(126 days)
Not Found
No
The device description details a physical, custom-molded oral appliance with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended to reduce night time snoring, which is a physiological condition, indicating a therapeutic purpose.
No
The device is described as intended to reduce snoring, which is a treatment or therapy, not a diagnostic function. It advances the mandible, a physical intervention, and there's no mention of measurement or analysis of physiological data for diagnosis.
No
The device description clearly states it is a "one piece, custom-molded device" made of physical material that is placed in the mouth, indicating it is a hardware device, not software only.
Based on the provided information, the Lamberg Sleep Well device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lamberg Sleep Well Device Function: The description clearly states that the Lamberg Sleep Well device is a custom-molded oral appliance designed to physically advance the mandible to reduce snoring. It is a mechanical device used directly on the patient's anatomy.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or perform any kind of diagnostic test. Its purpose is therapeutic (reducing snoring), not diagnostic.
Therefore, the Lamberg Sleep Well device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lamberg Sleep Well device is intended to reduce night time snoring.
The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment.
The Lamberg Sleep Well device is intended to reduce night time snoring in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.
Product codes
LRK
Device Description
The Lamberg Sleep Well device is a one piece, custom-molded device that advances the mandible by 5 mm. The body of the device extends over the upper incisors, and is 2 – 3 mm thick. A central protrusive element hangs down to contact the lingual lower incisors. An Adams clasp is placed to hold the device securely to each of the upper first molars. The appliance ends at the distal of the first molars on the palate.
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
a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.
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)
No performance data are required in support of this 510(k) notice.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Kevin Mulry, D.D.S. December 7, 2006 Page 9
Attachment 2: 510(k) Summary
510(k) SUMMARY
DEL 1 4 2006 Steven B. Lamberg, D.D.S.'s Lamberg Sleep Well Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson LLP 555 Thirteenth Street, NW Washington, D.C. 20004-1109 Phone: 202-637-5794 Facsimile: 202-637-5910
Contact Person: Jonathan S. Kahan
Date Prepared:December 5, 2006
Name of Device /Address of Sponsor
Lamberg Sleep Well Device
Steven B. Lamberg, D.D.S. 140 Main Street Northport, New York 11768 Phone: 631-261-6014 Facsimile: 631-261-6364
Common or Usual Name
Mandibular advancement device
Classification Name
Anti-snoring device (Product code: LRK)
Predicate Devices
TheraSnore (K973038) Distar, Inc.
Hawley retainer (Preamendments) Specialty Appliance Works, Inc.
Trubyte Denture Base Resin System, and Modification to Trubyte Denture Base Resin System Dentsply International (K011560, K032892)
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Kevin Mulry, D.D.S. December 7, 2006 Page 10
Intended Use / Indications for Use
The Lamberg Sleep Well device is intended to reduce night time snoring.
The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment.
Technological Characteristics
The Lamberg Sleep Well device is a one piece, custom-molded device that advances the mandible by 5 mm. The body of the device extends over the upper incisors, and is 2 – 3 mm thick. A central protrusive element hangs down to contact the lingual lower incisors. An Adams clasp is placed to hold the device securely to each of the upper first molars. The appliance ends at the distal of the first molars on the palate.
Principles of Operation
The patient inserts the device into their mouth, seating it against the soft palate, and engages it securely to the upper front molars with the Adams clasps. The central protrusive element hangs down and makes contact with the lingual surface of the mandibular incisors, thus moving the mandible forward by 5 mm. The forward placement of the mandible with respect to the maxilla serves to pull the tongue forward, which directly and indirectly reduces snoring.
Performance Data
No performance data are required in support of this 510(k) notice.
Substantial Equivalence
The Lamberg Sleep Well device is substantially equivalent in intended use and technology to the TheraSnore (K973038). The Lamberg Sleep Well device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Lamberg Sleep Well device and its predicate devices raise no new issues of safety or effectiveness. Thus, the Lamberg Sleep Well device is substantially equivalent.
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Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steven Lamberg, D.D.S C/O Mr. Jonathan S. Kahan Columbia Square Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109 DEC 1 4 2006
Re: K062333 Trade/Device Name: Lamberg Sleep Well Device Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: December 7, 2006 Received: December 7, 2006
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Mr. Lahan
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
Chiu Lin, Ph.D. 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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Kevin Mulry, D.D.S. December 7, 2006 Page 8
Attachment 1:
Indications for Use Statement
510(k) Number: K062333
Device Name: Lamberg Sleep Well Device
Indications for Use:
The Lamberg Sleep Well device is intended to reduce night time snoring in adults 18 years of The Earlover of Sleep laboratory environment. The device must be prescribed by a dentist or physician.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 C.F.R. 807 Subpart C)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Susan Runner | |
| Anesthesiology, General Hosp. Al. | |
| n Control, Dental Devices | |
| K062333 | |
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