(7 days)
The Tiara Medical Systems Advantage™ 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.
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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is an FDA 510(k) clearance letter for the "Advantage™ Nasal Mask" and an "Indications for Use Enclosure." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a specific study, including sample sizes, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types.
- Information regarding training set size or how its ground truth was established.
The document primarily focuses on the regulatory clearance based on substantial equivalence, rather than detailing the technical studies and their results.
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Public Health Service
JUL 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Geoffrey Sleeper Tiara Medical System, Inc. 14414 Detroit Avenue, Suite 205 Lakewood, OH 44107
Re: K012207
Advantage™ Nasal Mask Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: 73 BZD Dated: July 12, 2001 Received: July 16, 2001
Dear Mr. Sleeper:
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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
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Page 2 - Mr. Geoffrey Sleeper
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4646. 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" (21CFR 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 vours.
Dee Tellh
L. James E. Diller, III
ames E. Dillard I Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 3 - Indications for Use Enclosure
510(k) Number: 《ΟΙΖΖΟ 7
Device Name: Tiara Medical Systems Advantage™ Nasal Mask
Intended Use / Indications for Use:
The Tiara Medical Systems Advantage™ 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012207
Prescription Use
(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).