(245 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a custom-fit ear insert, with no mention of AI, ML, or data processing for decision-making or analysis.
Yes
The device is indicated as an aid in reducing temporomandibular disorder (TMD) pain, which is a therapeutic claim.
No
The device is indicated as an aid in reducing temporomandibular disorder (TMD) pain, making it a therapeutic device rather than a diagnostic one.
No
The device description explicitly states the device is comprised of physical ear inserts made of medical grade polymers, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the CID is a physical device (ear inserts) intended to be worn by the patient to reduce pain associated with temporomandibular disorder (TMD). It does not involve testing any biological samples.
- Mechanism of Action: The device works by being physically placed in the ear canal to potentially influence the temporomandibular joint, not by analyzing biological markers.
The information provided describes a medical device used for treatment and pain management, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The CID is indicated as an aid in reducing temporomandibular disorder (TMD) pain.
Product codes
MQC
Device Description
The CID is comprised of a pair of small, hollow, ear inserts made of medical grade polymers that is custom-fit to each subject's ear canals. It is constructed from methacrylate polymers and similar rigid plastics that have been safely used in commercially available hearing aids for decades. The CID is designed to rest in the outer third of the ear canal and has a small retraction post that allows for ease of removal of the device from the ear canal. It is designed to conform to the shape of the ear canal when the jaw is in a slightly open position.
The CID represents a non-invasive, reversible treatment modality. The ear canal is in immediate anatomical proximity to the temporomandibular joint (TMJ). The position of the condyle and disc within the TMJ, relative to the ear canal, differs depending on whether the jaw is in an opened or closed position, and a change in the configuration of the ear canal also accompanies the opening or closing of the jaw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Targeted to relieve tension in temporomandibular joint (TMJ) - positioned in ear canal during patient use (i.e., "near-field" to TMJ)
Indicated Patient Age Range
Patients with or susceptible to TMD
Intended User / Care Setting
Not Found
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
The safety and effectiveness of the CID, as well as the stabilization splint predicate comparison devices, in treating subjects with temporomandibular disorders was evaluated in a prospective, open-label, three-arm, randomized, unblinded clinical trial with a pre-treatment screening phase, baseline visit and three-month treatment phase. The study specifically addressed patients with TMD diagnoses (RDC/TMD criteria) included at least one of the following: myofascial pain; arthralgia, or disc displacement with reduction; and a screening VAS pain score of >4. The distribution of RDC/TMD diagnoses was very similar in all 3 treatment groups: I:Myofascial Pain (97-100%); II-a:Disc Displacement with Reduction (45-48%); and III-a: Arthralgia (55-61%). The study included 60 patients in the CID group, 64 patients in the stabilization splint group, and 28 patients in the jaw exercise regimen group. Patients in the CID group wore the device for an average of 18 hours per day in the first month, 20 hours per day in the second month and 21 hours per day in the third month.
The CID demonstrated statistically significant non-inferiority to the stabilization splint (p=0.0096), as assessed by reduction of Craniomandibular Index (CMI) scores from baseline to 3 months [primary efficacy objective]. The CMI scores were reduced in all treatment groups at 1, 2 and 3 months (with lower CMI scores representing reduced pain and dysfunction). Although the differences between study groups did not rise to the level of statistical significance, the average percentage changes in CMI scores from baseline to 1 month were: CID 27% reduction, stabilization splint 20% reduction, and jaw exercise regimen 12% reduction; and from baseline to 3 months, the percentage changes in CMI scores were: CID 45% reduction, stabilization splint 41% reduction, and jaw exercise regimen 36% reduction.
Statistically significant reductions from baseline in TMD pain, as assessed by in-office VAS (visual analog scale) scores, were also demonstrated for the CID device, with a 46% reduction at 1 month (p
N/A
0
510(k) SUMMARY
Clayton Intra-aural Device (CID)
FEB 2 4 2010
1. Submitter's Identification:
Ascentia Health, Inc. 5330 Parliament Place Rockford, Illinois 61107 815.519.6939
Contact Person: Roger Wixtrom, Ph.D. 703.646.5820 (office) 703.646.5821 (fax)
2. Date Summary Prepared:
February 16, 2010
3. Name of the Device:
| Common Name: | Intra-aural Appliance |
|---|---|
| Proprietary Name: | Clayton Intra-aural Device (CID) |
4. Predicate Device Information:
The CID is substantially equivalent to the following predicate devices:
Custom-fit flat plane occlusal appliances (also referred to as stabilization 1. splints or mouthguards) "individually fabricated for each patient by dentists in their offices since at least the 1940s;" and
NTI-Clenching Suppression System (K981546), Heraeus Kulzer, 2. Incorporated.
5. Device Description:
The CID is comprised of a pair of small, hollow, ear inserts made of medical grade polymers that is custom-fit to each subject's ear canals. It is constructed from methacrylate polymers and similar rigid plastics that have been safely used in commercially available hearing aids for decades. The CID is designed to rest in the outer third of the ear canal and has a small retraction post that allows for ease of removal of the device from the ear canal. It is designed to conform to the shape of the ear canal when the jaw is in a slightly open position.
The CID represents a non-invasive, reversible treatment modality. The ear canal is in immediate anatomical proximity to the temporomandibular joint (TMJ). The position of the condyle and disc within the TMJ, relative to the ear canal, differs depending on whether the jaw is in an opened or closed position,
1
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and a change in the configuration of the ear canal also accompanies the opening or closing of the jaw.
6. Intended Use:
The CID is indicated as an aid in reducing temporomandibular disorder (TMD) pain.
7. Comparison to Predicate Devices:
| Characteristic | CID | Custom-fit Flat Plane
Occlusal Appliances
(Stabilization Splints) | NTI-Clenching
Suppression System
(K981546) |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | "The CID is indicated as an
aid in reducing
temporomandibular disorder
(TMD) pain." | "Stabilization splints are the
most widely used
treatments for TMJ disorders"
(NIDCR. 2006. TMJ
Disorders. NIH Publication .
No. 06-3487). | "For the prevention of chronic
tension and temporal
mandibular joint syndrome
that is caused by chronic
clenching of the posterior
mandibular and maxillary
teeth by the temporalis
muscle. The device is
custom made for the
individual." |
| Target
population | Patients with or susceptible to
TMD | Patients with or susceptible to
TMD | Patients with or susceptible to
TMD |
| Anatomical site | Targeted to relieve tension in
temporomandibular joint
(TMJ) - positioned in ear
canal during patient use
(i.e., "near-field" to TMJ) | Targeted to relieve tension in
temporomandibular joint
(TMJ) -- positioned in mouth
during patient use
(i.e., "far-field" to TMJ) | Targeted to relieve tension in
temporomandibular joint
(TMJ) - positioned in mouth
during patient use
i.e., "far-field" to TMJ) |
| Reversibility of
treatment | Reversible, non-invasive
treatment | Reversible, non-invasive
treatment | Reversible, non-invasive
treatment |
| Rx vs. OTC | Prescription-only | Prescription-only | Prescription-only |
| Where used | Worn daily by patient | Worn daily by patient | Worn daily by patient |
| Materials,
biocompatibility
and chemical
safety | Methacrylate polymers and
similar rigid plastics that have
been safely used in
commercially available
hearing aids for decades. | Methacrylate polymers and
similar rigid polymers, as well
as soft polymers, that have a
long history of safe use in
stabilization splints | Polycarbonate plastic with
long history of safe use in
tissue contact applications |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile |
Comparison of Characteristics Between CID and Predicate Devices
With respect to the target population, indications for use and anatomical site, all three are targeted at patients experiencing or susceptible to temporomandibular disorders (TMD) and aim to reduce the tension on the temporomandibular joint (TMJ), with the CID acting on the TMJ from a somewhat closer location (the ear canal), as compared to the stabilization splints and NTI- Clenching Suppression
2
3074
System, which act from a more forward location between the teeth. All three provide the widely-recommended option of reversible, non-invasive treatments, are provided by prescription only and are typically worn on a daily basis by patients. The materials used to construct all three devices have a long history of safe use, without issues of chemical safety. Lastly, all three are provided non-sterile.
The strongest evidence supporting the substantial equivalence of the CID to the predicate devices is provided by the clinical testing of this device alongside the predicate device in a randomized clinical trial.
Based on the entire body of available information, including many similarities, as well as some differences, the latter of which have been demonstrated not to adversely affect safety and effectiveness, the comparison between the CID and the predicate devices demonstrates substantial equivalency.
8. Performance Data:
The safety and effectiveness of the CID, as well as the stabilization splint predicate comparison devices, in treating subjects with temporomandibular disorders was evaluated in a prospective, open-label, three-arm, randomized, unblinded clinical trial with a pre-treatment screening phase, baseline visit and three-month treatment phase. The study specifically addressed patients with TMD diagnoses (RDC/TMD criteria) included at least one of the following: myofascial pain; arthralgia, or disc displacement with reduction; and a screening VAS pain score of >4. The distribution of RDC/TMD diagnoses was very similar in all 3 treatment groups: I:Myofascial Pain (97-100%); II-a:Disc Displacement with Reduction (45-48%); and III-a: Arthralgia (55-61%). The study included 60 patients in the CID group, 64 patients in the stabilization splint group, and 28 patients in the jaw exercise regimen group. Patients in the CID group wore the device for an average of 18 hours per day in the first month, 20 hours per day in the second month and 21 hours per day in the third month.
The CID demonstrated statistically significant non-inferiority to the stabilization splint (p=0.0096), as assessed by reduction of Craniomandibular Index (CMI) scores from baseline to 3 months [primary efficacy objective]. The CMI scores were reduced in all treatment groups at 1, 2 and 3 months (with lower CMI scores representing reduced pain and dysfunction). Although the differences between study groups did not rise to the level of statistical significance, the average percentage changes in
3
CMI scores from baseline to 1 month were: CID 27% reduction, stabilization splint 20% reduction, and jaw exercise regimen 12% reduction; and from baseline to 3 months, the percentage changes in CMI scores were: CID 45% reduction, stabilization splint 41% reduction, and jaw exercise regimen 36% reduction.
Statistically significant reductions from baseline in TMD pain, as assessed by inoffice VAS (visual analog scale) scores, were also demonstrated for the CID device, with a 46% reduction at 1 month (p (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Renny
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091580 Page 1 of 1