(269 days)
No
The device description and performance studies focus on the physical mechanism of the intraoral device and biocompatibility testing, with no mention of AI or ML.
Yes.
The device is intended to reduce snoring by altering the user's anatomy, which is a therapeutic purpose.
No
The device is intended to reduce snoring by positioning the mandible forward, which is a therapeutic action, not a diagnostic one. It aids in air exchange rather than diagnosing a condition.
No
The device description explicitly states it is an "intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward," indicating it is a physical hardware device, not software only.
Based on the provided information, the SilentZPro 2.0 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aid in the reduction of snoring by physically repositioning the jaw. This is a mechanical action within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an intraoral appliance that physically alters the position of the mandible. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other typical methods used in in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The SilentZPro 2.0 does not fit this description.
N/A
Intended Use / Indications for Use
SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
SilentZPro 2.0 is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.
The device is intended for Over-the-Counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
In the mouth, on the lower and upper jaws
Indicated Patient Age Range
Adults at least 18 years old.
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
During sleep, at 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)
Non-Clinical Testing: Testing results have been included include cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). The results of the testing demonstrated that the subject device is biocompatible and meets the applicable requirements of ISO 10993. Device materials were tested for various physical properties.
Clinical Performance Testing: No clinical performance testing was conducted.
Risk Analysis: Shinrin-Yoku Traders LLC conducted a risk analysis on SilentZPro 2.0 in accordance with ISO 14971:2007 and the FDA guidance document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" (November 12, 2002). All identified risks have been addressed through device design, biocompatibility tests or through labeling provided to the consumer.
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
§ 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 for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2022
Shinrin-Yoku Traders LLC % Ryan Bruss Regulatory Consultant RGLM Consulting LLC 6915 225th St SW Mountlake Terrace, Washington 98043
Re: K220688
Trade/Device Name: SilentZPro 2.0 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: LRK Dated: November 4, 2022 Received: November 4, 2022
Dear Ryan Bruss:
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
1
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 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 medical devices and radiation-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,
Bobak Shirmohammadi -S
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) K220688
Device Name SilentZPro 2.0
Indications for Use (Describe)
SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Shinrin-Yoku Traders LLC
18450 SW Seiffert Rd Sherwood, OR 97140 USA +1-971-712-9175
shinrinyokutradersllc@gmail.com www.itusguardz.com
510(k) Summary
Device Name: SilentZPro 2.0
A. General Information
| Sponsor | Shinrin-Yoku Traders LLC
18450 SW Seiffert Rd, Sherwood, OR 97140 |
|----------------|----------------------------------------------------------------------------------|
| Contact Person | Ryan Bruss
CEO
Tel: 971-712-9175
Email: shinrinyokutradersllc@gmail.com |
| K Number | K220688 |
| Date prepared | November 3, 2022 |
B. Device
| Propriety Name | SilentZPro 2.0 |
|---|---|
| Common Name | Antisnoring device |
| Classification Name | Intraoral devices for snoring and obstructive sleep apnea |
| Product Code | LRK |
| Class | II |
| Regulation Number | 21 CFR 872.5570 |
C. Predicate Device
| Name | PureSleep® |
|---|---|
| Owner | Sleep Science Partners, Inc. |
| K number | K190058 |
| Reference Device: | SnoreRx® (K170825, Apnea Sciences, Inc.) |
D. Description of the Device
SilentZPro 2.0 is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.
510(k) Summary
4
Image /page/4/Picture/0 description: The image shows a stylized illustration of three evergreen trees. The trees are arranged in a row, with the middle tree being slightly taller than the other two. Above the trees, there are several short, dashed lines radiating outwards in a semi-circular pattern, resembling sun rays. The entire illustration is in a dark green color.
18450 SW Seiffert Rd Sherwood, OR 97140 USA +1-971-712-9175
shinrinyokutradersllc@gmail.com www.itusguardz.com
The device is intended for Over-the-Counter (OTC) use.
E. Intended Use Statement
SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.
F. Comparison of Technological Characteristics
The table below compares the similarities and differences between the SilentZPro 2.0 and the predicate device/Reference device.
| Attribute | Proposed device
(K220688) | Predicate device
(K190058) | Reference device
(K170825) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name | SilentZPro 2.0 | PureSleep® | SnoreRx® |
| Manufacturer | Shinrin-Yoku Traders LLC | Sleep Science Partners, Inc. | Apnea Sciences, Inc. |
| 510k Number | K220688 | K190058 | K170825 |
| Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Product Code | LRK | LRK | LRK |
| Class Name | Same | Intraoral Device for Snoring and
Obstructive Sleep Apnea | Same |
| Rx or OTC | OTC | OTC | OTC |
| Intended Use | SilentZ Pro 2.0 is intended as an aid
in the reduction of snoring for adults
at least 18 years old. | PureSleep® (OTC) is indicated for
use for adults 18 years and above as
an aid in the reduction of snoring
during hours of sleep | The SnoreRx is intended for use on
adult patients 18 years of age or
older as an aid for the reduction of
snoring. |
| Population | Same | Adult | Same |
| Environment | Same | During sleep, at home | Same |
| Mechanism of
action | Same as the Predicate Device | Mandibular repositioning device
(MRD) that advances the lower jaw
to increase pharyngeal space and
alleviate snoring | Mandibular repositioning device that
advances the lower jaw to increase
pharyngeal space. |
| Attribute | Proposed device
(K220688) | Predicate device (K190058) | Reference device
(K170825) |
| Placement of
device | In the mouth, on the lower and upper
jaws | In the mouth, on the lower and upper
jaws | In the mouth, on the lower and upper
jaws |
| Preparation /
Set-up | Same as reference device. (Squeeze
mouthpiece in a "c" position and
adjust. Mold the trays to the user's
mouth.) | Connect upper and lower parts per
user comfort. Mold the trays to the
user's mouth. | Squeeze mouthpiece in a 'C'
position and adjust. Mold tray Mold
the trays to the user's mouth. |
| Design | Custom-fitted intraoral device using
a "boil and bite" approach and
thermal setting (heat sensitive)
resins. Molded to the entire upper
and lower arch of teeth.
Consists of an upper and lower tray.
Outer shell provides with structural
support and inner shell is lined with
softer material that is heat sensitive
and thus allows for custom fitting. | Custom impression to each
individual's mouth using a "boil
and bite" approach and thermal
setting (heat sensitive) resins.
Molded to the entire upper and
lower arch of teeth.
Consists of an upper and lower
tray. Outer shell provides with
structural support and inner shell is
lined with softer material that is
heat sensitive and thus allows for
custom fitting. | Custom impression to each
individual's mouth using a "boil
and bite" approach and thermal
setting (heat sensitive) resins.
Molded to the entire upper and
lower arch of teeth.
Consists of an upper and lower
tray. Outer shell provides with
structural support and inner shell is
lined with softer material that is
heat sensitive and thus allows for
custom fitting. |
| Adjustments | Adjustable jaw advancement
position. Adjustably positions the
mandible forward in 3 positions,
4mm apart anteriorly, while
maintaining a 9mm inferior
placement for user comfort | custom fitting.
Adjustable jaw advancement
position. Adjustably positions the
mandible forward in three positions,
4mm apart anteriorly, while
maintaining a 9mm inferior
placement for user comfort | custom fitting.
Adjustable jaw advancement
position. Ability to reset the
adjustment. The upper and lower
trays are adjustable in 1mm
increments up to 6mm. |
| Single Patient/
Reusable | Single user, reusable. Non-sterile.
Requires daily cleaning, and
reusable with a life use of no more
than 30 days. | Single user, reusable.
Clean/rinse daily with toothbrush
and toothpaste or with effervescent
oral device cleaning tablets. Deep
clean once per week. Non-sterile. | Clean/rinse daily. Deep clean every
two weeks. Non-sterile. |
| Materials | Same as the Reference Device | Polypropylene homopolymer;
ethylene vinyl acetate copolymer
(EVA) | Polycarbonates (PC);
Ethylene-vinyl acetate copolymer
resin (EVA) |
| Attribute | Proposed device (K220688) | Predicate device (K190058) | Reference device (K170825) |
| Biocompatibility | Same | Assessment conducted for testing for
prolonged mucosal surface contact in
accordance with ISO 10993-1. | Same |
5
Image /page/5/Picture/0 description: The image shows a stylized illustration of three evergreen trees. The trees are arranged in a row, with the middle tree being slightly taller than the other two. Above the trees, there are several short, dashed lines radiating outwards in a semi-circular pattern, resembling sun rays. The entire image is rendered in a single color, a shade of green.
Shinrin-Yoku Traders LLC
18450 SW Seiffert Rd
Sherwood, OR 97140 USA +1-971-712-9175
shinrinyokutradersllc@gmail.com www.itusguardz.com
6
Image /page/6/Picture/0 description: The image shows a stylized logo with three evergreen trees in the center. Above the trees are radiating lines, resembling the sun's rays. A horizontal line runs along the base of the trees, grounding the design. The entire logo is rendered in a single color, a shade of green.
18450 SW Seiffert Rd Sherwood, OR 97140 USA +1-971-712-9175
shinrinyokutradersllc@gmail.com www.itusguardz.com
The SilentZPro 2.0 has the same general intended use as the predicate device, and the similar technological characteristics as the predicate device. The biocompatibility performance of the SilentZPro 2.0 met the standard of ISO 10993 biocompatibility testing. The materials of SilentZPro 2.0 are the same as the reference device. The differences between the SilentZPro 2.0 and the predicate device do not raise different questions of safety and effectiveness.
G. Performance Testing
Non-Clinical Testing
Testing results have been included include cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). The results of the testing demonstrated that the subject device is biocompatible and meets the applicable requirements of ISO 10993.
Device materials were tested for various physical properties.
Shinrin-Yoku Traders LLC conducted a risk analysis on SilentZPro 2.0 in accordance with ISO 14971:2007 and the FDA guidance document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea". All identified risks have been addressed through device design, biocompatibility tests or through labeling provided to the consumer.
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Image /page/7/Picture/0 description: The image shows a stylized graphic of three evergreen trees. The trees are arranged in a row, with the middle tree being slightly taller than the other two. Above the trees, there are several short, dashed lines radiating outwards in a semi-circular pattern, resembling sun rays. The entire graphic is in a dark green color.
18450 SW Seiffert Rd Sherwood, OR 97140 USA +1-971-712-9175
shinrinyokutradersllc@gmail.com www.itusguardz.com
Clinical Performance Testing
No clinical performance testing was conducted.
Risk Analysis
Shinrin-Yoku Traders LLC conducted a risk analysis on SilentZPro 2.0 in accordance with ISO 14971:2007 and the FDA guidance document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" (November 12, 2002). All identified risks have been addressed through device design, biocompatibility tests or through labeling provided to the consumer.
H. Conclusions
Based on the similarities in intended use and indications for use, together with technologic similarities and results of performance testing, we believe that SilentZPro 2.0 is substantially equivalent to the predicate device, PureSleep® .