(506 days)
The NightBlocks Appliance K192581
No
The device description focuses on mechanical design and manufacturing processes, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment. The customization is based on physical scans and dental technician expertise, not AI/ML processing of data.
Yes
The device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults, which are medical conditions, and it actively repositions the mandible to enlarge the airway for therapeutic effect.
No.
The device description and intended use indicate that the device is a treatment or therapy device for snoring and sleep apnea, designed to reposition the mandible. It does not mention any function for diagnosing conditions.
No
The device description clearly details physical components (trays, palatal bands, ramps) manufactured using additive manufacturing and biocompatible materials. It is a physical mandibular repositioning device, not software.
Based on the provided information, 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.
- Device Function: The DS8 device is a physical appliance worn in the mouth to reposition the jaw and alleviate snoring and sleep apnea. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is to reduce or alleviate symptoms, not to diagnose a condition.
- Device Description: The description focuses on the physical design, materials, and how it interacts with the patient's anatomy.
- Input: The input is intraoral scanning, which captures the physical structure of the mouth, not biological data.
Therefore, the DS8 device falls under the category of a medical device, specifically a dental appliance, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Product codes
LQZ, LRK
Device Description
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.
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
Adult Patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
No Animal or Human testing was conducted on DS8 device.
Description of the test set, sample size, data source, and annotation protocol
No Animal or Human testing was conducted on DS8 device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Panthera D-SAD K142344
Reference Device(s)
The NightBlocks Appliance K192581
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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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. RAC |
| BDRA Consulting LLC | |
| 1 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 Devices |
| For 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 Devices |
| For 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 or
alleviate snoring, mild to moderate Obstructive
Sleep Apnea while sleeping in adults. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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. |
| Operating Principle: | The Slow Wave DS8 (K191320), is a mandibular
repositioning device that acts to increase the users'
pharyngeal space and improves their ability to
exchange 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) Subject | |||
| device | The NightBlocks Appliance | |||
| (K192581) Primary Predicate | Panthera D-SAD (K143244) | |||
| Reference device | Comparisons | |||
| Picture of the | ||||
| device | Image: Slow Wave DS8 | Image: The NightBlocks Appliance | Image: Panthera D-SAD | Subjected Similar |
| to its Predicate | ||||
| Indications for | ||||
| Use | Intended to reduce or alleviate | |||
| snoring, mild to moderate | ||||
| Obstructive Sleep Apnea while | ||||
| sleeping in adults. | Intended to reduce nighttime snoring | |||
| and mild to moderate obstructive | ||||
| sleep apnea in adults. The | ||||
| NightBlocks™ Appliance is worn | ||||
| while sleeping to support the lower | ||||
| jaw in a forward position prescribed | ||||
| by the dentist. The customized | ||||
| appliance is inserted and removed by | ||||
| the patient and adjusted by the | ||||
| prescribing dentist. | Intended to reduce or alleviate | |||
| snoring, mild to moderate | ||||
| Obstructive Sleep Apnea while | ||||
| sleeping 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 mild | |||
| to moderate Obstructive Sleep | ||||
| Apnea | Intraoral Devices For Snoring And | |||
| Intraoral Devices For Snoring And | ||||
| Obstructive Sleep Apnea | Intraoral device for snoring and | |||
| mild to moderate Obstructive Sleep | ||||
| Apnea | Same to all | |||
| Feature | Slow Wave DS8 (K191320) Subject | |||
| device | 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. Single | |||
| patient multiple use. Prescription | ||||
| use only. | Removable intraoral device. Single | |||
| patient multiple use. Prescription | ||||
| use only. | Removable intraoral device. Single | |||
| patient multiple use. Prescription | ||||
| use only. | Same to all | |||
| Target Population | Adult Patients | Adult Patients | Adult Patients | Same to all |
| Principle of | ||||
| operation | Adjustment of the relative position | |||
| of the ramps guides the mandible | ||||
| forward and maintains | ||||
| advancement thus enlarging the | ||||
| airway. The vertical opening of jaw | ||||
| is not fixed in a single position. | ||||
| Traction-based mandibular | ||||
| repositioning device, allows nasal | ||||
| and/or oral breathing | Mandibular Repositioning with | |||
| custom fitted acrylic upper and | ||||
| lower components. This advances | ||||
| the mandible anteriorly to enlarge | ||||
| the airway. | ||||
| Expansion mechanism placed on | ||||
| buccal portions for unobstructed | ||||
| airway passage. | Adjustment of the relative position | |||
| of the splints guides the mandible | ||||
| forward and maintains | ||||
| advancement thus enlarging the | ||||
| airway. | ||||
| The vertical opening of jaw is not | ||||
| fixed in a single position. Traction- | ||||
| based mandibular repositioning | ||||
| device, allows nasal and/or oral | ||||
| breathing | Same to all | |||
| Mandibular | ||||
| Advancement | ||||
| Range | Up to 15 mm at 1 mm increments. | Mandible can be advanced with two | ||
| buccal expansion screws up to 6mm. | Up to 15 mm at 1 mm increments. | Same to all | ||
| Occlusion trays | It covers part of the occlusal surface | |||
| of upper and lower devices then | ||||
| covering inside gum area at upper | ||||
| and lower Incisors | Information not available | It covers part of the occlusal | ||
| surface of upper and lower devices | ||||
| then covering inside gum area at | ||||
| upper 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) Subject | |||
| device | 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 and | ||||
| Maintenance | Clean daily in lukewarm water | |||
| with a soft toothbrush. Rinse, dry | ||||
| and store in case provided. Twice | ||||
| a week use antibacterial | ||||
| orthodontic cleansing solution | ||||
| that are chlorine-free | Information not available online | |||
| or from FDA 510k summary. It is | ||||
| safe to assume some form of | ||||
| cleaning is advised. | Clean daily in lukewarm water | |||
| with a soft toothbrush. | ||||
| Rinse, dry and store in case | ||||
| provided. Twice a week use | ||||
| antibacterial orthodontic | ||||
| cleansing solution that are | ||||
| chlorine-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.