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.

AI/ML Overview

The provided text relates to a 510(k) premarket notification for a medical device called "Kava and Kava with Herbst." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria against well-defined acceptance criteria in the manner requested (e.g., an AI/ML device's diagnostic performance).

Therefore, the document does not contain the information requested in the prompt regarding:

A table of acceptance criteria and reported device performance for diagnostic accuracy (e.g., sensitivity, specificity). Instead, it discusses the device's physical and material properties (strength, elongation, biocompatibility) and its intended therapeutic function (reducing snoring and OSA by mandibular repositioning).
Sample sizes for test sets used for diagnostic performance evaluation or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or effect sizes for human readers with AI assistance.
Whether standalone performance was evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

This is a physical medical device (an intraoral appliance), not a diagnostic AI/ML system. The "performance testing" referred to in the document focuses on engineering and material testing (e.g., tensile strength, flexibility, biocompatibility), which are relevant for the safety and function of a physical device, but not for the diagnostic performance metrics typically associated with AI/ML-based medical devices as implied by the prompt's structure.

The document's purpose is to demonstrate substantial equivalence to predicate oral appliances for snoring and OSA, based on similar indications for use, principles of operation, technological characteristics, and material safety. It confirms the device passed a series of non-clinical performance tests related to its physical and biological properties.

Summary

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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.

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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)
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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 devicesfor 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 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 withHerbst	PrimaryPredicateSICATOPTISLEEP	Reference DeviceTheraSom-CAST	Comparison
510 (k) Number	Not Known	K153291	K113516	Same method
Manufacturer	SketchpadInnovations LLC	SICAT GmbH &Co	Family DentalService PC	NA
Primary Device Similarities to support Substantial Equivalence
Classification #	872-5570	872-5570	872-5570	Same
Product Code	Primary LRKSecondary LQZ	Primary LRKSecondary LQZ	Primary LRKSecondary LQZ	Same
Indications foruse	The Kava and Kavawith Herbst device(s) are intended toreduce nighttimesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults.	In adultpopulation• To reduce oralleviate snoring• To reduce oralleviate mild tomoderateobstructivesleep apnea(OSA)	The TheraSom-CAST is used toreduce oralleviate theoccurrenceof snoring and/orfor the treatmentof mild tomoderateobstructivesleep apnea(OSA) in patients	Same
Mode of Action			18 years of age or older
	These devicesfunction as amandibularrepositioner, whichacts to increase thepatient's pharyngealspace, by reducingobstructions of theairway and improvingtheir ability toexchange air duringsleep.	This devicefunctions as amandibularrepositioner,maintaining thelower jaw in aforward positionduring sleep.This mechanicalprotrusion actsto increase thepatient'spharyngealspace,improving theability toexchange airduring sleep byreducingmechanicalobstructions ofthe airway.	The devicefunctions as amandibularrepositioner,which acts toimprove thepatient's abilityto breathewithoutobstruction ofthe pharyngealairway	Similar mode ofaction with slighttechnicaldeviationsdiscussed below,not incurringadditional patientrisks
Material	Acrylic	Milled Acrylic	Cast Metal	The Kava and Kavawith Herbst andOptiSleep devicesare made of anacrylic materialwhile theTheraSom is madeof a dental metalalloy there is nosignificantdifferencebetween the Kavaand Kava withHerbst and theOptiSleep
	The main parts of thedevice(s) are made ofAcrylic Material,Stainless Steel, andDental Alloy Material	The main partsof the device aremade ofPolymethylmethacrylate. Theexchangeableconnectors aremade ofPolyamide	Dental AlloyMaterial
				regarding theacrylic basematerial used
Mode of Care	Adjustable by Dentistor Physician duringthe duration of use	Adjustable byDentist orPhysician duringthe duration ofuse	Adjustable byDentist orPhysician duringthe duration ofuse	Same
Usage	Removable andReusable by the samepatient.Night Time UsageOnly	Removable andReusable by thesame patient.Night TimeUsage Only	Removable andReusable by thesame patient.Night Time UsageOnly	Same
Biocompatible	Yes	Yes	Yes	Same
OTC or Rx	Rx	Rx	Rx	Same
Device Technological Differences Difference
Connectors	Consists of an upperand lower appliancethat are 2 separateappliances that workin conjunction witheach other -	Consists of anupper and lowerappliance thatare connectedtogether with aplasticconnector -limits the jawmovement toopening andclosing only	Consists of anupper and lowerappliance thatare connectedtogether with ametal spring -limits the jawmovement toopening andclosing only	2 separateappliances allowsfor 3 dimensionalfreedom ofmovement of thelower jaw andincurs noadditional risk tothe patient
Insertion	2 piece design allowsfor the upperappliance to beinserted first followedby the lowerappliance	the upper andlower applianceto be inserted atthe same time	the upper andlower applianceto be inserted atthe same time	Two piece designallows greaterease of insertionand incurs noadditional risk tothe patient
Fabrication	Hand made fromacrylic and wireformation	Computergenerated -	Hand waxed andmetal casted	Hand madecomponent existsin the TheraSom
		milled fromacrylic		device and asimilar acrylicmaterial is used inthe OptiSleepdevice neither ofthese variationsincur additionalrisk to thepatients than arealready present inthe currentlymarketed devices.
Retention	Upper appliance hasacrylic coverage onthe occlusal and midbuccal and lingualposterior teeth withretention clasp –Lower appliance hasball clasp retentionfrom the buccal of theposterior teethwrapping to thelingual with acrylicanterior lingualcoverage	Upper andlower appliancehas acryliccoverage on thebuccal andlingual aspect ofthe teeth to thegum line	Upper appliancehas metal castingthat are formedaround theheight of contourof the cuspid andbicuspid teeth –Lower applianceand metal castingcovering theocclusal surfaceof the premolarsand molar teeth	The Kava and Kavawith Herbst andOptiSleep bothhave acryliccoverage oncommensuratedentition on theupper applianceand lowerappliances theKava and Kavawith Herbst andthe TheraSomdevice both utilizea metal casting inthe lowerappliance forretentionincurring noadditional risk tothe patient thanare alreadypresent incurrentlymarketed 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 andElectrical Insulating Materials
3	ASTM D-792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) ofPlastics 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.

Regulation Number and Section

§ 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.”