(241 days)
Based on the input "Not Found", I cannot identify any K/DEN numbers for predicate devices. The request relies on the text for the information, and since the text states "Not Found", there's no data to extract.
Not Found
No
The description focuses on the physical components and function of a heated breathing circuit, with no mention of AI or ML.
No.
The device warms breathing gases before they enter a patient's airway, which is a supportive function rather than directly treating a disease or condition.
No.
The device is intended to warm breathing gases before they enter a patient's airway, and is used with mechanical ventilation, positive pressure breathing, or general medical gases. Its purpose is therapeutic/supportive, not diagnostic.
No
The device description clearly states it is a "heated breathing circuit" and mentions testing for physical properties like "Length, Resistance to Flow, Conical Connectors, Security of Attachment, Leakage, Compliance, Resistance to Melt," and "Electrical Safety," indicating it is a hardware device with physical components.
Based on the provided information, the AirLife Adult Heated Wire Circuit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm breathing gases before they enter a patient's airway. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description reinforces the function of delivering and warming breathing gases to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. The AirLife Adult Heated Wire Circuit's function is entirely focused on preparing and delivering gases for respiration, which is a therapeutic or supportive function, not a diagnostic one.
N/A
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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
CareFusion, Inc. Erika Fernandez Regulatory Affairs Manager 75 N Fairway Drive Vernon Hills, Illinois 60061
Re: K153234
Trade/Device Name: AirLife Adult Heated Wire Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: May 27, 2016 Received: May 31, 2016
Dear Erika Fernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
Form Approved OMB No 0910-0120 Expiration Date January 31, 2017 See PRA Statement below
510(k) Number (if known)
Device Name AirLife Adult Heated Wire Circuit
Indications for Use (Describe)
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hosport environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995
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
"An agency may not conduct or sponsor, and a person is not requred to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
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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 black. 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 847-362-8097 Phone: Fax: 312 949-0731
Contact Person: Erika Fernandez
Date Prepared: July 6, 2016
2. Device
| Product Name: | AirLife Adult 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.
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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller gray font, it says "has joined BD".
5. Indication for use
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. 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 Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
Comparison of technological characteristics with the predicate device 6.
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). The AirLife Adult Heated Wire Circuit is substantially equivalent to the predicate device AirLife Heated Wire Breathing Circuits regarding safety, effectiveness, design (technology), materials and intended use. The proposed AirLife Adult Heated Wire Circuit is designed to operate at the same minimum flow rate of 3 LPM as the predicate device. Successful test results (specific enthalpy, humidity output and surface temperature) ensured that the flow rate of the proposed device does not raise any different question of safety and effectiveness
| 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 | ||
| Circuit Characteristics | ||
| Limb Length (Inspiratory | ||
| and Expiratory) | 5 ft | 5 ft |
| Dryline Length | 1.7 ft | 1.7 ft |
| Intended Patient Use | Adult | Adult |
| Usage | Disposable | Disposable |
| Design | Dual and Single Limb | Dual and Single Limb |
| Tube Specifications | ||
| Nominal Inside Diameter | 21 mm | 21 mm |
| Design | Corrugated Breathing Tube with | |
| 22mm Adapters | Corrugated Breathing Tube | |
| with 22mm Adapters |
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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 |
|---|---|---|
| Circuit Specifications | ||
| Circuit Design | Dual or Single | Dual or Single |
| Maximum Power | 60W | 60W |
| Min circuit resistance per | ||
| Limb | 16.15 Ω | 16.24 - 17.75 Ω |
| Maximum Power/foot of | ||
| Limb | 6.0 | 6.0 |
| Conductor | Copper/Ni alloy | Copper/Ni alloy |
| Compatible Humidifiers | 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 |
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| Performance Characteristic | Standard |
|---|---|
| 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.
| Performance Characteristic | Standard |
|---|---|
| Length | BS EN ISO 5367: 2014 |
| Resistance to Flow | BS EN ISO 5367: 2014 |
| Resistance to Flow with Bending | BS EN ISO 5367: 2014 |
| Conical Connectors | BS EN ISO 5367: 2014 |
| Conical Connectors | BS EN ISO 8185: 2009 |
| Security of Attachment | ISO 5356-1 |
| Security of Attachment | BS EN ISO 5367: 2014 |
| Leakage | BS EN ISO 5367: 2014 |
| Compliance | BS EN ISO 5367: 2014 |
| Resistance to Melt | BS EN ISO 8185: 2009 |
| Security of Engagement Temperature Sensor | BS EN ISO 8185: 2009 |
| Leakage from Sensing Port | BS EN ISO 8185: 2009 |
| Specific Enthalpy | BS EN ISO 8185: 2009 |
| Surface Temperature | BS EN ISO 8185: 2009 |
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Image /page/7/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".
| Performance Characteristic | Standard |
|---|---|
| Humidity Output Invasive | BS EN ISO 8185: 2009 |
| Humidity Output Non-Invasive | BS EN ISO 8185: 2009 |
| Electrical Safety | IEC 60601-1:2005 (Third Edition) + CORR. |
| 1:2006 + CORR. 2:2007 + A1:2012 (or IEC | |
| 60601-1: 2012 reprint) | |
| Electromagnetic Compatibility | 60601-1-2 Edition 3: 2007-03 |
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.