The Gründler HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive 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 breathing circuits are used for 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 CER §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 passover humidification via an enhanced surface area for gas/water. The huge gas/water sufface 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 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 temperature sensors are included in the inspiratory and expiratory air tubing,

The HumiCare D900 system consists of a heater base with external power supply, connector cables, a 30day disposable water chambers, heated tubes (inspiratory), connection tube, antibacterial filter and filter heater. The 30day disposable water chamber and air tubing circuits are intended for single patient use, with the exception of when an antibacterial filter is incorporated into the circuit allowing multi-patient use of the chamber. The HumiCare D900 heater base and filter heater are intended for multi-patient re-use.

AI/ML Overview

The HumiCare D900 is a respiratory gas humidifier. The provided text from the 510(k) summary (K122765) states that various design and verification activities were performed to ensure the device met predetermined acceptance criteria. These tests confirmed that the product met these criteria, specifically highlighting side-by-side testing for humidification performance and resistance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices."

However, specific numerical acceptance criteria or detailed performance reports are not provided in this summary. The summary only generally states that the device met the criteria and was substantially equivalent to predicate devices for "humidification performance" and "resistance of the humidifier."

Acceptance Criteria	Reported Device Performance
Specific numerical criteria for humidification performance not provided	Demonstrated "Substantially Equivalent" humidification performance to predicate devices (K073706, K092256, K983112, K100104).
Specific numerical criteria for resistance of the humidifier not provided	Demonstrated "Substantially Equivalent" resistance of the humidifier to predicate devices (K073706, K092256, K983112, K100104).
Biocompatibility (Genotoxicity, Cytotoxicity, Implantation, Sensitization, and Irritation) for materials in contact with warm wet air path.	Met applicable requirements (ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO10993-10).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It also does not define the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or a ground truth established by them for the performance validation of the HumiCare D900. The testing appears to be of a technical/engineering nature, comparing the device's technical specifications and performance against predicate devices and relevant standards.

4. Adjudication Method for the Test Set

Since an expert-based ground truth is not mentioned, there is no adjudication method described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes a medical device (a respiratory gas humidifier) and its engineering and performance validation. It does not involve human readers interpreting data or a multi-reader multi-case comparative effectiveness study in the context of AI assistance.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done in the sense that the device's performance was evaluated against predetermined acceptance criteria and compared to predicate devices. The text states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices." This implies that the device (algorithm/system) was tested on its own to demonstrate its functionality and equivalence.

7. The Type of Ground Truth Used

The "ground truth" for the HumiCare D900's performance appears to be based on:

Engineering specifications and pre-determined acceptance criteria for device functionality.
The performance characteristics of legally marketed predicate devices, against which the HumiCare D900 was deemed "substantially equivalent."
Compliance with recognized standards (e.g., ISO 8185:2009 for humidifiers, ISO 10993 series for biocompatibility, IEC 60601-1 for safety).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical device (a humidifier) and not an AI/machine learning model that undergoes training on data.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" is not applicable to this device. Therefore, no ground truth for a training set was established.

Summary

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K12276S

510(k) Summary - HumiCare D900

MAY 2 1 2013 Date prepared April 12, 2013 Christoph Gründler Submitter Managing Director Gründler GmbH Official contact Jim Cassi V.P., Quality Assurance Americas ResMed Corp. 9001 Spectrum Center Blvd., San Diego CA 92123 USA Tel: +1 858-836-6081 +1 818-428-6401 Fax: Proprietary name HumiCare D900 Respiratory Gas Humidifier Common name 21 CFR 868.5450 Classification Product code 73 BTT Predicate Devices K073706, (Fisher & Paykel Healthcare) MR850 Respiratory Humidifier K092256, (Smiths Medical ASD Inc.) Thera-Heat™ Heated Humidifier K983112, (Fisher & Paykel Healthcare) Heated Tubing RT110 as part of MR850 Respiratory Humidifier K100104, (Plastiflex Group NV) Hybernite Rainout Control System

Reason for submission

New device

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Intended Use

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

Device Description

Substantial Equivalence

The new device is substantially equivalent to the above specified predicate devices based on:

Similar intended use 人
Similar operating principle
A Similar Circuit types
Same fundamental technological characteristics 人
Similar performance characteristics.

Design and Verification activities were performed on the HumiCare D900 as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices.

Materials that contact the heated humidified gas pathway are considered to be external communication permanent duration (tissue/bone/dentin). The biological tests for warm wet air path application, in accordance with FDA Guidance #G95-1 were:

ISO 10993-3 Genotoxicity >
ISO 10993-5 Cytotoxicity A
ISO 10993-6 Implantation A
ISO10993-10 Sensitisation and Irritation

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The new device complies with the applicable requirements referenced in the FDA guidance documents:

FDA Reviewer Guidance for Premarket Notification Submissions (November 1993)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
FDA Heated Humidifier Review Guide (February 1997)

The new device was designed and tested to the following standards:

FDA-3654 (IEC 60601-1:1988) *
大 FDA-3654 (IEC 60601-1-2:2007)
FDA-3654 (ISO 8185:2009)

Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. Performance data demonstrate that the new device is as safe and effective as the predicate devices. Thus the HumiCare D900 system is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

May 21, 2013

Gründler GmbH C/O Mr. Olaf Teichert Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891

Re: K122705

Trade/Device Name: HumiCare D900 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: May 3, 2013 Received: May 6, 2013

Dear Mr. Teichert:

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 of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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.

Kwame@-Him

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use 510(k) Number (if known): K 122 705

Device Name:

HumiCare D900

Indications for Use:

The Gründler's HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive 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 Grundler's HumiCare D900. The heated breathing circuits are used for flow rates greater than 3L/min.

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

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(Part 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)

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Status CalleryStatus of Children of ChildrenProperty of Children17

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K

Page 20

June 12, 2012

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).