(248 days)
Not Found
No
The document describes a heated breathing circuit and its intended use, device description, and performance testing. There is no mention of AI or ML technology in the provided text.
Yes
The device is intended to deliver and warm breathing gases to the patient's airway, which is a therapeutic intervention for medical conditions or procedures.
No
The device is a heated breathing circuit for delivering and warming breathing gases, not for diagnosing medical conditions. Its function is therapeutic/supportive.
No
The device description clearly states it is a "heated breathing circuit," which is a physical hardware component used to deliver and warm breathing gases. It also mentions testing for physical properties like length, resistance to flow, and electrical safety.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's purpose is to "deliver and warm breathing gases before they enter the patient's airway." This is a therapeutic and supportive function, not a diagnostic one involving testing bodily samples.
- Lack of Diagnostic Language: The text does not mention any diagnostic tests, analysis of biological samples, or providing information about a patient's disease state or condition based on such analysis.
The device is a component of a respiratory support system, designed to improve the delivery of breathing gases to the patient.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's airway
Indicated Patient Age Range
pediatric population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediatric subgroups.
Intended User / Care Setting
professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians.
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 (Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables), Electrical safety (Patient Leakage Current, Dielectric Strength Means, Insulation), Length, Resistance to Flow/Rated Flow, Resistance to Flow @ 2.5 LPM, Increase in Flow Resistance w/Bending @ Rated Flow (10 LPM), Increase in Flow Resistance w/Bending @ 2.5 LPM, Conical Connectors, Security of Attachment, Leakage, Compliance per Meter, Humidity Output (Invasive Mode), Humidity Output (Non-Invasive Mode), Corrugate Melt (100% Duty Cycle, Zero Gas Flow), Security of engagement temperature sensor, Leakage from sensing port, Specific enthalpy, Surface temperature, Steady state noise, Duration of Use (30 days), Longitudinal Temperature Profile, Patient End Temperature Profile. The test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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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 or |
| nebulizer) | |
| 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 1
Fisher and Paykel heated
wire breathing circuit
RT131 with flow rate
4L/min | Predicate Device 2
AirLife Heated and
Anesthesia Breathing
Circuits
with flow rate >3L/min | Proposed Device
AirLife Infant Heated
Wire Circuit
with flow rate
4L/min |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Principal of Operation | Resistance wires within
the tubing generate heat
to maintain
temperatures and
humidity | Resistance wires within
the tubing generate heat
to maintain
temperatures and
humidity | Resistance wires
within the tubing
generate heat to
maintain
temperatures and
humidity |
| Circuit Characteristics | | | |
| Infant Inspiratory Limb with
Unheated 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 and
Adults | 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 1
Fisher and Paykel heated
wire breathing circuit
RT131 with flow rate
4L/min | Predicate Device 2
AirLife Heated and
Anesthesia Breathing
Circuits
with flow rate >3L/min | Proposed Device
AirLife Infant Heated
Wire Circuit
with 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 at
ambient | 22 Ω | 27 Ω | 22 Ω |
| Wire Total Length | 115in | 99in | 121in |
| Constant Power | 22W | 16W | 22W |
| Typical Wattage/foot of
wire | 2 | 1.9 | 2 |
| Typical Watt/ foot of
circuit | 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 Paykel
MR850 |
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 and | |
| Testing | |
| FDA Guidance: Use of International Standard ISO- 10993, | |
| "Biological Evaluation of Medical Devices Part 1: Evaluation | |
| and Testing" | ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices Part 3: Tests for | |
| genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3:2014 |
| Biological Evaluation of Medical Devices Part 5: Tests for in | |
| vitro cytotoxicity | ISO 10993-5:2009 |
| Biological Evaluation of Medical Devices Part 6: Tests for local | |
| effects after implantation | ISO 10993-6:2007 |
| Biological Evaluation of Medical Devices Part 10: Tests for | |
| irritation 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: Chemical | |
| characterization 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 safety | ||
| Patient Leakage Current | To ensure, under normal system | |
| operating conditions, that | ||
| excessive current does not | ||
| reach the patient | IEC 60601-1:2005, 3rd | |
| Edition (Equivalent to | ||
| AAMI ES60601-1:2005) | ||
| Electrical safety | ||
| Dielectric Strength Means | To check the integrity of the | |
| wire insulation under excessive | ||
| power conditions. | IEC 60601-1:2005, 3rd | |
| Edition (Equivalent to | ||
| AAMI ES60601-1:2005) | ||
| Electrical Safety | ||
| Insulation | To ensure IEC requirements for | |
| creepage and clearance were | ||
| met. | IEC 60601-1:2005, 3rd | |
| Edition (Equivalent to | ||
| AAMI ES60601-1:2005) | ||
| Length | To ensure that the actual length | |
| of the device is within ±10% of | ||
| the labeled length | ISO 5367:2000, 4th Edition | |
| Test | Description | Relevant Standard |
| Resistance to Flow/Rated | ||
| Flow | To ensure, when tested per the | |
| standard, that the pressure | ||
| increase at the rated flow | ||
| through the breathing tube does | ||
| not exceed 0.2 kPa | ISO 5367:2000, 4th Edition | |
| Resistance to Flow @ 2.5 | ||
| LPM | To ensure, when tested per the | |
| standard, that the flow | ||
| resistance at 2.5 LPM through | ||
| the breathing tube does not | ||
| exceed 0.74 cmH2O/l/min | ISO 5367:2014, 5th Edition | |
| Increase in Flow Resistance | ||
| w/Bending @ Rated Flow | ||
| (10 LPM) | To ensure, when tested per the | |
| standard, that the pressure at | ||
| the rated flow when the | ||
| breathing tube is suspended | ||
| over a metal cylinder does not | ||
| exceed 150% of the value | ||
| obtained with the tube straight. | ISO 5367:2000, 4th Edition | |
| Increase in Flow Resistance | ||
| w/Bending @ 2.5 LPM | To ensure, when tested per the | |
| standard, that the pressure at | ||
| 2.5 LPM when the breathing | ||
| tube is suspended over a metal | ||
| cylinder does not exceed 150% | ||
| of the value obtained with the | ||
| tube straight. | ISO 5367:2014, 5th Edition | |
| Conical Connectors | To ensure, when tested per the | |
| standard, that required ports are | ||
| correctly sized. | ISO 5367:2000, 4th Edition | |
| ISO 5356-1:2004, 3rd Edition | ||
| ISO 8185:2008, 3rd Edition | ||
| (Corrected Version) | ||
| Security of Attachment | To ensure, when tested per the | |
| standard, that the adaptor shall | ||
| not become detached from the | ||
| tube at a force greater than 45N. | ISO 5367:2000, 4th Edition | |
| Leakage | To ensure, when tested per the | |
| standard, that the system | ||
| supplied ready to use does not | ||
| leak at a rate greater than 50 | ||
| ml/min. | ISO 5367:2000, 4th Edition | |
| Compliance per Meter | To ensure, when tested per the | |
| standard, that the compliance | ||
| per meter at a pressure of 6 kPa | ||
| does not exceed 10 ml*kPa-1 | ||
| per meter length of tube. | ISO 5367:2000, 4th Edition | |
| ISO 8185:2008, 3rd Edition | ||
| (Corrected Version) | ||
| Test | Description | Relevant Standard |
| Humidity Output (Invasive | ||
| Mode) | To ensure, when tested per the | |
| standard, that the system | ||
| delivers at least the minimum | ||
| humidity of at least 33 mg/L to | ||
| the patient. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Humidity Output (Non- | ||
| Invasive Mode) | To ensure, when tested per the | |
| standard, that the system | ||
| delivers at least the minimum | ||
| humidity of at least 10 mg/L to | ||
| the patient. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Corrugate Melt (100% Duty | ||
| Cycle, Zero Gas Flow) | To ensure that the breathing | |
| tubes do not collapse on | ||
| bending, occlude, or otherwise | ||
| cause a safety hazard at the | ||
| maximum output of the | ||
| humidification system. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Security of engagement | ||
| temperature sensor | To ensure that the temperature | |
| probes that accompany the | ||
| circuit do not become | ||
| disconnected under the | ||
| condition of no flow or | ||
| maximum rated flow. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Leakage from sensing port | To ensure, when tested per the | |
| standard, that the sensing port | ||
| does not leak more than 5 | ||
| ml/min. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Specific enthalpy | To ensure under normal and | |
| single fault conditions, a thermal | ||
| overshoot at the patient | ||
| connection port shall not exceed | ||
| an energy equivalent to 43C and | ||
| 100% relative humidity (a | ||
| specific enthalpy not to exceed | ||
| 194 kJ/kg dry gas) when | ||
| averaged over 30 seconds. | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Surface temperature | To ensure that the accessible | |
| temperature within 25 cm of the | ||
| patient port connection does | ||
| not exceed 44°C | ISO 8185:2008, 3rd Edition | |
| (Corrected Version) | ||
| Steady state noise | To ensure, when tested per the | |
| standard, that the noise at any | ||
| point within 1 m of the system | ||
| does 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 a | |
| 30 day time period | N/A | |
| Longitudinal Temperature | ||
| Profile | To assess the temperature range | |
| of the wire once a nominal | ||
| voltage is induced across it. | N/A | |
| Patient End Temperature | ||
| Profile | To assess the temperature of the | |
| airway gas delivered to the | ||
| patient when a given humidified | ||
| circuit is used with a ventilator | ||
| and the Fisher & Paykel MR850 | ||
| heater 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.