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

AI/ML Overview

The provided text describes the SnoreRx NS 9.0 device, its intended use, a comparison to predicate devices, and the results of non-clinical performance testing. However, it explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a study proving the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or relied upon for this submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study was performed or cited for the SnoreRx NS 9.0 to evaluate its performance against specific acceptance criteria for snoring reduction, this table cannot be generated. The document focuses on non-clinical performance (biocompatibility and material characterization).

Acceptance Criteria Category	Acceptance Criteria (from a clinical study)	Reported Device Performance (from a clinical study)
Clinical Efficacy (Snoring Reduction)	Not applicable; document states "This submission does not rely on clinical data"	Not applicable; no clinical data provided for SnoreRx NS 9.0 efficacy.
Biocompatibility	Non-cytotoxic	Passed ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells (Non-cytotoxic)
Bian-irritant	Passed ISO Intracutaneous Irritation Test (Non-irritant)
Sensitization	Negative for evidence of sensitization	Passed Guinea Pig Maximization (Negative for evidence of sensitization)
Material Equivalence	Materials identical to predicate device	Material characterization testing concluded materials are identical to listed predicate device.
Dimensional Conformance	Not specified (general testing mentioned)	Performed
Visual Inspections	Not specified (general testing mentioned)	Performed
Design Verification (Airway Passage Equivalency)	Not specified (general testing mentioned)	Performed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not applicable, as no clinical efficacy study was conducted.
Data Provenance: Not applicable, as no clinical efficacy study was conducted.

3. 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):

Not applicable, as no clinical efficacy study with a ground truth was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical efficacy study with expert adjudication was conducted.

5. 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:

Not applicable. This device is an anti-snoring mouthpiece, not an AI-assisted diagnostic or imaging device used by "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as no clinical efficacy study with a ground truth was conducted. For the non-clinical tests, the "ground truth" is established by the standard protocols of the ISO tests performed (e.g., cell viability for cytotoxicity, skin reaction for irritation).

8. The sample size for the training set:

Not applicable, as no machine learning algorithm or clinical training data was used for this submission.

9. How the ground truth for the training set was established:

Not applicable, as no machine learning algorithm or clinical training data was used for this submission.

In summary: The submission for the SnoreRx NS 9.0 relied on demonstrating substantial equivalence to predicate devices based on intended use, design, operating principle, mechanism of action, and technological characteristics. Non-clinical performance data (biocompatibility, material characterization, dimensional conformance, visual inspections, and airway passage equivalency) were provided to support the device's safety and fundamental function, but no clinical data or studies proving its efficacy in reducing snoring were included or deemed necessary for this 510(k) clearance.

Summary

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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 #110Laguna Niguel, CA 92677
CONTACT :	Gary Mocnik49 Coastal Oak, Aliso Viejo, CA 92656949.433.0413949.831.9944 faxgmocnik@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:

Consumer Health Products, Inc SnoreRx NS 9.0

Premarket Notification

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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-929Mouse 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 ofsensitization

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

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Section 6

ProductsSnoreRx NS9.0	or older as an aid for the reduction of snoring.	repositioningto increasepharyngealspace	device insertedover the upperand lower dentalarches.
SnoreGuard(K103004)	Intended to reduce night time snoring and mild tomoderate obstructive sleep apnea (OSA) in adults	SAME	SAME
Silencer(K954530)	Intended to reduce or eliminate night time snoringin patients 18 years of age or older only.	SAME	SAME
SnoreControl(K963591)	The anti-snoring device is intended to alleviate orcorrect snoring	SAME	SAME
SnoreMaster(9541285)	The anti-snoring device is intended to alleviate orcorrect 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

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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.

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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

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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)

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

Regulation Number and Section

§ 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.”