AirLife Adult Heated Wire Circuit

K153234 · Carefusion, Inc. · BZE · Jul 7, 2016 · Anesthesiology

Device Facts

• Record ID: K153234
• Device Name: AirLife Adult Heated Wire Circuit
• Applicant: Carefusion, Inc.
• Product Code: BZE · Anesthesiology
• Decision Date: Jul 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

AirLife Adult Heated Wire Circuit acts as an airway conduit between a breathing machine and a patient's endotracheal or tracheal tube. Input consists of breathing gases from a ventilator; device uses internal resistance wires (Copper/Ni alloy) to warm gases and maintain humidity levels. Output is warmed, humidified gas delivered to the patient. Used in professional healthcare and intra-hospital transport environments by skilled clinicians. Compatible with Fisher & Paykel MR850 humidifier. Device ensures gas temperature and humidity are maintained to prevent airway drying and thermal injury, benefiting patients on mechanical ventilation.

Clinical Evidence

Bench testing only. Compliance verified against BS EN ISO 5367:2014, BS EN ISO 8185:2009, IEC 60601-1, and IEC 60601-1-2. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, implantation, genotoxicity, extractables/leachables).

Technological Characteristics

Corrugated breathing tube (21mm ID) with 22mm adapters; Copper/Ni alloy resistance wires; 60W max power; 6.0 W/ft power density. Compatible with Fisher & Paykel MR850 humidifier. Standards: BS EN ISO 5367:2014, BS EN ISO 8185:2009, IEC 60601-1, ISO 10993 series.

Indications for Use

Indicated for adult patients requiring mechanical ventilation, positive pressure breathing, or general medical gases. Used in professional healthcare and intra-hospital transport settings under clinician supervision.

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

• AirLife Heated Ventilator and Anesthesia Breathing Circuits (K000697)

Submission Summary (Full Text)

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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.

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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 [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 at its toll-free number [phone] or [phone] 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)

K153234

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.

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FORM FDA 3881 (8/14)

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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: [phone]

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<br>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<br>gases before they enter a<br>patient's airway | Intended to warm breathing<br>gases before they enter a<br>patient's airway |
| Principal 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 |
| Circuit Characteristics | | |
| Limb Length (Inspiratory<br>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<br>22mm Adapters | Corrugated Breathing Tube<br>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<br>Limb | 16.15 Ω | 16.24 - 17.75 Ω |
| Maximum Power/foot of<br>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<br>and Testing<br>FDA Guidance: Use of International Standard ISO- 10993,<br>"Biological Evaluation of Medical Devices Part 1: Evaluation<br>and Testing" | ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices Part 3: Tests for<br>genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3:2014 |
| Biological Evaluation of Medical Devices Part 5: Tests for in<br>vitro cytotoxicity | ISO 10993-5:2009 |
| Biological Evaluation of Medical Devices Part 6: Tests for<br>local effects after implantation | ISO 10993-6:2007 |
| Biological Evaluation of Medical Devices Part 10: Tests for<br>irritation and skin sensitization | ISO 10993-10:2010 |
| Biological Evaluation of Medical Devices Part 17:<br>Establishment of allowable limits for leachable substances | ISO 10993-17:2002 |

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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, and the word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined BD" in a smaller font.

| Performance Characteristic | Standard |
|---------------------------------------------------------------------------------------------|-------------------|
| Biological Evaluation of Medical Devices Part 18: Chemical<br>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.<br>1:2006 + CORR. 2:2007 + A1:2012 (or IEC<br>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.