(88 days)
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No
The 510(k) summary describes a full face mask, which is a passive accessory for CPAP/bilevel systems. There is no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.
No
The device is described as a patient interface accessory for use with CPAP/bilevel systems, which are therapeutic devices. It does not exert a therapeutic effect itself but rather serves as a component.
No
The device is described as a patient interface accessory for CPAP and bilevel systems used in treatment, not for diagnosing conditions.
No
The device description clearly identifies it as a "Full Face Mask System," which is a hardware component used in respiratory therapy. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support." This describes a device used externally on a patient to deliver therapy, not a device used to test samples in vitro (outside the body).
- Device Description: The description "Sullivan® Mirage™ Full Face Mask System" further reinforces that it's a physical mask worn by a patient.
- Lack of IVD Characteristics: The provided information does not 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 diagnostic information based on laboratory testing
Based on the provided information, the Sullivan® Mirage™ Full Face Mask is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sullivan® Mirage™ Full Face Mask is a patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.
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
adult
Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1998
Mr. Scott Dudevoir ResMed Ltd. c/o ResMed Corp. 10121 Carroll Canyon Road San Diego, CA 92131
Re: K982530 Sullivan® Mirage™ Full Face Mask System Requlatory Class: II (two) Product Code: 73 BZD Dated: July 16, 1998 Received: July 20, 1998
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 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 Compliance at (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,
Thomas J. Callahan
Thomas J. CallaMan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): 1982530
Mirage Full Face Mask Device Name:
The Sullivan® Mirage™ Full Face Mask is a patient interface Indications For Use: accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
HPRen
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
(Optional Format 3-10-98)
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