(452 days)
Not Found
No
The device uses a microprocessor with embedded software and a proprietary algorithm for humidity compensation, but there is no mention of AI or ML techniques like neural networks, deep learning, or training on data. The algorithm appears to be a deterministic control algorithm.
Yes
The device is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance, and it conditions gases for patients by raising the delivered water vapor content and temperature of the gases, which are therapeutic actions.
No
The device is a humidifier designed to warm and add humidity to gases delivered to patients. It does not collect or analyze medical data to diagnose a condition.
No
The device description clearly outlines hardware components such as an electrically powered heat controller, heating element, tubes, electrical adaptor, and temperature probes, in addition to the embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 conditions gases for patient delivery. It does not analyze 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.
The device is a respiratory humidifier, which is a medical device used in patient care, but it falls under the category of devices that support physiological functions rather than diagnose conditions.
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 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 gases for patients by raising the delivered water vapor content and temperature of the gases.
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. A tube connects gas to the chamber input. Another tube connects to the chamber output and enables 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 humidifier will control the amount of heat provided. 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.
The MR850 Respiratory Humidifier differs from the predicate device by the addition of a new version of software (version 7.25) which includes a humidity compensation feature to the normal heater plate control mode of the modified device. This feature enables the chamber output set temperature to be increased (via a proprietary algorithm) to increase the relative humidity at the patient airway probe position. This is a risk mitigator against specific foreseeable misuse as identified in the Hazard Analysis of the MR850.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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
Testing submitted as part of this 510(k) includes:
- Humidity Performance Testing
- Enthalpy Testing
- Humidity Control Performance Testing
The testing confirmed that the modification to software had no impact on the MR850 meeting the humidity limits and enthalpy limits as established in ISO 8185.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing confirmed that the modification to software had no impact on the MR850 meeting the humidity limits and enthalpy limits as established in ISO 8185.
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.
K073706 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
MR850 Respiratory Humidifier
K110-019
MAR 3 0 2012
aykel Fisher & Po HEALTHCARE
Fisher & Paykel Healthcare Limited 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
| Contact person | Adele Bindon |
|---|---|
| Date prepared | 29 March 2012 |
| 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 | K073706 MR850 Respiratory Humidifier |
1
Device Description
The MR850 Respiratory Humidifier is designed to condition gases for patients by raising the delivered water vapor content and temperature of the gases.
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. A tube connects gas to the chamber input. Another tube connects to the chamber output and enables 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 humidifier will control the amount of heat provided. 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.
The MR850 Respiratory Humidifier differs from the predicate device by the addition of a new version of software (version 7.25) which includes a humidity compensation feature to the normal heater plate control mode of the modified device. This feature enables the chamber output set temperature to be increased (via a proprietary algorithm) to increase the relative humidity at the patient airway probe position. This is a risk mitigator against specific foreseeable misuse as identified in the Hazard Analysis of the MR850.
Intended 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 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.
Technological Characteristics
The following technological characteristics of the MR850 Respiratory Humidifier remain the same as the predicate device:
- Design
- 비 Material
- . Chemical composition
- Energy source 프
- . Control mechanism
- l Operating principle
- . Environmental specifications
- 트 Performance specifications
- 이 Dimensional specifications
2
- Ergonomics of the patient/user interface? .
This modification does involve a revision of the software to version 7.25 which will enable the introduction of a risk mitigator and the resolution of factory test issues.
Substantial Equivalence
The modified MR850 Respiratory Humidifier is substantially equivalent to the predicate MR850 Respiratory Humidifier and uses the same method of control and delivery of humidity. In addition, it has:
- · The same intended use
- · The same operating principle
- · The same design
- · The same material
- · The same mechanism of action
- · The same performance.
No modifications to the hardware of the MR850 system have been made with respect to the predicate.
Testing
Testing submitted as part of this 510(k) includes:
- 프 Humidity Performance Testing
- . Enthalpy Testing
- I Humidity Control Performance Testing
The testing confirmed that the modification to software had no impact on the MR850 meeting the humidity limits and enthalpy limits as established in ISO 8185.
Conclusion
The MR850 Respiratory Humidifier is substantially equivalent to the predicate MR850 Respiratory Humidifier. The information submitted as part of this 510(k) demonstrates that the MR850 Respiratory Humidifier is as safe, as effective and performs as well as the predicate device.
This summary includes only information that is also covered in the body of the 510(k).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Adele Bindon Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place P.O. Box 14348, Panmure Auckland NEW ZEALAND 1741
MAR 3 0 2012
Re: K110019
Trade/Device Name: Fisher & Paykel Healthcare 850 Respiratory Humidifier . Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: March 23, 2012 Received: March 26, 2012
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. 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.
4
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 6.
510(k) Number
KI10019
Device Name
Fisher & Paykel Healthcare 850 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.
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)
L. Schult Otten
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton Control, Devices
510(k) Number: u110019