(91 days)
Not Found
No
The description mentions a microprocessor with embedded software for control, but there is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The control appears to be based on feedback from temperature probes, which is standard control system technology, not necessarily AI/ML.
Yes
The device is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance, which is a therapeutic function.
No
Explanation: The device is described as a humidifier that warms and adds humidity to gases delivered to patients requiring ventilation or positive pressure breathing. Its function is to condition ventilatory gases, not to diagnose medical conditions.
No
The device description clearly outlines hardware components such as an electrically powered heat controller, heating element, breathing tubes, electrical adaptor, and temperature probes. While it mentions embedded software, it is integral to the function of the hardware.
Based on the provided information, the Fisher & Paykel Healthcare MR850 humidifier is not an IVD (In Vitro Diagnostic) 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 direct treatment/support function for the patient's respiratory system.
- Device Description: The device conditions gases for breathing and transports them to the patient. It does not perform any tests on biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The MR850 humidifier does not fit this definition.
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 condensation. They 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 (comma separated list FDA assigned to the subject device)
BTT
Device Description
The MR850 Respiratory Humidifier is designed to condition the ventilatory gases for patients requiring assisted breathing, by raising the water vapor content and temperature of the gases delivered to patients.
It consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a chamber. Breathing tubes enable the humidified gas to be transported to the patient. Depending on the chosen configuration, these tubes may be electrically heated, by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. An electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit and incorporates protection circuitry to prevent voltage and current transients on the heater-wire.
Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.
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
neonatal patients (for RT130 and RT131 accessories)
Intended User / Care Setting
hospital/institutional environment.
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: Testing of the MR850 Respiratory Humidifier was compared to the MR850 (predicate) humidifier for performance and safety. These tests show that the MR850 Respiratory Humidifier has substantial equivalence to the MR850 (predicate) humidifier.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033710 Fisher & Paykel Healthcare MR850 Respiratory Humidifier
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(K) SUMMARY 5
Image /page/0/Picture/4 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '073706'. The digits are written in a clear, legible manner, and the image appears to be a close-up of the sequence.
MAR 3 1 2008
Image /page/0/Picture/6 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a large ampersand between the two words. The word "HEALTHCARE" is on the second line, and it is underlined.
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person | Adele Bindon |
|---|---|
| Date prepared | 21 December 2007 |
| Trade name | MR850 Respiratory Humidifier |
| Common name | Respiratory Gas Humidifier |
| Classification name | Respiratory Gas Humidifier |
| II (21 CFR § 868.5450), product code BTT | |
| Predicate device | K033710 Fisher & Paykel Healthcare MR850 Respiratory Humidifier |
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Description 5.1
The MR850 Respiratory Humidifier is designed to condition the ventilatory gases for patients requiring assisted breathing, by raising the water vapor content and temperature of the gases delivered to patients.
It consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a chamber. Breathing tubes enable the humidified gas to be transported to the patient. Depending on the chosen configuration, these tubes may be electrically heated, by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. An electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit and incorporates protection circuitry to prevent voltage and current transients on the heater-wire.
Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.
5.2 Intended use
Gases available for medical use do not contain sufficient moisture and heat, which may damage or irritate the respiratory tract by desiccation in patients whose supraglottic airways have been bypassed.
Heated humidification, as provided by the MR850 Respiratory Humidifier, may be used for patients requiring mechanical ventilation, positive pressure breathing assistance, or general The MR850 humidifier is to be used on patients who are in the medical gases. hospital/institutional environment.
5.3 Technological characteristics comparison
The modified MR850 Respiratory Humidifier is substantially equivalent to the predicate MR850 humidifier and uses the same method of control and delivery of humidity.
The MR850 Respiratory Humidifier differs from the predicate device in the electrical adaptor for the heated breathing circuit. In the predicate system, the heater-wire adaptor is simply an electrical connection to provide power to the heater-wires in the breathing tubes. In the modified MR850 system, the electrical heater-wire adaptor incorporates surge and over-current protection circuitry.
In the event of a surge condition, the adaptor disconnects the heater-wire for a period of time which is dependent on the transient magnitude (for up to 4 seconds), to minimize the risks associated with such fault conditions. As the MR850 humidifier detects the presence of a heaterwire, if the heater-wire remains disconnected during a detection cycle, then the humidifier will illuminate the warning indicators and audibly alarm for the disconnection, thus alerting the user to abnormal operating conditions. Once the heater-wire is reconnected, normal operation resumes.
In the event of an over-current condition (such as an incompatible heated circuit or a fault condition such as a short-circuit), the heater-wire is disconnected for a fixed period of 4 seconds. When the heater-wire is reconnected (and should the over-current condition persist) the heaterwire is disconnected again, and the humidifier continues to alarm, thus minimizing the risk associated with such a fault condition.
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Non-clinical tests 5.4
Testing of the MR850 Respiratory Humidifier was compared to the MR850 (predicate) humidifier for performance and safety. These tests show that the MR850 Respiratory Humidifier has substantial equivalence to the MR850 (predicate) humidifier.
5.5 Conclusion
The MR850 Respiratory Humidifier is substantially equivalent to the MR850 (predicate) humidifier. The comparison of features, performance, and intended use demonstrate that the MR850 Respiratory Humidifier is at least as safe and effective for its intended purpose.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2008
Ms. Adele Bindon Regulatory Affairs Manager - RH Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14-348, Panmure Auckland, NEW ZEALAND
Re: K073706
Trade/Device Name: Fisher & Paykel Healthcare MR850 Respiratory Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 27, 2008 Received: March 3, 2008
Dear Ms. Bindon:
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.
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Page 2 - Ms. Bindon
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); 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.
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 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), please contact the Office of Compliance at (240) 276-0120. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syltte Y. Michaud
md.
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
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INDICATIONS FOR USE STATEMENT 4
510(k) Number
Device Name
Fisher & Paykel Healthcare MR850 Respiratory Humidifier
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 condensation. They 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)
Minh Khai
(Division Sign-Off) Tivision of Anesthesiology General Hospital nfection Control, Dental Devices
:10(k) Number: K073706
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