(53 days)
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.
Not Found
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (SleepNet IQ® Nasal Mask).
This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device. It does not contain details about specific acceptance criteria or the results of a study designed to prove the device meets those criteria.
Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text. The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles of three people facing to the right.
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.
{1}------------------------------------------------
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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
§ 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).