(109 days)
No
The device description focuses on the physical properties and function of an intraoral appliance for bruxism, with no mention of AI or ML technologies. The manufacturing process (3D printing) and performance studies described are based on physical properties and equivalence to predicate devices, not algorithmic performance.
Yes
The device is indicated for the treatment of sleep bruxism and associated headaches. Products that treat, mitigate, or prevent diseases or conditions are considered therapeutic.
No
The device description and intended use clearly state that the Slow Wave DS8 is an "intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces" and is "indicated for the treatment of sleep bruxism." It acts as a physical barrier and treats symptoms, rather than diagnosing conditions.
No
The device description clearly states it is an "intraoral appliance" consisting of "two trays worn on the maxilla and mandible," which are physical hardware components. The manufacturing process using a 3D printer also confirms it is a physical device, not software only.
Based on the provided information, the Slow Wave DS8 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of sleep bruxism and associated headaches. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an intraoral appliance designed to physically protect teeth and reduce muscle tension. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Slow Wave DS8 does not fit this description.
N/A
Intended Use / Indications for Use
The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.
Product codes (comma separated list FDA assigned to the subject device)
MQC, OCO
Device Description
The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The Slow Wave DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured using additive manufacturing, specifically on a 3D stereolithography (SLA) printer made by Formlabs using Dental LT Clear V2 (K222061).
The trays are designed to be an exact custom fit from a digital intraoral scan of the user. A digital scan of the user's dentition using a 3Shape or comparable intraoral scanner, registering one's full impressions of the upper and lower teeth is used to create the trays are shaped like an arch where the covered portions are connected to each other by two palatal bands, one connecting the upper tray, and the other connecting the lower tray leaving the tips of the front teeth exposed.
Additionally, each design is manufactured to be patient specific, ensuring that the device can be precisely tailored to meet the unique requirements of each individual.
Beyond the Slow Wave DS8's preventive role, the device also addresses the discomfort associated with various bruxism-induced issues. By minimizing direct contact and impact, it contributes to the alleviation of muscle tension and headaches, providing a holistic solution to the multifaceted challenges posed by bruxism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital intraoral scan
Anatomical Site
maxilla and mandible (teeth)
Indicated Patient Age Range
adults over the age of 18
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance requirements were determined through an assessment of the physical properties of the device. The assessment of the Slow Wave DS8's ability to achieve its intended use concluded that the appliance meets the same specifications as both reference devices and is substantially equivalent to the primary predicate.
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2024
Slow Wave Inc. Sam Murray Principal Consultant 26100 Countryside Dr. Spicewood, Texas 78669
Re: K240463
Trade/Device Name: Slow Wave DS8 (SWDS802) Regulatory Class: Unclassified Product Code: MQC, OCO Dated: February 16, 2024 Received: February 16, 2024
Dear Sam Murray:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Slow Wave DS8 (SWDS802)
Indications for Use (Describe)
The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Slow Wave
510(K) SUMMARY 1.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
1.1. Submitter's Information
| Name: | Slow Wave Inc. |
|---|---|
| Address: | 26100 Countryside Dr. |
| Spicewood, Texas 78669 | |
| Phone: | (210) 379-6269 |
| Contact Person: | Wayne Wagner |
| CEO | |
| Preparation Date: | 5 May 2024 |
1.2. Device Name
| Trade Name: | Slow Wave DS8 |
|---|---|
| Common Name: | Mouthguard |
| Classification Name: | Unclassified, Pre-amendment |
| Regulation | N/A |
| Regulatory Class: | N/A |
| Product Code | MQC, OCO |
1.3. Legally Marketed Predicate Device
The legally marked predicate is the Luco Hybrid OSA Appliance (K160477)
1.4. Device Description
The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
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Slow Wave
1.4.1. Brief Written Description of the Device
The Slow Wave DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured using additive manufacturing, specifically on a 3D stereolithography (SLA) printer made by Formlabs using Dental LT Clear V2 (K222061).
The trays are designed to be an exact custom fit from a digital intraoral scan of the user. A digital scan of the user's dentition using a 3Shape or comparable intraoral scanner, registering one's full impressions of the upper and lower teeth is used to create the trays are shaped like an arch where the covered portions are connected to each other by two palatal bands, one connecting the upper tray, and the other connecting the lower tray leaving the tips of the front teeth exposed.
Additionally, each design is manufactured to be patient specific, ensuring that the device can be precisely tailored to meet the unique requirements of each individual.
Beyond the Slow Wave DS8's preventive role, the device also addresses the discomfort associated with various bruxism-induced issues. By minimizing direct contact and impact, it contributes to the alleviation of muscle tension and headaches, providing a holistic solution to the multifaceted challenges posed by bruxism.
1.4.2. Materials of Use
The Slow Wave DS8 is additively manufactured by SLA (Formlabs Inc.) utilizing the medical-grade, acrylate-based photopolymer Dental LT Clear V2/BioMed Clear (Formlabs Inc.) (K222061).
Intended Use 1.5.
The Slow Wave DS8 is intended for protection of teeth and restorations.
Indications for Use 1.6.
The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.
1.7. Substantial Equivalence Discussion
The Slow Wave DS8 has the same intended use and technological characteristics as the predicate device. Differences in materials and manufacturing methods have been addressed through verification by analysis and do not raise questions of safety and effectiveness; the subject device is substantially equivalent to the predicate device. A comparison of the similarities and differences of the Slow Wave DS8 and cleared predicate are provided in Table 1.
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Slow Wave
Table 1: Predicate Comparison
| Specification/
Characteristic | Subject Device
Slow Wave DS8 | Predicate Device
Luco Hybrid OSA
Appliance (K160477) | Comparison | Reference Device
Formlabs Dental LT Clear V2
(K222061) | Reference Device
Slow Wave DS8 (K191320) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Unclassified | Unclassified | Identical | Unclassified | 21 CFR 872.5570 |
| Product Code | MQC, OCO | MQC, OCO | Identical | MQC, KMY, DYT | LQZ, LRK |
| Indications for
Use | The Slow Wave DS8 is indicated
for the treatment of sleep bruxism
and as an aid in the treatment of
associated tension/migraine type
headaches in adults over the age of
18. | The Luco Hybrid OSA
Appliance is indicated for: 1.
A device to be used for the
treatment of sleep bruxism
and 2. As an aid in the
treatment of associated
tension/migraine type
headaches in adults. | Identical | Dental Clear LT V2 Resin when
utilized to print dental or
orthodontic appliances such as
occlusal splints, night guards, or
mouth guards is indicated to
treat patients diagnosed with
Temporomandibular Joint
Disorders (TMD) and/or
Bruxism, respectively | Intended to reduce or
alleviate snoring, mild to
moderate Obstructive Sleep
Apnea (OSA) while sleeping
in adults. |
| Prescription
Status | Prescription Only | Prescription Only | Identical | Prescription Only | Prescription Only |
| Target
Population | Adults | Adults | Identical | Adults | Adults |
| Use of Device | Removable intraoral device. Single
patient multiple use. | Removable intraoral device.
Single patient multiple use. | Identical | 3D Printing Resin | Removable intraoral device.
Single patient multiple use. |
| Specification/
Characteristic | Subject Device | Predicate Device | Comparison | Reference Device | Reference Device |
| | Slow Wave DS8 | Luco Hybrid OSA
Appliance (K160477) | | Formlabs Dental LT Clear V2
(K222061) | Slow Wave DS8 (K191320) |
| Principle of
Operation | The Slow Wave DS8 is a
personalized appliance designed to
protect against bruxism forces and
relief from associated discomfort. It
creates a physical separation
between upper and lower teeth,
preventing damage from grinding
and clenching. The appliance
addresses muscle tension and
headaches related to bruxism.
Customized through intraoral scans,
it ensures an optimal fit and
functionality. | This patient-specific device
functions as a protective
barrier for teeth and
restorations by creating
physical separation between
upper and lower tooth
surfaces preventing tooth
damage caused by bruxism
(like grinding and clenching)
and alleviating muscle and
tension headache pains. | Substantially
equivalent | Light-curable polymer-based
resin designed for the
fabrication of biocompatible,
long-term use, removable dental
and orthodontic appliances by
additive manufacturing | Adjustment of the relative
position of the ramps guides
the mandible forward and
maintains advancement thus
enlarging the airway. The
vertical opening of the jaw is
not fixed in a single position.
Traction-based mandibular
repositioning device, allows
nasal and/or oral breathing |
| Features | • Mandibular and Maxillary arch
• Vertical opening | • Mandibular and
Maxillary arch
• Vertical opening | Identical | N/A | • Mandibular and
Maxillary arch
• Vertical opening |
| Material
Properties | Compliant with ISO 20795-2 | Unknown | Substantially
Equivalent | Compliant with ISO 20795-2 | Compliant with ISO 20795-2 |
| Materials | Formlabs Dental LT Clear V2 | Methyl methacrylate, chrome
cobalt, medical grade stainless
steel | Substantially
Equivalent | Formlabs Dental LT Clear V2 | Formlabs Dental LT Clear
V2 |
| Manufacturing
Method | CAD/CAM
3D printing (additive) | Casting | Substantially
Equivalent | CAD/CAM
3D printing (additive) | CAD/CAM
3D printing (additive) |
| Provided
Sterile | No | No | Identical | No | No |
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Slow Wave
8
Image /page/8/Picture/0 description: The image contains the words "Slow Wave" in a stylized, cursive font. The text is a shade of blue. The words are arranged horizontally, with "Slow" on the left and "Wave" on the right.
1.7.1. Statement on Substantial Equivalence
The proposed device and predicate device are both oral appliances devices with the same intended purpose. The proposed device and predicate share the same fundamental features. They are patient-specific dental appliances with a mandibular and maxillary arch which covers the top and bottom teeth allowing for a vertical opening. They are non-sterile appliances used intraorally by a single patient.
1.8. Performance Data
Performance requirements were determined through an assessment of the physical properties of the device. The assessment of the Slow Wave DS8's ability to achieve its intended use concluded that the appliance meets the same specifications as both reference devices and is substantially equivalent to the primary predicate.
1.8.1. Clinical Studies
Clinical testing was not necessary for the demonstration of substantial equivalence.
Conclusions 1.9.
The Slow Wave DS8 has the same intended use and technological characteristics as the predicate device. Differences in materials and manufacturing methods have been addressed through verification by analysis and do not raise questions of safety and effectiveness; the subject device is substantially equivalent to the predicate device.