SICAT OPTISLEEP is a pure hardware device. It is an oral appliance and will be manufactured by the SICAT dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

SICAT OPTISLEEP is fitted on the maxillary and mandibular arch covering all teeth. It consists of two main parts (upper and lower arch each) that are interconnected by exchangeable connectors. 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. Further this results in lower tendency to snore. The device has an adjustment mechanism, achieved by exchangeable connectors of different length, to adjust the mandibular advancement to be set by the dentist or physician at the time of fitting. The SICAT OPTISLEEP will be worn only during the sleep. The device will be used before replacement up to two years.

AI/ML Overview

The provided document is a 510(k) summary for the SICAT OPTISLEEP device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with performance metrics. Therefore, a table of acceptance criteria and reported device performance, and details on ground truth, sample sizes, and expert adjudication are not available in this document.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document focuses on comparing the new device, SICAT OPTISLEEP, to predicate devices (Narval CC and SomnoDent Classic) to establish substantial equivalence. It does not present specific performance metrics against pre-defined acceptance criteria for the SICAT OPTISLEEP device itself. The "Non-Clinical Performance Testing and Verification and Validation Activities" section lists various standards and guidance documents that were followed, implying that compliance with these standards served as a form of acceptance criteria, but no specific quantitative performance results are reported.

2. Sample size used for the test set and the data provenance

This information is not available in the provided 510(k) summary. The document mentions "verification and validation activities" including "usability testing" and "bench testing," but does not specify the sample sizes or data provenance for these tests. In a 510(k) submission, clinical study details are often summarized if they are necessary to demonstrate substantial equivalence and typically involve comparing the new device to a predicate rather than a standalone performance study with a test set as described in the prompt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided 510(k) summary. Given the absence of a detailed study on a "test set" with ground truth established by experts, this detail is not present.

4. Adjudication method for the test set

This information is not available in the provided 510(k) summary. Since there's no described test set with expert ground truth, an adjudication method is not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study and details about human readers improving with AI assistance are not applicable to this device. SICAT OPTISLEEP is described as "a pure hardware device," an oral appliance that is custom-manufactured. It does not involve AI or human readers for interpretation, but rather a physical intervention.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone algorithm performance study is not applicable to this device. As noted above, this is a physical, hardware-based medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not available in the provided 510(k) summary. Since no specific study establishing ground truth for a test set is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. The device is a physical appliance, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not available in the provided 510(k) summary. As no training set for an algorithm is applicable, the establishment of ground truth for it is also not applicable.

Summary of what is available from the document relevant to device equivalence:

The document focuses on demonstrating substantial equivalence of the SICAT OPTISLEEP to legally marketed predicate devices rather than proving performance against specific acceptance criteria in a clinical study for the new device.

Predicate Devices: Narval CC (K113201) and SomnoDent Classic (K050592).
Mechanism of Action: All three devices (SICAT OPTISLEEP and predicates) are mandibular repositioners that maintain the lower jaw in a forward position during sleep to increase pharyngeal space and improve air exchange, thereby reducing snoring and alleviating mild to moderate OSA.
Materials: SICAT OPTISLEEP uses Polymethylmethacrylate and Polyamide. Predicates use Acrylic/Stainless steel (SomnoDent Classic) or Polyamide (Narval CC).
Manufacturing: SICAT OPTISLEEP is produced by milling at a dental laboratory using CAD/CAM technology, similar to the Narval CC predicate (selective laser sintering of polymer) and the general "Dental laboratory" manufacturing for SomnoDent Classic.
Key Verification/Validation Activities (Non-Clinical):
- Evaluation of biocompatibility (following ISO 10993 series).
- Usability testing.
- Bench testing of compliance with specifications and handling.
- Compliance with various ISO standards and FDA guidance documents related to medical device labeling, risk management, usability engineering, and biological evaluation.
Conclusion for Substantial Equivalence: The FDA's review concludes that SICAT OPTISLEEP is substantially equivalent in design, material type, technological characteristics, and function to the predicate devices. Minor differences between the devices do not raise new questions concerning safety and effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2016

Sicat GmbH& Co. KG Dr. Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, North Rhine- Westphalia 53177 GERMANY

Re: K153291 Trade/Device Name: SICAT OPTISLEEP Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK, LQZ Dated: February 18, 2016 Received: February 19, 2016

Dear Dr. Breuer:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. 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

K153291 510(k) Number (if known):

Device Name:

SICAT OPTISLEEP

Indications for Use:

In adult population

· To reduce or alleviate snoring
To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)________________________________________________________________________________________________________________________________________________________________________

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510(k) Summary for SICAT OPTISLEEP

Content and format as required by section 21 CFR 807.92

( http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm\

1. SUBMITTER/510(K) HOLDER

SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany

Establishment Registration Number: 3006098230 Telephone: +49 228 854697-82 Primary Contact: Mr. Dr. Manfred Breuer Secondary Contact: Ms. Dr. Petra Benkel

Date Prepared: Nov. 12th, 2015

2. DEVICE NAME AND DEVICE CLASSIFICATION

Proprietary Name:	SICAT OPTISLEEP
Common/Usual Name:	Intraoral device for snoring and obstructive sleepapnea
Classification Name:	Intraoral devices for snoring and intraoral devices forsnoring and obstructive sleep apnea
Regulation Number:	21 CFR 872.5570
Classification Class:	2
Product Code:	LRK
Secondary Product Code:	LOZ

3. PREDICATE DEVICES

• Primary Predicate:	Narval CC (K113201)
• Reference Predicate:	SomnoDent Classic (K050592)

4. DEVICE DESCRIPTION

SICAT OPTISLEEP is fitted on the maxillary and mandibular arch covering all teeth. It consists of two main parts (upper and lower arch each) that are interconnected by exchangeable

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5 510(k) Summary
connectors. 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. Further this results in lower tendency to snore. The device has an adjustment mechanism, achieved by exchangeable connectors of different length, to adjust the mandibular advancement to be set by the dentist or physician at the time of fitting. The SICAT OPTISLEEP will be worn only during the sleep. The device will be used before replacement up to two years.

4.1 MATERIAL / PHYSICAL PROPERTIES

The main parts of the device are made of Polymethylmethacrylate. The exchangeable connectors are made of Polyamide.

5. INDICATIONS FOR USE

In adult population

· To reduce or alleviate snoring
· To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

6. DEVICE COMPARISON TABLE

The following table shows a summary of the intended use, technological characteristics, design and function of SICAT OPTISLEEP and the predicate devices.

	SICAT OPTISLEEP	Reference PredicateSomnomed MAS RxA (K050592)Last Brand Name: SomnoDent Classic	Primary PredicateNarval CC (K113201)
Regulation Information
Product Code	LRK	LRK	LQZ
SecondProduct Code	LQZ	-	-
ClassificationRegulation	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570
Device Class	2	2	2
DeviceClassificationName	Device, Anti-Snoring	Device, Anti-Snoring	Device, Jaw-Repositioning
Common /Usual Name	Intraoral device forsnoring and obstructivesleep apnea.	Mandibularadvancement device	Mandibular repositioningdevice
Manufacturer
Name	SICAT GmbH & Co. KG	SomnoMed Inc.	ResMed
Address	Brunnenallee 6,53177 Bonn,GERMANY	SomnoMed Inc., 20Clarke Street CrowsNest,NSW 2065, Australia	ResMed SASResMed Corp.9001 Spectrum CenterBoulevard, San Diego,
	SICAT OPTISLEEP	Reference PredicateSomnomed MAS RxA(K050592)Last Brand Name:SomnoDent Classic	Primary PredicateNarval CC (K113201)CA 92123, USA
		Indications for Use
	In adult population• To reduce or alleviatesnoring• To reduce or alleviatemild to moderateobstructive sleep apnea(OSA)	To reduce night-timesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults.	The Narval CC isintended to reduce oralleviate snoring andmild to moderateobstructive sleep apnea(OSA) in adults.
		Device Description
Design	SICAT OPTISLEEP is aremovable intraoraldevice used for treatingsnoring and sleepapnea. It consist of twocustom fabricatedsplints that fit separatelyover the upper andlower teeth and engageby means of adjustableconnectors. The devicefunctions as amandibular repositioner,maintaining the lowerjaw in a forward positionduring sleep. Thismechanical protrusionacts to increase thepatient's pharyngealspace, improving his/herability to exchange airduring sleep. The deviceis customized andpatient specific for eachpatient and has anadjustment mechanismenabling the amount ofmandibularadvancement to be setby the dentist orphysician at the time offitting.	The Somnomed MASRxA is an intraoraldevice used for treatingSnoring and SleepApnea. It consists oftwo custom fitted trayswhich fit over the upperand lower teeth andengage by means ofadjustable lugs. Thedevice functions as amandibular repositioner,which acts to increasethe patient's pharyngealspace, improving theirability to exchange airduring sleep. The deviceis custom made for eachpatient and has theadjustment mechanismenabling the amount ofmandibularadvancement to be setby the dentist orphysician at the time offitting the device.	The Narval CC is aremovable intraoraldevice used for treatingsnoring and sleepapnea. It consist of twocustom fabricatedsplints that fit separatelyover the upper andlower teeth and engageby means of adjustablerods. The devicefunctions as amandibular repositioner,maintaining the lowerjaw in a forward positionduring sleep. Thismechanical protrusionacts to increase thepatient's pharyngealspace, improving his/herability to exchange airand reducing thetendency to snore. Thedevice is custom madefor each patient and hasan adjustmentmechanism enabling theamount of mandibularadvancement to be setby the dentist orphysician at the time offitting.
Basic design	mandibular repositioner	mandibular repositioner	mandibular repositioner
	SICAT OPTISLEEP	Reference PredicateSomnomed MAS RxA(K050592)Last Brand Name:SomnoDent Classic	Primary PredicateNarval CC (K113201)
Mandibularadvancement	Adjustment of therelative position of thesplints guides themandible forward andmaintains advancementthus enlarging theairway. The verticalopening of the jaw isnot limited to a singleposition.	Adjustment of therelative position of thesplints guides themandible forward andmaintains advancementthus enlarging theairway.The vertical opening ofthe jaw is not limited toa single position.	Adjustment of therelative position of thesplints guides themandible forward andmaintains advancementthus enlarging theairway. The verticalopening of the jaw isnot fixed in a singleposition.
Adjustments	Adjusted via the use ofinterlocking connectorsof different lengthplaced on the sides ofthe splints, the longerthe connector, thefurther the mandible isadvanced.	Adjusted via the use ofinterlocking lugs andwings placed on thesides of the splints.	Adjusted via the use ofinterlocking rods placedon the sides of thesplints, the shorter therod, the further themandible is advanced.
		Properties
Material	• Acrylic (Polymethyl-methacrylate, PMMA)• Polyamide	• Acrylic• Stainless steel	• Polyamide
Reusable bysame patient	Yes	Yes	Yes
		Method of Manufacture
	Milling at SICAT dentallaboratory withCAD/CAM technology	Dental laboratory	Made by selective lasersintering of a polymermaterial in a dentallaboratory withCAD/CAM technology
Cleaning, Maintenance, Biocompatibility
Cleaning	Toothbrush with water;mild detergent; partialdenture cleaner withoutoxygen	Toothbrush with water;mild detergent; partialdenture cleaner withoutactive oxygen bySomnomed	Toothbrush with water;sonic cleaner; Narvalcleaner
Maintenance	Regular check up withdental medicalprofessional	Regular check up withdental medicalprofessional	Regular check up withdental medicalprofessional
	SICAT OPTISLEEP	Reference PredicateSomnomed MAS RxA(K050592)Last Brand Name:SomnoDent Classic	Primary PredicateNarval CC (K113201)
Bio-compatible	Yes	Yes	Yes
Miscellaneous
Design	Customized	Customized	Customized
Use	Only during sleep	Only during sleep	Only during sleep
Removable	Yes	Yes	Yes
Supplied sterile	No	No	No
Prescription only	Yes	Yes	Yes
Target Population	Persons in the age of 18years and older	Persons in the age of 18years and older	Persons in the age of 18years and older

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7. NON-CLINICAL PERFORMANCE TESTING AND VERIFICATION AND VALIDATION ACTIVITIES

For SICAT OPTISLEEP, verification and validation activities were performed, in accordance with the following guidance and standards:

Standard	Title
ISO 15223-1 SecondEdition:2012	Medical devices – Symbols to be used with medical device labels,labeling and information to be supplied – Part 1: Generalrequirements
ISO 14971 SecondEdition:2007	Medical devices – Application of risk management to medical devices
AAMI / ANSI / IEC62366:2007/(R)2013	Medical devices – Application of usability engineering to medicaldevices
ISO 7405 SecondEdition: 2008 +Amd. 1:2013	Dentistry – Evaluation of biocompatibility of medical devices used indentistry
ISO 10993-1 FourthEdition:2009	Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management system
ISO 10993-5 Edition3 2009-06-01	Biological evaluation of medical devices — Part 5: Tests for in vitrocytotoxicity
ISO 10993-12Fourth Edition 2012-07-01	Biological evaluation of medical devices — Part 12: Samplepreparation and reference materials (Biocompatibility)
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of

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allowable limits for leachable substances
ISO 10993-18 FirstEdition 2005-07-01	Biological Evaluation Of Medical Devices -- Part 18: ChemicalCharacterization Of Materials

Guidance

· Device Labeling Guidance, March 8, 1991 (G91-1)
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: July 18, 2000
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Document issued on: November 12, 2002
· Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Among others the following verification and validation activities were performed

evaluation of biocompatibility ●
usability testing
bench testing of compliance with specifications and handling ●

8. CONCLUSION

Based on the information and supporting documentation provided in this premarket notification, SICAT OPTISLEEP is considered to be substantially equivalent in design, material type, technological characteristics and function to the predicate devices Narval CC (K111066) and SomnoDent Classic (K102909).

The indications for use and patient populations of SICAT OPTISLEEP are the same for SICAT OPTISLEEP and the predicate devices.

All three devices are devices for a specific patient and are manufactured to and on the order of a dentist, physician or licensed practitioner. All devices use travs made of plastics (polyamide or acrylic). The adjustment mechanism for the mandibular advancement differs only slightly.

Any minor differences between SICAT OPTISLEEP and the predicate devices do not raise new questions concerning safety and effectiveness.

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.”