(188 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.
No
The device primarily delivers and warms breathing gases, acting as a support system rather than directly treating a medical condition.
No
The device is described as a heated breathing circuit intended to deliver and warm breathing gases, not to diagnose medical conditions.
No
The device description explicitly states it is a "heated breathing circuit" and describes physical components and performance tests related to hardware (e.g., resistance to flow, conical connectors, electrical safety). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- 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 performed on a sample.
- Lack of Diagnostic Language: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic claims.
The device is a medical device used for respiratory support, specifically for warming and delivering breathing gases.
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 heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
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 humidifier MR850.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
patient's airway
Indicated Patient Age Range
pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups.
Intended User / Care Setting
professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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: Length, Resistance to flow/ Rated Flow, Resistance to Flow @ 2.5 lpm, Increase in Flow Resistance with Bending, Conical Connectors, Security of Attachment, Leakage, Compliance, Humidity Output, Security of Engagement Temperature Sensor, Leakage from Sensing Port, Specific Enthalpy, Surface Temperature, Steady State Noise, Electrical safety (Patient Leakage Current, Dielectric Strength Means).
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.)
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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).
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§ 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 an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
CareFusion Inc. Erika Fernandez Regulatory Affairs Manager 75 N Fairway Drive Vernon Hills, Illinois 60061
Re: K151959
Trade/Device Name: AirLife Infant Single Limb Heated Wire Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: December 18. 2015 Received: December 23, 2015
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
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
AirLife Infant Single Limb 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 heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
Type of Use (Select one or both, as applicable)
[X] 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 19th, 2016
2. Device
| Product Name: | AirLife Infant Single Limb 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 AirLife Heated Ventilator and Anesthesia Breathing Circuits, K000697 was cleared on March 30, 2000. This predicate device has 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 humidifier MR850.
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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, and the text "CareFusion" in gray. Below the text, in smaller font, it 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 heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use 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.
6. Comparison of technological characteristics with the predicate device
The fundamental scientific technology is the same for both proposed and predicate device. 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).
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Intended Use | Intended to warm breathing | |
| gases before they enter a | ||
| patient's airway | Intended to warm breathing | |
| gases before they enter a | ||
| patient's airway | ||
| 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 | ||
| Single limb High Flow | Proposed Device | Predicate Device |
| Circuit Characteristics | ||
| Infant Inspiratory Limb with | ||
| Unheated Extension | 5 ft | 2 - 6 ft |
| Dryline Length | 2 ft | 2 ft |
| Inspiratory Limb Length | 4 ft | 4 ft |
| Heated Wire | Present | Present |
| Intended Patient Use | Infant | Infant |
| Usage | Disposable | Disposable |
| Design | Single Limb | Single Limb |
| Tube Specifications | ||
| Nominal ID | 11-12 mm (0.45in-0.46in) | 10-22mm |
| Design | Corrugate and smooth bore | Corrugate and smooth bore |
| Wire Design Criteria | ||
| Maximum Power | 60W | 60W |
| Min circuit resistance | $7.5 \Omega$ | $7.5 \Omega$ |
| Typical Wattage/foot of wire | 2 | 1.8-2.5 |
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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 word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined BD" in a smaller, lighter gray font.
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Maximum Power/ft of wire | 3.2 W/ft | 3.2 W/ft |
| Slack in wire (length in relation | ||
| to tubing length) | 6-9 in | 2-4in |
| Conductor | 304 Steel | Copper/Ni alloy |
| Compatible Humidifier | 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
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 |
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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. The text "CareFusion" is written in gray to the right of the circle. Below the text, it says "has joined BD" in a smaller font.
Performance
The following tests were performed for the proposed device to support the substantial equivalence decision.
| Performance Characteristic | Relevant Standard |
|---|---|
| Length | ISO 5367:2000 |
| Resistance to flow/ Rated Flow | ISO 5367: 2000 |
| Resistance to Flow @ 2.5 lpm | ISO 5367:2014 |
| Increase in Flow Resistance with Bending | ISO 5367:2000 |
| ISO 5367:2014 | |
| Conical Connectors | ISO 5367:2000 |
| ISO 5356-1:2004 | |
| ISO 8185:2008 | |
| Security of Attachment | ISO 5367:2000 |
| Leakage | ISO 5367:2000 |
| Compliance | ISO 5367:2000 |
| ISO 8185:2008 | |
| Humidity Output | ISO 8185:2008 |
| Security of Engagement Temperature Sensor | ISO 8185:2008 |
| Leakage from Sensing Port | ISO 8185:2008 |
| Specific Enthalpy | ISO 8185:2008 |
| Surface Temperature | ISO 8185:2008 |
| Steady State Noise | ISO 8185:2008 |
| Electrical safety | |
| Patient Leakage Current | IEC 60601-1:2005, 3rd Edition |
| (Equivalent to AAMI ES60601-1:2005) | |
| Electrical safety | |
| Dielectric Strength Means | IEC 60601-1:2005, 3rd Edition |
| (Equivalent to AAMI ES60601-1:2005) |
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.