HUMIDAIRE 2I

K080797 · Resmed, Ltd. · BTT · Jul 9, 2008 · Anesthesiology

Device Facts

• Record ID: K080797
• Device Name: HUMIDAIRE 2I
• Applicant: Resmed, Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Jul 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device. The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment. The HumidAire 2i is for use only as recommended by a physician.

Device Story

HumidAire 2i is a heated humidifier attachment for ResMed CPAP, APAP, and bilevel therapy devices. It functions by heating and humidifying air delivered to the patient's airway to improve comfort during respiratory therapy. The device is designed for both home (single-patient) and hospital/institutional (multi-patient) environments. It is operated by the patient or healthcare provider as part of a larger therapy system. The device helps manage patients with Obstructive Sleep Apnea (OSA) by mitigating dryness associated with positive airway pressure therapy. It is used under physician recommendation.

Clinical Evidence

Bench testing only. Design and verification activities were performed based on risk analysis and product requirements. All tests confirmed the device met predetermined acceptance criteria.

Technological Characteristics

Heated humidifier unit designed to attach to ResMed CPAP/APAP/bilevel devices. Operates as a single heated humidification unit. Complies with FDA guidance for ventilators, labeling for reusable medical devices, and heated humidifier review guides. Designed for multi-patient reprocessing.

Indications for Use

Indicated for humidification of air delivered from ResMed compatible CPAP therapy devices for patients requiring CPAP, APAP, or bilevel therapy, including those with Obstructive Sleep Apnea (OSA). Suitable for single-patient home use and multi-patient hospital/institutional use.

Regulatory Classification

Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Predicate Devices

• AutoSet Spirit™ with H2i (K013843)
• VPAP ADAPT™ with H2i (K051364)

Submission Summary (Full Text)

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RESMED

LOR079)

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HumidAire 2i Traditional 510(k) Premarket Notification

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# 510(k) Summary -- HumidAire 2i™

[As required by 21 CFR 807.92(c)]

| Date Prepared | 14th March 2008 | JUL - 9 2008 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact | Dr Lionel King<br>V.P., Global Quality Assurance & Regulatory Affairs<br>ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW 2153<br>Australia<br>Tel: [phone]<br>Fax: [phone] | |
| Classification Reference | 21 CFR 868.5450 (Class II device) | |
| Product Code | 73 BTT | |
| Common/Usual Name | Humidifier, respiratory gas, (direct patient interface) | |
| Proprietary Name | HumidAire 2i™ | |
| Predicate Device(s) | AutoSet Spirit™ with H2i (K013843) - Primary<br>VPAP ADAPT™ with H2i (K051364) | |
| Reason for submission | New Device | |

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#### Intended Use

The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.

The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.

The HumidAire 2i is for use only as recommended by a physician.

### Device Description

ResMed's HumidAire 2i™ is a humidify the air delivered to the airway during continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP) and bilevel therapy.

The HumidAire 21™ is designed to form a single heated humidification unit when attached to a CPAP, APAP or bilevel device.

The HumidAire 21™ is intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

### Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

- Similar intended use (modified only to include multiple patient re-use) ો
- /A Same operating principle
- 演 Same technologies
- ﺧﺮ Same manufacturing process

Design and Verification activities were performed on the HumidAire 2i™ as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device. The disinfection of the HumidAire 2i for re-use in a hospital/sleep lab environment has not altered the safety and effectiveness when used primarily in the management of patients with Obstructive Sleep Apnea (OSA).

The HumidAire 2i complies with the applicable standards and requirements referenced in the FDA quidance documents:

- ﺎﺯ FDA Draft Reviewer Guidance for Ventilators (July 1995)
- ;A Reviewer Guidance for Premarket Notification Submissions, November 1993, ARDB, CDRH, FDA
- 公 Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme: Draft
- FDA Reviewer Guidance: "Labeling reusable medical devices for reprocessing in health care facilities" 产 (Office of device evaluation, April 1996)
- FDA Heated Humidifier Review Guide 从

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2008

ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K080797

Trade/Device Name: HumidAire 2iTM Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: June 5, 2008 Received: June 27, 2008

Dear Mr. D'Cruz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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## Page 2 – Mr. D'Cruz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

V.K. Ammels-Tend, m.D. /for

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indication for Use

510(k) Number (if known):

Device Name:

HumidAire 2i™

#### Indication for Use

The HumidAire 21 is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.

The HumidAire 2 is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.

The HumidAire 2i is for use only as recommended by a physician.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

14* March, 2008