(62 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, ML, training sets, or performance studies related to algorithmic performance indicate that this is a mechanical device without AI/ML components.
Yes
The device is used to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it works by repositioning the jaw to improve airflow.
No
The device is described as an intraoral device for reducing snoring and sleep apnea, not for detecting or diagnosing these conditions. Its function is to reposition the jaw to improve airflow.
No
The device description clearly states it is a "removable intraoral device consisting of two custom fabricated trays" which are physical components, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The LambergSleepWell-Smartrusion is an intraoral device that physically repositions the mandible 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 by physically altering the airway, not by analyzing biological markers.
Therefore, the LambergSleepWell-Smartrusion falls under the category of a medical device, specifically a dental device or sleep apnea device, but not an IVD.
N/A
Intended Use / Indications 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.
The LambergSleepWell-Smartrusion is used to reduce or alleviate night-time 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 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.
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 18 years of age or older
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Not Found
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.
Lamberg Sleep Well Device - K062333, Somnomed MAS RxA - K050592
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.
Not Found
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.”
0
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:
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.
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
1
| Feature | |||
|---|---|---|---|
| Intended Use | Lamberg Sleep Well-Smartrusion | ||
| (LSW-S) | |||
| To reduce or alleviate night-time | |||
| snoring and mild and moderate | |||
| obstructive sleep apnea (OSA) in | |||
| adults. | Lamberg Sleep Well Device | ||
| K062333 | |||
| To reduce night-time snoring; for use | |||
| in adults 18 years of age or older in a | |||
| home or sleep laboratory environment | Somnomed MAS RXA | ||
| K050592 | |||
| To reduce night-time snoring and | |||
| mild 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 components | ||
| that fit separately over each of the | |||
| dental arches inside the mouth. | |||
| Adjustable by the dentist upon | |||
| delivery to the patient and at any | |||
| visit thereafter, as necessary. | One-piece custom molded appliance | ||
| that is seated against the palate of the | |||
| mouth, extends over the upper | |||
| incisors, and is 2-3 mm thick. | Custom fitted acrylic trays fit onto | ||
| the upper and lower teeth and are | |||
| locked into place. The two trays are | |||
| positioned in relation to each other | |||
| by an adjustable mechanism, made | |||
| of interlocking lugs and wings | |||
| Principle of operation/- means of mandibular advancement | The two component pieces are | ||
| engaged in the anterior area by | |||
| means of a protrusive element and its | |||
| mate, in complementary arches. The | |||
| jaws are repositioned in an anterior- | |||
| posterior relationship, moving the | |||
| mandible forward; the vertical | |||
| opening of the jaw is not fixed in a | |||
| single position. | Single piece device is placed in the | ||
| mouth and secured to the upper front | |||
| molars with Adams clasps. A central | |||
| protrusive element makes contact | |||
| with the lingual surface of the | |||
| mandibular incisors, repositioning the | |||
| mandible and tongue forward; the | |||
| vertical opening of the jaw is not | |||
| fixed in a single position. | Adjustment of the relative position | ||
| of the trays advances the mandible | |||
| forward, enlarging the airway while | |||
| the appliance is in place. The | |||
| vertical opening of the jaw is not | |||
| fixed in a single position. | |||
| Fixed/Removable | Removable | Removable | Removable |
| Adjustment | Adjusted by the prescribing dentist | ||
| by the addition of dental acrylic | |||
| material to the anterior protrusive | |||
| element. | Adjusted by the prescribing dentist by | ||
| the addition of dental acrylic to the | |||
| anterior protrusive element. | Adjusted via the use of interlocking | ||
| lugs and wings placed on both sides | |||
| of the trays with stainless steel | |||
| screws. | |||
| Supplied Sterile? | No | No | No |
| Single Use? | No; custom designed for each | ||
| patient; reusable | No; custom designed for each patient; | ||
| reusable | No; custom designed for each | ||
| patient; reusable | |||
| By prescription only? | Yes | Yes | Yes |
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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.
3
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
4
Abbreviated 510k Notification Section 4 '
LSW-S Page 4-1
Indications for Use
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