(219 days)
AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy.
The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and compatible to the Fisher & Paykel MR850 humidifier.
The AirLife Adult Heated Wire BiPAP/NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated wire circuit is intended for use for adult population that requires non-invasive (NIV) mechanical ventilation. It is intended for spontaneously breathing individuals who require mechanical ventilation. The duration of use is up to 7 days in a hospital environment. The aim is to maintain adequate ventilation and minimize the effort of breathing.
The AirLife Adult Heated Wire BiPAP/NIV Circuit is a corrugated plastic tube with a spiral resistance wires within the tubing that generate heat to maintain temperatures and humidity. It is intended to warm gases before they enter a patient's airway. The device delivers humidity to patients requiring active non-invasive humidification, acting as a conduit transporting gases between ventilators, humidifiers and the patient. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to operate at a minimum flow rate of 3 LPM and a maximum flow rate of 60 LPM.
The AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device designed to warm and deliver breathing gases to adult patients requiring non-invasive mechanical ventilation. The device was tested against several industry standards to ensure its safety and effectiveness.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were defined by compliance with various international standards related to breathing system heaters, anesthetic and respiratory equipment, and biocompatibility. The reported device performance uniformly indicated "Pass" for all tested characteristics, demonstrating that the device meets these established standards.
| Performance Characteristic | Standard | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Anaesthetic and respiratory equipment – Breathing sets and connectors | ISO 5367, 5th Ed: 2014-10-15 | Pass |
| Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification system | ISO 8185, 3rd Ed: 2008-06-15 | Pass |
| Anaesthetic and respiratory equipment. Conical connectors. Cones and sockets | ISO 5356-1: 3rd Ed; 2004-05-15 | Pass |
| Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (iec 60601-1:2005, mod) | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) | Pass |
| Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests | AAMI / ANSI / IEC 60601-1-2:2014 | Pass |
| Inspiratory Limb (Specific Test) | (Implicitly covered by general standards above) | Pass |
| Extension Line (Specific Test) | (Implicitly covered by general standards above) | Pass |
| Dry Line (Specific Test) | (Implicitly covered by general standards above) | Pass |
| System Leak Test | (Implicitly covered by general standards above) | Pass |
| Resistance to Flow | (Implicitly covered by general standards above) | Pass |
| % Increase in Flow Resistance with Bending | (Implicitly covered by general standards above) | Pass |
| Compliance of Breathing Tubes | (Implicitly covered by general standards above) | Pass |
| Security of Attachment | (Implicitly covered by general standards above) | Pass |
| Conical Connector | (Implicitly covered by general standards above) | Pass |
| Resistance to Melt | (Implicitly covered by general standards above) | Pass |
| Temperature Sensor Leakage | (Implicitly covered by general standards above) | Pass |
| Temperature Sensor Compatibility | (Implicitly covered by general standards above) | Pass |
| Breathing Tube Surface Temperature | (Implicitly covered by general standards above) | Pass |
| Specific Enthalpy | (Implicitly covered by general standards above) | Pass |
| Humidity Output | (Implicitly covered by general standards above) | Pass |
| Biocompatibility | ||
| Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 | Pass |
| Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) | Pass |
| Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) | Pass |
| Biological evaluation of medical devices – Part 6: Tests for local effects after implantation | AAMI/ANSI/ISO 10993-6:2009 (R2014) | Pass |
| Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010 (R2014) | Pass |
| Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | AAMI/ANSI/ISO 10993-11:2006 (R2010) | Pass |
| Biological evaluation of medical devices – Part 12: Sample preparation and reference materials | AAMI/ANSI/ISO 10993-12: 2012 | Pass |
| Biological Evaluation of Medical Devices Part 17: Establishment of allowable limits for leachable substances | AAMI/ANSI/ISO 10993-17:2002 | Pass |
| Biological Evaluation of Medical Devices Part 18: Chemical characterization of materials | AAMI/ANSI/ISO 10993-18:2005 | Pass |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size for individual tests conducted to prove compliance. However, the tests are a series of non-clinical performance and biocompatibility assessments performed on the device itself (e.g., inspiratory limb, extension line, dry line, system leak, resistance to flow). These typically involve a sufficient number of units to ensure statistical confidence and representativeness of the manufacturing process, as per the requirements of the standards cited.
The data provenance is from laboratory testing (non-clinical) of the device. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not relevant for non-clinical device performance studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
For non-clinical performance and biocompatibility testing as described, the "ground truth" is established by the specified parameters and methodologies outlined in the referenced international standards (e.g., ISO, AAMI/ANSI/IEC standards). The experts would be the engineers, scientists, and technicians who are trained and qualified to conduct these tests according to the standard operating procedures derived from these international standards. Their qualifications would typically include degrees in relevant engineering or scientific fields, experience in medical device testing, and specific training on the standards being applied. The document does not specify the number of individual experts, as it is a standard part of a manufacturer's quality system to have qualified personnel perform such testing.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple human readers (e.g., radiologists reading images). This is a non-clinical performance and biocompatibility study. The "adjudication method" in this context is the comparison of the test results against the acceptance criteria defined by the relevant standards. A simple "Pass" or "Fail" determination is made based on whether the device's performance meets or exceeds the specified thresholds in the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted, nor is it applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, usually in diagnostic imaging. This device is a heated breathing circuit, and its performance is assessed through objective physical and biological tests, not by human interpretation or AI assistance in a clinical setting related to diagnosis.
6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)
Yes, in a sense. The document describes the standalone (algorithm equivalent) performance of the device. The entire set of tests detailed under "Performance Testing" and "Biocompatibility" (e.g., System Leak Test, Resistance to Flow, Humidity Output, Cytotoxicity) measures the intrinsic performance characteristics of the device itself without direct human intervention in its operation during the test, beyond setting up and initiating the test. There is no "algorithm" in the conventional sense of AI, but rather the physical and chemical properties and functionality of the device are evaluated.
7. Type of Ground Truth Used
The ground truth used is based on established objective technical standards and regulatory requirements. This includes:
- Engineering/Performance Specifications: Derived from standards like ISO 5367, ISO 8185, ISO 5356-1, IEC 60601-1, and IEC 60601-1-2. These standards define acceptable ranges and limits for physical performance characteristics.
- Biocompatibility Standards: Derived from ISO 10993 series, which define acceptable levels of biological response for medical devices in contact with the body.
8. Sample Size for the Training Set
This is a non-clinical study for a medical device's physical and biological properties, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The device itself is the product being tested, not an algorithm being developed. The manufacturing process of the heated breathing circuits would have undergone internal validation and development which may involve iterative testing, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. For the manufacturing process, the "ground truth" (i.e., desired specifications and performance) would be established through a combination of design requirements, risk analysis, and engineering specifications based on relevant standards and intended use.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
Vyaire Medical Colleen Watson (O'Keeffe) Acting Director, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K170378
Trade/Device Name: AirLife Adult Heated Wire BiPAP/NIV Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing system heater Regulatory Class: Class II Product Code: BZE Dated: August 11, 2017 Received: August 14, 2017
Dear Colleen Watson (O'Keeffe):
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 device
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related 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.
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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S
Lori Wiggins, MPT, CLT Acting 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) K170378
Device Name
AirLife Adult Heated Wire BiPAP/NIV Circuit
Indications for Use (Describe)
AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy.
The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the word "MEDICAL" in smaller letters underneath. Above the word "Vyaire" are three light blue curved lines.
75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: 847 362-8107
Vyaire Medical.com
510(k) Summary
1. SUBMITTER
Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: (224) 706-6818
Contact Person: Colleen O'Keeffe Acting Director, Regulatory Affairs
Date Prepared: September 11, 2017
2. Device
| Product Name: | AirLife Adult Heated Wire BiPAP/NIV Circuit |
|---|---|
| Trade or proprietaryname: | AirLife™ |
| 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
RT 219 BiLevel /CPAP Circuit was cleared under 510(k) K983112 MR850 Respiratory Humidifier from Fisher and Paykel. The RT219 is an accessory of F&P 850 System. This predicate device has not been subject to a design-related recall.
4. Device Description
The AirLife Adult Heated Wire BiPAP/NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated wire circuit is intended for use for adult population that requires non-invasive (NIV) mechanical ventilation. It is intended for spontaneously breathing individuals who require mechanical ventilation. The duration of use is up to 7 days in a hospital environment. The aim is to maintain adequate ventilation and minimize the effort of breathing.
-
- Principle of Operation
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Image /page/4/Picture/0 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is written in a large, bold, blue font. Below the word "Vyaire" is the word "MEDICAL" written in a smaller, thinner, blue font. Above the word "Vyaire" is a blue, wave-like design.
75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: 847 362-8107
Vyaire Medical.com
The AirLife Adult Heated Wire BiPAP/NIV Circuit is a corrugated plastic tube with a spiral resistance wires within the tubing that generate heat to maintain temperatures and humidity. It is intended to warm gases before they enter a patient's airway. The device delivers humidity to patients requiring active non-invasive humidification, acting as a conduit transporting gases between ventilators, humidifiers and the patient. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to operate at a minimum flow rate of 3 LPM and a maximum flow rate of 60 LPM.
Indication for use 6.
The AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult only population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy.
The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and compatible with the Fisher & Paykel MR850 humidifier.
7. 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. The AirLife Adult Heated Wire BiPAP/NIV Circuit is substantially equivalent to the predicate device RT 219 BiLevel /CPAP Circuit regarding safety, effectiveness, design (technology), materials and intended use. The proposed AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to operate at the same minimum flow rate of 3 LPM and maximum 60 LPM. Successful test results (specific enthalpy, humidity output and surface temperature) ensured that the flow rate of the proposed device does not raise any concerns regarding safety and effectiveness. The similarities and differences between the proposed device and the predicate device are outlined below:
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Intended Use | Intended to warmbreathing gases beforethey enter a patient'sairway | Intended to warm breathinggases before they enter apatient's airway |
| Principle of Operation | Resistance wires within thetubing generate heat tomaintain temperatures andhumidity | Resistance wires within thetubing generate heat tomaintain temperatures andhumidity |
| Limb Length (Inspiratory) | 5 ft | 5 ft |
| Dryline Length | 1.7 ft | 1.7 ft |
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Image /page/5/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Vyaire" are three curved lines in a lighter shade of blue.
75 N. Fairway Dr.
Vernon Hills, IL 60061
Phone: 847 362-8107
Vyaire Medical.com
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Unheated Extension Length | 1 ft | 1 ft |
| Intended Patient Use | Adult | Adult |
| Usage | Disposable | Disposable |
| Design | Single Limb | Single Limb |
| Flow rate | Max 60 LPM | Max 70 LPM |
| Nominal Inside Diameter | 30 mm | 30 mm |
| Design | Corrugated Breathing Tubewith 22mm Adapters | Corrugated Breathing Tubewith 22mm Adapters |
| Circuit Design | Single | Single |
| Maximum Power of Heater Base | 60W | 60W |
| Maximum Power of Circuit | 36W | 60W |
| Min circuit resistance per Limb | 20.5 Ω | 12.0 Ω |
| Maximum Power/foot of Limb | 7.2W/ft | 12W/ft |
| Conductor | Copper/Ni alloy | Copper alloy |
| Disposable Exhalation Port (DEP) | Present | Present |
| Compatible Humidifiers | Fisher and Paykel MR850 | Fisher and Paykel MR850 |
8. Performance Data
The proposed device was tested to ensure compliance to the following standards:
8.1 Performance Testing
| Performance Characteristic | Standard |
|---|---|
| Anaesthetic and respiratory equipment – Breathing setsand connectors | ISO 5367, 5th Ed: 2014-10-15 |
| Respiratory tract humidifiers for medical use. Particularrequirements for respiratory humidification system | ISO 8185, 3rd Ed: 2008-06-15 |
| Anaesthetic and respiratory equipment. Conicalconnectors. Cones and sockets | ISO 5356-1: 3rd Ed;2004-05-15 |
| Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (iec 60601-1:2005, mod) | AAMI / ANSI ES60601-1:2005/(R)2012 AndA1:2012, |
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Image /page/6/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Vyaire" are two light blue curved lines.
75 N. Fairway Dr. Vernon Hills, IL 60061 Phone: 847 362-8107 Vyaire Medical.com
| Performance Characteristic | Standard |
|---|---|
| C1:2009/(R)2012 AndA2:2010/(R)2012(Consolidated Text) | |
| Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic SafetyAnd Essential Performance -- Collateral Standard:Electromagnetic Disturbances -- Requirements And Tests | AAMI / ANSI / IEC60601-1-2:2014 |
| Performance Characteristic | Results |
|---|---|
| Inspiratory Limb | Pass |
| Extension Line | Pass |
| Dry Line | Pass |
| System Leak Test | Pass |
| Resistance to Flow | Pass |
| % Increase in Flow Resistance with Bending | Pass |
| Compliance of Breathing Tubes | Pass |
| Security of Attachment | Pass |
| Conical Connector | Pass |
| Resistance to Melt | Pass |
| Temperature Sensor Leakage | Pass |
| Temperature Sensor Compatibility | Pass |
| Breathing Tube Surface Temperature | Pass |
| Specific Enthalpy | Pass |
| Humidity Output | Pass |
| ANSI/AAMI IEC 60601-1:2005 | Pass |
| IEC 60601-1-2, Ed. 4.0, 2014-02 | Pass |
8.2 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 Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices-Part 1:Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |
| Biological evaluation of medical devices – Part 3: Testsfor genotoxicity, carcinogenicity and reproductivetoxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 5: Testsfor In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological evaluation of medical devices – Part 6: Testsfor local effects after implantation | AAMI/ANSI/ISO 10993-6:2009 (R2014) |
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Image /page/7/Picture/0 description: The image contains the logo for Vyaire Medical. The logo consists of the word "Vyaire" in a bold, sans-serif font, with the word "MEDICAL" in a smaller, lighter font underneath. Above the word "Vyaire" are two curved lines in a light blue color, which appear to be stylized representations of air waves.
75 N. Fairway Dr. Vernon Hills, IL 60061
Phone: 847 362-8107 Vyaire Medical.com
| Performance Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices-Part 10: Testsfor Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010(R2014) |
| Biological evaluation of medical devices – Part 11:Tests for systemic toxicity | AAMI/ANSI/ISO 10993-11:2006(R2010) |
| 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 |
9. Conclusion
The non-clinical data demonstrates that the AirLife Adult Heated Wire BiPAP/NIV Circuit is as safe and as 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).