(207 days)
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a mechanical mandibular repositioner.
Yes
The device is described as treating medical conditions (snoring and obstructive sleep apnea) and functions as a mandibular repositioner to improve air exchange, indicating a therapeutic purpose.
No
Explanation: The device is intended for the treatment of snoring and obstructive sleep apnea by repositioning the mandible to increase pharyngeal space, not for diagnosing these conditions.
No
The device description clearly states it is an "intraoral device" consisting of "two custom fitted trays" and "adjustable components," which are physical hardware components.
Based on the provided information, the Pantino Pro Positioner is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Pantino Pro Positioner Function: The Pantino Pro Positioner is an intraoral device that is physically placed inside the patient's mouth. Its function is to mechanically reposition the mandible to treat snoring and sleep apnea. It does not perform any tests on biological samples.
The device description clearly indicates it's a physical appliance used for a therapeutic purpose, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable components. The device functions as a mandibular repositioner, which acts to increase the patients Pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has adjustment mechanisms enabling the amount of mandibular advancement to be set by the dentist or physician at the time of the device fitting.
The Pantino Pro Positioner is offered in two model designs. The Pantino Pro "A" has a single interlocking mechanism centrically located on the anterior occlusal surface of the upper and lower arches. This design offers lateral movement of the maxillary and mandible for those patients who require this freedom of motion. The Pantino Pro "B" has dual interlocking mechanisms located parallel to one another on the left and right occlusal surfaces positioned as posterior as possible to maintain maximum protrusion and a comfortable fit for the patient. This model offers vertical adjustment control for those patients who require this dimension of vertical stability.
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
18 years of age or older.
Intended User / Care Setting
dentist or physician (for setting mandibular advancement)
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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510(K) SUMMARY
MAR 2 8 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information: Bradley Southworth
SomnoMed Inc. 3537 Teasley Ln Denton, Tx 76210
Tel: 1-940-381-5200 Fax: 1-940-566-3727 e-mail: bsouthworth@somnomed.com
Date Summary Prepared: 8/31/2010
Contact Persons: Bradley Southworth
Device Name:
Trade Name(s): Pantino Pro Positioner Classification Name: Intraoral Devices for Snoring and Intraoral Devices for Obstructive Sleep Apnea Panel: Dental Product Code: LRK
| Device Name | Manufacturer | 510(k) Reference |
|---|---|---|
| MAS RxA | SomnoMed Inc. | K050592 |
| TAP-T | Airway Management Inc. | K061732 |
| TAP III | Airway Management Inc. | K062951 |
Predicate Device Information:
Device Description: The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable components. The device functions as a mandibular repositioner, which acts to increase the patients Pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has adjustment mechanisms enabling the amount of mandibular advancement to be set by the dentist or physician at the time of the device fitting
The Pantino Pro Positioner is offered in two model designs. The Pantino Pro "A" has a single interlocking mechanism centrically located on the anterior occlusal surface of the upper and lower arches. This design offers lateral movement of the
1
maxillary and mandible for those patients who require this freedom of motion. The Pantino Pro "B" has dual interlocking mechanisms located parallel to one another on the left and right occlusal surfaces positioned as posterior as possible to maintain maximum protrusion and a comfortable fit for the patient. This model offers vertical adjustment control for those patients who require this dimension of vertical stability.
Intended Use: The Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Comparison to Predicate Device: The Pantino Pro Positioner is considered to be substantially equivalent to the SomnoMed MAS RxA, TAP III, and TAP-T devices. The Pantino Pro Positioner and the MAS RxA, TAP III, and the TAP-T are prescription custom made titratable mandibular repositioning devices for the dental treatment of patients suffering from snoring and obstructive sleep apnea.
The technical designs and manufacture of these devices are very similar, being composed of custom fitted acrylic trays which fit onto the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism. The only design difference is in the type of adjustable mechanisms used. The Pantino Pro Positioner, TAP III, and TAP-T use a male rail pin clasp on the upper portion of the device that insert into a a female interlocking rail clasp on the lower device that have a locking screw mechanism to set the correct amount of mandible protrusion. The SomnoMed RxA uses interlocking titratable screw lugs on the upper device aligned to the lower wings to achieve the correct amount of protrusion. The adjustment screws, hooks, and clasps used to manufacture the Pantino Pro Positioner have not been granted prior 510(k) approval for use in the manufacture of dental appliances; however the screws, hooks, and clasps are made of ATI Ti-6AI-4v ELI (Extra Low Inerstitals). This grade of titanium is used in biomedical applications such as surgical instruments and also orthopedic implants. The titanium screws, hooks, and clasps do not contain any lead, nickel, cadmium, or mercury in the alloy. The acrylic material used is the same as what is used to manufacture the SomnoMed MAS RxA and is cleared under K050592.. Also, the SMH Flex material used in the SomnoMed MAS RxA soft model and also will be used to manfucture the Pantino Pro "A" and "B" appliances is cleared under K073004.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Bradley Southworth Quality Assurance Manager SommoMed, Incorporated 3537 Teasley Lane Denton, Texas 76210
MAR 2 8 2011
Re: K102521
Trade/Device Name: Pantino Pro Positioner Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring Regulatory Class: II Product Code: LRK Dated: March 18, 2011 Received: March 18, 2011
Dear Mr. Southworth:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2- Mr. Southworth
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K 10252 510(k) Number (if known):
:
Device Name: Pantino Pro Positioner
The Pantino Pro Positioner is intended for the treatment of Indications for Use: nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
NO
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruan
(Division Sign-Off) Division of Anesthesiology. General Hospital Intection Control, Dental Devices
510(k) Number. K103521