(166 days)
Not Found
No
The device description and performance studies focus on the physical design and clinical efficacy of a dental appliance, with no mention of AI or ML technologies.
Yes
The device is indicated to treat Obstructive Sleep Apnea, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a sleep apnea appliance designed to treat Obstructive Sleep Apnea, not to diagnose it. Its effectiveness is measured by the reduction of snoring and apneic events using polysomnograms, which are diagnostic tools, but the device itself is a treatment.
No
The device description clearly states it is a physical appliance made of acrylic dental plates, not software.
Based on the provided information, the Nu Sleep appliance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Nu Sleep Appliance Function: The Nu Sleep appliance is a physical device worn inside the mouth to treat Obstructive Sleep Apnea. It works by physically repositioning the jaw and tongue to open the airway. It does not involve the analysis of any bodily specimens.
- Intended Use: The intended use is to treat a condition, not to diagnose it through laboratory testing.
Therefore, the Nu Sleep appliance falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
Nu Sleep appliance is a patient specific made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The attachment is at a 40 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front and allowing the patient to inhale and exhale more air per breath.
The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.
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 patients
Intended User / Care Setting
Indicated for use at home or sleep labratories
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)
Bench testing - Comparable Chemical Structure testing was conducted with Nu Sleep and its predicate devices. Test results have demonstrated the equivalent and/or similarity of Nu Sleep to its predicate devices.
GPC testing was conducted in order to determine the molecular weight and the molecular weight distribution. Test results have met all acceptable criteria.
Clinical evaluation study was conducted on 31 patients, female & male, at one facility. The study observation was conducted in two stages, stage one without the appliance, stage two with the appliance. Objective criteria have been observed and have been measured, such as: total sleep, RDI, AHI, ODI, at both stages. Clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms. Thus, Nu Sleep appliance shares similarity in the indication of use to its predicate devices.
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.
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
ERLI MEDICAL REGISTRATION
SECTION 5.................. 510(k) Summary (21.CEB 807.92)
510(k) Number K 481344
| 1 | Submission Owner | RH Associates LLC
257 Middle Country Rd.
Smithtown, 11787 NY
Phone 631-724-4664
Fax 631-360-7880 |
|---|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Official Correspondent
Contact Person | Sterling Medical Registration
Daniela Levy - Regulatory Consultant
22817 Ventura Blvd#161
Woodland Hills, 91364 CA
Phone 213-787-3026
Phone 213-447-5297
Web www.sterlingmedicalregistration.com |
| 3 | Submission Date | February 2012 |
| 4 | Device Trade Name | Nu Sleep |
| 5 | Regulation Description | Intraoral devices for snoring and intraoral devices
for snoring and obstructive sleep apnea (OSA) |
| 6 | Classification | Device Name : Device, Anti-Snoring
Product Code : LRK
Regulation No : 872.5570
Class : II
Panel : Dental |
| 7 | Reason for the Premarket Notification Submission | New Device |
1
ס״ד
OCT 1 7 2012
- Identification of Legally Marketed Predicate Devices : 8
ﻟ
. -
- · · Nu Sleep appliance is substantially equivalent to Respire Blue Series K111207;
- Somnomed MAS Flex S K073004; EMA K971794; in terms of intended use, い
1
ס״ר
FERLING MEDICAL REGISTRATION
indication for use, technological characteristics, performance and user interface. The predicate devices are Class II medical devices.
- Device Description ರಿ
Nu Sleep appliance is a patient specific made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The attachment is at a 40 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front and allowing the patient to inhale and exhale more air per breath.
The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.
10 Intended use
- The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep . Apnea.
11 Performance Standards or Special Controls
- Recognized Consensus Standard: ISO 7405:2008 Dentistry Evaluation of . biocompatibility of medical devices used in dentistry
| Substantial Equivalent Table | Candidate
NU Sleep
Device | Respire Blue Series
(Hard/Soft Surface) | EMA | Somnomed
Flex S |
|----------------------------------------------------------|---------------------------------|--------------------------------------------|-------------------------------|--------------------|
| 510k Number | | K111207 | K971794 | K073004 |
| Company Name | RH
Associates
LLC | Respire Medical LLC | Frantz Design
Incorporated | Somnomed
Inc |
| Intended Use | | | | |
| Intended as an intraoral device | YES | YES | YES | YES |
| Intended to reduce snoring or
help alleviate snoring | YES | YES | YES | YES |
| Treatment of mild to moderate
obstructive sleep apnea | YES | YES | YES | YES |
| Indicated for single patient multi -
use | YES | YES | YES | YES |
| Indicated for use at home or sleep
labratories | YES | YES | YES | YES |
| Target population - Adults
patients | YES | YES | YES | YES |
| Prescription Device | YES | YES | YES | YES |
12 Substantial Equivalence
2
ס״ד
| Design | ||||
|---|---|---|---|---|
| Rigid tray pieces | YES | YES | YES | YES |
| Separate tray pieces | YES | YES | YES | YES |
| patient specific fit for each patient | YES | YES | YES | YES |
| Works by mandibular | ||||
| advancement | YES | YES | YES | YES |
| Can be adjusted or refit | YES | YES | YES | YES |
| Placed in patient mouth each | ||||
| evening | YES | YES | YES | YES |
| Cleaned daily | YES | YES | YES | YES |
| Easily removed from mouth | YES | YES | YES | YES |
| Lower jaw adjustment using a | ||||
| supplied adjustment key | YES | YES | YES | YES |
| Upper and lower tray unhook for | ||||
| easy removal from mouth | YES | YES | YES | YES |
| Permits patients to breat through | ||||
| mouth | YES | YES | YES | YES |
| Material | ||||
| Trays constructed from molded | ||||
| hard acrylic and ball clasps | YES | YES | YES | NO |
| Trays constructed from a soft | ||||
| lining material adhered to a hard | ||||
| surface acrylic | YES | YES | ||
| [No for hard] | NO | YES | ||
| Trays constructed from a heat | ||||
| sensitive impermissible material | ||||
| for fitting to teeth | NO | NO | NO | NO |
| Non Sterile | YES | YES | YES | YES |
Summary of Equivalence: Nu Sleep appliance is substantially equivalent to Respire Blue Series K111207; Somnomed MAS Flex SK073004 and EMA K971794 devices. As similar to its predicate device Nu Sleep appliance is a patient specific made device, consists of two parts, upper and lower trays, made of acrylic.
Nu Sleep differs from both the Respire Blue and the Somnomed in that the both require a very rigged plastic to handle the forces applied to the acrylic wings. Nu Sleep utilizes steel to handle the forces so that the contact position can be placed further back in the mouth.
The design differences emphasis the advantages of Nu Sleep technology. Nu Sleep shares the same technological characteristics as its predicate devices and thus, the Nu Sleep appliance is substantially equivalent to its predicate devices.
Risk Assessment performance to ensure the safety and effectiveness related to the appliances.
3
ס״ד
MEDICAL REGISTRATION
Bench testing - Comparable Chemical Structure testing was conducted with Nu Sleep and its predicate devices. Test results have demonstrated the equivalent and/or similarity of Nu Sleep to its predicate devices. Thus, Nu Sleep appliance shares similarity with its predicate devices.
GPC testing was conducted in order to determine the molecular weight and the molecular weight distribution. Test results have met all acceptable criteria.
Clinical evaluation study was conducted on 31 patients, female & male, at one facility. The study observation was conducted in two stages, stage one without the appliance, stage two with the appliance. Objective criteria have been observed and have been measured, such as: total sleep, RDI, AHI, ODI, at both stages. Clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms. Thus, Nu Sleep appliance shares similarity in the indication of use to its predicate devices.
Conclusion:
As verified by clinical and non clinical data, bench testing and substantial equivalence table, Nu Sleep appliance shares similarity with its predicated device by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus Nu Sleep appliance is considered to be substantially equivalent to the its predicates devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring what appears to be an abstract representation of people or human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 17 2012
RH Associates, Limited Liability Company C/O Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Boulevard # 161 Woodland Hills, California 91364
Re: K121344
Trade/Device Name: Nu Sleep 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 Dated: September 13, 2012 Received: September 17, 2012
Dear Ms. Levy:
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.
5
Page 2- Ms. Levy
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 vours.
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
6
RLI MEDICAL REGISTRATION
SECTION 4 - Indication for Use Statement
Indications for Use
Indications for Use
1
510(k) Number (if known): _ K121344
Device Name:
Nu Sleep
Indications for Use:
The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.
Prescription Use _ > (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shoar Raman
Isian Stan-Off of Anesthesiology, General Hospital Infection Control, Dental I
Page 1 of _
510(k) Number: