(271 days)
No
The document does not mention AI, ML, or any related concepts like neural networks, deep learning, or algorithms that learn from data. The description focuses on providing heat and humidity to respiratory gases.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the F&P 820 System is "intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases."
No
The device is described as providing therapeutic levels of heat and humidity to respiratory gases, which is a treatment, not a diagnostic function.
No
The device description and performance studies clearly indicate the device is a hardware system (humidifier base, breathing tubes, humidification chamber) with associated software, not a standalone software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is designed to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases. This is a direct treatment or support function for the patient's respiratory system.
- Device Description: The description reinforces that it provides respiratory humidification by delivering heat, humidity, and respiratory gases to patients.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The F&P 820 System does not interact with or analyze such specimens.
The device is a respiratory support system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
F&P 820 System Humidifier Base:
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P 820A10 Breathing Tubes:
The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P MR325 Humidification Chamber:
The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
Product codes
BTT
Device Description
The Fisher & Paykel 820 Humidification (also referred to as F&P 820 System) is designed to provide respiratory humidification by providing heat, humidity, and delivering respiratory gases to patients.
The F&P 820 System is a revision of the predicate device platform, the Fisher & Paykel MR810 Respiratory Humidifier (K143646).
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 and pediatric patients (excluding neonate)
Intended User / Care Setting
Qualified medical professionals.
Hospitals, long term care facilities and homes.
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 820 Respiratory Humidifier has been tested to the applicable requirements of the following standards:
- 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.
- 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, C1:2009/(R)2012 and A2:2010/(R)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. *excluding clause 201.12.1.102a
- 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 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62366-1:2015 + AMD:2020 Medical devices - Part 1: Application of usability engineering to medical devices
Biocompatibility Testing:
The biocompatibility evaluation for the F&P 820 Humidification System 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 risk management process" as recognized by the FDA. FDA's guidance document on Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",2020. Testing of the F&P 820 Humidification System 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 Humidification System. 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:
A human Factors and Usability Engineering study was conducted on the F&P820 Respiratory Humidifier and accessories, and documentation was updated and provided as recommended by FDA's guidance. The study demonstrated that the human factors assessment had been sufficiently evaluated and was 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 .
Conclusion:
The F&P 820 Humidification System 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 5, 2023
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager - North America 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K223684
Trade/Device Name: F&P 820 Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: December 8, 2022 Received: December 8, 2022
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,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223684
Device Name F&P 820 Humidification System
Indications for Use (Describe)
F&P 820 System Humidifier Base:
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P 820A10 Breathing Tubes:
The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P MR325 Humidification Chamber:
The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
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 | Arisha Samad
Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 05 September 2023 |
II. DEVICE
| Name of Device | F&P 820 Humidification System |
|---|---|
| Common/Usual Name | Respiratory Humidifier |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II |
| Primary Classification | BTT (21 CFR §868.5450) |
| Product Code |
5
PREDICATE DEVICE III.
- Primary Predicate device: .
| 510(k) Number | Device Name |
|---|---|
| K143646 | F&P MR810 Respiratory Humidifier |
- Secondary Predicate devices: .
| 510(k)
| Number | Device Name | Reason for secondary predicate |
|---|---|---|
| K983112 | Adult breathing circuit (RT102) | Used as a predicate for the F&P 820A10J |
| accessory breathing circuit kits. | ||
| K003973 | F&P humidification chamber | |
| (HC325) | Used as a predicate for the F&P MR325 | |
| accessory humidification chamber. |
- . Reference device(s):
| 510(k)
| Number | Device Name | Reason for reference |
|---|---|---|
| K152029 | Hamilton-BC4022- Adult single | |
| limb breathing set | Used to address the technological differences | |
| between the subject and predicate device and | ||
| support claims of safety and effectiveness with | ||
| respect to breathing circuit use in patient | ||
| population | ||
| K143646 | F&P Adult breathing circuit | |
| (900MR810) | Used to address the technological differences | |
| between the subject and predicate device. |
DEVICE DESCRIPTION IV.
The Fisher & Paykel 820 Humidification (also referred to as F&P 820 System) is designed to provide respiratory humidification by providing heat, humidity, and delivering respiratory gases to patients.
The F&P 820 System is a revision of the predicate device platform, the Fisher & Paykel MR810 Respiratory Humidifier (K143646).
6
V. INDICATIONS FOR USE STATEMENT
F&P 820 System Humidifier Base:
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.
The F&P 820 System is designed for adult and pediatric (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P 820A10 Breathing Tubes:
The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P MR325 Humidification Chamber:
The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.
The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
7
VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Design /
Technological
Characteristics | Subject Device
F&P 820 System - Humidifier Base | Predicate Device
F&P MR810 Respiratory Humidifier (K143646) | Comments |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use
statement | The Fisher & Paykel 820 System is intended to provide
therapeutic levels of heat and humidity to a patient's inspired
respiratory gases, when using a continuous or intermittent
ventilator system or a continuous gas flow.
The 820 System is intended for both non-invasive and
invasive therapies. Addition of heat and humidity to the
supply of cold and dry respiratory gases provided through
non-invasive or invasive ventilation is beneficial to prevent
drying of the patient airways.
The 820 System is for adult and pediatric (excluding
Neonatal) patients requiring a flow range $≥5$ L/min. For use in
hospitals, long term care facilities and homes under the
prescription of a qualified medical professional. | The Fisher & Paykel MR810 System is intended to provide
therapeutic levels of heat and humidity to a patient's inspired
respiratory gases, when using a continuous or intermittent
ventilator system or a continuous gas flow system.
The MR810 System is intended for both non-invasive and
invasive therapies. Addition of heat and humidity to the supply
of cold and dry respiratory gases provided through non-
invasive or invasive ventilation is beneficial to prevent drying of
the patient airways.
The MR810 System is for use for adult and pediatric patients
requiring a flow range $≥5$ L/min. The MR810 System is
designed for use in hospitals, long term care facilities and
homes under the prescription of a qualified medical
professional. | Identical |
| Application | Non-invasive
Invasive | Non-invasive
Invasive | Identical |
| Use Environment | Hospital
Home | Hospital
Home | Identical |
| Patient Population | Adult and Paediatric (Excluding Neonatal) | Adult and Paediatric (Excluding Neonatal) | Identical |
| Intended User Group | Medical or clinical professionals.
Technical healthcare professionals.
Professional Care givers.
Lay users. | Medical or clinical professionals.
Technical healthcare professionals.
Professional Care givers.
Lay users. | Identical |
| Operating Principle | Provides heat and humidity to the respiratory gases by
passing the gas through a humidification chamber and heated
breathing tube. | Provides heat and humidity to the respiratory gases by passing
the gas through a humidification chamber and heated
breathing tube. | Identical |
| Design /
Technological
Characteristics | Subject Device
F&P 820 System - Humidifier Base | Predicate Device
F&P MR810 Respiratory Humidifier (K143646) | Comments |
| Humidity
Performance | ≥ 12 mg/L in Settings 1, 2 or 3
For 5 - 70 L/min Flow Range
≥ 33 mg/L in Setting 4
For 5 - 40 L/min Flow Range | ≥ 10 mg/L in Setting Low, Med or High:
For 5 - 60 L/min Flow Range
≥ 33 mg/L in Setting High
For 5 - 30 L/min Flow Range | Equivalent
The 820 System meets the
applicable requirements of ISO
80601-2-74:2017 |
| Gas temperature at
patient end of
breathing tube for
flow range | Setting 1: 26-30 °C
Setting 2: 29-37 °C
Setting 3: 32-40 °C
For 5 - 70 L/min Flow Range
Setting 4: 35-43 °C
For 5 - 40 L/min Flow Range | Setting Low: 28 - 29 °C
Setting Medium: 28 - 31 °C
For 5 - 60 L/min Flow Range
Setting High: 33 - 36°C
For 5 - 30 L/min Flow Range | Equivalent
The 820 System meets the
applicable requirements of ISO
80601-2-74:2017 |
| Time to reach set
temperature | 10 kg | Adult patients | Different |
| | | | The subject device is compliant to |
| | | | the pneumatic requirements of |
| | | | ISO 5367 for the indicated patient |
| | | | populations. |
| Intended Interface | Non-invasive and invasive interfaces | Non-invasive and invasive interfaces | Identical |
| | | | |
| Duration of Use | 14 Days | 7 Days | Different |
| 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 | Equivalent |
| | | | The subject device falls within the |
| | | | secondary predicate device storage |
| | | | condition range. |
| Characteristic for
comparison | Subject Device
F&P MR325 | Secondary Predicate Device
F&P HC325 (K003973) | Comments |
| Intended Use | Holds water and adds heat and humidity to respiratory
gases | Holds water and adds heat and humidity to
respiratory gases | Identical |
| Indications for Use | The MR325 humidification chamber is an accessory to the
F&P 820 System and compatible with F&P 820 series
humidifiers. The F&P 820 System is intended to provide
therapeutic levels of heat and humidity to a patient's inspired
respiratory gases, when using a continuous or intermittent
ventilator system or a continuous gas flow.
The 820 System is intended for both non-invasive and invasive
therapies. Addition of heat and humidity to the supply of cold and
dry respiratory gases provided through non-invasive or invasive
ventilation is beneficial to prevent drying of the patient airways.
The 820 System is for adult and paediatric (excluding Neonatal)
for use in hospitals, long term care facilities and homes under
the prescription of a qualified medical professional. | The HC325 humidification chamber is an accessory to the
F&P HC150 Respiratory Humidifier.
The HC150 respiratory humidifier is used to warm and
humidify gases delivered to patients requiring continuous
positive airway pressure (CPAP) therapy or mask
ventilation.
The HC325 Humidification Chamber has been designed as
a Passover humidifier for use with Nasal CPAP and Nasal
Mask ventilation systems. | Different
Subject device tested to ISO
5367:2014, ISO 80601-2-74:2017,
ISO 10993-1:2018 and ISO 18562-
1:2017 and is equivalent to the
secondary predicate device. |
| Operating Principle | Water in the humidification chamber is heated to add water
vapour and heat energy to the passing gas flow. The gas then
enters the breathing tube. | Water in the humidification chamber is heated to add water
vapour and heat energy to the passing gas flow. The gas
then enters the breathing tube. | Identical |
| Patient Population | Adult and paediatric patients (excluding neonates) | Patients requiring positive pressure breathing therapy such
as CPAP | Different
The subject device is compliant to
the requirements of ISO 5367 for
the indicated patient populations. |
| Intended Interface | Non-invasive and invasive interfaces | Non-invasive and invasive interfaces | Identical |
| Duration of use | 14 days | No-predefined duration of use | Different
Subject device has a 14-day
Duration of use. |
| Reusability | Single Use | Single Patient Reusable. With cleaning instructions. | Different
Subject device is for single use. |
| Shelf Life | 3 years | No-predefined shelf-life | Different
Subject device shelf-life is 3 years |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical |
Table 1: Subject Device and Primary Predicate Comparison Table
8
9
Table 2: F&P 820A10J – Circuit Heated Single Limb to Secondary Predicate Comparison Table
10
Table 3: F&PMR325 – Chamber Manual Fill to Secondary Predicate Comparison Table
11
PERFORMANCE DATA VII.
Summary of non-clinical tests
The F&P 820 Respiratory Humidifier has been tested to the applicable requirements* of the following standards:
| Standards | Title |
|---|---|
| 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. |
| 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, C1:2009/(R)2012
and A2:2010/(R)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.
*excluding clause 201.12.1.102a |
| 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 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety
and essential performance - Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment |
| IEC 62366-1:2015 +
AMD:2020 | Medical devices - Part 1: Application of usability engineering to medical devices |
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Biocompatibility Testing:
The biocompatibility evaluation for the F&P 820 Humidification System 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 risk management process" as recognized by the FDA. FDA's guidance document on Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",2020. Testing of the F&P 820 Humidification System 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 Humidification System. 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:
A human Factors and Usability Engineering study was conducted on the F&P820 Respiratory Humidifier and accessories, and documentation was updated and provided as recommended by FDA's guidance. The study demonstrated that the human factors assessment had been sufficiently evaluated and was 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 .
VIII. CONCLUSION
The F&P 820 Humidification System 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.