(160 days)
No
The description mentions a microprocessor with embedded software for controlling heating elements and temperature sensors, which is standard for medical devices with automated functions, but does not indicate the use of AI or ML for learning or adaptive behavior.
Yes
The device is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, which aims to prevent drying of the patient's airways, indicating a therapeutic purpose.
No
The device is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases. It conditions respiratory gases by raising the delivered water vapor content and temperature. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device description clearly lists hardware components such as a respiratory humidifier, breathing circuits, and a humidification chamber, and describes the function of these physical parts. While it mentions embedded software, the device is fundamentally a hardware system with software control.
Based on the provided information, the Fisher & Paykel MR810 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is 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 device conditions respiratory gases and delivers them to the patient. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease or condition, monitor a disease or condition, or screen for a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The MR810 System's function is entirely focused on modifying and delivering gases for therapeutic benefit.
N/A
Intended Use / Indications for Use
The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respired respired respired respired respired respired gases, when using a continuous or internittent non-invasive ventilator system or a continuous gas flow system.
The MR810 System is intended for non-invasive therapies only. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive ventilation is beneficial to prevent drying of the patient airways.
The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.
Product codes
BTT
Device Description
The Fisher & Paykel Healthcare MR810 System is designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
The MR810 System consists of the following components:
- . MR810 Respiratory Humidifier
- Accessories: .
- O Breathing circuit (i.e. 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit)
Note: The 900MR810 and 900MR810E breathing circuits have identical heated inspiratory limbs, however the 900MR810E also includes an expiratory limb (unheated) and a Y-piece (which connects the inspiratory and expiratory limbs).
- O Humidification chamber (as cleared in K934140 and K913368).
The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element which transfer heat to the water in a humidification chamber and control power to the heated inspiratory limb of the breathing circuit.
A dryline tube (part of the breathing circuit) transports respiratory gases from a gas source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.
The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube of the 900MR810 and 900MR810E breathing circuits is electrically heated by means of a heaterwire placed internally to the tube, which is controlled by the MR810 respiratory humidifier.
The MR810 respiratory humidifier also includes a built-in heaterwire adaptor. The heaterwire adaptor makes an electrical connection with the heated inspiratory limb of the breathing circuit for the purpose of powering the heated limb. The heater wire adaptor incorporates an ambient (room) temperature sensor and a chamber temperature sensor. The heaterwire adaptor also includes an embedded LED to visually indicate that the heated breathing circuit has been connected correctly.
The expiratory limb of the breathing circuit transports expired gas from the patient when a return flow of expired gases from the patient to the gas source is required (the 900MR810E Adult Dual Limb Breathing Circuit should be used as it includes an expiratory limb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professional / 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)
Non-Clinical Tests:
The MR810 System is compliant with the same product standards as the previously cleared HC500 Servo-Controlled Heated Respiratory Humidifier (K953392) and MR880 Respiratory Humidification System (K100554). These standards include ISO 8185: 1997, IEC 60601-1: 1988, IEC 60601-1-2: 2001, and ISO 5367:2000.
Bench testing demonstrates that the MR810 System conforms to the particular standard for humidification systems, ISO 8185.
Key results: Humidity performance of the MR810 System in Heaterwire mode for non-invasive use is > 10 mg/L (Flow: 5 to 60 L/min), meeting the ISO 8185:1997 requirement. The enthalpy is 10 mg/L
Enthalpy:
§ 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
MR810 System
510(k) Summary 5
Fisher&Paykel
HEALTHCARE
15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
DEC 0 4 2013
Contact person/submitter
Elizabeth Goldstein
8 November 2013
Date prepared
Contact details
Address: 15 Maurice Paykel Place
East Tamaki Auckland 2013, New Zealand
Telephone: +64 9 574 0100
Fax: +64 9 574 0148
Trade name
Common name
Classification name
Predicate devices
MR810 System
Respiratory gas humidifier
Respiratory gas humidifier II (21 CFR §868.5450), product code BTT
K953392 HC500 Servo-Controlled Heated Respiratory Humidifier K100554 880 Respiratory Humidification System
1
Device Description 5.1
The Fisher & Paykel Healthcare MR810 System is designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
The MR810 System consists of the following components:
- . MR810 Respiratory Humidifier
- Accessories: .
- O Breathing circuit (i.e. 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit)
Note: The 900MR810 and 900MR810E breathing circuits have identical heated inspiratory limbs, however the 900MR810E also includes an expiratory limb (unheated) and a Y-piece (which connects the inspiratory and expiratory limbs).
- O Humidification chamber (as cleared in K934140 and K913368).
The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element which transfer heat to the water in a humidification chamber and control power to the heated inspiratory limb of the breathing circuit.
A dryline tube (part of the breathing circuit) transports respiratory gases from a gas source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.
The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube of the 900MR810 and 900MR810E breathing circuits is electrically heated by means of a heaterwire placed internally to the tube, which is controlled by the MR810 respiratory humidifier.
The MR810 respiratory humidifier also includes a built-in heaterwire adaptor. The heaterwire adaptor makes an electrical connection with the heated inspiratory limb of the breathing circuit for the purpose of powering the heated limb. The heater wire adaptor incorporates an ambient (room) temperature sensor and a chamber temperature sensor. The heaterwire adaptor also includes an embedded LED to visually indicate that the heated breathing circuit has been connected correctly.
The expiratory limb of the breathing circuit transports expired gas from the patient when a return flow of expired gases from the patient to the gas source is required (the 900MR810E Adult Dual Limb Breathing Circuit should be used as it includes an expiratory limb).
2
5.2 Intended Use
The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspiratory gases, when using a continuous or 'intermittent non-invasive ventilator system or a continuous gas flow system.
The MR810 System is intended for non-invasive therapies only. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive ventilation is beneficial to prevent drying of the patient airways.
The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.
5.2.1 Indications for Use Comparison
The indications for Use Statements of the subject device, MR810 System, and the predicate device, HC500 Servo-Controlled Heated Respiratory Humidifier (K953392) are identical with the exception of the following:
- · The subject device identifies compatible ventilators by function/intended purpose rather than examples of device types;
- · The subject device is intended for use for non-invasive therapy only, whereas the predicate device is intended for use for both non-invasive of invasive therapies.
Refer to Table 1 for a side-by-side comparison of the Indications for Use Statements of the subject and predicate devices.
| Device feature | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|
| Indications for use | 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 | |||
| non-invasive ventilator | |||
| system or a continuous gas | |||
| flow system. | The intended use of the | ||
| HC500 is to provide | |||
| therapeutic levels of heat | |||
| and humidity to a patient's | |||
| inspired respiratory gases, | |||
| when using an artificial | |||
| ventilation system. This | |||
| includes use with systems | |||
| such as portable volume | |||
| ventilation systems, | |||
| pressure support ventilation | |||
| and continuous positive | |||
| airway pressure (CPAP) | |||
| devices. | Identical intended use - | ||
| identification of all | |||
| artificial ventilator | |||
| systems that the MR810 | |||
| System is to be used with | |||
| using the systems' | |||
| function/intended | |||
| purpose rather than | |||
| examples of device | |||
| types. | |||
| These systems may bypass | |||
| the patient airway (using an | |||
| endotracheal tube) | The subject device | ||
| (MR810'System) is not | |||
| recommended for | |||
| invasive therapy (i.e. for | |||
| patients with bypassed | |||
| airways). |
Table I Comparison of MR810 and HC500 Indications for Use
3
Fisher & Paykel Healthcare
| The MR810 System is
intended for non-invasive
therapy only. | or use mask ventilation. | Identical therapy -
addition of the term
'non-invasive therapy' to
describe 'mask
ventilation'. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Providing heat and
humidification to these
gases counteracts the
effects of bypassing the
nose, pharynx and trachea,
where this function would
not normally be carried out
by the body. | The subject device
(MR810 System) is not
recommended for
invasive therapy (i.e. for
patients with bypassed
airways). | |
| Addition of heat and
humidity to the supply of
cold and dry respiratory
gases provided through non-
invasive ventilation is
beneficial to prevent drying
of the patient airways. | Addition of heat and
humidity to the supply of
cold and dry respiratory
gases provided through
mask ventilation is
similarly beneficial to
prevent drying of the
patient airways. | Identical operating
principle - use of the
term 'non-invasive
therapy' to describe
'mask ventilation' to be
consistent with the
therapy statement above
('...intended for non-
invasive therapy only'). |
| The MR810 System is
designed for use in hospitals,
long term care facilities and
homes under the prescription
of a qualified medical
professional. | The HC500 is primarily
intended for a home-use
situation, typically for
patients requiring long-term
respiratory assistance of a
non-critical nature (i.e. not
requiring hospital or
intensive care levels of
attention). | The environment for use
of the subject device
(MR810 System) has
been extended to include
hospital and long term
care facilities, under the
prescription of a
qualified medical
professional. |
5.3 Technological Characteristics Comparison
5.3.1 Comparison to HC500 (K953392)
The subject device, MR810 System, and the predicate device, HC500 Servo-Controlled Heated Respiratory Humidifier (K953392), control the heaterplate temperature identically, however the related user controls (i.e. buttons) have been simplified in the subject device. Refer to Table 2 for a side-by-side comparison of the technological characteristics of the subject device, MR810 System, and the predicate device, HC500 Servo-Controlled Heated Respiratory Humidifier (K953392).
| Device Feature | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|
| Heaterplate temperature | |||
| control | MR810 controls | ||
| heaterplate temperature | |||
| by adjusting delivered | |||
| power. | HC500 controls | ||
| heaterplate temperature | |||
| by adjusting delivered | |||
| power. | Identical |
| Table 2 Comparison of the MR810 and HC500 Technological Characteristics | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
4
| Device Feature | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|
| Switchable Heaterwire | |||
| mode | Connection of | ||
| compatible heated circuit | |||
| changes operating mode | |||
| to Heaterwire mode. | Front panel button | ||
| ("Heaterwire" button) | |||
| switches operating mode | |||
| between Heaterwire | |||
| mode and Non-Hose | |||
| Heated mode | Heaterwire mode is the | ||
| recommended mode of | |||
| operation for the MR810. | |||
| Disconnection of | |||
| compatible heated circuit | |||
| changes mode to Non- | |||
| Hose Heated mode. | |||
| Patient-end set | |||
| temperature: | |||
| Heaterwire mode | Temperature setting: | ||
| LOW: 28 to 29°C | |||
| MED: 28 to 30°C | |||
| HIGH: 31 to 32°C | |||
| (Flow 5 to 20 L/min) | 32 to 39 °C | ||
| (dial allows intermediate | |||
| values to be set). | |||
| (Flow 10 mg/L and the enthalpy is of both the subject and predicate devices is 10 mg/L | |||
| Flow: 5 to 60 | |||
| L/min | > 10 mg/L | ||
| Flow: 5 to 60 | |||
| L/min | Identical |
Table 5 Comparison of MR810 and HC500 humidification system performance as per ISQ 8185:1997
7
| Device feature | Requirement | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|---|
| Humidity | ||||
| performance, | ||||
| Heaterwire mode- | ||||
| for invasive use | ||||
| (i.e. patients with | ||||
| bypassed airways) | ≥ 33 mg/L | |||
| (as required by ISO | ||||
| 8185:1997) | Not applicable - | |||
| the MR810 System | ||||
| is intended for non- | ||||
| invasive use only | ≥ 33 mg/L | The MR810 not | ||
| intended for use | ||||
| with bypassed | ||||
| airways and | ||||
| therefore the | ||||
| humidity | ||||
| performance | ||||
| requirements (as | ||||
| per ISO 8185) are | ||||
| different | ||||
| Enthalpy |