(234 days)
Not Found
Not Found
No
The provided text describes a CPAP mask system and does not mention any AI or ML capabilities.
Yes
Explanation: The device is indicated for use with CPAP and VPAP systems, which are therapeutic interventions for conditions like sleep apnea. The predicate device is also a CPAP system, further supporting its therapeutic nature.
No
The device is a mask system for CPAP/VPAP therapy, which is a treatment modality, not a diagnostic one.
No
The 510(k) summary describes a "Mask System," which is a physical component used with CPAP/VPAP systems. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Sullivan Mirage Mask System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with CPAP and VPAP systems for respiratory support. This involves delivering air pressure to a patient, which is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Predicate Device: The predicate device (Sullivan Autoset Nasal CPAP System) is also a respiratory support device, not an IVD.
Therefore, the Sullivan Mirage Mask System is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.
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
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
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Key Metrics
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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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Scott Dudevoir Resmed Ltd. c/o Resmed Corp. 10121 Carroll Canyon Road San Diego, CA 92131
K984428 Re: Sullivan Autoset Nasal CPAP System Requlatory Class: II (two) Product Code: 73 BZD Dated: April 23, 1999 Received: April 26, 1999
Dear Mr. Dudevoir:
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 Cosmetic Act (Act). 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 (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 requlation 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Scott Dudevoir
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 requlation (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 Compliance at (301) 594-4639. Also, please note the requlation 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
4428 510(k) Number (if known): _ K98
Sullivan MIRAGE MASK SYSTEM Device Name:
Indications For Use: The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.
(Sign-Off)
Cardiovascular, Respiratory,
ical Devices
K984428
(Optional Format 3-10-98)
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