(139 days)
No
The device description explicitly states it is a "pure hardware device" and functions as a mechanical mandibular repositioner. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is intended "To reduce or alleviate snoring" and "To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)", which are therapeutic indications. It functions as a mandibular repositioner to improve air exchange during sleep, directly addressing a health condition.
No
The device is an oral appliance intended to alleviate snoring and mild to moderate obstructive sleep apnea by repositioning the jaw, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that SICAT OPTISLEEP is a "pure hardware device" and describes it as an oral appliance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The SICAT OPTISLEEP is a physical oral appliance that mechanically repositions the jaw to improve airflow during sleep. It does not analyze biological samples.
- Intended Use: The intended use is to reduce snoring and mild to moderate obstructive sleep apnea through a mechanical action, not through diagnostic testing of biological samples.
Therefore, the SICAT OPTISLEEP falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In adult population
- To reduce or alleviate snoring
- To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, lower jaw
Indicated Patient Age Range
Persons in the age of 18 years and older
Intended User / Care Setting
dentist, physician or licensed practitioner
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 testing and verification and validation activities were performed in accordance with several standards and guidance documents. These include:
- evaluation of biocompatibility
- usability testing
- bench testing of compliance with specifications and handling
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.
Narval CC (K113201)
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.
SomnoDent Classic (K050592)
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/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.
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 (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 sleep |
| apnea | |
| Classification Name: | Intraoral devices for snoring and intraoral devices for |
| snoring 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 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
4
- 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 Predicate
Somnomed MAS RxA (K050592)
Last Brand Name: SomnoDent Classic | Primary Predicate
Narval CC (K113201) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Information | | | |
| Product Code | LRK | LRK | LQZ |
| Second
Product Code | LQZ | - | - |
| Classification
Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Device Class | 2 | 2 | 2 |
| Device
Classification
Name | Device, Anti-Snoring | Device, Anti-Snoring | Device, Jaw-Repositioning |
| Common /
Usual Name | Intraoral device for
snoring and obstructive
sleep apnea. | Mandibular
advancement device | Mandibular repositioning
device |
| Manufacturer | | | |
| Name | SICAT GmbH & Co. KG | SomnoMed Inc. | ResMed |
| Address | Brunnenallee 6,
53177 Bonn,
GERMANY | SomnoMed Inc., 20
Clarke Street Crows
Nest,
NSW 2065, Australia | ResMed SAS
ResMed Corp.
9001 Spectrum Center
Boulevard, San Diego, |
| | SICAT OPTISLEEP | Reference Predicate
Somnomed MAS RxA
(K050592)
Last Brand Name:
SomnoDent Classic | Primary Predicate
Narval CC (K113201)
CA 92123, USA |
| | | Indications for Use | |
| | In adult population
• To reduce or alleviate
snoring
• To reduce or alleviate
mild to moderate
obstructive sleep apnea
(OSA) | To reduce night-time
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. | The Narval CC is
intended to reduce or
alleviate snoring and
mild to moderate
obstructive sleep apnea
(OSA) in adults. |
| | | Device Description | |
| Design | SICAT OPTISLEEP is a
removable intraoral
device used for treating
snoring and sleep
apnea. It consist of two
custom fabricated
splints that fit separately
over the upper and
lower teeth and engage
by means of adjustable
connectors. The 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 his/her
ability to exchange air
during sleep. The device
is customized and
patient specific for each
patient and has an
adjustment mechanism
enabling the amount of
mandibular
advancement to be set
by the dentist or
physician at the time of
fitting. | The Somnomed MAS
RxA is an intraoral
device used for treating
Snoring and Sleep
Apnea. It consists of
two custom fitted trays
which fit over the upper
and lower teeth and
engage by means of
adjustable lugs. The
device functions as a
mandibular repositioner,
which acts to increase
the patient's pharyngeal
space, improving their
ability to exchange air
during sleep. The device
is custom made for each
patient and has the
adjustment mechanism
enabling the amount of
mandibular
advancement to be set
by the dentist or
physician at the time of
fitting the device. | The Narval CC is a
removable intraoral
device used for treating
snoring and sleep
apnea. It consist of two
custom fabricated
splints that fit separately
over the upper and
lower teeth and engage
by means of adjustable
rods. The 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 his/her
ability to exchange air
and reducing the
tendency to snore. The
device is custom made
for each patient and has
an adjustment
mechanism enabling the
amount of mandibular
advancement to be set
by the dentist or
physician at the time of
fitting. |
| Basic design | mandibular repositioner | mandibular repositioner | mandibular repositioner |
| | SICAT OPTISLEEP | Reference Predicate
Somnomed MAS RxA
(K050592)
Last Brand Name:
SomnoDent Classic | Primary Predicate
Narval CC (K113201) |
| Mandibular
advancement | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains advancement
thus enlarging the
airway. The vertical
opening of the jaw is
not limited to a single
position. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains advancement
thus enlarging the
airway.
The vertical opening of
the jaw is not limited to
a single position. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains advancement
thus enlarging the
airway. The vertical
opening of the jaw is
not fixed in a single
position. |
| Adjustments | Adjusted via the use of
interlocking connectors
of different length
placed on the sides of
the splints, the longer
the connector, the
further the mandible is
advanced. | Adjusted via the use of
interlocking lugs and
wings placed on the
sides of the splints. | Adjusted via the use of
interlocking rods placed
on the sides of the
splints, the shorter the
rod, the further the
mandible is advanced. |
| | | Properties | |
| Material | • Acrylic (Polymethyl-
methacrylate, PMMA)
• Polyamide | • Acrylic
• Stainless steel | • Polyamide |
| Reusable by
same patient | Yes | Yes | Yes |
| | | Method of Manufacture | |
| | Milling at SICAT dental
laboratory with
CAD/CAM technology | Dental laboratory | Made by selective laser
sintering of a polymer
material in a dental
laboratory with
CAD/CAM technology |
| Cleaning, Maintenance, Biocompatibility | | | |
| Cleaning | Toothbrush with water;
mild detergent; partial
denture cleaner without
oxygen | Toothbrush with water;
mild detergent; partial
denture cleaner without
active oxygen by
Somnomed | Toothbrush with water;
sonic cleaner; Narval
cleaner |
| Maintenance | Regular check up with
dental medical
professional | Regular check up with
dental medical
professional | Regular check up with
dental medical
professional |
| | SICAT OPTISLEEP | Reference Predicate
Somnomed MAS RxA
(K050592)
Last Brand Name:
SomnoDent Classic | Primary Predicate
Narval 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 18
years and older | Persons in the age of 18
years and older | Persons in the age of 18
years and older |
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6
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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 Second | |
| Edition:2012 | Medical devices – Symbols to be used with medical device labels, |
| labeling and information to be supplied – Part 1: General | |
| requirements | |
| ISO 14971 Second | |
| Edition:2007 | Medical devices – Application of risk management to medical devices |
| AAMI / ANSI / IEC | |
| 62366:2007/(R)2013 | Medical devices – Application of usability engineering to medical |
| devices | |
| ISO 7405 Second | |
| Edition: 2008 + | |
| Amd. 1:2013 | Dentistry – Evaluation of biocompatibility of medical devices used in |
| dentistry | |
| ISO 10993-1 Fourth | |
| Edition:2009 | Biological evaluation of medical devices – Part 1: Evaluation and |
| testing within a risk management system | |
| ISO 10993-5 Edition | |
| 3 2009-06-01 | Biological evaluation of medical devices — Part 5: Tests for in vitro |
| cytotoxicity | |
| ISO 10993-12 | |
| Fourth Edition 2012- | |
| 07-01 | Biological evaluation of medical devices — Part 12: Sample |
| preparation and reference materials (Biocompatibility) | |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of |
8
| allowable limits for leachable substances | |
|---|---|
| ISO 10993-18 First | |
| Edition 2005-07-01 | Biological Evaluation Of Medical Devices -- Part 18: Chemical |
| Characterization 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.