HUMICARE D900

K133766 · Gruendler GmbH · BTT · Nov 24, 2014 · Anesthesiology

Device Facts

• Record ID: K133766
• Device Name: HUMICARE D900
• Applicant: Gruendler GmbH
• Product Code: BTT · Anesthesiology
• Decision Date: Nov 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

HumiCare D900 is an active pass-over respiratory gas humidifier; warms and humidifies medical gases for patients receiving ventilatory support. Ventilator gas enters water chamber; heated/humidified gas travels through heated inspiratory tubing to patient interface. System includes heated breathing circuits to prevent condensation (rain out). Temperature sensors in inspiratory tubing provide feedback for closed-loop temperature regulation. Used in hospital, institutional, or home settings by medically trained healthcare users. Output is conditioned gas at controlled temperature and humidity. Benefits include optimized gas delivery and reduced condensation in breathing circuits, improving patient comfort and safety during respiratory therapy.

Clinical Evidence

Bench testing only. Side-by-side testing verified performance against HumiCare D900 (K122705) specifications, including gas temperature accuracy, surface temperature of tubes, and condensation prevention per ISO 8185. Biocompatibility evaluations (ISO 10993-3, -5, -6, -10) and testing for volatiles, particulates, and leachables were performed. Cleaning and reuse validation for the T2 plug-in sensor was completed.

Technological Characteristics

Active pass-over humidifier; heated water chamber; heated inspiratory/expiratory tubing. Materials biocompatibility per ISO 10993-1. Closed-loop temperature regulation via integrated sensors. Connectivity: T2 plug-in sensor. Sterilization/Cleaning: Validated for reuse. Software: Embedded control for temperature regulation.

Indications for Use

Indicated for patients requiring heated and humidified respiratory gases during invasive ventilation (tracheal tube or cannula), non-invasive ventilation, or respiratory therapy via mask or other interface. For use in hospital, institutional, or home environments by medically trained healthcare users.

Regulatory Classification

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.

Predicate Devices

• HumiCare D900 (K122705)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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.

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 Cassi<br>Vice President - Quality Assurance Americas<br>ResMed Corp.<br>9001 Spectrum Center Boulevard<br>San Diego CA 92123 USA<br>Tel: [phone] |
| 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 and<br>humidify medical respiratory gases for patients. The device is for use<br>during artificial ventilation or ventilatory support (e.g. invasive<br>ventilation via tracheal tube or cannula), non-invasive ventilation, or<br>respiratory therapy by means of a mask or other patient interface.<br>Heated breathing circuits are intended to provide warmed and/or<br>humidified breathing gases before entering the patient airway<br>reducing or eliminating water. They are accessories for the<br>Gründler's HumiCare D900. The heated breathing circuits are used<br>for flow rates greater than 3L/min.<br>The system is for use in hospital/institutional environment or in the<br>home 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 air<br>tubing circuits | Comments |
| Intended use<br>including target<br>population and<br>location of use | The Gründler's HumiCare D900<br>system is intended to heat and<br>humidify medical respiratory gases<br>for patients. The device is for use<br>during artificial ventilation or<br>ventilatory support (e.g. invasive<br>ventilation via tracheal tube or<br>cannula), non-invasive ventilation, or<br>respiratory therapy by means of a<br>mask or other patient interface.<br>Heated breathing circuits are<br>intended to provide warmed and/or<br>humidified breathing gases before<br>entering the patient airway reducing<br>or eliminating water. They are<br>accessories for the Gründler's<br>HumiCare D900. The heated<br>breathing circuits are used for flow<br>rates greater than 3L/min.<br>The system is for use in hospital/<br>institutional environment or in the<br>home environment by medically<br>trained healthcare users. | The Gründler's HumiCare D900<br>system is intended to heat and<br>humidify medical respiratory gases<br>for patients. The device is for use<br>during artificial ventilation or<br>ventilatory support (e.g. invasive<br>ventilation via tracheal tube or<br>cannula), non-invasive ventilation, or<br>respiratory therapy by means of a<br>mask or other patient interface.<br>Heated breathing circuits are<br>intended to provide warmed and/or<br>humidified breathing gases before<br>entering the patient airway reducing<br>or eliminating water. They are<br>accessories for the Gründler's<br>HumiCare D900. The heated<br>breathing circuits are used for flow<br>rates greater than 3L/min.<br>The system is for use in hospital/<br>institutional environment or in the<br>home environment by medically<br>trained healthcare users. | Equivalent |
| Operating modes | Invasive Mode, Non-invasive Mode<br>Last Setting | Invasive Mode, Non-invasive Mode<br>Last Setting | Equivalent. |
| Circuit type | Single/ Dual heated Limb system | Single/ Dual heated Limb system | Equivalent |

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# RESMED

| Chamber type | Passover with extended<br>water/respiratory gas interface | Passover with extended<br>water/respiratory gas interface | Equivalent |
|-------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Humidification | Invasive mode: Flow up to 60 L/min<br>> 33 mg/L<br>Non-invasive mode: Flow up to 100<br>L/min > 10 mq/L | Invasive mode: Flow up to 60 L/min<br>> 33 mg/L<br>Non-invasive mode: Flow up to 100<br>L/min > 10 mg/L | Equivalent |
| Monitoring of<br>values | Temperature (patient)<br>Temperature (chamber)<br>Temperature (expiration tube) | Temperature (patient)<br>Temperature (chamber)<br>Temperature (expiration tube) | Substantially<br>Equivalent<br>Temperature of the<br>expiration tube of the<br>modified device is<br>controlled via the<br>temperature probe of<br>the inspiratory tube.<br>The closed loop<br>temperature regulation<br>has 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.