(139 days)
No
The document describes a standard respiratory gas humidifier with temperature and flow monitoring and control. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
Explanation: The device is a respiratory gas humidifier that warms and adds humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance, directly impacting patient treatment and well-being.
No
The device is a humidifier designed to warm and add humidity to gases delivered to patients requiring respiratory support. While it monitors temperature and flow parameters to ensure proper function and alerts users to issues, its primary purpose is therapeutic (humidification), not to diagnose a medical condition.
No
The device description clearly outlines physical components such as a thermoplastic enclosure, heater plate, connection sockets, control buttons, and a display. It also mentions accessories like humidification chambers and breathing circuits, all of which are hardware.
Based on the provided information, the Fisher & Paykel Healthcare MR850 humidifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm and add humidity to gases delivered to patients requiring respiratory support. This is a therapeutic function, not a diagnostic one.
- Device Description: The device description details a humidifier that physically alters the breathing gas before it is delivered to the patient. It does not analyze biological samples or provide information for diagnosis.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for the diagnosis of a disease or condition.
Therefore, the MR850 humidifier falls under the category of a respiratory therapy device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fisher & Paykel Healthcare MR850 humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce or parceded and to it are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.
Product codes
BTT
Device Description
The MR850 humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide evaporated water content to dry breathing gases. Heated or unheated breathing tubes can be used to deliver the humidified gas to the patient. Heated breathing tubes increase operating efficiency and reduce excessive water and heat loss.
The MR850 has a thermoplastic enclosure with dimensions of 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate 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 chambers, breathing circuits, electrical adapters and temperature / flow probes.
The chamber slides on to the heater plate 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 yentilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. When used with heated breathing circuits the electrical adapter from the humidifier 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. Invasive Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Non-Invasive Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 ℃. The MR850 humidifier monitors temperature, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature, or incorrect equipment set-up conditions, and when in the invasive mode, of inadequate delivered humidity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory tract
Indicated Patient Age Range
The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.
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 electro-medical and EMC standards, and the relevant USA deviations to these in UL 2601-1. It meets the, EMC testing requirements of the FDA Reviewer Guidance for Excerpts related to EMI from November 1993. It complies with performance and safety requirements of the ISO 8185 and ASTM F1690 (USA) particular standards for Humidification Systems with the exception of clauses 51.6.2 and 51.7, and 50.2.4.1 for non-heated breathing circuits.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MR850 Respiratory Humidifier, K020332, MR730 Respiratory Humidifier, K913368
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
APR 1 3 2004
Image /page/0/Picture/2 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold font on the top line. Below that is the word "HEALTHCARE" in a smaller, bold font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
Fisher & Paykel He 15 Maurice Paykel Place, E P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
1.3 Summary of safety and effectiveness
Contact person Brett Whiston Date prepared 8 October 2003 Trade name MR850 Respiratory Humidifier Common name Respiratory Humidificr Classification name Respiratory Gas Humidifier (21 CFR § 868.5450) Predicate device MR850 Respiratory Humidifier, K020332 MR730 Respiratory Humidifier, K913368
1
Description of device
The MR850 humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide evaporated water content to dry breathing gases. Heated or unheated breathing tubes can be used to deliver the humidified gas to the patient. Heated breathing tubes increase operating efficiency and reduce excessive water and heat loss.
The MR850 has a thermoplastic enclosure with dimensions of 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate 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 chambers, breathing circuits, electrical adapters and temperature / flow probes.
The chamber slides on to the heater plate 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 yentilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. When used with heated breathing circuits the electrical adapter from the humidifier 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. Invasive Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Non-Invasive Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 ℃. The MR850 humidifier monitors temperature, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature, or incorrect equipment set-up conditions, and when in the invasive mode, of inadequate delivered humidity.
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.
2
Technological characteristics summary
The MR850 is equivalent to the predicate MR850 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 predicate MR730 in terms of unheated breathing circuits.
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 electro-medical and EMC standards, and the relevant USA deviations to these in UL 2601-1. It meets the, EMC testing requirements of the FDA Reviewer Guidance for Excerpts related to EMI from November 1993. It complies with performance and safety requirements of the ISO 8185 and ASTM F1690 (USA) particular standards for Humidification Systems with the exception of clauses 51.6.2 and 51.7, and 50.2.4.1 for non-heated breathing circuits.
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.
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.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2004
Fisher & Paykel Healthcare, Limited C/O Laura Danielson TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K033710
Trade/Device Name: MR850 Respiratory Humidifier, Model MR850JHU Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: April 2, 2004 Received: April 2, 2004
Dear Ms. Danielson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 mean that 1 DA mas made statutes and regulations administered by other Federal agencies. or the Act of ury I edenal the Act's requirements, including, but not limited to: registration r ou intist compry mart 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF real in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betrenic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premiuries hemicate 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), 11 you deente spee of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inter Small Manufacturers, International and Consumer 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,
Ching-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1.2 Indications for use
く033710 510(k) Number
Respiratory Humidifier Device Name
Indications for use
The Fisher & Paykel Healthcare MR850 humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce or parceded and to it are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
tstutasharl
ion Sign-Off) ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033710
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