(632 days)
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.
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.
The provided 510(k) summary for the GERGEN'S ORTHODONTIC LAB INC. Acrylic Herbst Appliance (K113126) does not include specific acceptance criteria or a dedicated study demonstrating the device meets quantitative performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance."
Therefore, based on the provided text, I cannot complete the requested tables and sections with quantitative acceptance criteria or a study proving those criteria are met for performance of the device in its intended clinical use. However, I can extract information related to the device's technical characteristics and the comparison to predicate devices, which forms the basis of its clearance.
Here's a breakdown of what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study":
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there are no quantitative clinical acceptance criteria or reported clinical performance metrics for the subject device in this document. The "performance data" mentioned refers only to material properties.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as presented in the 510(k) summary) |
|---|---|
| Device has the same intended use as predicate devices. | 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. (This matches the intended use of predicate devices). |
| Device has the same technological characteristics as predicate devices (design, function, materials, adjustability, manufacturing method, sterility). | Technological Characteristics: The Acrylic Herbst Appliance shares the same basic design (upper and lower trays with bilateral Herbst mechanisms), function (increase pharyngeal space by anterior mandibular repositioning), materials (medical grade acrylic and stainless steel), adjustability, method of manufacture (customized), and sterility (non-sterile) as its predicate devices. |
| Device material properties are suitable. | Material Properties: Data supporting general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus) were provided. (Specific values are not detailed in the summary). |
| Device poses no new safety concerns. | Risk Analysis: A risk analysis found no new safety concerns specific to the Gergen's Orthodontic Acrylic Herbst Appliance. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used for the subject device's clearance. The clearance is based on substantial equivalence to predicate devices, not on a direct clinical study of the subject device.
- Data Provenance: Not applicable for a clinical test set. The data provenance for material properties is not specified beyond "provided in support of clearance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set was used for this device's clearance.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used for this device's clearance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an anti-snoring appliance, not an AI-powered diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable for clinical performance. The "ground truth" for the device's clearance is its demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices, which are presumed safe and effective.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets "acceptance criteria" (in the context of this 510(k) submission) is a comparison to predicate devices (Allesee Orthodontic Appliances, Inc. (K070327), Specialty Appliances Works, Inc. (K083209), Dynaflex Inc. (K103076), and Embassy Dental (K111009)). The submission states:
"Clinical testing of the subject device was not used in support of clearance."
"The fundamental scientific technology of the Gergen's Orthodontic Acrylic Herbst Appliance is the same as previously cleared devices... i.e., each of the design features is common to one or more of the predicate devices."
"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 "proof" is the argument for substantial equivalence based on shared fundamental technology, intended use, and material properties, rather than direct clinical performance data for the subject device itself.
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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 andobstructive sleep apnea | ||
| Device Product Code: | LRK | ||
| Device Description: | The Acrylic Herbst Appliance is comprised of upper and lower customizedacrylic splints which are connected bilaterally via a telescoping Herbstmechanism for the treatment of mild to moderate sleep apnea. | ||
| The device aims to improve the patient's air exchange thereby reducesnoring and apnea by increasing the pharyngeal space through anteriorrepositioning of the mandible. | |||
| Intended Use: | The Acrylic Herbst Appliance is intended for the reduction of night timesnoring and mild to moderate obstructive sleep apnea (OSA) in adults 18years 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 insupport of clearance. The data included general properties (water solubilityand absorption) and physical properties (tensile and flexural strength, andelastic modulus). | ||
| In addition, a risk analysis found no new safety concerns specific to theGergen's Orthodontic Acrylic Herbst Appliance. | |||
| Clinical testing of the subject device was not used in support of clearance. | |||
| TechnologicalCharacteristics: | The fundamental scientific technology of the Gergen's Orthodontic AcrylicHerbst Appliance is the same as previously cleared devices as shownbelow, i.e., each of the design features is common to one or more of the |
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| System: | Gergen'sOrthodontic -Acrylic HerbstAppliance | EmbassyDental -AcrylicHerbstAppliance | AlleseeOrthodontic- RemovableAcrylicHerbst | SpecialtyAppliances -AcrylicHerbst SplintAppliance | Dynaflex Inc.- AdjustableHerbstAppliance |
|---|---|---|---|---|---|
| Intendeduse/Indicationsfor use :: | The reduction of nighttime snoring and mildto moderateobstructive sleepapnea (OSA) | Same - | Same | Same | Same |
| Target population: | Adults | Same | Same | Same | Same |
| Prescription use: | Prescription only | Same | Same | Same | Same |
| Basic Design: | Upper and lowertrays connectedbilaterally bytelescoping Herbstmechanisms | Same | Same | Same | Same |
| Function: | To increase thepatient's thepharyngeal spaceand improve airexchange therebyreduce snoring andapnea by anteriorrepositioning of themandible | Same | Same | Same | Same |
| Materials ofmanufacture: | Medical grade acrylicand stainless steel | Same | Same | Same | Same |
| Adjustability: | Yes, by prescribingdentist or physician | Same | Same | Same | Same |
| Method ofmanufacture: | Customized to thespecifications of asingle 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.
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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.
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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
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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
§ 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.”