K Number
K160764
Device Name
AirLife Autofill Humidification Chamber
Date Cleared
2016-08-25

(157 days)

Product Code
Regulation Number
868.5450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.
More Information

Not Found

No
The document describes a simple humidification chamber and explicitly states "Mentions AI, DNN, or ML: Not Found".

No
The device is a humidification chamber that holds water to humidify breathing gases, acting as an accessory to a heated humidifier rather than providing direct therapeutic action itself.

No
The device's intended use is to hold water for humidifying breathing gases, not to diagnose medical conditions.

No

The device description and performance studies clearly indicate this is a physical medical device (a humidification chamber) and not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to hold water for humidifying breathing gases delivered to patients. This is a device used in the delivery of respiratory support, not for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Description: The description reinforces its function as a water chamber for humidification.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to aid in diagnosis, monitoring, or screening. This device's function is purely related to the delivery of humidified air to the patient's respiratory system.

N/A

Intended Use / Indications for Use

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.

Product codes

BTT

Device Description

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

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

used in professional healthcare environments under a doctor's supervision and by skilled clinician.

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)

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.
Performance tests performed: Humidity Output Invasive, Humidity Output Non-Invasive, Specific Enthalpy, Hazardous Output, Resistance to Flow, Maximum Peak Flow, Leakage & Maximum Operating Pressure, Liquid Overflow, Compliance, Compressible Volume, Accessible Surface Temperature, Steady State Noise, Shelf Life/Accelerated Aging, End-use Simulation/Duration of Use.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Humidity Output Invasive mode: 39.0 mg/L
Humidity Output Non Invasive mode: 24.3 mg/L
Maximum Operating pressure: 13.2kPa
Maximum Continuous Gas Flow Rate: 60 LPM in invasive mode and 120 LPM in non-Invasive mode
Compliance: 6.23 mL/kPa
Resistance to Flow @60L/min: 0.40 cmH2O
Enthalpy Maximum Value: 156 kJ/kg Max.
Enthalpy Averaged Value: 117 kJ/kg Avg.
Compressible volume: 245 mL
Gas leakage:

§ 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).

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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.

1

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/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 (800) 638-2041 or (301) 796-7100 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

2

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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75 N. Fairway Dr Vernon Hills. IL 60061 Phone: 847 362-8097 312 949-0731

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: 312 949-0731 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: 847 362-8097
Fax: carefusion.com

    1. 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 comparisonProposed DevicePredicate Device
Indications for UseThe 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 a single use device, non-sterile
and used in professional healthcare
environments under a doctor's supervision
and by skilled clinicians.The MR290 Humidification Chamber is
intended to hold water required to
humidify the air being delivered to
patients. The MR290 is an auto-fill
humidification chamber suitable for all
patients and compatible with all F&P
MR-series humidifiers
Principal of OperationThe humidification chamber works with a
respiratory humidifier (also called a "heater
base") that provides the heat source,
temperature control system, and alarm
system to heat and humidity respiratory
gases.The humidification chamber works
with a respiratory humidifier (also
called a "heater base") that provides
the heat source, temperature control
systems, and alarm systems to heat
and humidifies respiratory gases.
Characteristics
Connection22 mm ISO conical connections for breathing
circuit attachment
Flexible tubing bonded to close piercing
device (spike) and chamber inlet for
supplying water22 mm ISO conical connections for
breathing circuit attachment
Flexible tubing bonded to close
piercing device (spike) and chamber
inlet for supplying water
DesignMaximum and minimum waterline marks for
visual confirmation of proper water levelsMaximum water line mark for visual
confirmation of proper water levels
Independent primary and secondary floats to
regulate water level and to prevent overfill
condition if the primary float fails.Independent primary and secondary
floats to regulate water level and
prevent overfill condition if the
primary float fails open.
Clear Housing to allow visibility of water
level for monitoringClear Housing to allow visibility of
level for monitoring
Humidity OutputInvasive mode: 39.0 mg/L
Non Invasive mode: 24.3 mg/LInvasive mode: 39.2 mg/L
Non Invasive mode: 24.6 mg/L
Maximum Operating
pressure13.2kPa13.2kPa
Element of comparisonProposed DevicePredicate Device
Maximum Continuous Gas
Flow RateMaximum continuous gas flow rate of 60
LPM in invasive mode and 120 LPM in non-
Invasive modeMaximum continuous gas flow rate of
60 LPM in invasive mode and 120 LPM
in non-Invasive mode
Compliance6.23 mL/kPa5.54 mL/kPa
Resistance to Flow
@60L/min0.40 cmH2O0.50 cmH2O
Enthalpy Maximum Value
Enthalpy Averaged Value156 kJ/kg Max.
117 kJ/kg Avg.151 kJ/kg Max.
120 kJ/kg Avg.
Compressible volume245 mL255 mL
MaterialUses Noryl for float frameUses Polycarbonate for float frame
Gas leakage