(248 days)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatic population. specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 vears of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifiers.
This document describes the regulatory submission for the AirLife Infant Heated Wire Circuit, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML study. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, expert qualifications for ground truth in AI, etc.) is not applicable to this document.
Here's an analysis based on the provided text:
Device: AirLife Infant Heated Wire Circuit
Intended Use: To deliver and warm breathing gases before they enter the patient's airway, used with a Fisher and Paykel MR850 humidifier for neonatal and infant pediatric populations.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table directly comparing acceptance criteria and a single "reported device performance" value for each. Instead, it lists numerous performance tests against established standards. The general acceptance criterion for all these tests is compliance with the specified standard.
Here's a table summarizing the performance characteristics and their corresponding standards, implying that the device met these standards to be considered substantially equivalent. The "Reported Device Performance" column indicates the successful completion of the test in compliance with the standard mentioned.
| Performance Characteristic | Acceptance Criteria (Referenced Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Implantation, Genotoxicity, Leachables) | ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, ISO 10993-17:2002, ISO 10993-18:2005 | Compliant with standards |
| Electrical Safety (Patient Leakage Current) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Electrical Safety (Dielectric Strength Means) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Electrical Safety (Insulation) | IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) | Compliant with standard |
| Length | ISO 5367:2000, 4th Edition (within ±10% of labeled length) | Compliant with standard |
| Resistance to Flow/Rated Flow | ISO 5367:2000, 4th Edition (pressure increase not to exceed 0.2 kPa at rated flow) | Compliant with standard |
| Resistance to Flow @ 2.5 LPM | ISO 5367:2014, 5th Edition (flow resistance not to exceed 0.74 cmH2O/l/min) | Compliant with standard |
| Increase in Flow Resistance w/Bending @ Rated Flow (10 LPM) | ISO 5367:2000, 4th Edition (pressure not to exceed 150% of value with tube straight) | Compliant with standard |
| Increase in Flow Resistance w/Bending @ 2.5 LPM | ISO 5367:2014, 5th Edition (pressure not to exceed 150% of value with tube straight) | Compliant with standard |
| Conical Connectors | ISO 5367:2000, 4th Edition; ISO 5356-1:2004, 3rd Edition; ISO 8185:2008, 3rd Edition (Corrected Version) (correctly sized ports) | Compliant with standards |
| Security of Attachment | ISO 5367:2000, 4th Edition (adaptor not to detach at force > 45N) | Compliant with standard |
| Leakage | ISO 5367:2000, 4th Edition (leakage rate not > 50 ml/min) | Compliant with standard |
| Compliance per Meter | ISO 5367:2000, 4th Edition; ISO 8185:2008, 3rd Edition (Corrected Version) (compliance at 6 kPa not to exceed 10 ml*kPa-1 per meter) | Compliant with standards |
| Humidity Output (Invasive Mode) | ISO 8185:2008, 3rd Edition (Corrected Version) (delivers ≥ 33 mg/L humidity) | Compliant with standard |
| Humidity Output (Non-Invasive Mode) | ISO 8185:2008, 3rd Edition (Corrected Version) (delivers ≥ 10 mg/L humidity) | Compliant with standard |
| Corrugate Melt (100% Duty Cycle, Zero Gas Flow) | ISO 8185:2008, 3rd Edition (Corrected Version) (tubes do not collapse, occlude, or cause safety hazard) | Compliant with standard |
| Security of engagement temperature sensor | ISO 8185:2008, 3rd Edition (Corrected Version) (temperature probes do not disconnect) | Compliant with standard |
| Leakage from sensing port | ISO 8185:2008, 3rd Edition (Corrected Version) (sensing port not to leak > 5 ml/min) | Compliant with standard |
| Specific enthalpy | ISO 8185:2008, 3rd Edition (Corrected Version) (thermal overshoot at patient connection not to exceed energy equivalent to 43°C and 100% RH, averaged over 30s) | Compliant with standard (specific enthalpy not to exceed 194 kJ/kg dry gas) |
| Surface temperature | ISO 8185:2008, 3rd Edition (Corrected Version) (accessible temperature within 25 cm of patient port not to exceed 44°C) | Compliant with standard |
| Steady state noise | ISO 8185:2008, 3rd Edition (Corrected Version) (noise at any point within 1 m of system not to exceed 50 dB) | Compliant with standard |
| Duration of Use (30 days) | N/A (Assessed circuit use over 30 day period) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
| Longitudinal Temperature Profile | N/A (Assessed temperature range of wire once nominal voltage induced) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
| Patient End Temperature Profile | N/A (Assessed temperature of airway gas delivered to patient with humidifier and ventilator) | Assessed, results not explicitly detailed but implied compliant for safety/effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (e.g., number of circuits tested) for each performance test. It only states that "The following tests were performed for the proposed device to support the substantial equivalence decision." The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards. This is prospective testing against product specifications. There is no mention of country of origin for any data or retrospective analysis as would be relevant for an AI/ML study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualification of Those Experts
This information is not applicable. The "ground truth" for this device is established by objective performance criteria defined in international standards (e.g., ISO, IEC). Performance is measured against these engineering and safety specifications, not against expert human interpretations or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging reads). For device performance testing against objective standards, the results are typically determined by measurement and adherence to predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic accuracy or clinical utility where human readers are involved, often in the context of AI/ML software. This document describes the safety and performance testing of a physical medical device (heated breathing circuit).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical heated breathing circuit and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is objective, measurable criteria and limits set forth in recognized international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). This is akin to engineering specifications and regulatory standards. It is not based on expert consensus, pathology, or outcomes data in the manner relevant to an AI/ML diagnostic system.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The device likely underwent design verification and validation testing, which is similar in concept to testing for traditional devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI/ML device and therefore has no "training set" or corresponding ground truth establishment in that context. The "ground truth" for its design and manufacturing is based on established engineering principles, material science, and compliance with the aforementioned international performance and safety standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
CareFusion 2200, Inc. Erika Fernandez Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K151303
Trade/Device Name: AirLife Infant Heated Wire Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: December 20, 2015 Received: December 23, 2015
Dear Ms. 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
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the quality systems (OS) 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 (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
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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Indications for Use
510(k) Number (if known)
Device Name AirLife Infant Heated Wire Circuit
Indications for Use (Describe)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatic population. specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 vears of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.
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".
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
Phone: 847 362-8097 Fax: 312 949-0731
Contact Person: Erika Fernandez
Date Prepared: January 20, 2016
2. Device
| Product Name: | AirLife Infant Heated Wire Circuit |
|---|---|
| Device Name: | Heated Breathing Circuit |
| Common Name: | Heater, breathing system w/wo controller (not humidifier ornebulizer) |
| Classification Name: | Breathing system heater (21 CFR 868.5270) |
| Regulatory Class: | II |
| Product Code: | BZE |
3. Predicate Device
This submission demonstrates substantial equivalence to the Fisher and Paykel Heated Breathing Circuit K020332 cleared on July 700, 2003 and AirLife Heated Ventilator and Anesthesia Breathing Circuits, K000697 cleared on March 30, 2000. The predicate devices have not been subject to a design-related recall.
4. Device Description
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifiers.
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Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".
5. Indication for use
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatric population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.
6. Comparison of technological characteristics with the predicate device
The fundamental scientific technology is the same for both proposed and predicate devices. It is based on acting as an airway conduit between a breathing machine and the patient (typically attached to an endotracheal or tracheal tube previously insert into the patient's airway). The differences in the design do not raise any different questions of safety and effectiveness.
| Element of comparison | Predicate Device 1Fisher and Paykel heatedwire breathing circuitRT131 with flow rate>4L/min | Predicate Device 2AirLife Heated andAnesthesia BreathingCircuitswith flow rate >3L/min | Proposed DeviceAirLife Infant HeatedWire Circuitwith flow rate>4L/min |
|---|---|---|---|
| Principal of Operation | Resistance wires withinthe tubing generate heatto maintaintemperatures andhumidity | Resistance wires withinthe tubing generate heatto maintaintemperatures andhumidity | Resistance wireswithin the tubinggenerate heat tomaintaintemperatures andhumidity |
| Circuit Characteristics | |||
| Infant Inspiratory Limb withUnheated Extension | 5 ft | 5 ft | 5 ft |
| Dryline Length | 2 ft | 2 ft | 2 ft |
| Inspiratory Limb Length | 4 ft | 4 ft | 4 ft |
| Heated wire | Present | Present | Present |
| Expiratory Limb Length | 5ft 6in | 4 ft 3 in | 4 ft 5in |
| Water trap | Present | Not Present | Not Present |
| Heated Wire | Not Present | Present | Present |
| Patient population | Neonates | Infants, pediatric andAdults | Infants and Neonates |
| Usage | Disposable | Disposable | Disposable |
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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. The shield has a yellow accent on the top right. To the right of the circle is the text "CareFusion" in gray. Below the text is the phrase "has joined BD" in a smaller, lighter gray font.
| Element of comparison | Predicate Device 1Fisher and Paykel heatedwire breathing circuitRT131 with flow rate>4L/min | Predicate Device 2AirLife Heated andAnesthesia BreathingCircuitswith flow rate >3L/min | Proposed DeviceAirLife Infant HeatedWire Circuitwith flow rate>4L/min |
|---|---|---|---|
| Design | Dual Limb | Dual Limb | Dual Limb |
| Tube Specifications | |||
| ID | 0.44in-0.45in | 0.394in | 0.45in-0.46in |
| Design | Corrugate | Corrugate | Corrugate |
| Wire Design | |||
| Minimum Resistance atambient | 22 Ω | 27 Ω | 22 Ω |
| Wire Total Length | 115in | 99in | 121in |
| Constant Power | 22W | 16W | 22W |
| Typical Wattage/foot ofwire | 2 | 1.9 | 2 |
| Typical Watt/ foot ofcircuit | 6 | 4 | 6 |
| Conductor | Copper | Copper/Ni alloy | 304 Steel |
| Anchor Position of Wire | 19 cm | 5-10 cm | 19 cm |
| Compatible Humidifier | Fisher and Paykel MR850 | Fisher and Paykel MR850 | Fisher and PaykelMR850 |
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 shield inside, followed by the word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined BD" in a smaller, lighter gray font.
Standards
| Performance Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices Part 1: Evaluation andTestingFDA Guidance: Use of International Standard ISO- 10993,"Biological Evaluation of Medical Devices Part 1: Evaluationand Testing" | ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices Part 3: Tests forgenotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3:2014 |
| Biological Evaluation of Medical Devices Part 5: Tests for invitro cytotoxicity | ISO 10993-5:2009 |
| Biological Evaluation of Medical Devices Part 6: Tests for localeffects after implantation | ISO 10993-6:2007 |
| Biological Evaluation of Medical Devices Part 10: Tests forirritation and skin sensitization | ISO 10993-10:2010 |
| Biological Evaluation of Medical Devices Part 17:Establishment of allowable limits for leachable substances | ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18: Chemicalcharacterization of materials | ISO 10993-18:2005 |
Performance
The following tests were performed for the proposed device to support the substantial equivalence decision.
| Test | Description | Relevant Standard |
|---|---|---|
| Electrical safetyPatient Leakage Current | To ensure, under normal systemoperating conditions, thatexcessive current does notreach the patient | IEC 60601-1:2005, 3rdEdition (Equivalent toAAMI ES60601-1:2005) |
| Electrical safetyDielectric Strength Means | To check the integrity of thewire insulation under excessivepower conditions. | IEC 60601-1:2005, 3rdEdition (Equivalent toAAMI ES60601-1:2005) |
| Electrical SafetyInsulation | To ensure IEC requirements forcreepage and clearance weremet. | IEC 60601-1:2005, 3rdEdition (Equivalent toAAMI ES60601-1:2005) |
| Length | To ensure that the actual lengthof the device is within ±10% ofthe labeled length | ISO 5367:2000, 4th Edition |
| Test | Description | Relevant Standard |
| Resistance to Flow/RatedFlow | To ensure, when tested per thestandard, that the pressureincrease at the rated flowthrough the breathing tube doesnot exceed 0.2 kPa | ISO 5367:2000, 4th Edition |
| Resistance to Flow @ 2.5LPM | To ensure, when tested per thestandard, that the flowresistance at 2.5 LPM throughthe breathing tube does notexceed 0.74 cmH2O/l/min | ISO 5367:2014, 5th Edition |
| Increase in Flow Resistancew/Bending @ Rated Flow(10 LPM) | To ensure, when tested per thestandard, that the pressure atthe rated flow when thebreathing tube is suspendedover a metal cylinder does notexceed 150% of the valueobtained with the tube straight. | ISO 5367:2000, 4th Edition |
| Increase in Flow Resistancew/Bending @ 2.5 LPM | To ensure, when tested per thestandard, that the pressure at2.5 LPM when the breathingtube is suspended over a metalcylinder does not exceed 150%of the value obtained with thetube straight. | ISO 5367:2014, 5th Edition |
| Conical Connectors | To ensure, when tested per thestandard, that required ports arecorrectly sized. | ISO 5367:2000, 4th EditionISO 5356-1:2004, 3rd EditionISO 8185:2008, 3rd Edition(Corrected Version) |
| Security of Attachment | To ensure, when tested per thestandard, that the adaptor shallnot become detached from thetube at a force greater than 45N. | ISO 5367:2000, 4th Edition |
| Leakage | To ensure, when tested per thestandard, that the systemsupplied ready to use does notleak at a rate greater than 50ml/min. | ISO 5367:2000, 4th Edition |
| Compliance per Meter | To ensure, when tested per thestandard, that the complianceper meter at a pressure of 6 kPadoes not exceed 10 ml*kPa-1per meter length of tube. | ISO 5367:2000, 4th EditionISO 8185:2008, 3rd Edition(Corrected Version) |
| Test | Description | Relevant Standard |
| Humidity Output (InvasiveMode) | To ensure, when tested per thestandard, that the systemdelivers at least the minimumhumidity of at least 33 mg/L tothe patient. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Humidity Output (Non-Invasive Mode) | To ensure, when tested per thestandard, that the systemdelivers at least the minimumhumidity of at least 10 mg/L tothe patient. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Corrugate Melt (100% DutyCycle, Zero Gas Flow) | To ensure that the breathingtubes do not collapse onbending, occlude, or otherwisecause a safety hazard at themaximum output of thehumidification system. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Security of engagementtemperature sensor | To ensure that the temperatureprobes that accompany thecircuit do not becomedisconnected under thecondition of no flow ormaximum rated flow. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Leakage from sensing port | To ensure, when tested per thestandard, that the sensing portdoes not leak more than 5ml/min. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Specific enthalpy | To ensure under normal andsingle fault conditions, a thermalovershoot at the patientconnection port shall not exceedan energy equivalent to 43C and100% relative humidity (aspecific enthalpy not to exceed194 kJ/kg dry gas) whenaveraged over 30 seconds. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Surface temperature | To ensure that the accessibletemperature within 25 cm of thepatient port connection doesnot exceed 44°C | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Steady state noise | To ensure, when tested per thestandard, that the noise at anypoint within 1 m of the systemdoes not exceed 50 dB. | ISO 8185:2008, 3rd Edition(Corrected Version) |
| Test | Description | Relevant Standard |
| Duration of Use (30 days) | To assess the circuit use over a30 day time period | N/A |
| Longitudinal TemperatureProfile | To assess the temperature rangeof the wire once a nominalvoltage is induced across it. | N/A |
| Patient End TemperatureProfile | To assess the temperature of theairway gas delivered to thepatient when a given humidifiedcircuit is used with a ventilatorand the Fisher & Paykel MR850heater base. | N/A |
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Image /page/7/Picture/0 description: The image shows the CareFusion logo, which includes an orange circle with a white shield-like shape inside. To the right of the logo is the text "CareFusion" in a dark gray, sans-serif font. Below the company name, in a smaller, lighter font, is the phrase "has joined BD".
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Image /page/8/Picture/0 description: The image shows the CareFusion logo, which includes an orange circle with a white shield-like shape inside. To the right of the logo is the text "CareFusion" in a dark gray, sans-serif font. Below the company name, in a smaller, lighter font, is the phrase "has joined BD".
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Image /page/9/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, followed by the text "CareFusion" in gray. Below the text, in smaller gray font, it says "has joined BD."
8. Conclusion
The test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).