The Gründler's HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilatory support (e.g. invasve ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.

Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breath or flow rates greater than 3L/min.

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

Device Description

The HumiCare D900 system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a pass-over humidification via an enhanced surface area for gas/water. The huge gas/water surface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle operation of the HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated. Therefore a temperature sensor is included in the inspiratory air tubing to control the temperature regulation of the air tubing.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the HumiCare D900 respiratory gas humidifier, which is a modification of an already cleared device (K122705). The submission primarily focuses on demonstrating substantial equivalence to the predicate device through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the format of specific numerical targets vs. achieved results. Instead, it indicates that the modified device was tested against the "predetermined pass/fail requirements of the HumiCare D900 System Specification".

However, some performance characteristics are mentioned and compared between the predicate and modified device, which can be inferred as meeting acceptance criteria due to the "Equivalent" or "Substantially Equivalent" comments.

Acceptance Criterion (Inferred from comparison)	Reported Device Performance (Modified HumiCare D900)
Humidification - Invasive mode:
Flow up to 60 L/min	Flow up to 60 L/min
> 33 mg/L	> 33 mg/L
Humidification - Non-invasive mode:
Flow up to 100 L/min	Flow up to 100 L/min
> 10 mg/L	> 10 mg/L
Accuracy of displayed gas temperature	Met predetermined pass/fail requirements
Surface temperature of the tubes	Met predetermined pass/fail requirements
System performance according to ISO 8185	Met predetermined pass/fail requirements
Absence of condensate formation	Met predetermined pass/fail requirements
Biocompatibility (ISO 10993-1, -3, -5, -6, -10)	Passed all requirements
Absence of volatiles, particulates, leachables	Passed all requirements
Cleaning and reuse validation	Completed, establishing reusability of T2 plug-in sensor

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 primarily discusses non-clinical bench testing.

Sample size: The document does not specify the exact sample size for the bench tests (e.g., number of devices tested, number of test runs). It generally refers to "Side-by-Side bench testing" and "Design and Verification activities."
Data provenance: The testing was "Side-by-Side bench testing" and "Design and Verification activities" performed by the manufacturer, ResMed Corp., which is based in San Diego, California, USA (though the original submitter, Dr. Christoph Gründler, and the device name "Gründler's HumiCare D900" suggest a European origin for the base technology). The nature of the testing is non-clinical/laboratory, not human subject data. Therefore, the terms "retrospective" or "prospective" are not applicable in this context.

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 as the study did not involve human interpretation or subjective judgment to establish ground truth. The acceptance criteria were based on "predetermined pass/fail requirements of the HumiCare D900 System Specification" and international standards like ISO 8185 and ISO 10993. These are objective measurements and engineering specifications, not expert consensus.

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

This information is not applicable as the testing was non-clinical bench testing and did not involve human observers or interpretation 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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a respiratory gas humidifier, not an AI-powered diagnostic or assistive technology that would involve human readers.

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

The concept of "standalone algorithm only" is not applicable to this device. It is a physical medical device (humidifier) that performs its function directly, not through an algorithm interpretation. The device does contain software for control and monitoring, but its performance is assessed via its physical output (temperature, humidity), not through an inferential algorithm's output.

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

The "ground truth" or reference for evaluating performance was based on:

Predetermined pass/fail requirements from the HumiCare D900 System Specification.
International standards: ISO 8185 for system performance and ISO 10993 for biocompatibility.
Objective physical measurements: Such as temperature accuracy, humidification output (mg/L), and absence of condensation.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 24, 2014

ResMed Corp Mr. Jim Cassi Vice President-Ouality Assurance 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K133766

Trade/Device Name: HUMICARE D900 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: II Product Code: BTT Dated: October 24, 2014 Received: October 27, 2014

Dear Mr. Jim Cassi:

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.

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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 contact the Division of Industry and Consumer Education 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. 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.gov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin | Keith -S

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name HumiCare D900

Indications for Use (Describe)

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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6 510(k) Summary

510(k) SUMMARY

[As required by 21 CFR 807.92]

Date Prepared	December 6th, 2013, updated at November 20th, 2014
Submitter Name	Dr. Christoph Gründler
Official Contact	Mr. Jim CassiVice President - Quality Assurance AmericasResMed Corp.9001 Spectrum Center BoulevardSan Diego CA 92123 USATel: (858) 836-5984
Device Trade Name	HumiCare D900
Device Common Name/	Respiratory Gas Humidifier
Classification	21 CFR 868.5450
Product code	73 BTT
Predicate Device	HumiCare D900 (K122705)
Reason for Submission	Device modified
Intended Use	The Gründler's HumiCare D900 system is intended to heat andhumidify medical respiratory gases for patients. The device is for useduring artificial ventilation or ventilatory support (e.g. invasiveventilation via tracheal tube or cannula), non-invasive ventilation, orrespiratory therapy by means of a mask or other patient interface.Heated breathing circuits are intended to provide warmed and/orhumidified breathing gases before entering the patient airwayreducing or eliminating water. They are accessories for theGründler's HumiCare D900. The heated breathing circuits are usedfor flow rates greater than 3L/min.The system is for use in hospital/institutional environment or in thehome environment by medically trained healthcare users.

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Description The HumiCare D900 system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a pass-over humidification via an enhanced surface area for gas/water. The huge gas/water surface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle operation of the HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated. Therefore a temperature sensor is included in the inspiratory air tubing to control the temperature regulation of the air tubing.

	Predicate	Modified Device
Characteristics	HumiCare D900	HumiCare D900 with the T2 airtubing circuits	Comments
Intended useincluding targetpopulation andlocation of use	The Gründler's HumiCare D900system is intended to heat andhumidify medical respiratory gasesfor patients. The device is for useduring artificial ventilation orventilatory support (e.g. invasiveventilation via tracheal tube orcannula), non-invasive ventilation, orrespiratory therapy by means of amask or other patient interface.Heated breathing circuits areintended to provide warmed and/orhumidified breathing gases beforeentering the patient airway reducingor eliminating water. They areaccessories for the Gründler'sHumiCare D900. The heatedbreathing circuits are used for flowrates greater than 3L/min.The system is for use in hospital/institutional environment or in thehome environment by medicallytrained healthcare users.	The Gründler's HumiCare D900system is intended to heat andhumidify medical respiratory gasesfor patients. The device is for useduring artificial ventilation orventilatory support (e.g. invasiveventilation via tracheal tube orcannula), non-invasive ventilation, orrespiratory therapy by means of amask or other patient interface.Heated breathing circuits areintended to provide warmed and/orhumidified breathing gases beforeentering the patient airway reducingor eliminating water. They areaccessories for the Gründler'sHumiCare D900. The heatedbreathing circuits are used for flowrates greater than 3L/min.The system is for use in hospital/institutional environment or in thehome environment by medicallytrained healthcare users.	Equivalent
Operating modes	Invasive Mode, Non-invasive ModeLast Setting	Invasive Mode, Non-invasive ModeLast Setting	Equivalent.
Circuit type	Single/ Dual heated Limb system	Single/ Dual heated Limb system	Equivalent

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RESMED

Chamber type	Passover with extendedwater/respiratory gas interface	Passover with extendedwater/respiratory gas interface	Equivalent
Humidification	Invasive mode: Flow up to 60 L/min> 33 mg/LNon-invasive mode: Flow up to 100L/min > 10 mq/L	Invasive mode: Flow up to 60 L/min> 33 mg/LNon-invasive mode: Flow up to 100L/min > 10 mg/L	Equivalent
Monitoring ofvalues	Temperature (patient)Temperature (chamber)Temperature (expiration tube)	Temperature (patient)Temperature (chamber)Temperature (expiration tube)	SubstantiallyEquivalentTemperature of theexpiration tube of themodified device iscontrolled via thetemperature probe ofthe inspiratory tube.The closed looptemperature regulationhas been validated.

Clinical Testing Clinical testing is not required, bench testing alone is sufficient to demonstrate the product remains substantially equivalent to the predicate device HumiCare D900 (K122705). Non-Clinical Testing Side-by-Side bench testing was performed to verify that the HumiCare D900 met the predetermined pass/fail requirements of the

HumiCare D900 System Specification when compared to the predicate devices [HumiCare D900 (K122705)]. This bench testing included testing the performance of each therapy mode which included:

. Determination of the accuracy of displayed gas temperature
. Determination of surface temperature of the tubes
System performance according to ISO 8185
. Absence of condensate formation

As was the case with the predicate, the HumiCare D900 materials not previously cleared by FDA were subject to appropriate biocompatibility evaluations according to ISO 10993-1. Materials used the construction of components that:

contact the heated humidified gas pathway have been ● classified as permanent "external communicating devices" (with tissue/bone/dentin)
As relevant and to support the biocompatibility evaluation of each tube component, following biological effects (selected in accordance with FDA guidance #G95-1) were assessed:
Genotoxicity (ISO 10993-3) ●
Cytotoxicity (ISO 10993-5) .
Implantation (ISO 10993-6) ●
. Sensitization (ISO 10993-10)

In addition the device was tested for volatiles, particulates and leachable substances. The device was shown to pass all requirements.

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Validation of cleaning and reuse was completed to establish that the T2 plug in sensor can be reused in the home or hospital/institutional environment.

Substantial equivalence

Comparison with previously cleared HumiCare D900

The modified device has the following similarities to the previously cleared HumiCare D900:

Same intended use 久
A Similar operating principle
Similar circuit types A
A Same fundamental technological characteristics
A Similar performance characteristics.
A Similar manufacturing process

Design and Verification activities were performed on the modified HumiCare D900 as a result of the risk analysis and product requirements. All tests confirmed that the product met the predetermined acceptance criteria and that the modified HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are substantially equivalent to the predicate device (K122705).

The modified device complies with the applicable requirements referenced in the FDA quidance documents:

FDA Reviewer Guidance for Premarket Notification A Submissions (November 1993)
A FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
FDA Heated Humidifier Review Guide (February 1997)
Conclusion The indications for use, technological characteristics, and principles of operation are similar to the predicate device. Performance data demonstrate that the modified HumiCare D900 system is substantially equivalent to the predicate device.

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).