(157 days)
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.
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.
The provided text describes a 510(k) premarket notification for the AirLife Autofill Humidification Chamber, comparing it to a predicate device (MR290 Humidification Chamber). The document focuses on demonstrating substantial equivalence rather than a study with acceptance criteria and a detailed performance evaluation of an AI-powered device.
Therefore, the requested information components related to AI/algorithm performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.
The document primarily evaluates the physical and functional characteristics of a medical device (humidification chamber) against recognized standards and a predicate device.
Here's the closest representation of the requested table and related information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly compliance with relevant medical device standards and demonstrating performance comparable to the predicate device. The "acceptance criteria" for each performance characteristic are often defined by the standard itself or by the performance of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Humidity Output Invasive | Comparable to predicate (39.2 mg/L) & BS EN ISO 8185:2009 | 39.0 mg/L |
| Humidity Output Non-Invasive | Comparable to predicate (24.6 mg/L) & BS EN ISO 8185:2009 | 24.3 mg/L |
| Specific Enthalpy | Comparable to predicate (Max: 151 kJ/kg, Avg: 120 kJ/kg) & BS EN ISO 8185:2009 | Max: 156 kJ/kg, Avg: 117 kJ/kg |
| Hazardous Output | BS EN ISO 8185:2009 | Not explicitly stated, assumed met |
| Resistance to Flow @60L/min | Comparable to predicate (0.50 cmH2O) & BS EN ISO 5367:2014 | 0.40 cmH2O |
| Maximum Peak Flow | BS EN ISO 8185:2014 | Maximum continuous gas flow rate of 60 LPM in invasive mode and 120 LPM in non-Invasive mode (Comparable to predicate) |
| Leakage & Maximum Operating Pressure | Comparable to predicate (>100 mL/min for leakage, 13.2kPa for pressure) & BS EN ISO 8185:2009, BS EN ISO 5367:2014 | <30mL/min for leakage, 13.2kPa for pressure |
| Liquid Overflow | BS EN ISO 8185:2009 | Not explicitly stated, assumed met |
| Compliance | Comparable to predicate (5.54 mL/kPa) & BS EN ISO 8185:2009, BS EN ISO 5367:2014 | 6.23 mL/kPa |
| Compressible Volume | Comparable to predicate (255 mL) | 245 mL |
| Accessible Surface Temperature | BS EN ISO 8185:2009, IEC 60601-1:2005 | Not explicitly stated, assumed met |
| Steady State Noise | BS EN ISO 8185:2009, IEC 60601-1:2005 | Not explicitly stated, assumed met |
| Shelf Life/Accelerated Aging | N/A (Predicate not published) | 24 months |
| End-use Simulation/Duration of Use | N/A | 14 days (Comparable to predicate) |
| Biocompatibility | AAMI/ANSI/ISO 10993 series | Tests performed for cytotoxicity, sensitization, irritation, muscle implantation, genotoxicity, extractables/leachables. (Assumed met) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is a physical device and the tests are for its physical and functional characteristics, not an AI algorithm. There is no "test set" in the sense of a dataset for an algorithm. The "tests" refer to laboratory evaluations of the device's physical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for a physical medical device typically refers to engineering specifications, performance standards, and the capabilities of a predicate device, not expert consensus on interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of results from an AI algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established medical device standards (e.g., ISO, IEC) and the performance characteristics of a legally marketed predicate device (MR290 Humidification Chamber).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI algorithm.
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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 (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
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Indications for Use
510(k) Number (if known)
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
-
- 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.
- Comparison of technological characteristics with the predicate device
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Indications for Use | The AirLife Autofill Humidification Chamberis intended to hold water required tohumidify breathing gases delivered to anypatient using a heated humidifier. Theproduct is a single use device, non-sterileand used in professional healthcareenvironments under a doctor's supervisionand by skilled clinicians. | The MR290 Humidification Chamber isintended to hold water required tohumidify the air being delivered topatients. The MR290 is an auto-fillhumidification chamber suitable for allpatients and compatible with all F&PMR-series humidifiers |
| Principal of Operation | The humidification chamber works with arespiratory humidifier (also called a "heaterbase") that provides the heat source,temperature control system, and alarmsystem to heat and humidity respiratorygases. | The humidification chamber workswith a respiratory humidifier (alsocalled a "heater base") that providesthe heat source, temperature controlsystems, and alarm systems to heatand humidifies respiratory gases. |
| Characteristics | ||
| Connection | 22 mm ISO conical connections for breathingcircuit attachmentFlexible tubing bonded to close piercingdevice (spike) and chamber inlet forsupplying water | 22 mm ISO conical connections forbreathing circuit attachmentFlexible tubing bonded to closepiercing device (spike) and chamberinlet for supplying water |
| Design | Maximum and minimum waterline marks forvisual confirmation of proper water levels | Maximum water line mark for visualconfirmation of proper water levels |
| Independent primary and secondary floats toregulate water level and to prevent overfillcondition if the primary float fails. | Independent primary and secondaryfloats to regulate water level andprevent overfill condition if theprimary float fails open. | |
| Clear Housing to allow visibility of waterlevel for monitoring | Clear Housing to allow visibility oflevel for monitoring | |
| Humidity Output | Invasive mode: 39.0 mg/LNon Invasive mode: 24.3 mg/L | Invasive mode: 39.2 mg/LNon Invasive mode: 24.6 mg/L |
| Maximum Operatingpressure | 13.2kPa | 13.2kPa |
| Element of comparison | Proposed Device | Predicate Device |
| Maximum Continuous GasFlow Rate | Maximum continuous gas flow rate of 60LPM in invasive mode and 120 LPM in non-Invasive mode | Maximum continuous gas flow rate of60 LPM in invasive mode and 120 LPMin non-Invasive mode |
| Compliance | 6.23 mL/kPa | 5.54 mL/kPa |
| Resistance to Flow@60L/min | 0.40 cmH2O | 0.50 cmH2O |
| Enthalpy Maximum ValueEnthalpy Averaged Value | 156 kJ/kg Max.117 kJ/kg Avg. | 151 kJ/kg Max.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 inhalationwater containers (water feed set contains airvent provision for rigid containers) | Compatible with flexible and rigidinhalation water containers (waterfeed set contains air vent provision forrigid containers) |
| Compatibility (2) | Compatible with Fisher and Paykel MR850Humidifiers | Compatible with Fisher and Paykel MRseries 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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Standards
| Performance Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices--Part 1:Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices-Part 5: Testsfor In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009(R2014) |
| Biological Evaluation of Medical Devices-Part 10:Tests for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010(R2014) |
| Biological Evaluation of Medical Devices Part 12:Sample Preparation and Reference Materials | AAMI/ANSI/ISO 10993-12:2012 |
| Biological Evaluation of Medical Devices Part 17:Establishment of allowable limits for leachablesubstances | AAMI/ANSI/ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18: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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| 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 8185:2009BS EN ISO 5367:2014 |
| Liquid Overflow | BS EN ISO 8185:2009 |
| Compliance | BS EN ISO 8185:2009BS EN ISO 5367:2014 |
| Compressible Volume | N/A |
| Accessible Surface Temperature | BS EN ISO 8185:2009IEC 60601-1:2005 |
| Steady State Noise | BS EN ISO 8185:2009IEC 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.
§ 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).