(53 days)
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No
The 510(k) summary describes a nasal mask for CPAP therapy and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for the treatment of adult obstructive sleep apnea, which is a medical condition, and it is used with positive airway pressure devices (CPAP), which are therapeutic. Therefore, the mask itself is part of a therapeutic system.
No
Explanation: The device is a nasal mask used with CPAP devices for treating obstructive sleep apnea. Its function is to deliver positive airway pressure, not to diagnose a condition.
No
The device is a nasal mask, which is a physical hardware component used with positive airway pressure devices. The description clearly indicates it is a physical mask, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering positive airway pressure for the treatment of obstructive sleep apnea. This is a therapeutic device used directly on the patient, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or calibrators.
Therefore, the SleepNet Corporation IQ® Nasal Mask is a medical device, but it falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
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.
Product codes
73 BZD
Device Description
SleepNet IO® Nasal Mask
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
airway
Indicated Patient Age Range
adult patients (>30kg)
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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.
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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 (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
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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