(318 days)
The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.
TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask
The provided text pertains to an FDA 510(k) clearance letter for a medical device called "AirPilotMask, Model TMS-900." This document does not contain information about acceptance criteria, the study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for that information based solely on the provided text. The document is an administrative letter indicating that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not detail the technical performance studies or criteria used to make that determination.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2000
Mr. Geoffrey Sleeper Tiara Medical Systems, Inc. 14414 Detroit Avenue, Suite 205 Lakewood, OH 44107
K992192 Re : AirPilotMask, Model TMS-900 Regulatory Class: II (two) Product Code: BZD February 23, 2000 Dated: Received: February 24, 2000
Dear Mr. Sleeper:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosing the determined the device is the device referenced above and no indications for use stated in the substancially ogaally marketed predicate devices marketed in enclosure) to regally marketed productions the enactment date of the Interstate Commerce prior of the devices that have been reclassified Medical Device Amendments) of to actic Federal Food, Drug, and in accordance with the provisioner ce, market the device, subject to Cosmeric Act (ACC) . "Tod may) chouses . The general controls the general concrolo proclude requirements for annual registration, provisions of the not including practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device Is Classifica (boo aboroval), it may be subject to such Controls) of Class III (Fremail.compressions affecting your device 200 additional Collections. Existing may and the 21, Parts 800 can be round in the ood equivalent determination assumes compliance co our. It dabbandad and acturing Practice requirements, as set with the Current Cood have Regulation (QS) for Medical Devices: forth in the gadire) by can art 820) and that, through periodic QS General regulation (2) Orug Administration (FDA) will verify such Inspections, Failure to comply with the GMP regulation may result in assumptions. Fallat regulatory action. is in the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premains under sections 531 through 542 of the Act obiligation you might have ander broduct Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Geoffrey Sleeper
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in four of your device to a legally marketed predicate device equirelios on 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 azaghobers as roos procestions on the promotions on the promotion and (301) 331 your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). first general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtained from the Brisblom (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark n Millum
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 510(k) Notification AirPilotMaskTM Additional Requested Information / Amended Submission
Tiara Medical Systems. Inc. 14414 Detroit Ave. Ste. 205 Lakewood Ohio 44107 Phone (216) 521-1220 Fax (216) 521-1399
Section 5 - Statement of Indications for Use
510(k) Number: _
Device Name: TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask
Intended Use / Indications for Use:
The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous positive airway pressure) devices for the treatment of adult obstructive sleep apnea.
Environment of Use / Patient Population:
For single patient use in the home or hospital/institutional environment. The mask is to r or single 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)
Mark n. Mulham
(Division Sign-On)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
§ 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).