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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study description with all the requested information categories. However, based on the available text, here's an attempt to answer your questions as much as possible:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that "Bench testing of the subject device confirms that it meets pre-defined specifications" and "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed performance metrics. The primary claim for regulatory approval is substantial equivalence to a predicate device, not necessarily meeting a specific set of performance thresholds outlined in a table.

Therefore, a table of acceptance criteria and reported device performance cannot be generated with the given information as the specific criteria and corresponding performance values are not disclosed. The device is intended to "reduce or eliminate snoring."

Study Information (Based on available text)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The text states "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide any details about the sample size, the country of origin of the data, or whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not an AI device. The InVent Snoring Device is a physical nasal dilator. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the device's function (reducing snoring), the "ground truth" for effectiveness in a clinical study would likely involve objective measurements of snoring (e.g., sound intensity, apnea-hypopnea index if linked to sleep-disordered breathing) or subjective patient/partner reports of snoring reduction. However, the text does not specify the type of ground truth used in their clinical testing.
The sample size for the training set:
This is not an AI/algorithm-based device, so the concept of a "training set" in the context of machine learning is not applicable here.
How the ground truth for the training set was established:
As above, the concept of a "training set" and its ground truth is not applicable for this physical device.

Summary of what can be gleaned from the text:

Device Type: Nasal dilator for snoring.
Approval Basis: Substantial equivalence to a predicate device (BR2 Nasal Dilator).
Performance Evidence:
- Bench testing confirmed conformity to "pre-defined specifications" (details not provided).
- Clinical testing supported "safety and effectiveness for its intended use" (details not provided).
Missing Information: Specific acceptance criteria, detailed performance metrics, sample sizes for any studies, data provenance, expert qualifications, ground truth establishment methods, and any AI/algorithm-related study details are absent because the device is not an AI product.

Summary

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120665'

JUN 1 2 2012

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:

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.

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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

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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)

Page of

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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,
Devices Devices Devices Division of OFF
Nose and Throat Devices

K120665

510(k) Nümber

Regulation Number and Section

§ 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.