(211 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML.
Yes
The device is used to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults, which are medical conditions, and it actively repositions the jaw to open the airway, indicating a therapeutic function.
No.
The device description clearly states it is an intraoral device for reducing snoring and sleep apnea by repositioning the jaw, which is a treatment, not a diagnostic function.
No
The device description clearly states it is an "intraoral device" and describes physical components (two splints, two parallel sliding connectors, spacers) and mechanical adjustments, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and OSA by physically repositioning the jaw. This is a mechanical intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical intraoral device that mechanically alters the airway. It does not describe any components or processes for analyzing biological samples.
- Lack of Diagnostic Activity: The device's function is to treat a condition (snoring/OSA) by altering the physical structure of the airway, not to diagnose a condition by analyzing biological markers.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
LQZ, LRK
Device Description
The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower jaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.
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
adults.
Intended User / Care Setting
prescribing dentist office; in the patient's home
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)
Benchtop Performance Testing Overview: Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand to similar forces a patient's mouth will exhibit on the device. The mean peak force the device can withstand is 10 standard deviations above the acceptance criteria. These results indicated that the subject device performance is substantially equivalent to the predicate device, the SomnoDent G2, and it introduces no new questions of safety or effectiveness.
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.
No reference devices were used in this submission.
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
§ 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.”
0
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July 20, 2021
Wade Munsch, Regulatory Affairs Manager Biotex, Inc. 114 Holmes Rd., Houston, Texas 77045
Re: K203712
Trade/Device Name: The Slide 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: January 19, 2021 Received: January 19, 2021
Dear Wade Munsch:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203712
Device Name The Slide
Indications for Use (Describe)
The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
| 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) |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
1. SUBMITTER
Biotex. Inc. 114 Holmes Road Houston, TX 77045 USA Tel: (713) 741-0111 ex 208 Fax: (713) 741-0122 Email: wade.munsch@biotexmedical.com Contact Person: Wade Munsch Date Prepared: July 19th, 2021
2. DEVICE
| Name of Device: | The Slide |
|---|---|
| Classification Name: | Device, Anti-Snoring |
| Regulation: | 21 CFR §872.5570 |
| Regulatory Class: | Class II |
| Product Classification Code: | LQZ, LRK |
| 510(k): | K203712 |
3. PREDICATE DEVICE
| Predicate Manufacturer: | Somnomed |
|---|---|
| Predicate Trade Name: | Somnodent G2 |
| Predicate 510(k): | K121340 |
No reference devices were used in this submission.
4. DEVICE DESCRIPTION
- The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce 4.1. nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.
5. INDICATIONS FOR USE
- 5.1. The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
- 6.1. The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
4
| | The Slide
K203712 | SomnoDent G2 –
K121340 | Evaluation of
Differences |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Slide is for
use to reduce
night-time
snoring and
mild to
moderate
obstructive
sleep apnea
(OSA) in adults. | The SomnoDent
G2 is intended for
the treatment of
nightime snoring
and mild to
moderate
obstructive sleep
apnea in patients
18 years of age or
older. | N/A |
| Intended Use | | | |
| Intended as intraoral device | Yes | Yes | N/A |
| Intended to reduce snoring
or help alleviate snoring | Yes | Yes | N/A |
| Intended for treatment of
mild to moderate
obstructive sleep apnea | Yes | Yes | N/A |
| Intended for nighttime use | Yes | Yes | N/A |
| Indicated for single patient
multiuse | Yes | Yes | N/A |
| Indicated for use in the
patient's home | Yes | Yes | N/A |
| Target Population: Adults | Yes | Yes | N/A |
| Prescription device | Yes | Yes | N/A |
| Design | | | |
| Customized fit for each
patient | Yes | Yes | N/A |
| Separate upper and lower
tray pieces | Yes | Yes | N/A |
| Works by mandibular
advancement | Yes | Yes | N/A |
| Advancement components
are attached to the occlusal
side of the device. | Yes | No | The SomnoDent G2
advancement
components are
attached to the buccal
side. While these
alignment features
which prevent shifting
from side to side have
been changed to a
simple rail system in
line with the teeth, there
are no additional forces
introduced and no new
questions of safety or
effectiveness. |
| | The Slide
K203712 | SomnoDent G2 –
K121340 | Evaluation of
Differences |
| Lower jaw adjustment using
supplied components | Yes | Yes | N/A |
| Permits patient to breathe
through mouth | Yes | Yes | N/A |
| Upper and lower trays
disengage for easy removal | Yes | Yes | N/A |
| Materials | | | |
| Splint | Yes | No, Trays
constructed from a
soft lining material
adhered to a hard
surface acrylic | The 3D trays are
printed at Dental labs
from materials
approved to make
dental splints. Use of
3D printed trays does
not introduce any
questions of safety or
effectiveness. |
| Advancement mechanism
constructed of
biocompatible, medical
grade polycarbonate | Yes | Yes | N/A |
Table 1: Comparison of The Slide with SomnoDent G2 (K121340).
5
7. SUMMARY OF TECHNICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE
- The device and predicate device (K121340) are identical in the following ways: 7.1. -
- 7.1.1. Regulation name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea
- 7.1.2. Regulation number: 21 CFR 872.5570
- 7.1.3. Regulatory Class: II
- 7.2. The predicate device claims product code LRK (anti-snoring), and the subject device claims LRK and LQZ (jaw repositioning). While the predicate device's submission does not reference product code LQZ, the mechanisms of action and intended use are in line with this code.
- 7.3. The predicate device has advancement components attached to the buccal side of the mouth, while the Slide has advancement components attached to the occlusal side of the mouth. While these alignment features which prevent shifting from side to side have been changed to a simple rail system in line with the teeth, there are no additional forces introduced and no new questions of safety or effectiveness. K203712.S003 Doc 010 046-0012 Device Mechanics Comparison includes a more in-depth discussion of these differences.
- 7.4. To demonstrate substantial equivalence, bench testing was conducted to assess the mechanical integrity of the subject device when subjected to forces expected in the patient's mouth during use. These results, summarized in Vol 018 Doc 001 Benchtop Performance Testing Overview, indicated that the subject device performance is substantially equivalent to the predicate device, the SomnoDent G2, and it introduces no new questions of safety or effectiveness.
- 7.5. The subject device and predicate device have equivalent indications for use and technological characteristics, with the exception of the custom 3D printed tray, which does not introduce any questions of safety or effectiveness.
8. PERFORMANCE DATA
- 8.1. The following performance data were provided in support of the substantial
6
equivalence determination.
8.2. Biocompatibility Testing
- 8.2.1. Material biocompatibility established to be in compliance with ISO 10993-1:2018.
8.3. Mechanical Testing
- 8.3.1. Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand to similar forces a patient's mouth will exhibit on the device. The mean peak force the device can withstand is 10 standard deviations above the acceptance criteria.
8.4. Animal Study
- 8.4.1. Animal performance testing was not required to demonstrate safety and effectiveness of the device.
8.5. Clinical Studies
- 8.5.1. Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing.
9. CONCLUSIONS
- 9.1. The subject device, The Slide, is substantially equivalent to the predicate device, the SomnoDent G2, and it introduces no new questions of safety or effectiveness.