(632 days)
Not Found
No
The summary describes a physical, mechanical device (an oral appliance) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Not Found" entries for AI/ML mentions, training/test sets, and performance metrics further support this conclusion.
Yes
The device is intended for the treatment of obstructive sleep apnea (OSA) and aims to improve air exchange, which are therapeutic interventions.
No
The device is described as an "Acrylic Herbst Appliance" intended for "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)" by physically repositioning the mandible to improve air exchange. This indicates a therapeutic or treatment-oriented function, not a diagnostic one.
No
The device description explicitly states it is comprised of "upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The Acrylic Herbst Appliance is a physical device worn by the patient to reposition the mandible and improve airflow. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for the reduction of snoring and sleep apnea by physically altering the patient's anatomy, not by analyzing biological samples.
Therefore, the Acrylic Herbst Appliance falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Acrylic Herbst Appliance is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
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
Prescribing dentist or physician
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)
Data regarding performance testing of the device material was provided in support of clearance. The data included general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus).
In addition, a risk analysis found no new safety concerns specific to the Gergen's Orthodontic Acrylic Herbst Appliance.
Clinical testing of the subject device was not used in support of clearance.
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.
K070327, K083209, K103076, K111009
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 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.”
0
K113126
510(k) Summary
| 510(k) Summary | JUL 1 7 2013 | ||
|---|---|---|---|
| Date: | 5 June 2013 | ||
| Sponsor: | GERGEN'S ORTHODONTIC LAB INC | ||
| 1745 West Deer Valley Rd, Suite 112 | |||
| Phoenix, AZ 85027 | |||
| Phone: | 623-879-6066 | ||
| Fax: | 623-879-6166 | ||
| Contact Person: | Chris Morrison, Lab Manager | ||
| Proposed Trade Name: | Acrylic Herbst Appliance | ||
| Common Name: | Anti-snoring appliance | ||
| Device Classification | Class II | ||
| Classification Name: | Device, Anti-Snoring | ||
| Regulation and Name: | 872.5570, Intraoral devices for snoring and intraoral devices for snoring and | ||
| obstructive sleep apnea | |||
| Device Product Code: | LRK | ||
| Device Description: | The Acrylic Herbst Appliance is comprised of upper and lower customized | ||
| acrylic splints which are connected bilaterally via a telescoping Herbst | |||
| mechanism for the treatment of mild to moderate sleep apnea. | |||
| The device aims to improve the patient's air exchange thereby reduce | |||
| snoring and apnea by increasing the pharyngeal space through anterior | |||
| repositioning of the mandible. | |||
| Intended Use: | The Acrylic Herbst Appliance is intended for the reduction of night time | ||
| snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 | |||
| years of age or older. | |||
| Materials: | Medical grade polymethylmethacrylate (acrylic splints) and stainless steel | ||
| (Herbst mechanism) | |||
| Predicate Devices: | Allesee Orthodontic Appliances, Inc. (K070327) | ||
| Specialty Appliances Works, Inc. (K083209) | |||
| Dynaflex Inc. (K103076) | |||
| Embassy Dental (K111009) | |||
| Performance Data: | Data regarding performance testing of the device material was provided in | ||
| support of clearance. The data included general properties (water solubility | |||
| and absorption) and physical properties (tensile and flexural strength, and | |||
| elastic modulus). | |||
| In addition, a risk analysis found no new safety concerns specific to the | |||
| Gergen's Orthodontic Acrylic Herbst Appliance. | |||
| Clinical testing of the subject device was not used in support of clearance. | |||
| Technological | |||
| Characteristics: | The fundamental scientific technology of the Gergen's Orthodontic Acrylic | ||
| Herbst Appliance is the same as previously cleared devices as shown | |||
| below, i.e., each of the design features is common to one or more of the |
1
| System: | Gergen's
Orthodontic -
Acrylic Herbst
Appliance | Embassy
Dental -
Acrylic
Herbst
Appliance | Allesee
Orthodontic
- Removable
Acrylic
Herbst | Specialty
Appliances -
Acrylic
Herbst Splint
Appliance | Dynaflex Inc. - Adjustable
Herbst
Appliance |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------|
| Intended
use/Indications
for use :: | The reduction of night
time snoring and mild
to moderate
obstructive sleep
apnea (OSA) | Same - | Same | Same | Same |
| Target population: | Adults | Same | Same | Same | Same |
| Prescription use: | Prescription only | Same | Same | Same | Same |
| Basic Design: | Upper and lower
trays connected
bilaterally by
telescoping Herbst
mechanisms | Same | Same | Same | Same |
| Function: | To increase the
patient's the
pharyngeal space
and improve air
exchange thereby
reduce snoring and
apnea by anterior
repositioning of the
mandible | Same | Same | Same | Same |
| Materials of
manufacture: | Medical grade acrylic
and stainless steel | Same | Same | Same | Same |
| Adjustability: | Yes, by prescribing
dentist or physician | Same | Same | Same | Same |
| Method of
manufacture: | Customized to the
specifications of a
single patient | Same | Same | Same | Same |
| Sterility: | Non-sterile | Same | Same | Same | Same |
Conclusion:
In comparison to the predicate devices, the Acrylic Herbst Appliance has
- the same intended use (as described above), .
- ◆ the same technological characteristics (as described above)
and so does not raise new questions of safety and effectiveness.
Therefore the Acrylic Herbst Appliance is as safe and as effective for its intended use, and performs as well as the predicate devices. The Acrylic Herbst Appliance can be found substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G68 Silver Spring, MD 20993-0002
July 17, 2013
Gergens Orthodontic Lab C/O Karen E. Warden, Ph.D. President BackRoads Consulting, Incorporated 11825 Sate Route 40 Suite 101 DUNLAP IL 61525
Re: K113126
Trade/Device Name: Acrylic Herbst Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: June 5, 2013 Received: June 6, 2013
Dear Dr. Warden:
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: CDRII 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.
3
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Image /page/3/Picture/6 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a signature or a name tag.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
GERGENS ORTHODONTIC LAB INC
1745 West Deer Valley Rd Suite 112 Phoenix, AZ 85027
510(k) Number: K113126
Device Name: Acrylic Herbst Appliance
Indications for Use:
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
| Prescription Use | X |
|---|---|
| AND/OR Over-the-Counter Use | |
| 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mary S. Runner -S | |
|---|---|
| Susan Runner DDS, MA 2013.07.17 | |
| 15:48:43 -04'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K113126 |
|---|---|
| ---------------- | --------- |
Gergens Othodontic Lab, Inc