(133 days)
The OPAP ® device is an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea. This device is indicated for use with CPAP and Bilevel systems. The OPAP Of facilitated delivery of or CPAP and Bilevel is similar to nasal mask CPAP and Bilevel. Individual patients and specific problems may or may not be treated more effectively with the OPAP C. Consult your sleep physician or dentist.
an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea.
This document is a 510(k) clearance letter from the FDA for a medical device called OPAP®. It does not contain information about acceptance criteria or a study proving device performance in the context of the requested details (AI/ML performance, ground truth, sample sizes, etc.). The letter primarily states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is regulatory correspondence, not a study report or clinical trial documentation.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 1999
William T. Hart, M.D. OPAP, Inc. P.O. Box 189 Pioneer, CA 95666
K991926 Re: OPAP® Regulatory Class: II (two) Product Code: 73 BZD Dated: September 20, 1999 September 21, 1999 Received:
Dear Dr. Hart:
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, Druq, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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 - William T. Hart, M.D.
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 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,
Jacomo El West erhausen
Wolf Sapirstein, M.D. 124 Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10/12/98 10:28 FAX J01 480 4204 - - - FDA CDRH_QDE DCRND
FDA CDRH QDE DCRND
0002
| 510(k) Number (if known): | K 991926 |
|---|---|
| Device Name: | OPAP ® |
Indications For Use:
The OPAP @ device is an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea. This device is indicated for use with CPAP and Bilevel systems. The OPAP Of facilitated delivery of or CPAP and Bilevel is similar to nasal mask CPAP and Bilevel. Individual patients and specific problems may or may not be treated more effectively with the OPAP C. Consult your sleep physician or dentist.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, and Neurological Devices | ||
| 510(k) Number _________ | ||
| Prescription Use ✓(Per 21 CFR 801.109) | OR | Over-The-Counter Use _________ |
(Optional Formal 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).