The LSW-S is a removable intraoral device consisting of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth by means of a protrusive element on the upper member relating to the protrusive element's mate on the lower member. This interface, and thus this device, productions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. Every device is pharying a open your of reach patient and is adjustable at the time of delivery and anytime thereafter.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (LambergSleepWell-Smartrusion, LSW-S) and a declaration of substantial equivalent to predicate devices. It describes the device, its intended use, and a comparison with predicate devices. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics on how ground truth was established.

The document is a regulatory submission demonstrating substantial equivalence to pre-existing devices, rather than a clinical study report proving specific performance metrics against acceptance criteria. The FDA's letter (frames 2-3) confirms the "substantial equivalence determination" based on the provided information, not an evaluation of device performance against pre-defined acceptance criteria from a clinical study.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor can I answer the questions regarding study specifics, as this information is not present in the provided text.

Summary

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Abbreviated 510k Notification Section 5

510K SUMMARY

101709

Submitter of 510k: Emily B. Rossiter on behalf of Steve Lamberg, DDS

Contact Person:

Emily B. Rossiter President, Regulatory Resources, Inc. 800 E. Leigh Street, Suite 206-5 Virginia Biotechnology Research Park Richmond, VA 23219 804-370-9459 rri@infionline.net

June 18, 2010 Date of Summary:

Trade Name: LambergSleepWell-Smartrusion (LSW-S)

Classification Name: Anti-snoring device, Jaw Repositioning Device

Device Product Code: LRK, LQZ

Somnomed MAS RxA - K050592 Predicate Devices: Lamberg Sleep Well Device - K062333

Intended Use/Indication for Use: For the reduction of night-time snoring or mild to moderate obstructive sleep apnea in adults 18 years of age or older. Prescription use only.

Device Description:

Comparison Table with Predicate Device:

The following table displays the differences and similarities between the new LambergSleepWell-Smartrusion and two other previously marketed devices. Equivalence is based on similarities in intended use, materials of construction, design, and operating principles, as summarized in the table on the following page.

AUG 1 8 2010

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Feature
Intended Use	Lamberg Sleep Well-Smartrusion(LSW-S)To reduce or alleviate night-timesnoring and mild and moderateobstructive sleep apnea (OSA) inadults.	Lamberg Sleep Well DeviceK062333To reduce night-time snoring; for usein adults 18 years of age or older in ahome or sleep laboratory environment	Somnomed MAS RXAK050592To reduce night-time snoring andmild to moderate obstructive apnea(OAS) in adults.
Materials of construction	Methyl methacrylate, copolyester,stainless steel	Methyl methacrylate, stainless steel	Dentocryl methylmethacrylate,stainless steel
Design	Two custom-molded componentsthat fit separately over each of thedental arches inside the mouth.Adjustable by the dentist upondelivery to the patient and at anyvisit thereafter, as necessary.	One-piece custom molded appliancethat is seated against the palate of themouth, extends over the upperincisors, and is 2-3 mm thick.	Custom fitted acrylic trays fit ontothe upper and lower teeth and arelocked into place. The two trays arepositioned in relation to each otherby an adjustable mechanism, madeof interlocking lugs and wings
Principle of operation/- means of mandibular advancement	The two component pieces areengaged in the anterior area bymeans of a protrusive element and itsmate, in complementary arches. Thejaws are repositioned in an anterior-posterior relationship, moving themandible forward; the verticalopening of the jaw is not fixed in asingle position.	Single piece device is placed in themouth and secured to the upper frontmolars with Adams clasps. A centralprotrusive element makes contactwith the lingual surface of themandibular incisors, repositioning themandible and tongue forward; thevertical opening of the jaw is notfixed in a single position.	Adjustment of the relative positionof the trays advances the mandibleforward, enlarging the airway whilethe appliance is in place. Thevertical opening of the jaw is notfixed in a single position.
Fixed/Removable	Removable	Removable	Removable
Adjustment	Adjusted by the prescribing dentistby the addition of dental acrylicmaterial to the anterior protrusiveelement.	Adjusted by the prescribing dentist bythe addition of dental acrylic to theanterior protrusive element.	Adjusted via the use of interlockinglugs and wings placed on both sidesof the trays with stainless steelscrews.
Supplied Sterile?	No	No	No
Single Use?	No; custom designed for eachpatient; reusable	No; custom designed for each patient;reusable	No; custom designed for eachpatient; reusable
By prescription only?	Yes	Yes	Yes

K101709

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH &" are vertically oriented on the left side of the logo, and the words "HUMAN SERVICES" are vertically oriented on the right side of the logo.

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

Steven B. Lamberg, DDS C/O Ms. Emily B. Rossiter Regulatory Resources, Incorporated 800 East Leigh Street, Suite 206-5 Richmond, Virginia 23219

AUG 1 8 2010

Re: K101709

Trade/Device Name: LambergSleep Well-Smartrusion (LSW-S) 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: LQZ Dated: July 22, 2010 Received: July 22, 2010

Dear Ms. Rossiter:

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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Page 2- Ms. Rossiter

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Abbreviated 510k Notification Section 4 '

LSW-S Page 4-1

Indications for Use

K101709

510(k) Number (if known):

Device Name: LambergSleepWell-Smartrusion (LSW-S)

Indications for Use:

The LambergSleepWell-Smartrusion is used to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nulllallall for h. Keun Muhy
Page 1 of +

(Posted November 13, 2003)

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number K101709

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.”