(99 days)
BR2 Nasal Dilator
Not Found
No
The description focuses on mechanical function (nasal dilation, pressure, flow pathways) and makes no mention of AI/ML terms or data-driven learning processes.
No
The device is intended to reduce or eliminate snoring, which is a lifestyle improvement rather than a medical condition requiring therapy. It functions as a nasal dilator to improve airflow and not to treat a disease or condition.
No
Explanation: The device is intended to reduce or eliminate snoring by dilating the nasal airway, which is a therapeutic function, not a diagnostic one. It does not identify a condition or disease.
No
The device description clearly states it is an external nasal dilator placed over the patient's nostrils, indicating a physical hardware component.
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 or eliminate snoring." This is a physical intervention to address a physiological issue (snoring), not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as a "nasal dilator" that is placed externally over the nostrils. It works by physically dilating the nasal airway and maintaining pressure. This is a mechanical action, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
In summary, the InVent Snoring Device is a physical medical device intended for therapeutic purposes (reducing snoring) and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InVent Snoring Device is intended to reduce or eliminate snoring.
Product codes
LWF
Device Description
As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal airway / nasal passage / nostrils
Indicated Patient Age Range
Not Found
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
Bench testing of the subject device confirms that it meets pre-defined specifications and is substantially equivalent to the predicate device. Clinical testing also supports that the device is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
BR2 Nasal Dilator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
120665'
JUN 1 2 2012
1
510(k) Summary
Date Summary Prepared: June 12, 2012
| 510(k) Owner: | Ventus Medical, Inc. |
|---|---|
| 101 Metro Drive, Suite 620 | |
| San Jose, CA 95110 | |
| Phone: 408-200-5299 | |
| Fax: 408-200-5298 | |
| info@ventusmedical.com | |
| Contact Person: | Cindy Domecus, R.A.C. (US & EU) |
| Principal, Domecus Consulting Services LLC | |
| Consultant to Ventus Medical, Inc. | |
| (650) 343-4813 | |
| Trade Name: | InVent Snoring Device |
| Common Name: | Nasal Dilator |
| Classification Name: | 21 CFR 874.3900 Nasal Dilator; Product Code LWF |
| Predicate Device: | BR2 Nasal Dilator |
Device Description:
As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
Intended Use:
The InVent Snoring Device is intended to reduce or eliminate snoring.
Technological Characteristics Comparison:
The predicate device and subject device have the same mechanism of action – expiratory resistance. Minor changes have been made to the dimensions and materials.
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Performance Data:
Bench testing of the subject device confirms that it meets pre-defined specifications and is substantially equivalent to the predicate device. Clinical testing also supports that the device is safe and effective for its intended use.
Conclusion:
The InVent Snoring Device is substantially equivalent to the BR2 predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ventus Medical, Incorporated % Ms. Cindy Domecus, R.A.C. (US & EU) Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010
Re: K120665
Trade/Device Name: InVent Snoring Device Regulation Number: 21 CFR 874.3900 Regulation Name: Nasal dilator Regulatory Class: Class I Product Code: LWF Dated: May 2, 2012 Received: May 3, 2012
Dear Ms. Domecus:
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.
We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food. Drug. and Cosmetic Act (21 CFR Part 874.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 874.9 will be exempt from the premarket notification requirements of the Act.
JUN 1 2 2012
3
Page 2- Ms. Cindy Domecus
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.
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/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 Tou thay 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/cdrh/industry/support/index.html.
Sincerely yours,
Affang for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ventus Medical, Inc.
Indications for Use Statement 1.
Indications for Use Form
Indications for Use 510(k) Number (if known): Device Name: InVent Snoring Device
Indications for Use:
The InVent Snoring Device is intended to reduce or eliminate snoring.
Prescription Use (Part 21 CFR 801 Subpart D)
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AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) X
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Anabul
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear,
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Nose and Throat Devices
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