(259 days)
No
The summary describes a standard respiratory gas humidifier with heated components and sensors for temperature control. There is no mention of AI, ML, or any advanced algorithms for data analysis or decision-making beyond basic control loops.
Yes
The device description explicitly states, "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."
No
The device is described as a respiratory gas humidifier intended to heat and humidify medical respiratory gases for patients, functioning as a therapeutic device. It does not perform any diagnostic function.
No
The device description explicitly lists multiple hardware components including a heater base, external power supply, connector cables, water chambers, heated tubes, connection tube, antibacterial filter, and filter heater. This indicates it is a hardware device with potentially embedded software, not a software-only medical device.
Based on the provided text, the Gründler HumiCare D900 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for heating and humidifying medical respiratory gases for patients during ventilation or respiratory therapy. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a respiratory gas humidifier that warms and adds humidity to breathing gases. This aligns with a therapeutic device, not a device used to examine specimens from the human body for diagnostic purposes.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators
The device is classified as a respiratory gas humidifier, which is a therapeutic device according to the FDA classification mentioned in the text.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT
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.
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
Not Found
Intended User / Care Setting
The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073706, K092256, K983112, K100104
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
Intended Use
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.
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
2
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.
3
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.
4
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
5
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)
Page of
| Status Callery
Status of Children of Children
Property of Children
| 17 | |
|---|---|
| ﺔ ﺍﻟ | . . |
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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