(109 days)
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 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 provided document does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets such criteria.
The document is a 510(k) premarket notification for the Slow Wave DS8 device, which is an intraoral appliance indicated for the treatment of sleep bruxism and associated tension/migraine type headaches. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies.
The document explicitly states in section 1.8.1 "Clinical Studies": "Clinical testing was not necessary for the demonstration of substantial equivalence." This means there was no study conducted to measure and report device performance against acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on comparing the Slow Wave DS8 to a predicate device (Luco Hybrid OSA Appliance K160477) and reference devices (Formlabs Dental LT Clear V2 K222061 and Slow Wave DS8 K191320) based on characteristics like classification, product code, indications for use, prescription status, target population, use of device, principle of operation, features, material properties, materials, manufacturing method, and sterility. The "Performance Data" section (1.8) only states that "Performance requirements were determined through an assessment of the physical properties of the device," implying engineering or material testing, not clinical performance data against specific acceptance criteria relevant to the device's therapeutic claims.
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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"
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(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).
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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
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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)
< | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 WagnerCEO |
| 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 DeviceSlow Wave DS8 | Predicate DeviceLuco Hybrid OSAAppliance (K160477) | Comparison | Reference DeviceFormlabs Dental LT Clear V2(K222061) | Reference DeviceSlow 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 forUse | The Slow Wave DS8 is indicatedfor the treatment of sleep bruxismand as an aid in the treatment ofassociated tension/migraine typeheadaches in adults over the age of18. | The Luco Hybrid OSAAppliance is indicated for: 1.A device to be used for thetreatment of sleep bruxismand 2. As an aid in thetreatment of associatedtension/migraine typeheadaches in adults. | Identical | Dental Clear LT V2 Resin whenutilized to print dental ororthodontic appliances such asocclusal splints, night guards, ormouth guards is indicated totreat patients diagnosed withTemporomandibular JointDisorders (TMD) and/orBruxism, respectively | Intended to reduce oralleviate snoring, mild tomoderate Obstructive SleepApnea (OSA) while sleepingin adults. |
| PrescriptionStatus | Prescription Only | Prescription Only | Identical | Prescription Only | Prescription Only |
| TargetPopulation | Adults | Adults | Identical | Adults | Adults |
| Use of Device | Removable intraoral device. Singlepatient 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 OSAAppliance (K160477) | Formlabs Dental LT Clear V2(K222061) | Slow Wave DS8 (K191320) | ||
| Principle ofOperation | The Slow Wave DS8 is apersonalized appliance designed toprotect against bruxism forces andrelief from associated discomfort. Itcreates a physical separationbetween upper and lower teeth,preventing damage from grindingand clenching. The applianceaddresses muscle tension andheadaches related to bruxism.Customized through intraoral scans,it ensures an optimal fit andfunctionality. | This patient-specific devicefunctions as a protectivebarrier for teeth andrestorations by creatingphysical separation betweenupper and lower toothsurfaces preventing toothdamage caused by bruxism(like grinding and clenching)and alleviating muscle andtension headache pains. | Substantiallyequivalent | Light-curable polymer-basedresin designed for thefabrication of biocompatible,long-term use, removable dentaland orthodontic appliances byadditive manufacturing | Adjustment of the relativeposition of the ramps guidesthe mandible forward andmaintains advancement thusenlarging the airway. Thevertical opening of the jaw isnot fixed in a single position.Traction-based mandibularrepositioning device, allowsnasal and/or oral breathing |
| Features | • Mandibular and Maxillary arch• Vertical opening | • Mandibular andMaxillary arch• Vertical opening | Identical | N/A | • Mandibular andMaxillary arch• Vertical opening |
| MaterialProperties | Compliant with ISO 20795-2 | Unknown | SubstantiallyEquivalent | Compliant with ISO 20795-2 | Compliant with ISO 20795-2 |
| Materials | Formlabs Dental LT Clear V2 | Methyl methacrylate, chromecobalt, medical grade stainlesssteel | SubstantiallyEquivalent | Formlabs Dental LT Clear V2 | Formlabs Dental LT ClearV2 |
| ManufacturingMethod | CAD/CAM3D printing (additive) | Casting | SubstantiallyEquivalent | CAD/CAM3D printing (additive) | CAD/CAM3D printing (additive) |
| ProvidedSterile | No | No | Identical | No | No |
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Slow Wave
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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.
N/A