(74 days)
No
The description focuses on the physical mechanism of the device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training and test sets.
Yes
The device is described as treating mild to moderate obstructive sleep apnea, which is a medical condition, and reducing snoring, which can be considered a therapeutic outcome.
No
The device is described as treating snoring and sleep apnea by physically opening the airway, not by diagnosing conditions.
No
The device description explicitly states it is made of thermal plastic material and fits over teeth, indicating it is a physical, hardware-based device.
Based on the provided information, the O'Brien MPA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to reduce snoring and treat mild to moderate obstructive sleep apnea by physically altering the position of the mandible to open the airway. This is a mechanical intervention directly on the patient's anatomy.
- Device Description: The device is a physical appliance made of thermal plastic material that fits over teeth. It works by physically manipulating the jaw position.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The O'Brien MPA does not involve the analysis of any biological specimens.
The device is a medical device used for therapeutic purposes (treating sleep apnea and reducing snoring) by physically interacting with the patient's body.
N/A
Intended Use / Indications for Use
The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.
Product codes
LRK
Device Description
The O'Brien MPA is made of thermal plastic material (ADA approved materials). It is a very simple device that fits snugly over the upper and lower anterior teeth in such a way as to keep the mandible in a stationary, anterior protrusive position. The reason for this is to physically open the airway and thus potentially reduce the occurrence of snoring and sleep apnea. (This theory of airway management is common, standard operating procedures in the emergency medical field for airway management purposes.) The device also includes air channels to allow breathing through the mouth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or in a sleep laboratory.
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)
SUAD - K023836, TAP - K962516, OASYS - Oral Airway System - K030440
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
Abbreviated 510(k) Summary
.
:
JUN – 2 2006
.
| Device Type: | Sleep Apnea/Anti-Snoring Device |
|---|---|
| Applicant: | O'Brien Dental Lab, Inc. |
| Contact person: | Suzie Downing |
| Executive Assistant | |
| 541-754-1238 (office) | |
| 541-754-7478 (fax) | |
| suzie@obrien-dl.com | |
| MD#: | 6025024-956733 |
| Trade Name: | O'Brien MPA |
| Common Name: | Oral Appliance / Anti-Snoring Device |
| Classification Name: Anti-Snoring Device | |
| Classification Reg .: | Class II (special controls) |
| Panel: | Dental |
| Product Code: | LRK |
| Predicate Devices: | SUAD - K023836 |
| TAP - K962516 | |
| OASYS - Oral Airway System - K030440 | |
| Description: | The O'Brien MPA is made of thermal plastic material (ADA |
| approved materials). It is a very simple device that fits snugly over | |
| the upper and lower anterior teeth in such a way as to keep the | |
| mandible in a stationary, anterior protrusive position. The reason | |
| for this is to physically open the airway and thus potentially reduce | |
| the occurrence of snoring and sleep apnea. (This theory of airway | |
| management is common, standard operating procedures in the | |
| emergency medical field for airway management purposes.) The | |
| device also includes air channels to allow breathing through the | |
| mouth. | |
| Intended Use: | The O'Brien MPA is intended to reduce snoring and to treat mild |
| to moderate obstructive sleep apnea. This individually fabricated, | |
| non-sterile prescription device is a single patient, multi-use product | |
| for use at home or in a sleep laboratory. |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: the HHS symbol and the department's name. The HHS symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
Ms. Suzie Downing Executive Assistant O' Brien Dental Lab, Incorporated 4311 SW Research Way Corvallis, Oregon 97333
Re: K060744
Trade/Device Name: O'Brien MPA (Mandibular Positioning Appliance) Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 19, 2006 Received: May 23, 2006
Dear Ms. Downing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Downing
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
for Susan Runne
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):_ K060744
Device Name: __ O'Brien MPA (Mandibular Positioning Appliance)
Indications For Use: The O'Brien MPA is intended to reduce snoring and to treat mild to moderate OSA (obstructive sleep apnea). This individually fabricated, non-sterile, prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Susan Runyer
Size ( 11) n of Anasthesiology, General Hospital, Control, Dental Devices
Number. K060744