(27 days)
Not Found
Not Found
No
The 510(k) summary describes a nasal mask, a physical device used with CPAP machines. There is no mention of software, algorithms, or any terms related to AI or ML. The description focuses on the physical components and intended use for sleep apnea treatment.
Yes
The device is intended to be used with positive airway pressure devices for the treatment of adult obstructive sleep apnea, which is a therapeutic purpose.
No
The device, a nasal mask for CPAP, is used for the treatment of obstructive sleep apnea, not for diagnosing it.
No
The device description clearly identifies it as a "Nasal Mask," which is a physical hardware component used in conjunction with positive airway pressure devices. There is no mention of software as the primary or sole component of the device.
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 externally on the patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: It's a nasal mask, which is a physical interface for delivering air pressure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are typically things like blood glucose meters, pregnancy tests, or laboratory analyzers that test samples like blood, urine, or tissue. This device is a medical device, but not an IVD.
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 cmH₂O for the treatment of adult obstructive sleep apnea.
Product codes
73 BZD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adult patients (>30kg)
Intended User / Care Setting
single patient use and re-use in the home or hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Comocroniano
(301) 504 4630 mil (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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