AirLife Autofill Humidification Chamber

K160764 · Carefusion 2200, Inc. · BTT · Aug 25, 2016 · Anesthesiology

Device Facts

• Record ID: K160764
• Device Name: AirLife Autofill Humidification Chamber
• Applicant: Carefusion 2200, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Aug 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

Device Story

AirLife Autofill Humidification Chamber holds water for humidifying breathing gases in clinical settings. Device connects to a respiratory humidifier (heater base) via 22 mm ISO conical connections; uses primary and secondary floats to regulate water levels and prevent overfill. Input is water from flexible or rigid containers; output is humidified gas delivered to patient. Operated by skilled clinicians in professional healthcare environments. Provides visual water level monitoring via clear housing. Benefits patient by ensuring consistent gas humidification during respiratory therapy. Single-use, non-sterile device.

Clinical Evidence

Bench testing only. Performance evaluated against BS EN ISO 8185:2009, BS EN ISO 5367:2014, and IEC 60601-1:2005. Testing included humidity output (invasive: 39.0 mg/L; non-invasive: 24.3 mg/L), resistance to flow, leakage, maximum operating pressure, liquid overflow, and compressible volume. Biocompatibility testing conducted per ISO 10993 series (cytotoxicity, sensitization, irritation, implantation, genotoxicity, extractables/leachables).

Technological Characteristics

Materials: Noryl (float frame). Sensing: Independent primary/secondary mechanical floats. Connectivity: 22 mm ISO conical connections. Form factor: Clear housing with waterline marks. Sterilization: Non-sterile. Standards: AAMI/ANSI/ISO 10993-1, 5, 10, 12, 17, 18; BS EN ISO 8185:2009/2014; BS EN ISO 5367:2014; IEC 60601-1:2005.

Indications for Use

Indicated for any patient requiring humidified breathing gases via a heated humidifier in professional healthcare environments under clinician supervision.

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

• MR290 Humidification Chamber (K934140)

Submission Summary (Full Text)

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

August 25, 2016

CareFusion 2200, Inc. Erika Fernandez Regulatory Affairs Manager 75 N. Fairway Dr. Vernon Hills, Illinois 60061

Re: K160764

Trade/Device Name: AirLife Autofill Humidification Chamber Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: July 25, 2016 Received: July 26, 2016

Dear Erika Fernandez:

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.

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 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Division 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)

K160764

Device Name ArLife Autofill Humidification Chamber

#### Indications for Use (Describe)

The AirLife Autofill Humidication Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".

75 N. Fairway Dr Vernon Hills. IL 60061 Phone: [phone] 949-0731

# Summary of Safety and Effectiveness

510k summary complying with 21 CFR 807.92.

# 1. SUBMITTER

CareFusion 2200, Inc. 75 N Fairway Drive, Vernon Hill, IL 60061 847-362-8097 Phone: Fax: [phone] Contact Person: Erika Fernandez Date Prepared: August 24th , 2016

# 2. Device

| Product Name: | AirLife Autofill Humidification Chamber |
|----------------------|-----------------------------------------------|
| Device Name: | Humidifier Chamber |
| Common Name: | Humidifier Chamber |
| Classification Name: | Humidifier, Respiratory Gas (21 CFR 868.5450) |
| Regulatory Class: | II |
| Product Code: | BTT |

#### 3. Predicate Device

This submission demonstrates substantial equivalence to the MR290 Humidification Chamber, K934140 cleared on January 24, 1994. This predicate device has not been subject to a design-related recall.

#### 4. Device Description

The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.

# 5. Indication for use

The AirLife Auto Fill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The AirLife Auto Fill Humidification Chamber is compatible with Fisher and Paykel MR850 system.

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Image /page/4/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield inside, and a small portion of the shield is colored yellow. To the right of the circle is the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller, lighter font, it says "has joined BD".

75 N. Fairway Dr.
Vernon Hills, IL 60061 Phone: [phone]
Fax: carefusion.com

- 6. Comparison of technological characteristics with the predicate device
The fundamental scientific technology is the same for both the proposed and predicate device. The AirLife Humidification Chamber is substantially equivalent to the predicate device, MR290 Humidification Chamber, regarding safety, effectiveness, design (technology), materials and intended use.

| Element of comparison | Proposed Device | Predicate Device |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The AirLife Autofill Humidification Chamber<br>is intended to hold water required to<br>humidify breathing gases delivered to any<br>patient using a heated humidifier. The<br>product is a single use device, non-sterile<br>and used in professional healthcare<br>environments under a doctor's supervision<br>and by skilled clinicians. | The MR290 Humidification Chamber is<br>intended to hold water required to<br>humidify the air being delivered to<br>patients. The MR290 is an auto-fill<br>humidification chamber suitable for all<br>patients and compatible with all F&P<br>MR-series humidifiers |
| Principal of Operation | The humidification chamber works with a<br>respiratory humidifier (also called a "heater<br>base") that provides the heat source,<br>temperature control system, and alarm<br>system to heat and humidity respiratory<br>gases. | The humidification chamber works<br>with a respiratory humidifier (also<br>called a "heater base") that provides<br>the heat source, temperature control<br>systems, and alarm systems to heat<br>and humidifies respiratory gases. |
| Characteristics | | |
| Connection | 22 mm ISO conical connections for breathing<br>circuit attachment<br>Flexible tubing bonded to close piercing<br>device (spike) and chamber inlet for<br>supplying water | 22 mm ISO conical connections for<br>breathing circuit attachment<br>Flexible tubing bonded to close<br>piercing device (spike) and chamber<br>inlet for supplying water |
| Design | Maximum and minimum waterline marks for<br>visual confirmation of proper water levels | Maximum water line mark for visual<br>confirmation of proper water levels |
| | Independent primary and secondary floats to<br>regulate water level and to prevent overfill<br>condition if the primary float fails. | Independent primary and secondary<br>floats to regulate water level and<br>prevent overfill condition if the<br>primary float fails open. |
| | Clear Housing to allow visibility of water<br>level for monitoring | Clear Housing to allow visibility of<br>level for monitoring |
| Humidity Output | Invasive mode: 39.0 mg/L<br>Non Invasive mode: 24.3 mg/L | Invasive mode: 39.2 mg/L<br>Non Invasive mode: 24.6 mg/L |
| Maximum Operating<br>pressure | 13.2kPa | 13.2kPa |
| Element of comparison | Proposed Device | Predicate Device |
| Maximum Continuous Gas<br>Flow Rate | Maximum continuous gas flow rate of 60<br>LPM in invasive mode and 120 LPM in non-<br>Invasive mode | Maximum continuous gas flow rate of<br>60 LPM in invasive mode and 120 LPM<br>in non-Invasive mode |
| Compliance | 6.23 mL/kPa | 5.54 mL/kPa |
| Resistance to Flow<br>@60L/min | 0.40 cmH2O | 0.50 cmH2O |
| Enthalpy Maximum Value<br>Enthalpy Averaged Value | 156 kJ/kg Max.<br>117 kJ/kg Avg. | 151 kJ/kg Max.<br>120 kJ/kg Avg. |
| Compressible volume | 245 mL | 255 mL |
| Material | Uses Noryl for float frame | Uses Polycarbonate for float frame |
| Gas leakage | <30mL/min | <100 mL/min |
| Duration for Use | 14 days | 14 days |
| Shelf life | 24 months | Not Published |
| Compatibility (1) | Compatible with flexible and rigid inhalation<br>water containers (water feed set contains air<br>vent provision for rigid containers) | Compatible with flexible and rigid<br>inhalation water containers (water<br>feed set contains air vent provision for<br>rigid containers) |
| Compatibility (2) | Compatible with Fisher and Paykel MR850<br>Humidifiers | Compatible with Fisher and Paykel MR<br>series Humidifiers |

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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in a sans-serif font. Below the text, there is a smaller text that says "has joined BD". The logo is simple and modern, and the colors are bright and eye-catching.

#### 7. Performance Data

The proposed device was tested to ensure compliance to the following standards:

#### Biocompatibility

Tests for an externally communicating, tissue by way of gas path and direct mucosal contact with prolonged contact (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables

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Image /page/6/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white and yellow shield inside, followed by the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".

# Standards

| Performance Characteristic | Standard |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Biological Evaluation of Medical Devices--Part 1:<br>Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices-Part 5: Tests<br>for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009<br>(R2014) |
| Biological Evaluation of Medical Devices-Part 10:<br>Tests for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010<br>(R2014) |
| Biological Evaluation of Medical Devices Part 12:<br>Sample Preparation and Reference Materials | AAMI/ANSI/ISO 10993-12:2012 |
| Biological Evaluation of Medical Devices Part 17:<br>Establishment of allowable limits for leachable<br>substances | AAMI/ANSI/ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18:<br>Chemical characterization of materials | AAMI/ANSI/ISO 10993-18:2005 |

# Performance

The following tests were performed for the proposed device to support the substantial equivalence decision.

| Performance Characteristic | Relevant Standard |
|------------------------------|---------------------|
| Humidity Output Invasive | BS EN ISO 8185:2009 |
| Humidity Output Non-Invasive | |
| Specific Enthalpy | BS EN ISO 8185:2009 |
| Hazardous Output | BS EN ISO 8185:2009 |

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Image /page/7/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".

| Performance Characteristic | Relevant Standard |
|--------------------------------------|--------------------------------------------|
| Resistance to Flow | BS EN ISO 5367:2014 |
| Maximum Peak Flow | BS EN ISO 8185:2014 |
| Leakage & Maximum Operating Pressure | BS EN ISO 8185:2009<br>BS EN ISO 5367:2014 |
| Liquid Overflow | BS EN ISO 8185:2009 |
| Compliance | BS EN ISO 8185:2009<br>BS EN ISO 5367:2014 |
| Compressible Volume | N/A |
| Accessible Surface Temperature | BS EN ISO 8185:2009<br>IEC 60601-1:2005 |
| Steady State Noise | BS EN ISO 8185:2009<br>IEC 60601-1:2005 |
| Shelf Life/Accelerated Aging | N/A |
| End-use Simulation/Duration of Use | N/A |

#### 8. Conclusion

Test results demonstrate that the proposed device is as safe and effective as the predicate device, and therefore, is substantially equivalent to the predicate device.