(279 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of action and material properties, with no mention of AI or ML.
No.
The device is described as an aid for the reduction of snoring. While it addresses a physiological issue, it is not described as treating or alleviating a disease or medical condition, which is typically the definition of a therapeutic device. It is intended to reposition the jaw to improve airflow and decrease air turbulence, thus reducing snoring, rather than curing a disease.
No
The SnoreRx is intended for the reduction of snoring by repositioning the jaw, not for diagnosing any medical condition or snoring itself. It acts as an aid rather than a diagnostic tool.
No
The device description clearly states that the SnoreRx is an "intraoral device" consisting of "two custom fabricated trays" that fit over the dental arches. This describes a physical, hardware-based medical device, not a software-only device.
Based on the provided information, the SnoreRx device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid for the reduction of snoring." This is a physical intervention to address a physiological issue (snoring), not a test performed on biological samples to diagnose a condition or provide information about a patient's health status.
- Device Description: The device is an "intraoral device that repositions the jaw." This describes a physical appliance used within the mouth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SnoreRx does not fit this description.
N/A
Intended Use / Indications for Use
The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, lower jaw, dental arches, mouth
Indicated Patient Age Range
adult patients 18 years of age or older
Intended User / Care Setting
Home use
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)
Nonclinical Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. Biocompatibility test reports have been submitted as part of this filing.
Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183). All materials met device specifications.
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.”
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2016
Apnea Sciences Corporation c/o James Smith, Ph.D. 29442 Pointe Royale Laguna Niguel. California 92677
Re: K153200
Trade/Device Name: SnoreRx® Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: July 27, 2016 Received: July 28, 2016
Dear Dr. James Smith:
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.
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153200
Device Name SnoreRx
Indications for Use (Describe)
The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Apnea Sciences. The logo is a blue rectangle with the words "APNEA" and "SCIENCES" in white letters. There is a white crescent moon shape between the two words. Below the rectangle, the words "SLEEP BETTER... LIVE BETTER" are written in a smaller font.
510(k) SUMMARY
| Submitted by: | |
|---|---|
| Owner's Name: | Apnea Sciences Corporation |
| Address: | 27121 Aliso Creek Road, Ste. 140 |
| Aliso Viejo, CA 92656 | |
| Contact: | James Fallon, President/CEO |
| Telephone: | (949) 680-2770 |
| Fax: | (928) 569-5974 |
| E-mail: | jfallon@apneasciences.com |
| Contact Person: | |
| Name | James Smith, Ph.D. |
| Address | 29442 Pointe Royale |
| Laguna Niguel, CA 92677 | |
| Telephone | 949-340-7261 |
| Fax: | 949-340-7141 |
| E-mail: | jrsmith00@cox.net |
| Date Prepared: | October 30, 2015 |
| Trade Name: | SnoreRx |
| Common Name: | Mandibular repositioning device |
| Classification Name: | Anti-Snoring Device |
| Device Class: | Class II |
| Product Code: | LRK |
| Regulation No. | 21 CFR 872.5570 |
| Predicate Device: | SnoreRx NS 9.0 (Consumer Health Products, Inc.) |
| Predicate 510(k) #: | K112205 |
| Device Description: | The SnoreRx is an intraoral device that repositions the jaw |
| anteriorly in order to increase the patient's pharyngeal space, | |
| which improves the ability to exchange air and decreases air | |
| turbulence, a causative factor in snoring. 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. | |
| Intended Use: | The SnoreRx is intended for use on adult patients 18 years of |
| age or older as an aid for the reduction of snoring. | |
| Technology Comparison: | |
| The devices are nearly identical in design and functionality. | |
| Both the SnoreRx and its predicate consist of intraoral mouth | |
| pieces that are molded to the patient's teeth using a 'boil and |
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Image /page/4/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in white letters on a blue background. There is a white crescent moon shape between the two words. Below the logo is the tagline "SLEEP BETTER... LIVE BETTER" in a smaller font.
bite' method, and allows adjustment of the anterior positioning of the jaw to the patient's comfort. The SnoreRx is provided non-sterile and uses the same packaging system as the predicate device. The table below compares the technological aspects of the new and predicate devices.
| Subject Area | New Device | Predicate | Differences |
|---|---|---|---|
| Product Code | - LRK | - LRK | |
| Product | |||
| Classification | - Class II | - Class II | |
| Classification | |||
| Name | - Anti-Snoring Device | - Anti-Snoring Device | |
| Proprietary | |||
| Name | SnoreRx | SnoreRx NS 9.0 | |
| Technological | Mandibular | ||
| repositioning device | |||
| that advances the | |||
| lower jaw to increase | |||
| pharyngeal space. | Mandibular | ||
| repositioning device | |||
| that advances the | |||
| lower jaw to increase | |||
| pharyngeal space. | |||
| Intended Use | Minimize air | ||
| turbulence that causes | |||
| snoring. Device is | |||
| intended for | |||
| prescription use. | Minimize air | ||
| turbulence that causes | |||
| snoring. Device is | |||
| intended for | |||
| prescription use. | |||
| Materials | - Polycarbonate resin |
- Ethylene vinyl acetate
copolymer | - Polycarbonate resin - Ethylene vinyl acetate
copolymer | The new device utilizes
a polycarbonate resin
with a higher tensile
strength, and a
copolymer with a
slightly different
durometer. |
| Desirable
Characteristics | - Home use, heat
sensitive / moldable,
adjustable jaw
advancement position | - Home use, heat
sensitive / moldable,
adjustable jaw
advancement position | |
| Specifications: - Physical:
- Mechanical:
- Single use: | - Custom-fitted
intraoral device - Repositions mandible
anteriorly up to 6 mm - Reusable | - Custom-fitted
intraoral device - Repositions mandible
anteriorly up to 6 mm - Reusable | The new device utilizes
a streamlined
manufacturing process
and has a frontal airway
opening that is larger
than the predicate
device. |
| Sterility | Non-sterile | Non-sterile | |
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Image /page/5/Picture/0 description: The image is a logo for Apnea Sciences. The logo consists of the word "APNEA" on the left, a crescent moon shape in the middle, and the word "SCIENCES" on the right. The words and the crescent moon are all in blue and are contained within a blue rectangle with rounded edges. Below the rectangle, in a smaller font, are the words "SLEEP BETTER... LIVE BETTER".
Nonclinical Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. Biocompatibility test reports have been submitted as part of this filing.
Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183). All materials met device specifications.
Conclusion of Comparison: SnoreRx and its predicate are technologically identical. The minor differences in design and materials do not raise any new questions of safety or effectiveness. Therefore, the new device (SnoreRx) is determined to be substantially equivalent to the predicate device.