(141 days)
K153291 OptiSleep Device by SICAT
K113516 CAST device by TheraSom
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or related concepts like data sets or algorithms.
Yes
The device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is described as an oral appliance intended to reduce snoring and mild to moderate obstructive sleep apnea by repositioning the mandible to increase pharyngeal space, which is a therapeutic function, not diagnostic.
No
The device description explicitly states that the Kava and Kava with Herbst are "simple hardware devices" and "oral appliances." It details their physical components (custom fitted trays, metal screws or lugs, ball clasps) and their mechanical function as mandibular repositioners. There is no mention of software as a component of the device itself.
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 nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an oral appliance that physically repositions the mandible to improve airflow. It does not involve testing samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to diagnose a condition, measure a substance in the body, or provide information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical appliance used for treatment.
N/A
Intended Use / Indications for Use
The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ
Device Description
The Kava and Kava with Herbst are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.
The Kava and Kava with Herbst are intra-oral devices used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air.
The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint.
The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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
Dentist or Physician
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 Performance Data:
Strength and elongation testing:
- ASTM D-638-14 Standard Test Method For Tensile Properties of Plastics
- ASTM D-790-10 Standard Test Methods for Flexure Properties of Unreinforced Plastics and Electrical Insulating Materials
- ASTM D-792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
Key Results: The Kava and Kava with Herbst passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device.
Biocompatibility:
Evaluated in accordance with ISO 10993-1 and guidance document entitled "Use of International Standard ISO-10993-1,"Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process". The device's biological safety was evaluated for in vitro cytotoxicity, skin sensitization, and irritation, and mutagenicity and chemical characterization.
Key Results:
- Biocompatibility testing per ISO 10993-1 Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process: Passed
- Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
- Biocompatibility testing HET-CAM Tests for irritation and skin sensitization: Passed
- Biocompatibility testing mutagenicity (Ames test): Passed
- Biocompatibility testing per ISO 10993-12 chemical analysis of eluted components acc.: Passed
Risk Analysis:
Formal Risk Assessment of the Kava was performed in accordance with ISO 14971.
Key Results: The outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.
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.
K153291 OptiSleep Device by SICAT
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.
K113516 CAST device by TheraSom
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 two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sketchpad Innovations LLC % Cheryl Fisher Principal Consultant FisherMed Consulting LLC 820 Civic Center Dr. Santa Clara, California 95050 February 13, 2019
Re: K182661
Trade/Device Name: Kava and Kava with Herbst 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, LQZ Dated: January 4, 2019 Received: January 7, 2019
Dear Cheryl Fisher:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Marv S. Mary S. Runner -S3 Runner -S3 Date: 2019.02.13
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) Not Known
Device Name Kava and Kava with Herbst device(s)
Indications for Use (Describe)
The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) 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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510(k) Summary
Kava and Kava with Herbst device(s)
1. Submission Sponsor
Sketchpad Innovations LLC
10767 Glendover Ln.
San Diego
CA, 92016
United States
Contact: Phillip "Sonnie" Bocala
Title: CEO
2. Submission Correspondent
FisherMed Consulting, LLC
820 Civic Center Drive
Santa Clara, CA 95050
Office Phone: (408) 410-5920
Contact: Cheryl Fisher
Title: Principal Consultant, RA/QA
3. Date Prepared
9/19/2018
4. Device Identification
| Trade/Proprietary Name: | Kava and Kava with Herbst | |
|---|---|---|
| Common/Usual Name: | Intraoral Devices for Snoring and/or Obstructive Sleep Apnea | |
| Classification Name: | Intraoral Devices for Snoring and/or Obstructive Sleep Apnea | |
| Regulation Number: | 872.5570 | |
| Product Code: | LRK, Device, Anti Snoring- Intraoral devices for snoring and intraoral devices | |
| for snoring and obstructive sleep apnea. |
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LQZ, Device, Jaw Repositioning- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea
Device Class: Class II
Classification Panel: Dental
5. Legally Marketed Predicate Device(s)
Primary Predicate K153291 OptiSleep Device by SICAT
Reference Device K113516 CAST device by TheraSom
6. Indication for Use Statement
The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
7. Device Description
The Kava and Kava with Herbst are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.
The Kava and Kava with Herbst are intra-oral devices used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air.
The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint.
The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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8. Substantial Equivalence Discussion
The following table compares the Kava and Kava with Herbst device(s) to the predicate device(s) with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Feature | Kava and Kava with
Herbst | Primary
Predicate
SICAT
OPTISLEEP | Reference Device
TheraSom-CAST | Comparison |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | Not Known | K153291 | K113516 | Same method |
| Manufacturer | Sketchpad
Innovations LLC | SICAT GmbH &
Co | Family Dental
Service PC | NA |
| Primary Device Similarities to support Substantial Equivalence | | | | |
| Classification # | 872-5570 | 872-5570 | 872-5570 | Same |
| Product Code | Primary LRK
Secondary LQZ | Primary LRK
Secondary LQZ | Primary LRK
Secondary LQZ | Same |
| Indications for
use | The Kava and Kava
with Herbst device(s) are intended to
reduce nighttime
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. | In adult
population
• To reduce or
alleviate snoring
• To reduce or
alleviate mild to
moderate
obstructive
sleep apnea
(OSA) | The TheraSom-
CAST is used to
reduce or
alleviate the
occurrence
of snoring and/or
for the treatment
of mild to
moderate
obstructive
sleep apnea
(OSA) in patients | Same |
| Mode of Action | | | 18 years of age or older | |
| | These devices
function as a
mandibular
repositioner, which
acts to increase the
patient's pharyngeal
space, by reducing
obstructions of the
airway and improving
their ability to
exchange air during
sleep. | This device
functions as a
mandibular
repositioner,
maintaining the
lower jaw in a
forward position
during sleep.
This mechanical
protrusion acts
to increase the
patient's
pharyngeal
space,
improving the
ability to
exchange air
during sleep by
reducing
mechanical
obstructions of
the airway. | The device
functions as a
mandibular
repositioner,
which acts to
improve the
patient's ability
to breathe
without
obstruction of
the pharyngeal
airway | Similar mode of
action with slight
technical
deviations
discussed below,
not incurring
additional patient
risks |
| Material | Acrylic | Milled Acrylic | Cast Metal | The Kava and Kava
with Herbst and
OptiSleep devices
are made of an
acrylic material
while the
TheraSom is made
of a dental metal
alloy there is no
significant
difference
between the Kava
and Kava with
Herbst and the
OptiSleep |
| | The main parts of the
device(s) are made of
Acrylic Material,
Stainless Steel, and
Dental Alloy Material | The main parts
of the device are
made of
Polymethylmeth
acrylate. The
exchangeable
connectors are
made of
Polyamide | Dental Alloy
Material | |
| | | | | regarding the
acrylic base
material used |
| Mode of Care | Adjustable by Dentist
or Physician during
the duration of use | Adjustable by
Dentist or
Physician during
the duration of
use | Adjustable by
Dentist or
Physician during
the duration of
use | Same |
| Usage | Removable and
Reusable by the same
patient.
Night Time Usage
Only | Removable and
Reusable by the
same patient.
Night Time
Usage Only | Removable and
Reusable by the
same patient.
Night Time Usage
Only | Same |
| Biocompatible | Yes | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Rx | Same |
| Device Technological Differences Difference | | | | |
| Connectors | Consists of an upper
and lower appliance
that are 2 separate
appliances that work
in conjunction with
each other - | Consists of an
upper and lower
appliance that
are connected
together with a
plastic
connector -
limits the jaw
movement to
opening and
closing only | Consists of an
upper and lower
appliance that
are connected
together with a
metal spring -
limits the jaw
movement to
opening and
closing only | 2 separate
appliances allows
for 3 dimensional
freedom of
movement of the
lower jaw and
incurs no
additional risk to
the patient |
| Insertion | 2 piece design allows
for the upper
appliance to be
inserted first followed
by the lower
appliance | the upper and
lower appliance
to be inserted at
the same time | the upper and
lower appliance
to be inserted at
the same time | Two piece design
allows greater
ease of insertion
and incurs no
additional risk to
the patient |
| Fabrication | Hand made from
acrylic and wire
formation | Computer
generated - | Hand waxed and
metal casted | Hand made
component exists
in the TheraSom |
| | | milled from
acrylic | | device and a
similar acrylic
material is used in
the OptiSleep
device neither of
these variations
incur additional
risk to the
patients than are
already present in
the currently
marketed devices. |
| Retention | Upper appliance has
acrylic coverage on
the occlusal and mid
buccal and lingual
posterior teeth with
retention clasp –
Lower appliance has
ball clasp retention
from the buccal of the
posterior teeth
wrapping to the
lingual with acrylic
anterior lingual
coverage | Upper and
lower appliance
has acrylic
coverage on the
buccal and
lingual aspect of
the teeth to the
gum line | Upper appliance
has metal casting
that are formed
around the
height of contour
of the cuspid and
bicuspid teeth –
Lower appliance
and metal casting
covering the
occlusal surface
of the premolars
and molar teeth | The Kava and Kava
with Herbst and
OptiSleep both
have acrylic
coverage on
commensurate
dentition on the
upper appliance
and lower
appliances the
Kava and Kava
with Herbst and
the TheraSom
device both utilize
a metal casting in
the lower
appliance for
retention
incurring no
additional risk to
the patient than
are already
present in
currently
marketed devices! |
Table 5A - Comparison of Characteristics
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9. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the Kava with Herbst to the predicate/reference devices that are subject to this 510(k) submission, Sketchpad Innovations LLC completed a number of non-clinical performance tests, including:
Strength and elongation testing:
| # | Standard |
|---|---|
| 1 | ASTM D-638-14 Standard Test Method For Tensile Properties of Plastics |
| 2 | ASTM D-790-10 Standard Test Methods for Flexure Properties of Unreinforced Plastics and |
| Electrical Insulating Materials | |
| 3 | ASTM D-792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of |
| Plastics by Displacement |
The Kava and Kava with Herbst passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device:
Biocompatibility - The biological safety of the components of the Kava and Kava with Herbst were evaluated in accordance with ISO 10993-1 and guidance document entitled Use of International Standard ISO-10993-1,"Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process". Under this, for the stated indications for use, each component of the device's biological safety was evaluated for in vitro cytotoxicity, skin sensitization, and irritation, and mutagenicity and chemical characterization.
- Biocompatibility testing per ISO 10993-1 Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process: Passed
- . Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
- Biocompatibility testing HET-CAM Tests for irritation and skin sensitization: Passed ●
- Biocompatibility testing mutagenicity (Ames test): Passed
- Biocompatibility testing per ISO 10993-12 chemical analysis of eluted components acc.: ● Passed
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Risk Analysis - Formal Risk Assessment of the Kava was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, Sketchpad Innovations LLC believes the outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.
10. Performance Testing Summary
As part of demonstrating the substantial equivalence of the Kava with Herbst and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Sketchpad Innovations LLC completed a number of tests. The Kava with Herbst meet all the requirements for overall design, biocompatibility, and performance testing confirming that the output meets the design inputs and specifications. The Kava and Kava with Herbst passed all testing stated above as shown by the acceptable results obtained.
The Kava and Kava with Herbst complies with the applicable voluntary standards for biocompatibility per materials used. The device passed all the testing in accordance with national standards.
11. Statement of Substantial Equivalence
lt has been shown in this 510(k) submission that the differences between the Kava and Kava with Herbst and the predicate device do not raise any different questions regarding its safety and effectiveness. The performance testing provided demonstrates that the subject device(s) is substantially equivalent to the predicate device and reference device. The Sketchpad LLC, Kava and Kava with Herbst, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.