(204 days)
Not Found
No
The description focuses on a mechanical device for repositioning the jaw and does not mention any computational or learning components.
Yes
The device is described as "intended for use in patients ... for the reduction of night time snoring and mild to moderate obstructive sleep apnea," which indicates a therapeutic purpose.
No
Explanation: The device description states its purpose is to increase air exchange and reduce snoring and apnea by repositioning the jaw, which is a treatment function, not a diagnostic one. No part of the description indicates it is used for detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is comprised of physical components: upper and lower patient-specific acrylic splints and a telescoping Herbst mechanism. It is a physical appliance, not software.
Based on the provided information, the Crane Acrylic Herbst Appliance 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.
- Device Function: The Crane Acrylic Herbst Appliance is a physical device worn by the patient to reposition the jaw and improve airflow. It does not perform any tests on biological samples.
- Intended Use: The intended use is for the reduction of snoring and sleep apnea by physically altering the jaw position, not by analyzing biological markers.
Therefore, the device falls under the category of a physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.
The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.
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)
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping profiles creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2014
Crane Dental Laboratory Inc. Ms. Kate Young Management Representative 200 Airpark Drive Suite 30 Rochester, New York 14624
Re: K140429
Trade/Device Name: Crane Acrylic Herbst Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral device for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK Dated: August 5, 2014 Received: August 14, 2014
Dear Ms. Young:
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 - Ms. Young
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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
510(k) Number (if known): K140429
Device Name: Crane Acrylic Herbst Appliance
Indications for Use:
The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Type of Use (Select one or both, as applicable)
Prescription Use V (Part 21 CFR 801 Subpart 0)
AND/OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CER 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiologic Health (CDRH)
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Revised 510(k) Summary
| Submission Owner: | Crane Dental Laboratory, Inc.
200 Airpark Drive, Suite 30
Rochester, New York 14624
Phone: (585) 730-5100
Fax: (585) 730-5095 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kate Young, Management Representative |
| Submission Date: | February 17, 2014 |
| Device Name: | Trade Name-Crane Acrylic Herbst Appliance |
| Regulation Description: | Intraoral device for snoring and mild to moderate
obstructive sleep apnea (OSA) |
| Classification: | DEVICE, ANTI-SNORING
Regulation- Number 21 CFR 872.5570, Intraoral devices
for snoring and obstructive sleep apnea
Definition- Regulation Medical Specialty-Dental
Review Panel- Dental
Product Code- LRK |
Substantial Equivalence is claimed to this Predicate Device:
- Respire Medical LLC- Respire Pink Series (K131138)
Device Description:
The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.
The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.
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Intended Use of the Device:
The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Risks to Health:
As noted below the design of the Crane Acrylic Herbst Appliance addresses the risks outlined in the Guidance Document: Class II Special Controls Guidance Document: Intraoral Device for Snoring and/or Sleep Apnea; Guidance for Industry and FDA issued on November 12, 2002.
Intraoral gingival, palatal or dental soreness:
As similar to the predicate device, The Crane Acrylic Herbst Appliance is a patient-specific custom dental device fitted to the upper and lower arches, constructed of medical grade acrylic to contact the teeth on the lingual, occlusal and buccal surfaces, and a small area of the supporting tissue and dental-alveolar structures during sleep. The device design distributes the force of the repositioning of the mandibular arch throughout the appliance and the entire arch and supporting structures. Because the dvice is designed to eliminate single-point contact with individual teeth and these supporting structures, it reduces the opportunity for gingival, palatal, or dental soreness. Taking dental undercuts into consideration, the device is manufactured to reduce any possible soreness to the teeth and supporting structures.
Temporomandibular Joint (TMJ) Dysfuntion Syndrome:
The Crane Acrylic Herbst Applaince increases the patient's pharyngeal space by projecting the mandible down and forward to prevent the tongue and soft tissues from impeding the airway. The appliance is adjustable using a titration key and screw in the Herbst Mechanism, which enables the jaw to be brought forward in small increments by the prescribing dentist. It is recognized by the dental community that this type of repositioning can also affect the temporomanidibular joint. The prescribing dentist should evaluate the TMJ prior to prescribing the Crane Acrylic Herbst Appliance to be sure the patient does not possess risk factors to the TMJ that may be aggravated by using the appliance. Patients do sometimes report sensation in the TMJ the first few initial uses of the appliance, but usually resolve with continued wear. The prescribing dentist can also adjust the position of the mandible by changing either the length of the Herbst mechanism or the thickness of the acrylic interproximally. Patients who continue to have TMJ pain or discomfort that does not resolve through continued use should decide with their dentist to discontinue treatment with this modality.
Obstruction of Oral Breathing:
The design of the Crane Acrylic Herbst Appliance will not obstruct oral breathing.
Loosening or Flaring of Lower Anterior Teeth or General Tooth Movement:
Full arch coverage of the Crane Acrylic Herbst Appliance helps to minimize these issues. The full arch design helps to reduce localized forces and pressure on individual teeth, or sections of teeth such as the lower anterior segment. The dentist can easily modify the amount of mandibular repositioning. This also helps to reduce the forces on the teeth and supporting alveolar structures.
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Material Composition:
- Medial Grade Acrylic-Polymethyl methacrylate Acrylic Splints. Methyl methacrylate has been used for decades in the dental industry and does not pose any known health hazards in its polymerized form.
- . Stainless Steel-Herbst mechanism and ball clasps (if requested by the dentist). Stainles steel is and accepted material for dental products.
Sustantial Equivalence:
The Craen Acrylic Herbst Appliance is substantially equivalent to other legally marketed devices in the United States. The Crane Acrylic Herbst Appliance has the same intended use and technological characteristics as the following device:
| Substantially Equivalent
Devices | Crane Dental Laboratory, Inc. Crane
Acrylic Herbst Appliance
[510(k) TBD] | Respire Medical, LLC Respire
Pink Series Herbst
(K131138) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use Indications
for Use | To reduce or alleviate nighttime snoring and
mild to moderate OSA | Same |
| Single or Multiple Use | Multiple | Same |
| Target Population | Adults age 18 and older | Same |
| Prescription usage | Prescription Only | Same |
| Basic Design | Upper and lower trays connected bilaterally via
Telescopic Herbst Mechanisms | Same |
| Device Functionality | Increase patient's pharyngeal space to improve
air exchange by repositioning the mandible
thus reducing snoring and mild to moderate
OSA | Same |
| Mandibular Advancement
Range | Up to 8mm | Same |
| Device Components | Medical grade acrylic splints and stainless steel
telescopic Herbst mechanisms | Same |
| Colorants | Red / Blue | Pink |
| Adjustability | By prescribing dentist or physician | Same |
| Method of Manufacture | Patient-specific Customization | Same |
| Sterility | Non-sterile | Same |
- Respire Medical LLC-Respire Pink Series Herbst (K131138) ●
Conclusion:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and same technological characteristics as the previously cleared predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The fundamental scientific technology and intended use of the Crane Acrylic Herbst appliance is the same as the above mentioned predicate device, and therefore raises no new safety and/or effectiveness issues.