(506 days)
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured at Slow Wave facilities using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors) uncovered. The trays are shaped like arch because the covered portion of the device is connected to each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray.
Additionally, the trays are built with ramps that guide the mandible forward and downward, thus maintaining advancement, enlarging the airway, allowing more room for the tongue to migrate forward naturally. The vertical opening of the jaw is not fixed in a single position. DS8 is a traction-based mandibular repositioning device that allows nasal and/or oral breathing.
The provided text is a 510(k) Premarket Notification summary for the Slow Wave DS8 device. It evaluates the substantial equivalence of the Slow Wave DS8 to legally marketed predicate devices, specifically the Panthera D-SAD and The NightBlocks Appliance.
However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical testing (e.g., clinical trials or performance assessments with ground truth and expert reviews). This type of detailed study showcasing device performance against defined acceptance criteria, often seen with AI/ML-driven medical devices, is not part of this 510(k) submission.
The 510(k) process for this device relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness. The document primarily focuses on comparing the Slow Wave DS8's features and operating principles to its predicates.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on claims of substantial equivalence rather than quantifying direct device performance against specific metrics.
- Sample size used for the test set and the data provenance: No "test set" in the context of an AI/ML performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert-established ground truth.
- Adjudication method for the test set: Not applicable.
- 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, as this device is a physical intraoral device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document explicitly states:
- "Animal or Human testing: No Animal or Human testing was conducted on DS8 device." This confirms that there were no clinical studies or human/animal trials to generate performance data for this submission. The biocompatibility assessment was performed on the material itself by Formlabs, not on the finished device in biological systems for efficacy.
In summary, this 510(k) submission primarily addresses the substantial equivalence of a physical medical device (intraoral device for snoring/sleep apnea) to predicate devices based on shared intended use and technological similarities, rather than demonstrating performance against specific acceptance criteria through empirical studies with test sets, ground truth, or expert evaluations.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 2, 2020
Slow Wave, Inc. Wayne Wagner President / Owner 26100 Countryside Dr. Spicewood, Texas 78669
Re: K191320
Trade/Device Name: Slow Wave DS8 Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LQZ, LRK Dated: September 17, 2020 Received: September 18, 2020
Dear Wayne Wagner:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
for Srinivas ''Nandu'' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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
510(k) Number (if known) K191320
Device Name Slow Wave DS8
Indications for Use (Describe)
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary
| 510k Owner: | Slow Wave, Inc. |
|---|---|
| 510k Owner Address: | 26100 Countryside Dr., Spicewood, TX 78669, USA |
| Owner: | Wayne R Wagner |
| Contact: | Valentina Ovalle |
| Phone: | (210)-379-6269 |
| Email: | tina@wagnerfamily.cc |
| Submission Correspondent: | Shree Koushik Ph.D. RACBDRA Consulting LLC1 Clearwater Court, Damascus, MD 20872 |
| Phone: | 301-922-7231 |
| Email: | shree@bdraga.com |
| Date Prepared: | October 1, 2020 |
| Device Trade Name: | Slow Wave DS8 |
| 510k Number: | K191320 |
| Primary Predicate: | |
| Device Name: | Panthera D-SAD |
| Classification Name: | Intraoral Devices for Snoring and Intraoral DevicesFor Snoring And Obstructive Sleep Apnea |
| 510k Number: | K142344 |
| Classification: | Class II |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LQZ, LRK |
| Review Panel: | Dental |
| Reference Device: | |
| Device Name: | The NightBlocks Appliance |
| Classification Name: | Intraoral Devices for Snoring and Intraoral DevicesFor Snoring And Obstructive Sleep Apnea |
| 510k Number: | K192581 |
| Classification: | Class II |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LQZ, LRK |
| Review Panel: | Dental |
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| Intended Use/Indications for Use: | Slow Wave DS8 device is intended to reduce oralleviate snoring, mild to moderate ObstructiveSleep Apnea while sleeping in adults. |
|---|---|
| Device Description: | DS8 consists of two trays worn on the maxilla andmandible. The device is manufactured at SlowWave facilities using additive manufacturing,specifically on a Formlabs 3D Printer utilizingstereolithography (SLA) using biocompatiblematerial.The trays are designed to be an exact custom fit bya trained dental technician, using a 3Shapeintraoral scanning device, or comparable intraoralscanner such as the iTero, or Cerec, registeringone's full impressions of the upper teeth, lowerteeth. A bite scan registration with a gap (typically8 mm), which is a crucial design feature. The gapresults from the design of the lower and uppertrays. The upper and lower trays, the molars,premolars, and canines, are covered by the device.However, the lateral or central incisors are notcovered, which effectively leaves eight teeth (fourmaxillary incisors and four mandibular incisors)uncovered. The trays are shaped like arch becausethe covered portion of the device is connected toeach other by two palatal bands one connectingthe upper left and upper tray, and the otherconnecting the lower tray.Additionally, the trays are built with ramps thatguide the mandible forward and downward, thusmaintaining advancement, enlarging the airway,allowing more room for the tongue to migrateforward naturally. The vertical opening of the jaw isnot fixed in a single position. DS8 is a traction-based mandibular repositioning device that allowsnasal and/or oral breathing. |
| Operating Principle: | The Slow Wave DS8 (K191320), is a mandibularrepositioning device that acts to increase the users'pharyngeal space and improves their ability toexchange air during sleep. The device consists of |
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two separate trays worn on the maxilla and mandible, which allow the user to:
- . Open and close their jaw when asleep
Provide full lateral movement of the mandible . Move the tongue forward to enhance air exchange during sleep.
The DS8 trays worn on the maxilla and mandible with integrally formed molar extensions forming forward-leaning left and right ramps configured so that when the apparatus is in a users' mouth, the ramps create a tendency for the lower tray, lower dentition and mandible to move in a normal downward position as they move back toward the users' throat, keeping users' airway open by maintaining an anterior Gap making more space for the tongue and helps to alleviate snoring and mild to moderate obstructive sleep apnea. Figure 1 and 2 provide pictorial representation of a blocked airway and DS8 mediated clearing of the blocked airway.
Biocompatibility: ISO 7405 and ISO 10993 compliant biocompatibility assessment on 3D printed material using Dental LT Clear V2 and BioMed Clear materials was completed by Formlabs. Based on the risk assessment Formlabs conducted, Cytotoxicity, Irritation, Sensitivity, acute systemic toxicity, subchronic systemic toxicity, genotoxicity and implantation studies. All tests passed and the material was deemed to be biocompatible for its intended use. Animal or Human testing: No Animal or Human testing was conducted on DS8 device. Substantial Equivalence:
Slow Wave DS8 has the same intended use as the predicate devices. Additionally, the differences in technological characteristics do not raise new questions of safety and effectiveness. Therefore, based on the substantial equivalence evaluation,
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Slow Wave concludes that the Slow Wave DS8 is substantially equivalent to Panthera D-SAD.
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| Substantial Equivalence Table: | ||||
|---|---|---|---|---|
| Feature | Slow Wave DS8 (K191320) Subjectdevice | The NightBlocks Appliance(K192581) Primary Predicate | Panthera D-SAD (K143244)Reference device | Comparisons |
| Picture of thedevice | Image: Slow Wave DS8 | Image: The NightBlocks Appliance | Image: Panthera D-SAD | Subjected Similarto its Predicate |
| Indications forUse | Intended to reduce or alleviatesnoring, mild to moderateObstructive Sleep Apnea whilesleeping in adults. | Intended to reduce nighttime snoringand mild to moderate obstructivesleep apnea in adults. TheNightBlocks™ Appliance is wornwhile sleeping to support the lowerjaw in a forward position prescribedby the dentist. The customizedappliance is inserted and removed bythe patient and adjusted by theprescribing dentist. | Intended to reduce or alleviatesnoring, mild to moderateObstructive Sleep Apnea whilesleeping in adults. | |
| Product Codes | LQZ, LRK | LQZ, LRK | LRK | Same to all |
| Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | Same to all |
| Common Name | Intraoral device for snoring and mildto moderate Obstructive SleepApnea | Intraoral Devices For Snoring AndIntraoral Devices For Snoring AndObstructive Sleep Apnea | Intraoral device for snoring andmild to moderate Obstructive SleepApnea | Same to all |
| Feature | Slow Wave DS8 (K191320) Subjectdevice | The NightBlocks Appliance(K192581) Primary Predicate | Panthera D-SAD (K143244)Reference device | Comparisons |
| Classification | Class II | Class II | Class II | Same to all |
| Use of Device | Removable intraoral device. Singlepatient multiple use. Prescriptionuse only. | Removable intraoral device. Singlepatient multiple use. Prescriptionuse only. | Removable intraoral device. Singlepatient multiple use. Prescriptionuse only. | Same to all |
| Target Population | Adult Patients | Adult Patients | Adult Patients | Same to all |
| Principle ofoperation | Adjustment of the relative positionof the ramps guides the mandibleforward and maintainsadvancement thus enlarging theairway. The vertical opening of jawis not fixed in a single position.Traction-based mandibularrepositioning device, allows nasaland/or oral breathing | Mandibular Repositioning withcustom fitted acrylic upper andlower components. This advancesthe mandible anteriorly to enlargethe airway.Expansion mechanism placed onbuccal portions for unobstructedairway passage. | Adjustment of the relative positionof the splints guides the mandibleforward and maintainsadvancement thus enlarging theairway.The vertical opening of jaw is notfixed in a single position. Traction-based mandibular repositioningdevice, allows nasal and/or oralbreathing | Same to all |
| MandibularAdvancementRange | Up to 15 mm at 1 mm increments. | Mandible can be advanced with twobuccal expansion screws up to 6mm. | Up to 15 mm at 1 mm increments. | Same to all |
| Occlusion trays | It covers part of the occlusal surfaceof upper and lower devices thencovering inside gum area at upperand lower Incisors | Information not available | It covers part of the occlusalsurface of upper and lower devicesthen covering inside gum area atupper and lower Incisors | Same to all |
| Fixed/Removable | Removable | Removable | Removable | Same to all |
| Supplied sterile /non sterile | Non sterile | Non Sterile | Non sterile | Same to all |
| Feature | Slow Wave DS8 (K191320) Subjectdevice | The NightBlocks Appliance(K192581) Primary Predicate | Panthera D-SAD (K143244)Reference device | Comparisons |
| Single Use /reusable | Reusable | Reusable | Reusable | Same to all |
| Prescription /Over the Counter | Prescription | Prescription | Prescription | Same to all |
| Cleaning andMaintenance | Clean daily in lukewarm waterwith a soft toothbrush. Rinse, dryand store in case provided. Twicea week use antibacterialorthodontic cleansing solutionthat are chlorine-free | Information not available onlineor from FDA 510k summary. It issafe to assume some form ofcleaning is advised. | Clean daily in lukewarm waterwith a soft toothbrush.Rinse, dry and store in caseprovided. Twice a week useantibacterial orthodonticcleansing solution that arechlorine-free | Same to all |
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Conclusion:
Slow Wave DS8 has the same intended use as the predicate device. Additionally, the differences in technological characteristics do not raise new questions of safety and effectiveness. Therefore, based on the substantial equivalence evaluation, Slow Wave concludes that the Slow Wave DS8 is substantially equivalent to Panthera D-SAD and the NighBlocks Appliance.
§ 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.”