(238 days)
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)
Nasal-Aire IITM Accessory to a Positive Pressure Ventilation Device
This looks like a 510(k) clearance letter for a medical device (Nasal-Aire II accessory) that does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The provided text is a standard FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance generally relies on demonstrating similarity to existing devices rather than presenting novel performance studies with specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted with the 510(k) application, which would detail any performance testing conducted.
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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.
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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
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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 |
|---|---|
| ---------------- | --------- |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).