MODIFICATION TO NASAL-AIRE

K022465 · Innomed Technologies · BZD · Mar 21, 2003 · Anesthesiology

Device Facts

• Record ID: K022465
• Device Name: MODIFICATION TO NASAL-AIRE
• Applicant: Innomed Technologies
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nasal-Aire II™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel) Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Nasal-Aire II is a patient interface accessory for positive pressure ventilation devices (CPAP/BiLevel). It delivers prescribed air pressure to patients with Obstructive Sleep Apnea. Used in clinical or home settings; operated by patient under physician prescription. Device functions as a conduit for airflow; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal interface accessory for positive pressure ventilation. Non-electronic, mechanical device. No software, sensors, or energy source.

Indications for Use

Indicated for patients with Obstructive Sleep Apnea requiring positive pressure breathing therapy (CPAP or BiLevel).

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Innomed Technologies, Incorporated C/O Ms. Marge Walls-Walker Ventlab Corporation 2934 Highway 601 North Mocksville, North Carolina 27028

Re: K022465

Trade/Device Name: Nasal-Aire IITM Accessory to a Positive Pressure Ventilation Device Regulation Number: 868.5905 Regulation Name: Accessory to Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: December 18, 2002 Received: December 23, 2002

Dear Ms. Walker:

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.

{1}------------------------------------------------

Page 2 - Ms. Walker

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/dsma/dsmamain.html

Sincerely yours,

Susan Runner, DDS, MA

Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use:

510k Number: k022465

Applicant: Innomed Technologies

Device Name: Nasal-Aire //™ accessory to a Positive Pressure Ventilation Device.

The Nasal-Aire //™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)

Federal (USA) law restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

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

| 510(k) Number: | K022465 |
|----------------|---------|
|----------------|---------|