(67 days)
Not Found
No
The description focuses on standard humidification technology, temperature control, and safety features. There is no mention of AI, ML, or any learning or adaptive algorithms.
Yes
The device is intended to add moisture and warm breathing gases for administration to a patient, directly addressing physiological needs and preventing harm to the respiratory tract.
No
The device is described as a "Respiratory Gas Humidifier" intended to add moisture and warmth to breathing gases for patients, not to diagnose a medical condition. While it monitors temperature and flow parameters to ensure proper function, this is for performance stability and user notification, not for diagnostic purposes.
No
The device description clearly outlines physical hardware components such as a thermoplastic enclosure, heaterplate, connection sockets, control buttons, and accessories like humidification chambers and breathing circuits. While it has a serial data interface and controls/displays, the core function relies on physical heating and humidification of gases.
Based on the provided text, the Fisher & Paykel Healthcare MR850 Humidifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "Respiratory Gas Humidifier" intended to "add moisture to and warm breathing gases for administration to a patient." This is a direct interaction with the patient's breathing gases before they enter the body, not an analysis of samples taken from the body.
- Device Description: The description details how the device heats water to humidify breathing gases and how it connects to breathing circuits and ventilators. This aligns with a respiratory support device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device's function is to modify the physical properties of the gas being delivered to the patient, which falls under the category of respiratory support equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MR850 Humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed.
This may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by face mask or through bypassing the upper airways, for example use of an endotracheal tube.
The Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient.
The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases.
Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Heat is used to increase the water output of the humidifier. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
Product codes
73 BTT
Device Description
The MR850 Humidifier is a Respiratory Gas Humidifier (heated passover type) according to 21 CFR 8868,5450. Heat is used to provide an evaporated water content to dry breathing gases. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
The MR850 has a thermoplastic enclosure with dimensions of 140mm high × 135mm wide × 173mm deep, and weighs 2.8kg. A heaterplate is positioned in the top of the unit, where the enclosure rim and finger guard allow a humidification chamber to be added. Temperature probe and heater wire connection sockets are on the right side of the unit. A serial data interface port is located in the underside of the unit, with a mounting bracket at the back of the device.
The unit controls and displays are located on the front panel. Controls consist of power, operating mode and alarm mute buttons. A setup / alarm display indicates if a part of the equipment is incorrectly installed, or type of alarm condition occurring.
Accessories for the MR850 Humidification chamidification chambers, breathing circuits, electrical adaptors and temperature / flow probes.
The chamber slides on to the heaterplate and contains the water supply for adding humidity to breathing gases. The breathing circuit transports gases to the patient, and includes sections for connection from ventilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. Heated wires in the inspiratory and expiratory limbs prevent condensation. The electrical adaptor supplies power to the heated wires. The temperature / flow probe has sensors at the chamber and patient airway ends of the inspiratory section for heater control.
The MR850 Humidifier has two operating modes. Intubated Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37°C (body temperature). Mask Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31°C. The MR850 Humidifier monitors temperature and flow parameters, and equipment integrity, in order to maintain stable performance conditions and notify the user of high delivered temperature, inadequate delivered humidity, or incorrect equipment set-up conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory tract, supraglottic airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing of the MR850 Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy.
The MR850 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electromedical and EMC standards, and the relevant USA deviations to these in UL 2601-1. It meets the mechanical, electrical and environmental testing requirements of the 1993 FDA Reviewer Guidance for Premarket Notification Submissions. It complies with performance and safety requirements of the ISO 8185 and ASTM F1690 (USA) particular standards for Humidification Systems.
Clinical verification studies on the MR850 Humidifier demonstrated the safety, effectiveness and performance of the device. The humidifier was able to provide required temperature and humidification output across a variety of respiratory gas therapies. It required a low level of user intervention and had reduced susceptibility to user error factors. Modified technological components fulfilled their purpose of safety and effectiveness improvements, and did not introduce further hazards to user or patient.
The testing carried out for the MR850 Humidifier indicates that it meets design and performance functional requirements. Clinical verification studies demonstrate the successful use of the humidifier and its ability to provide effective humidity levels. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key performance and safety requirements from the particular standard for humidification systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fisher & Paykel, MR730 Respiratory Humidifier, K913368, Fisher & Paykel, HC500 Respiratory Humidifier, K953392, Fisher & Paykel, MR290 Humidification Chamber, K934140, Puritan-Bennett, 7200 Microprocessor Ventilator, K902506
Reference Device(s)
Not Found
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
NOV 10 1998
Image /page/0/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a line underneath. The word "Healthcare" is on the second line in all caps.
Fisher & Paykel Electronics Limited
25 Carbine Road, Panmure, Auckland, New Zealand
P.O. Box 14-348, Panmure, Auckland, New Zealand
Tel: +64-9-574-0100 Fax: +64-9-574-0158
31 August, 1998
510(k) Summary of Safety and Effectiveness Information
Model No. / Name: MR850 Respiratory Humidifier
Classification Name: Humidifier, Respiratory Gas (Direct Patient Interface) - 73 BTT Anesthesiology Devices, 21 CFR §868.5450 (Class II) Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Predicate Devices: Fisher & Paykel, HC500 Respiratory Humidifier, K953392 Fisher & Paykel, MR290 Humidification Chamber, K934140 Puritan-Bennett, 7200 Microprocessor Ventilator, K902506
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92:
(a)(1) - (a)(3) Refer to information above and concluding this summary.
(a)(4) Description of the Device
The MR850 Humidifier is a Respiratory Gas Humidifier (heated passover type) according to 21 CFR 8868,5450. Heat is used to provide an evaporated water content to dry breathing gases. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
The MR850 has a thermoplastic enclosure with dimensions of 140mm high × 135mm wide × 173mm deep, and weighs 2.8kg. A heaterplate is positioned in the top of the unit, where the enclosure rim and finger guard allow a humidification chamber to be added. Temperature probe and heater wire connection sockets are on the right side of the unit. A serial data interface port is located in the underside of the unit, with a mounting bracket at the back of the device.
The unit controls and displays are located on the front panel. Controls consist of power, operating mode and alarm mute buttons. A setup / alarm display indicates if a part of the equipment is incorrectly installed, or type of alarm condition occurring.
Accessories for the MR850 Humidification chamidification chambers, breathing circuits, electrical adaptors and temperature / flow probes.
The chamber slides on to the heaterplate and contains the water supply for adding humidity to breathing gases. The breathing circuit transports gases to the patient, and includes sections for connection from ventilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. Heated wires in the inspiratory and expiratory limbs prevent condensation. The electrical adaptor supplies power to the heated wires. The temperature / flow probe has sensors at the chamber and patient airway ends of the inspiratory section for heater control.
1
510(k) Summary continued - Fisher & Paykel MR850 Respiratory Humidifier
The MR850 Humidifier has two operating modes. Intubated Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37°C (body temperature). Mask Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31°C. The MR850 Humidifier monitors temperature and flow parameters, and equipment integrity, in order to maintain stable performance conditions and notify the user of high delivered temperature, inadequate delivered humidity, or incorrect equipment set-up conditions.
(a)(5) Statement of the Intended Use
The MR850 Humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed.
This may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by face mask or through bypassing the upper airways, for example use of an endotracheal tube.
(a)(6) Technological Characteristics Summary
The technological characteristics of the MR850 Humidifier are equivalent to the predicate devices listed above.
The MR850 is equivalent to the MR730 and HC500 Humidifiers in terms of: type (heated passover humidification), configuration (chamber, heated wire breathing circuits, dual-sensor temperature probe), power usage (same heater system ratings), performance (same temperature and humidity output), control method (electronic and PID algorithm microprocessor), and uses equivalent materials and some common components.
The MR850 is equivalent to the 7200 Ventilator in terms of the use of heated-wire flow-sensing technology for respiratory gas flow-sensing purposes.
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the MR850 Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy.
The MR850 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electromedical and EMC standards, and the relevant USA deviations to these in UL 2601-1. It meets the mechanical, electrical and environmental testing requirements of the 1993 FDA Reviewer Guidance for Premarket Notification Submissions. It complies with performance and safety requirements of the ISO 8185 and ASTM F1690 (USA) particular standards for Humidification Systems.
2
510(k) Summary continued - Fisher & Paykel MR850 Respiratory Humidifier
(b)(2) Discussion of the Clinical Tests
Clinical verification studies on the MR850 Humidifier demonstrated the safety, effectiveness and performance of the device. The humidifier was able to provide required temperature and humidification output across a variety of respiratory gas therapies. It required a low level of user intervention and had reduced susceptibility to user error factors. Modified technological components fulfilled their purpose of safety and effectiveness improvements, and did not introduce further hazards to user or patient.
(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance
The testing carried out for the MR850 Humidifier indicates that it meets design and performance functional requirements. Clinical verification studies demonstrate the successful use of the humidifier and its ability to provide effective humidity levels. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key performance and safety requirements from the particular standard for humidification systems.
This information indicates that the MR850 Humidifier is equivalent to or better than the predicate devices in terms of safety, effectiveness and performance.
signed:
Chris Mander Fisher & Paykel Healthcare Ltd
te: 31 August 1998
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol composed of three human profiles facing right, with flowing lines suggesting movement or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1998
Mr. Chris Mander Fisher & Paykel Healthcare 25 Carbine Road P.O. Box 14-348 Panmure, Auckland NEW ZEALAND
Re: K983112 Respiratory Humidifier - Model MR850 Requlatory Class: II (two) Product Code: 73 BTT Dated: August 31, 1998 Received: September 4, 1998
Dear Mr. Mander:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Chris Mander
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The logo consists of the words "Fisher & Paykel" in a bold, sans-serif font, with an ampersand (&) between the two names. Below the names is the word "HEALTHCARE" in a slightly smaller, sans-serif font. A horizontal line is placed above the word "HEALTHCARE" and below the company name.
[510(k)] Number:
K983/2
Fisher & Paykel Electronics Limited
25 Carbine Road, Panmure, Auckland, New Zealand
P.O. Box 14-348, Panmure, Auckland, New Zealand
Tel: +64-9-574-0100 Fax: +64-9-574-0158
31 August, 1998
Fisher & Paykel MR850 Respiratory Humidifier
PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT
The Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient.
The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases.
Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Heat is used to increase the water output of the humidifier. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
Concurrence of CDRH, Office of Device Evaluation (ODE)
gtame
: Douglas
11-9-98
Prescription Use (Per 21 CFR §801.109)