IQ NASAL MASK, MODEL P/N 50160

K993269 · Sleepnet Corporation · BZD · Oct 27, 1999 · Anesthesiology

Device Facts

• Record ID: K993269
• Device Name: IQ NASAL MASK, MODEL P/N 50160
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 27, 1999
• 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 cmH₂O for the treatment of adult obstructive sleep apnea.

Device Story

The IQ™ Nasal Mask is a patient interface for CPAP therapy. It functions as a conduit to deliver pressurized air from a CPAP device to the patient's airway. Used in home or clinical settings by adult patients prescribed positive airway pressure. The mask facilitates therapy by maintaining a seal, allowing the CPAP device to provide pneumatic splinting of the airway to treat obstructive sleep apnea. Benefits include improved patient compliance and effective delivery of prescribed pressure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal mask interface for CPAP systems. Designed for single-patient use. Operates with positive airway pressure devices at or above 3 cmH₂O. No electronic, software, or algorithmic components.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring positive airway pressure therapy (≥3 cmH₂O). Intended for single-patient use in home or hospital/institutional settings.

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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DEPARTMENT OF HEALTH & HUMAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

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

K993269 Re : IQ™ Nasal Mask Requlatory Class: II (two) Product Code: 73 BZD September 29, 1999 Dated: Received: September 30, 1999

Dear Mr. Chiesa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 In accordance "Ith anyou 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act obrigation you might or other Federal laws or regulations.

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Page 2 - Mr. Paul Chiesa

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Comocroniano
[phone] mil [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

- ourne The water grays. Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SleepNet Corp.

## Attachment 3 – Indications for Use Enclosure

510(k) Number:

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 cmH₂O for the treatment of adult obstructive sleep apnea.

## Environment of Use / Patient Population:

The mask is intended for single patient use and re-use 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)

tean J.A. Wetherstein

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number

Prescription Use J (per 21 CFR 801.109)

OR

Over the Counter Use Optional Format 1-2-96