IQ NASAL MASK, MODEL 50160 REV. D

K021534 · Sleepnet Corporation · BZD · Jul 2, 2002 · Anesthesiology

Device Facts

• Record ID: K021534
• Device Name: IQ NASAL MASK, MODEL 50160 REV. D
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SleepNet Corporation IQ® Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). operating at or above 3 cmHzO for the treatment of adult obstructive sleep apnea. Environment of Use / Patient Population: The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be used in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

Device Story

SleepNet IQ® Nasal Mask is a patient interface for CPAP therapy; delivers pressurized air to patient airways. Used in home or hospital settings; prescribed by physicians for adult obstructive sleep apnea patients. Device functions as a physical conduit between CPAP machine and patient; ensures seal for effective pressure delivery. Benefits include improved compliance and therapeutic efficacy for sleep apnea treatment. No electronic components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal mask interface for CPAP devices. Designed for single or multi-patient use (with high-level disinfection). Operates with positive airway pressure systems (≥3 cmH2O). Mechanical design only; no electronic or software components.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring positive airway pressure therapy (≥3 cmH2O).

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Mr. Paul Chiesa SleepNet Corporation 1050 Perimeter Road Manchester, NH 03103

Re: K021534

SleepNet IO® Nasal Mask Regulation Number: 868.5905 Regulation Name: Ventilator, Non-continuous Regulatory Class: II (two) Product Code: 73 BZD Dated: June 15, 2002 Received: June 20, 2002

Dear Mr. Chiesa:

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. Paul Chiesa

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Time 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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## Attachment 3A - Indications for Use Enclosure

510(k) Number: K021534

Device Name: SleepNet IQ® Nasal Mask

Intended Use / Indications for Use:

The SleepNet Corporation IQ® Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). operating at or above 3 cmHzO for the treatment of adult obstructive sleep apnea. Environment of Use / Patient Population:

The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be used in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Ditch

(Division Sign-Off) (Division Sign of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription UseV (per 21 CFR 801.109)

OR

Over the Counter Use Optional Format 1-2-96