|---|---|
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systemsfor Medical Devices |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
| ISO 18562-1:2017 | Biocompatibility Evaluation of Breathing Gas Pathways inHealthcare Applications- Part 1: Evaluation and Testing Within aRisk Management Process |
| IEC 62304:2015Consolidated Version | Medical device software - software lifecycle processes |
| IEC 60601-1-2:2014 +AMD1:2020 Ed 4.1 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic compatibility - Requirements and tests. |
| AIM Standard 7351731 Rev.2.00 2017-02-23 | Medical Electrical Equipment and System ElectromagneticImmunity Test for Exposure to Radio Frequency IdentificationReaders - An AIM Standard |
| ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets andconnectors |
| ISO 5356-1:2004 | Anaesthetic and Respiratory Equipment - Conical Connectors -Part 1: Cones and Sockets. |
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (edition 3.1). |
| ISO 80601-2-74: 2017 | Medical Electrical Equipment- Part 2-74: Particular RequirementsFor Basic Safety and Essential Performance Of RespiratoryHumidifying Equipment |
| IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| IEC 60601-1-8:2012 | Medical electrical equipment: Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard:General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems. |
| IEC 62366-1:2015 +AMD:2020 | Medical devices - Part 1: Application of usability engineering tomedical devices |
| ISTA 3A | Packaged-Products for Parcel Delivery System Shipment 70 kg(150 lb) or Less |
Biocompatibility Testing:
The biocompatibility evaluation for the F&P 950 Respiratory Humidifier and accessory breathing circuit kits was conducted in accordance with the International Standards ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process," and ISO 18562-1:2017 "Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a
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risk management process" as recognized by the FDA. Testing of the F&P 950 Respiratory Humidifier and accessory breathing circuit kits demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety, Electromagnetic Compatibility (EMC), and Alarms:
Electrical safety and EMC testing were conducted on the F&P 950 Respiratory Humidifier and accessory breathing circuit kits. The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. Alarms testing was performed in accordance with IEC 60601-1-8:2006 and A1:2012.
Software Verification and Validation Testing:
Software verification and validation was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Human Factors Testing:
A Human Factors and Usability Engineering validation study was conducted on the F&P 950 Respiratory Humidifier and accessory breathing circuit kits, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". The validation study demonstrates that the device has been found to be safe and effective for the intended users, uses, and use environments.
Bench / Performance Testing:
Performance testing was conducted to demonstrate substantial equivalence including:
- . Humidification output, thermal overshoot, surface temperature of applied parts in line with ISO 80601-2-74:2017
- Resistance to flow, compliance, and gas leak testing in line with ISO 5367:2014 ●
- . Comparative ME systems testing in line with ISO 80601-2-12:2020
- Comparative Disposable Exhalation Port leak rate ●
- Comparative testing of MDI port performance .
VIII. CONCLUSION
The F&P 950 Respiratory Humidifier and accessory breathing circuit kits are substantially equivalent to the predicate devices based on intended uses, comparison of the technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the devices are substantially equivalent to the legally marketed predicate devices.
§ 868.5450 Respiratory gas humidifier.
(a)
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.(b)
Classification. Class II (performance standards).