(160 days)
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 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.
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).
The Fisher & Paykel Healthcare MR810 System is a respiratory gas humidifier designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Feature | Requirement (Acceptance Criteria) | MR810 Performance (Reported) | Comment |
|---|---|---|---|
| Humidity Performance | ≥ 10 mg/L (as required by ISO 8185:1997 for all humidification systems, non-invasive use) | > 10 mg/L (Flow: 5 to 60 L/min) | Meets requirement |
| Humidity Performance (Invasive Use) | ≥ 33 mg/L (as required by ISO 8185:1997 for invasive use) | Not applicable (MR810 is for non-invasive use only) | N/A |
| Enthalpy | < 194 kJ/kg dry gas (as required by ISO 8185:1997 for all humidification systems) | < 194 kJ/kg dry gas | Meets requirement |
| Heaterplate Max Temperature | Software Limit (e.g., in comparison to predicates) | ≤ 70 °C (Software limit) | - |
| Patient-end Temperature (Heaterwire mode) | Target ranges (e.g., compared to predicate's adjustable 32-39 °C) | LOW: 28-29°C, MED: 28-30°C, HIGH: 31-32°C (Flow 5-20 L/min) | Depends on ambient temperature & setting |
| Heaterplate Set Temperature | Fixed values for different settings (e.g., compared to predicate's adjustable 45-80 °C) | LOW: 45°C, MED: 60°C, HIGH: 70°C | Fixed values for each setting |
| Compliance to Standards | ISO 8185:1997 (Humidifiers for medical use) | Compliant | Achieved |
| Compliance to Standards | IEC 60601-1: 1988 +A1:1991 +A2:1995 (Medical Electrical Equipment - General Requirements for Safety) | Compliant | Achieved |
| Compliance to Standards | IEC 60601-1-2: 2001 (Medical electrical equipment - EMC) | Compliant | Achieved |
| Compliance to Standards | ISO 5367:2000 (Breathing tubes) | Compliant (for single-heated circuits) | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials or data for algorithm validation. Instead, the performance evaluation relies on bench testing to demonstrate compliance with international standards.
- Sample Size: Not explicitly stated as a numerical sample size of devices or patient data. Testing would have involved a sufficient number of MR810 units to demonstrate compliance with the specified standards under controlled conditions.
- Data Provenance: The data is from non-clinical (bench) testing performed by Fisher & Paykel Healthcare. The country of origin for the testing is implied to be consistent with the manufacturer's location, New Zealand. The data is prospective in the sense that it was generated specifically for this submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the study did not involve human experts establishing ground truth for a clinical test set. The "ground truth" for the device's performance was established by internationally recognized engineering and medical device standards (e.g., ISO 8185), against which the device performance was measured through objective bench tests.
4. Adjudication Method for the Test Set
This section is not applicable. There was no subjective evaluation by experts that would require an adjudication method. Compliance was determined by objective measurements against predefined standard requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The MR810 System is a medical device for providing heat and humidity to respiratory gases, and its performance is evaluated through engineering and physiological standards, not human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is partially applicable in the sense that the device's performance was evaluated in a standalone manner through bench testing against established standards (ISO 8185, IEC 60601-1, IEC 60601-1-2, ISO 5367). The device's ability to achieve the specified humidity output, enthalpy, and maintain temperature controls was tested directly, without human intervention in operating the device for the purpose of the test (beyond setting up and initiating the tests). There is no "algorithm" in the sense of AI/ML models being evaluated for diagnostic accuracy, but the embedded software controls were part of the system being tested.
7. The Type of Ground Truth Used
The ground truth used was established international standards and regulatory requirements for medical humidifiers and electrical medical equipment. Specifically:
- ISO 8185:1997: Humidifiers for medical use - General requirements for humidification systems. This standard dictated the acceptable range for humidity output and enthalpy.
- IEC 60601-1: 1988 +A1:1991 +A2:1995: Medical Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2: 2001: Medical electrical equipment. Part 1: General requirements for safety. 2. Collateral standard: Electromagnetic compatibility.
- ISO 5367:2000: Breathing tubes intended for use with anaesthetic apparatus and ventilators.
8. The Sample Size for the Training Set
This is not applicable. The MR810 System is a hardware device with embedded software for control, not a machine learning or AI-based system that requires a "training set" of data in the typical sense. The software development and tuning would have occurred during the product development cycle, but it would not be described as a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there was no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and engineering principles would be based on established physics, electronics, and engineering best practices, alongside the requirements of the aforementioned international standards.
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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
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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).
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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 MR810System is intended toprovide therapeutic levels ofheat and humidity to apatient's inspired respiratorygases, when using acontinuous or intermittentnon-invasive ventilatorsystem or a continuous gasflow system. | The intended use of theHC500 is to providetherapeutic levels of heatand humidity to a patient'sinspired respiratory gases,when using an artificialventilation system. Thisincludes use with systemssuch as portable volumeventilation systems,pressure support ventilationand continuous positiveairway pressure (CPAP)devices. | Identical intended use -identification of allartificial ventilatorsystems that the MR810System is to be used withusing the systems'function/intendedpurpose rather thanexamples of devicetypes. |
| These systems may bypassthe patient airway (using anendotracheal tube) | The subject device(MR810'System) is notrecommended forinvasive therapy (i.e. forpatients with bypassedairways). |
Table I Comparison of MR810 and HC500 Indications for Use
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Fisher & Paykel Healthcare
| The MR810 System isintended for non-invasivetherapy only. | or use mask ventilation. | Identical therapy -addition of the term'non-invasive therapy' todescribe 'maskventilation'. |
|---|---|---|
| Providing heat andhumidification to thesegases counteracts theeffects of bypassing thenose, pharynx and trachea,where this function wouldnot normally be carried outby the body. | The subject device(MR810 System) is notrecommended forinvasive therapy (i.e. forpatients with bypassedairways). | |
| Addition of heat andhumidity to the supply ofcold and dry respiratorygases provided through non-invasive ventilation isbeneficial to prevent dryingof the patient airways. | Addition of heat andhumidity to the supply ofcold and dry respiratorygases provided throughmask ventilation issimilarly beneficial toprevent drying of thepatient airways. | Identical operatingprinciple - use of theterm 'non-invasivetherapy' to describe'mask ventilation' to beconsistent with thetherapy statement above('...intended for non-invasive therapy only'). |
| The MR810 System isdesigned for use in hospitals,long term care facilities andhomes under the prescriptionof a qualified medicalprofessional. | The HC500 is primarilyintended for a home-usesituation, typically forpatients requiring long-termrespiratory assistance of anon-critical nature (i.e. notrequiring hospital orintensive care levels ofattention). | The environment for useof the subject device(MR810 System) hasbeen extended to includehospital and long termcare facilities, under theprescription of aqualified medicalprofessional. |
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 temperaturecontrol | MR810 controlsheaterplate temperatureby adjusting deliveredpower. | HC500 controlsheaterplate temperatureby adjusting deliveredpower. | Identical |
| Table 2 Comparison of the MR810 and HC500 Technological Characteristics | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
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| Device Feature | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|
| Switchable Heaterwiremode | Connection ofcompatible heated circuitchanges operating modeto Heaterwire mode. | Front panel button("Heaterwire" button)switches operating modebetween Heaterwiremode and Non-HoseHeated mode | Heaterwire mode is therecommended mode ofoperation for the MR810.Disconnection ofcompatible heated circuitchanges mode to Non-Hose Heated mode. |
| Patient-end settemperature:Heaterwire mode | Temperature setting:LOW: 28 to 29°CMED: 28 to 30°CHIGH: 31 to 32°C(Flow 5 to 20 L/min) | 32 to 39 °C(dial allows intermediatevalues to be set).(Flow <30 L/min) | MR810 patienttemperature is dependenton both ambienttemperature andTemperature Setting |
| Heaterplate maximumtemperature:$\leq$ 70 °C(Software limit) | Heaterplate maximumtemperature:$\leq$ 100 °C(Software limit) | HC500 maximum'heaterplate temperatureis set by solder pads onthe PCB. Optional limitsof 50, 80 and 90°C canbe set. | |
| Heaterplate settemperature | Temperature setting:LOW: 45°CMED: 60°CHIGH: 70°C | Adjustable in the range45 to 80 °C | MR810 controls to afixed value for theheaterplate temperaturedependent on theTemperature Setting |
5.3.2 Comparison to MR880 (K100554)
The subject device, MR810 System, and the predicate device, MR880 Respiratory Humidification System (K100554), set the power delivered to the heaterwire identically (i.e. using an ambient sensor). The subject device controls the desired heaterplate setpoint to maintain the chamber output temperature whilst the predicate device controls the chamber output temperature directly.
Refer to Table 3 for a side-by-side comparison of the technological characteristics of the subject device, MR810 System, and the predicate device, MR880 Respiratory Humidification System (K100554).
| Device feature | MR810 | MR880 (predicate) | Comment |
|---|---|---|---|
| Ambient (room)temperature sensor | Over moulded feature onheaterwire adapter | Over moulded feature onheaterwire adapter | Identical. |
| Heaterwire control usingambient sensor | MR810 uses ambienttemperature to set thepower delivered to theheaterwire | MR880 uses ambienttemperature to set thepower delivered to theheaterwire. | Identical.Sensor used to setdelivered power to theheaterwire contained ininspiratory limb |
| Table 3 Comparison of the MR810 and MR880 Technological Characteristics | |
|---|---|
| ------------------------------------------------------------------------- | -- |
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| Device feature | MR810 | MR880 (predicate) | Comment |
|---|---|---|---|
| Chamber output control | MR810 controlsheaterplate temperatureto maintain desiredchamber outputtemperature. | MR880 controls chamberoutput temperature. | MR880 controls chamberoutput temperaturedirectly. |
| Breathing circuit - Adult | • Single-heatedbreathing circuits (i.e.900MR810,900MR810E)Length: 1.5m (60")Diameter: 22mm (0.9") | • Single-heatedbreathing circuits (i.e.RT241)Length: 1.8m (70.9")Diameter: 10.6mm (0.4") | The MR810 and MR880Systems are both offeredwith single-heatedbreathing circuit optionsonly.The breathing circuitsused with the MR880System are longer andnarrower than those usedwith the MR810,however both circuits aresingle-heated and arefitted with standard22mm connectors as perISO 5356-1. |
5.4 Non-Clinical Tests
The MR810 System is compliant with the same product standards as the previously cleared HC500 Servo-Controlled Heated Respiratory Humidifier (K953392) as follows:
Table 3 Comparison of MR810 and HC500 Standards
| Standard | MR810 | HC500 (Predicatedevice) | Comment |
|---|---|---|---|
| ISO 8185: 1997Humidifiers for medicaluse - Generalrequirements forhumidification systems | Compliant with ISO8185:1997 | Compliant with ISO8185:1997 | Identical |
| IEC 60601-1: 1988Medical ElectricalEquipment - Part 1:General Requirementsfor Safety, Amendment1, 1991, Amendment 2,1995 | Compliant with IEC60601-1:1998 +A1:1991+A2:1995 | Compliant with IEC60601-1:1998 +A1:1991+A2:1995 | Identical |
| IEC 60601-1-2: 2001Medical electricalequipment. Part 1:General requirementsfor safety. 2. Collateralstandard:Electromagneticcompatibility -requirements and tests,Amendment 1 | Compliant with IEC60601-1-2:2001 | Compliant with IEC60601-1-2:2001 | Identical |
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The MR810 System is compliant with the same product standards as the previously cleared MR880 Respiratory Humidification System (K100554) as follows:
Table 4 Comparison of MR810 and MR880 Standards
| Standard | MR810 | MR880 (predicate) | Comment |
|---|---|---|---|
| ISO 5367:2000Breathing tubes intendedfor use with anaestheticapparatus and ventilators | Single-heated breathingcircuit accessories (i.e.900MR810,900MR810E) compliantwith ISO 5367:2000 | Single-heated breathingcircuit accessories (i.e.RT241) compliant withISO 5367:2000 | Identical |
Compliance of the subject device, MR810 System, and the:
- · Predicate device HC500 Servo-Controlled Heated Respiratory Humidifier (K953392); and
- · Single-heated breathing circuit accessories provided with the MR880 Respiratory Humidification System (K100554)
to the same device standards supports substantial equivalence of these products.
In addition, testing to ISO 8185:2007, the particular standard for humidification systems, supports performance of the subject device in accordance with the intended use and substantial equivalence to the predicate device HC500 Servo-Controlled Heated Respiratory Humidifier (K953392).
As summarized in Table 5 below, the humidity output of both the subject device, MR810 System, and the predicate device, HC500 Servo-Controlled Heated Respiratory Humidifier (K953392), is >10 mg/L and the enthalpy is of both the subject and predicate devices is <194 kJ/kg dry gas and therefore the performance of the devices is substantially equivalent.
Note: ISO 8185 requires that the predicate device also meet additional performance requirements for humidification systems intended for use with bypassed airways. These additional requirements are not applicable to the subject device as it is intended for noninvasive use only.
| Device feature | Requirement | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|---|
| Humidity ·performance,Heaterwire mode -for non-invasiveuse | ≥ 10 mg/L(as required by ISO8185:1997 for allhumidificationsystems) | > 10 mg/LFlow: 5 to 60L/min | > 10 mg/LFlow: 5 to 60L/min | Identical |
Table 5 Comparison of MR810 and HC500 humidification system performance as per ISQ 8185:1997
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| Device feature | Requirement | MR810 | HC500 (predicate) | Comment |
|---|---|---|---|---|
| Humidityperformance,Heaterwire mode-for invasive use(i.e. patients withbypassed airways) | ≥ 33 mg/L(as required by ISO8185:1997) | Not applicable -the MR810 Systemis intended for non-invasive use only | ≥ 33 mg/L | The MR810 notintended for usewith bypassedairways andtherefore thehumidityperformancerequirements (asper ISO 8185) aredifferent |
| Enthalpy | < 194 kJ/kg dry gas(as required by ISO8185:1997 for allhumidificationsystems) | < 194 kJ/kg dry gas | < 194 kJ/kg dry gas | Identical |
5.5 Clinical Tests
Not applicable - no clinical testing was performed with respect to the MR810 System.
5.6 Conclusion
The comparison of the intended use and temperature control system demonstrate that the MR810 System is substantially equivalent to the predicate device, Fisher & Paykel Healthcare HC500 Servo-Controlled Heated Respiratory Humidifier (K953392), and the comparison of the temperature sensor and hardware control demonstrate that the MR810 System is substantially equivalent to the predicate device, Fisher & Paykel Healthcare 880 Respiratory Humidification System (K100554). In addition, bench testing demonstrates that the MR810 System conforms to the particular standard for humidification systems, ISO 8185, supporting performance in accordance with the intended use.
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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2013
Fisher & Paykel Healthcare Ms. Elizabeth Goldstein Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, New Zealand
Re: K131957
Trade/Device Name: MR810 System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: October 31, 2013 Received: November 4, 2013
Dear Ms. Goldstein:
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. 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.
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Page 2 - Ms. Golstein
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/9/Picture/8 description: The image shows the name "Erin DKeith" in a stylized font. The letters "Erin" are in a bold, sans-serif font, while the letters "DKeith" are in a more decorative font with outlines and patterns. The "D" and "K" are particularly stylized, with the "D" having a circular pattern inside and the "K" having a geometric design.
Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131957
Device Name MR810 System
Indications for Use (Describe)
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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
:: :: FOR FDA USE ONLY . . . . . :・・・・・・ : : : . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by James J. Lee DN c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=James J. Lee, 0:9.2342:19200300.100.1.1=2000954859
Date: 2013.11.26 23:26:32 -05'00'
FORM FDA 3881 (9/13)
§ 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).