(107 days)
Not Found
No
The device description and performance studies focus on mechanical function and material biocompatibility, with no mention of AI or ML.
Yes
The device is described as an "aid for the reduction of snoring" and functions to "increase the patient's pharyngeal space, improving the ability to exchange air during sleep," which indicates a therapeutic purpose.
No
The device is described as an aid for the reduction of snoring by advancing the lower jaw to minimize air obstruction and turbulence, functioning as a mandibular anterior repositioner to increase pharyngeal space. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states it is an "intraoral device" consisting of "two custom fabricated trays" and describes its physical mechanism of action ("advancing the lower jaw"). The performance studies also focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring by physically repositioning the lower jaw. This is a mechanical action within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an intraoral appliance that physically alters the airway. It doesn't involve any testing of biological samples.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on test results
The device is a physical aid for a physiological issue (snoring), not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Product codes
LRK
Device Description
The Consumer Health Products SnoreRx NS 9.0 is an intraoral device used at night to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. The device consists 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. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Not Found
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)
Performance testing was conducted to evaluate and characterize the performance of the Consumer Health Products SnoreRx NS 9.0. Preclinical testing conducted included dimensional conformance evaluation, visual inspections, design verification testing to confirm airway passage equivalency, and biocompatibility testing of device materials based on the applicable elements of ISO 10993-1 shown below.
| Test Performed | Standard | Test Result/Conclusion |
|---|---|---|
| ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells | ISO 10993-5 | Passed. Non-cytotoxic |
| ISO Intracutaneous Irritation Test | ISO 10993-10 | Passed. Non-irritant |
| Sensitization: Guinea Pig Maximization | ISO 10993-10 | Passed/Negative for evidence of sensitization |
Additionally material characterization testing was performed and concluded that the materials used in the construction of the Consumer Health Products SnoreRx NS 9.0 are identical the listed predicate device.
This submission does not rely on clinical data to determine substantial equivalency to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SnoreGuard (K103004), Silencer (K954530), Snore Control (K963591), SnoreMaster (K954128)
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.”
0
K112205/S2 Response to Al email 11-01-11 Page 20 of 23
Section 6
510(k) Summary
510(k) Summarv
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Consumer Health Products, Inc.
17 Brownsbury Road #110
Laguna Niguel, CA 92677 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| CONTACT : | Gary Mocnik
49 Coastal Oak, Aliso Viejo, CA 92656
949.433.0413
949.831.9944 fax
gmocnik@cox.net |
| DATE PREPARED | July 25, 2011 |
| TRADE NAME: | SnoreRx NS 9.0 |
| COMMON NAME: | Anti-Snoring Mouth Piece |
| CLASSIFICATION NAME: | Anti-Snoring Device, 21 CFR, 872.5570 |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | LRK |
| PREDICATE DEVICES: | SnoreGuard (K103004), Silencer (K954530), Snore |
Control (K963591), SnoreMaster (K954128)
Substantially Equivalent To:
The Consumer Health Products SnoreRx NS 9.0 is substantially equivalent in intended use, principal of operation and technological characteristics to the SnoreGuard (K103004), the Silencer (K954530), the SnoreControl (K963591), and the SnoreMaster (K954128), as well as other predicate devices cleared with an LRK Product Code.
Description of the Device Subject to Premarket Notification:
The Consumer Health Products SnoreRx NS 9.0 is an intraoral device used at night to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. The device consists 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. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep
Consumer Health Products, Inc SnoreRx NS 9.0
Premarket Notification
1
Indication for Use:
The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Discussion of Technological Characteristics:
The Consumer Health Products SnoreRx NS 9.0 has similar physical and technical characteristics to the predicate devices. The Consumer Health Products SnoreRx NS 9.0 and the identified predicates all provide means for advancing the lower jaw in a predetermined manner. The technical designs and manufacture of the SnoreRx NS 9.0 and the predicate devices are very similar, being composed of custom fitted acrylic trays which fit onto the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism.
Non-Clinical Performance Data:
.. . .
Performance testing was conducted to evaluate and characterize the performance of the Consumer Health Products SnoreRx NS 9.0. Preclinical testing conducted included dimensional conformance evaluation, visual inspections, design verification testing to confirm airway passage equivalency, and biocompatibility testing of device materials based on the applicable elements of ISO 10993-1 shown below.
| Test Performed | Standard | Test Result/Conclusion |
|---|---|---|
| ISO MEM Elution Assay with L-929 | ||
| Mouse Fibroblast Cells | ISO 10993-5 | Passed. |
| Non-cytotoxic | ||
| ISO Intracutaneous Irritation Test | ISO 10993-10 | Passed. |
| Non-irritant | ||
| Sensitization: Guinea Pig Maximization | ISO 10993-10 | Passed/Negative for evidence of |
| sensitization |
Additionally material characterization testing was performed and concluded that the materials used in the construction of the Consumer Health Products SnoreRx NS 9.0 are identical the listed predicate device.
Clinical Data
This submission does not rely on clinical data to determine substantial equivalency to the predicate devices.
Basis for Determination of Substantial Equivalence:
The following table displays the differences and similarities between the new SnoreRx NS 9.0 and other previously marketed devices.
Consumer Health Products, Inc SnoreRx NS 9.0
Premarket Notification
2
Section 6
| Products
SnoreRx NS
9.0 | or older as an aid for the reduction of snoring. | repositioning
to increase
pharyngeal
space | device inserted
over the upper
and lower dental
arches. |
|-------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------|
| SnoreGuard
(K103004) | Intended to reduce night time snoring and mild to
moderate obstructive sleep apnea (OSA) in adults | SAME | SAME |
| Silencer
(K954530) | Intended to reduce or eliminate night time snoring
in patients 18 years of age or older only. | SAME | SAME |
| SnoreControl
(K963591) | The anti-snoring device is intended to alleviate or
correct snoring | SAME | SAME |
| SnoreMaster
(9541285) | The anti-snoring device is intended to alleviate or
correct snoring | SAME | SAME |
Conclusions Drawn
As shown, the Consumer Health Products SnoreRx NS 9.0 has the following similarities to the predicate devices:
- . Same intended use
- . Same design characteristics
- · Same operating principal-
- Same mechanism of action .
- . Same technological characteristics
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Consumer Health Products SnoreRx NS 9.0 is determined to be substantially equivalent to existing legally marketed devices, performs as well as the predicate devices, and is as safe and effective for its intended use.
Premarket Notification
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 6 2011
Consumer Health Products, Incorporated C/O Mr. Gary Mocnik Regulatory Consultants Gary Mocnik and Associates 49 Coastal Oak Aliso Viejo, California 92656
Re: K112205
Trade/Device Name: SnoreRx NS 9.0 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: November 4, 2011 Received: November 7, 2011
Dear Mr. Mocnik:
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.
4
Page 2 - Mr. Mocnik
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 (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.
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 /ucm 1 1 5809.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
5
K112205/S2 Response to Al email 11-01-11 Page 18 of 23
Image /page/5/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K112205". The characters are written in a cursive style, with some connections between the letters and numbers. The writing appears to be done with a pen or marker.
Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: SnoreRx NS 9:0
Indications for Use:
The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ X (Per 21 CFR 801.109)
.
Over-The-Counter Use (Optional Format 1-2-96)
Page of
Susan Roses
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k12205