(133 days)
Not Found
Not Found
No
The summary describes a physical mouthpiece/appliance for delivering positive airway pressure, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as treating obstructive sleep apnea by facilitating the application of positive airway pressure, which is a therapeutic intervention.
No
Explanation: The Intended Use / Indications for Use section states that the device facilitates the application of positive airway pressure to treat obstructive sleep apnea, indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a "mandibular repositioner mouthpiece / appliance," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat obstructive sleep apnea by applying positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples (like blood, urine, or tissue).
- Device Description: The description details a physical appliance used to reposition the jaw and facilitate airflow. It doesn't describe a test kit, reagent, or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in the body.
- Providing information for diagnosis, monitoring, or screening.
Therefore, the OPAP® device, as described, falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 ® 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 ®. Consult your sleep physician or dentist.
Product codes
73 BZD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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 contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
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.
1
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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0ct 12 99 08:54p William T.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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)