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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MR850 Respiratory Humidifier (K110019):

The provided 510(k) summary for the MR850 Respiratory Humidifier lacks detailed information about specific acceptance criteria and the comprehensive study that proves the device meets them, especially in the context of clinical performance or human-in-the-loop studies. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing related to humidity and enthalpy.

However, based on the information available, we can extract the following:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Meeting humidity limits as established in ISO 8185	"The testing confirmed that the modification to software had no impact on the MR850 meeting the humidity limits...as established in ISO 8185."
Meeting enthalpy limits as established in ISO 8185	"The testing confirmed that the modification to software had no impact on the MR850 meeting the...enthalpy limits as established in ISO 8185."
Maintaining the same performance as the predicate device	"The modified MR850 Respiratory Humidifier...has: The same performance." (This is a claim of substantial equivalence, implicitly stating its performance meets or exceeds the predicate's standards).
Software modification (version 7.25) to act as a risk mitigator against foreseeable misuse	"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..."
Resolution of factory test issues	"This modification does involve a revision of the software to version 7.25 which will enable...the resolution of factory test issues."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets, nor does it provide information about the provenance (country of origin, retrospective/prospective) of the data. The testing mentioned appears to be laboratory-based engineering performance testing ("Humidity Performance Testing," "Enthalpy Testing," "Humidity Control Performance Testing") rather than clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The testing described is technical performance testing against an international standard (ISO 8185), not a comparison against expert-established ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no mention of a human-reviewed test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a respiratory humidifier, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's software (version 7.25) includes a "humidity compensation feature" via a "proprietary algorithm." The "Humidity Control Performance Testing" would inherently evaluate the standalone performance of this algorithm in controlling humidity output according to the device's design and the relevant ISO standard. However, the document does not elaborate on the specific methodology or results of this standalone algorithm performance beyond stating it met the limits.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing cited is the established limits and specifications within the ISO 8185 standard for respiratory gas humidifiers. This is a technical, rather than a clinical, ground truth.

8. The sample size for the training set

Not applicable. As this device is a hardware humidifier with embedded software for control, there is no mention of a "training set" in the context of machine learning. The software modification is for a control algorithm, not a learning algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in this context.

Summary

{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.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

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

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

Regulation Number and Section

§ 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).