(463 days)
No
The description focuses on standard sensor-based control for heating and humidification, and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is intended to provide heat and humidity to respiratory gases delivered to patients, supporting medical procedures like ventilation, which directly affects a patient's physiological state.
No
Explanation: The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases, not to diagnose a medical condition. Its function is therapeutic/supportive rather than diagnostic.
No
The device description explicitly states it is made up of hardware components (heaterbase, sensor cartridge, expiratory heater wire adapter) and breathing circuit kits, in addition to being a programmable electrical medical device that uses sensors. While it contains software, it is not solely software.
Based on the provided information, the F&P 950 Respiratory Humidifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide heat and humidity to respiratory gases delivered to patients." This describes a device that modifies and delivers gases for therapeutic purposes, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanical and electrical aspects of warming and humidifying air and delivering it to the patient. It does not mention any analysis of biological samples.
- Performance Studies: The performance studies listed are related to the device's physical performance, safety, and usability in delivering respiratory gases (e.g., humidification output, resistance to flow, electrical safety, software validation, human factors). There are no studies related to the analysis of biological samples or diagnostic accuracy.
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVD devices, such as "specimen," "assay," "analyte," "diagnosis," "monitoring biological markers," etc.
In summary, the F&P 950 Respiratory Humidifier is a medical device used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT, BZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, adolescent and child patients
Neonatal, infant, child and adolescent patients
Neonatal, infant and child patients
Intended User / Care Setting
Health professional / Hospital or long-term care facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of non-clinical tests
The F&P 950 Respiratory Humidifier was tested against the following standards:
- ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 18562-1:2017: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications- Part 1: Evaluation and Testing Within a Risk Management Process
- IEC 62304:2015 Consolidated 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 for basic 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 Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- ISO 5367:2014: Anaesthetic and respiratory equipment - Breathing sets and connectors
- 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 for basic safety and essential performance (edition 3.1).
- ISO 80601-2-74: 2017: Medical Electrical Equipment- Part 2-74: Particular Requirements For Basic Safety and Essential Performance Of Respiratory Humidifying Equipment
- IEC 60601-1-6:2013: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8:2012: Medical electrical equipment: Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- IEC 62366-1:2015 + AMD:2020: Medical devices - Part 1: Application of usability engineering to medical devices
- ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Biocompatibility Testing:
The biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018 and ISO 18562-1:2017. Testing demonstrated an appropriate biocompatibility profile for the device.
Electrical Safety, Electromagnetic Compatibility (EMC), and Alarms:
Electrical safety and EMC testing were conducted. 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. 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 complies with 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, and documentation complies with FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". The study demonstrates that the device is safe and effective for its intended users, uses, and 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110019, K122432, K162553, K103767, K212031, K020332
Reference Device(s)
K050927, K173770, K131895, K211096, K982454, K031745, K091111, K133666
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 12mg/L
for flow 33mg/L
for flow 10mg/L
for flow 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 for
comparison | Subject Device
950N80J | Secondary Predicate Device
F&P RT265 / RT266 (K103767) | Comments |
| 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 |
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 for
comparison | Subject Device
950N81J | Secondary Predicate Device
F&P RT265 / RT266 (K103767) | 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 neonatal, infant and child patients,
within the limits of its stated technical
specifications. | The dual-heated breathing circuits are
intended as conduits of breathing gas for
ventilation of infant patients, and to maintain
the temperature of humidified inspired gas.
The RT265 is used for flow rates greater than
4 L/min, and the RT266 is for flow rates
between 0.3 and 4 L/min. | 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 | For neonatal patients with tidal volume below
50 mL
For infant and child patients with tidal volume
50 mL - 300 mL | Infant | 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: | Invasive ventilation:
Endotracheal tube (ETT) or tracheostomy
interface
Noninvasive ventilation: | Identical |
15
| Characteristic for
comparison | Subject Device
950N81J | Secondary Predicate Device
F&P RT265 / RT266 (K103767) | Comments |
|----------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Midline or lateral CPAP interface with nasal
prongs or a nasal mask | Midline or lateral CPAP interface with nasal
prongs or a nasal mask | |
| Specified Flow Range | $0.5 - 40$ L/min | RT266
$0.3 - 4$ L/min
RT265
$>4$ L/min | Equivalent
The subject device covers an equivalent flow range
to the secondary predicate device. The AirSpiral™
technology in the F&P 950 inspiratory 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). |
| 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 |
| Pressure Line | 498042167 Pressure Line with 693040108
Elbow | 498042167 Pressure Line with 693040108
Elbow | Identical |
Table 8: 950N40J – Optiflow™ Junior Circuit Kit to Secondary Predicate Comparison Table
| Characteristic for
comparison | Subject Device
950N40J | Secondary Predicate Device
F&P AirSpiral™ Heated Breathing
Circuit (K162553) | Comments |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code | BTT | BTT | Identical |
| 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 neonatal, infant and child patients,
within the limits of its stated technical | Heated breathing tube for delivery of
humidified respiratory gases.
For use with AIRVO and AIRVO2 Series
humidifiers in hospitals and long-term care
facilities. | Equivalent
Both the subject and secondary predicate device are
indicated to provide heat and humidity to respiratory
gases delivered to patients. |
16
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
|---|---|---|---|
| comparison | 950N40J | F&P AirSpiral™ Heated Breathing | |
| Circuit (K162553) | |||
| specifications. | For use at flows from 2 to 60 L.min-1 | ||
| depending on the patient interface. | |||
| Operating Principle | Breathing circuit kit contains a 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 | Neonatal, infant and child patients | 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 | |||
| 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 | 0.5 – 36 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | Different |
| The 950N40J flow range has been aligned directly | |||
| with the specified flow range (0.5 – 36 L/min) of the | |||
| previously cleared F&P OJR215 Pressure Relief | |||
| Manifold NHF (K173770) that is contained within the | |||
| kit. | |||
| 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 |
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 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. | The dual-heated breathing circuits are | ||
| intended as conduits of breathing gas for | |||
| ventilation of infant patients, and to maintain | |||
| the temperature of humidified inspired gas. | |||
| The RT265 is used for flow rates greater than | |||
| 4 L/min, and the RT266 is for flow rates | |||
| between 0.3 and 4 L/min. | 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 | For neonatal patients with tidal volume below | ||
| 50 mL | |||
| For infant, child and adolescent patients with | |||
| tidal volume 50 mL - 300 mL | Infant | 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: | |||
| Midline or lateral nasal CPAP interface, or | |||
| non-vented mask with standard elbow | Invasive ventilation: | ||
| Endotracheal tube (ETT) or tracheostomy | |||
| interface | |||
| Noninvasive ventilation: | |||
| Midline or lateral nasal CPAP interface, or | |||
| non-vented mask with standard elbow | Identical | ||
| Specified Flow Range | 1 — 60 L/min | RT266 | |
| 0.3 — 4 L/min | |||
| RT265 |
4 L/min | Equivalent
The subject device covers an equivalent flow range
to the secondary predicate device. The AirSpiral™
technology in the F&P 950 inspiratory 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). |
| Reusability | Single Use | Single Use | Identical |
| Shelf Life | 3 years | 5 years | Equivalent |
| Characteristic for
comparison | Subject Device
950P40J | Secondary Predicate Device
F&P AirSpiral™ Heated Breathing
Circuit (K162553) | Comments |
| Classification Product
Code | BTT | BTT | Identical |
| 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 neonatal, infant, child and
adolescent 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 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 | Neonatal, infant, child and adolescent patients | 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
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 | 1 - 60 L/min | 2 - 60 L/min on the F&P AIRVO 2 (K131895). | Equivalent
The subject and secondary predicate devices have
equivalent 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 for
comparison | Subject Device
950P40J | Secondary Predicate Device
F&P AirSpiral™ Heated Breathing
Circuit (K162553) | Comments |
|----------------------------------|---------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 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 |
Table 11: AA451SU – Optiflow™ Oxygen Kit to Secondary Predicate Comparison Table
| Characteristic for
comparison | Subject Device
AA451SU | Secondary Predicate Device
F&P AirSpiral™ Heated Breathing
Circuit (K162553) | Comments |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code | BTT | BTT | Identical |
| 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. |
| 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 for
comparison | Subject Device
AA451SU | Secondary Predicate Device
F&P AirSpiralTM Heated Breathing
Circuit (K162553) | Comments |
|----------------------------------|---------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specified Flow Range | 5 – 70 L/min | 10 - 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 OptiflowTM
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 |
Table 12: 950A60J – Bi-Level / CPAP Single Limb Circuit Kit to Secondary Predicate Comparison Table
| Characteristic for
comparison | Subject Device
950A60J | Secondary Predicate Device
F&P 850 AirSpiral Adult NIV And NHF
Circuit Kit (K212031) | Comments |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratory
gases | Heated breathing tube for delivery of
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. | For the delivery of heated, humidified
breathing gases to spontaneously breathing
adult patients. This breathing set is suitable
for use with Fisher & Paykel Healthcare
MR850 Humidifiers in hospital and long-term
care environments. | Equivalent
Both the subject and secondary predicate device
are indicated to deliver heated and humidified
respiratory gases to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
disposable exhalation port to create a single
limb with intentional leak for delivery of
noninvasive ventilation. | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
disposable exhalation port to create a single
limb with intentional leak for delivery of
noninvasive ventilation. | Identical
Both the subject device and the secondary
predicate device contain the components that
connect together to allow for noninvasive
ventilation. |
| Patient Population | Adult, adolescent and child patients weighing
above 10 kg. | Spontaneously breathing adult patients
requiring flows between 10 – 120 L/min | Different |
21
| Characteristic for
comparison | Subject Device
950A60J | Secondary Predicate Device
F&P 850 AirSpiral Adult NIV And NHF
Circuit Kit (K212031) | Comments |
|----------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | | depending on the required therapy and patient
interface. | The subject device is compliant to the pneumatic
requirements of ISO 5367 for the indicated patient
populations. |
| Intended Interface | Non-vented mask (used with DEP) and
vented mask | Non-vented mask (used with DEP) and
vented mask | Identical |
| Specified Flow Range | 5 – 120 L/min | 10 - 120 L/min | Equivalent |
| Ambient operating
conditions | 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 | Equivalent
The 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 for
comparison | Subject Device
950A61J | Secondary Predicate Device
F&P 850 AirSpiral Adult NIV And NHF
Circuit Kit (K212031) | Comments |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratory
gases. | Heated breathing tube for delivery of
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. | For the delivery of heated, humidified
breathing gases to spontaneously breathing
adult patients. This breathing set is suitable
for use with Fisher & Paykel Healthcare
MR850 Humidifiers in hospital and long-term
care environments. | Equivalent
Both the subject and secondary predicate device are
indicated to deliver heated and humidified respiratory
gases to patients. |
| Operating Principle | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
disposable exhalation port to create a single | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
disposable exhalation port to create a single | Equivalent |
22
| Characteristic for
comparison | Subject Device
950A61J | Secondary Predicate Device
F&P 850 AirSpiral Adult NIV And NHF
Circuit Kit (K212031) | Comments |
|----------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | limb with intentional leak for delivery of
noninvasive ventilation. | limb with intentional leak for delivery of
noninvasive ventilation. | Both the subject device and the secondary predicate
device contain the components that connect together
to allow for noninvasive ventilation |
| Patient Population | Adult, adolescent and child patients
weighing above 10 kg. | Spontaneously breathing adult patients
requiring flows between 10 – 120 L/min
depending on the required therapy and
patient interface. | Different
The subject device is compliant to the pneumatic
requirements of ISO 5367 for the indicated patient
populations. |
| Intended Interface | Non-vented mask (used with DEP) and
vented mask | Non-vented mask (used with DEP) and
vented mask | Identical |
| Specified Flow Range | 5 – 120 L/min | 10 – 120 L/min | Equivalent |
| Ambient operating
conditions | 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 | Equivalent
The 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 for
comparison | Subject Device
950N61J | Secondary Predicate Device
F&P RT130 / RT131 (K020332) | Comments |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code | BTT | BTT | Identical |
| Intended Use | Deliver heated and humidified respiratory
gases. | Deliver heated and humidified respiratory
gases for mechanical ventilation or support. | 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 neonatal, infant and child patients, | The heated-wire breathing circuits are
intended as conduits of breathing gas for
ventilation of patients, and to maintain the
temperature of humidified inspired gas, to
reduce condensation. They are accessories | Equivalent
Both the subject and secondary predicate device are
indicated to deliver heated and humidified respiratory
gases to patients. |
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
| comparison | 950N61J | F&P RT130 / RT131 (K020332) | |
| | within the limits of its stated technical
specifications. | for the Fisher & Paykel Healthcare MR850
Respiratory Gas Humidifier. The RT130 is
used for flow rates between 0.3 and 4 L/min,
and the RT131 is for flow rates greater than 4
L/min, for neonatal patients. | |
| Operating Principle | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
adapters to allow for delivery of Nasal CPAP. | Breathing circuit kit contains a dryline,
humidification chamber, inspiratory limb, and
expiratory limb to allow for the delivery of
Nasal CPAP. | Equivalent
Both the subject device and the secondary predicate
device contain the components that connect together
to allow for Nasal CPAP. |
| Patient Population | Neonatal, infant and child patients. | Infant patients. | Different
The subject device is compliant to the pneumatic
requirements of ISO 5367 for the indicated patient
populations. |
| Intended Interface | CPAP Generator assembly with nasal
interface (prongs or mask) | Nasal CPAP interface with nasal prongs or
nasal mask | Equivalent |
| Specified Flow Range | 0.5 – 40 L/min | RT130
0.3 – 4 L/min
RT131
4 L/min | Equivalent
The subject device covers an equivalent flow range
to the two secondary predicate devices. The
AirSpiral™ technology in the F&P 950 inspiratory
limb removes the need for separate low flow and
high flow inspiratory limbs. |
| Ambient operating
conditions | 20°C – 26°C | 20°C – 26°C | Identical |
| Reusability | Single Use | Single Use | Identical |
| Duration of Use | 14 Days | 7 Days | Different
The subject device has a different duration of use to
the RT130/RT131 secondary predicate (K020332).
However, the duration of use is the same as the
RT380/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 Systems |
| for Medical Devices | |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| ISO 18562-1:2017 | Biocompatibility Evaluation of Breathing Gas Pathways in |
| Healthcare Applications- Part 1: Evaluation and Testing Within a | |
| Risk Management Process | |
| IEC 62304:2015 | |
| Consolidated 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 for |
| basic 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 Electromagnetic |
| Immunity Test for Exposure to Radio Frequency Identification | |
| Readers - An AIM Standard | |
| ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and |
| connectors | |
| 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 for |
| basic safety and essential performance (edition 3.1). | |
| ISO 80601-2-74: 2017 | Medical Electrical Equipment- Part 2-74: Particular Requirements |
| For Basic Safety and Essential Performance Of Respiratory | |
| Humidifying Equipment | |
| IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Usability | |
| IEC 60601-1-8:2012 | Medical electrical equipment: Part 1-8: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| General requirements, tests and guidance for alarm systems in | |
| medical electrical equipment and medical electrical systems. | |
| IEC 62366-1:2015 + | |
| AMD:2020 | Medical devices - Part 1: Application of usability engineering to |
| medical 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
25
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.