AirLife Adult Heated Wire BiPAP/NIV Circuit

K170378 · Vyaire Medical · BZE · Sep 14, 2017 · Anesthesiology

Device Facts

• Record ID: K170378
• Device Name: AirLife Adult Heated Wire BiPAP/NIV Circuit
• Applicant: Vyaire Medical
• Product Code: BZE · Anesthesiology
• Decision Date: Sep 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

AirLife Adult Heated Wire BiPAP/NIV Circuit is a single-use, non-sterile corrugated plastic tube with internal spiral resistance wires. It functions as an airway conduit between a noninvasive ventilator and a patient. The device connects to a Fisher & Paykel MR850 humidifier to deliver warmed, humidified breathing gases. Resistance wires generate heat to maintain gas temperature and humidity, minimizing breathing effort. Used in hospital environments for up to 7 days, operated by skilled clinicians. Output is the delivery of conditioned gas to the patient's airway. Benefits include maintained ventilation and reduced work of breathing.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 5367 (breathing sets), ISO 8185 (humidifiers), ISO 5356-1 (connectors), and electrical safety/EMC (IEC 60601-1, IEC 60601-1-2). Biocompatibility testing performed per ISO 10993 series for prolonged contact (cytotoxicity, sensitization, irritation, implantation, genotoxicity, extractables/leachables). All tests passed.

Technological Characteristics

Corrugated plastic tube with internal spiral resistance wires (Copper/Ni alloy). Single-limb design with 22mm adapters. Max power 36W. Compatible with Fisher & Paykel MR850 humidifier. Operates at 3-60 LPM flow. Standards: ISO 5367, ISO 8185, ISO 5356-1, AAMI/ANSI ES60601-1, AAMI/ANSI/IEC 60601-1-2.

Indications for Use

Indicated for adult patients requiring mechanical ventilation, including spontaneously breathing individuals benefiting from high flow therapy. Used in professional healthcare environments under clinician supervision. Compatible with noninvasive ventilators and Fisher & Paykel MR850 humidifier.

Regulatory Classification

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.

Predicate Devices

• RT 219 BiLevel /CPAP Circuit (K983112)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 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, stacked on top of each other.

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 [phone] or [phone] 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 [phone] or [phone] 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*)

| <div> <span> <b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> </div> |

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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: [phone]
Vyaire Medical.com

# 510(k) Summary

#### 1. SUBMITTER

Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: [phone]

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 proprietary<br>name: | AirLife™ |
| Device Name: | Heated Breathing Circuit |
| Common Name: | Heater, breathing system w/wo controller (not humidifier or<br>nebulizer) |
| 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.

- 5. 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: [phone]
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 warm<br>breathing gases before<br>they enter a patient's<br>airway | Intended to warm breathing<br>gases before they enter a<br>patient's airway |
| Principle of Operation | Resistance wires within the<br>tubing generate heat to<br>maintain temperatures and<br>humidity | Resistance wires within the<br>tubing generate heat to<br>maintain temperatures and<br>humidity |
| 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: [phone]
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 Tube<br>with 22mm Adapters | Corrugated Breathing Tube<br>with 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 sets<br>and connectors | ISO 5367, 5th Ed: 2014-<br>10-15 |
| Respiratory tract humidifiers for medical use. Particular<br>requirements for respiratory humidification system | ISO 8185, 3rd Ed: 2008-<br>06-15 |
| Anaesthetic and respiratory equipment. Conical<br>connectors. Cones and sockets | ISO 5356-1: 3rd Ed;<br>2004-05-15 |
| Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (iec 60601-1:2005, mod) | AAMI / ANSI ES60601-<br>1:2005/(R)2012 And<br>A1:2012, |

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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: [phone] Vyaire Medical.com

| Performance Characteristic | Standard |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | C1:2009/(R)2012 And<br>A2:2010/(R)2012<br>(Consolidated Text) |
| Medical Electrical Equipment -- Part 1-2: General<br>Requirements For Basic Safety<br>And Essential Performance -- Collateral Standard:<br>Electromagnetic Disturbances -- Requirements And Tests | AAMI / ANSI / IEC<br>60601-1-2:2014 |

| 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:<br>Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |
| Biological evaluation of medical devices – Part 3: Tests<br>for genotoxicity, carcinogenicity and reproductive<br>toxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 5: Tests<br>for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological evaluation of medical devices – Part 6: Tests<br>for 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: [phone] Vyaire Medical.com

| Performance Characteristic | Standard |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Biological Evaluation of Medical Devices-Part 10: Tests<br>for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010<br>(R2014) |
| Biological evaluation of medical devices – Part 11:<br>Tests for systemic toxicity | AAMI/ANSI/ISO 10993-11:2006<br>(R2010) |
| Biological evaluation of medical devices – Part 12:<br>Sample preparation and reference materials | AAMI/ANSI/ISO 10993-12: 2012 |
| Biological Evaluation of Medical Devices Part 17:<br>Establishment of allowable limits for leachable<br>substances | AAMI/ANSI/ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18:<br>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.