The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.

Device Description

The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency. The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.

AI/ML Overview

The provided text describes the CPAP/Pro Interface with Advantage™, a device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). Based on the information available, a detailed acceptance criteria table and study breakdown can be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Bench Testing	Meets design requirements and specifications.	"Bench testing was performed and confirms that the device meets design requirements and specifications."
Validation	Satisfactory completion of validation.	"Validation was also satisfactory completed."
Product Equivalency	Demonstrate product equivalency with the predicate device.	"The Advantage™ has also been validated to demonstrate product equivalency with the predicate."
Safety and Effectiveness	Support the safety and effectiveness of the product (referencing predicate's post-market studies).	"Post-market studies of CPAP/Pro has supported the safety and effectiveness of the product."
Substantial Equivalence	Demonstrates substantial equivalence to the predicate device and performs as well.	"Based on the information drawn from the Testing and Validation as well as the risk assessment, it is demonstrated that the device is substantially equivalent and performs as well as the predicate device."
Material Equivalence	Materials of the new device are similar to the predicate.	"Similar" (for materials listed: Teflon, polyethylene, silicone, elastomer, styrene, nylon, EVA thermoplastic)
Intended Use Equivalence	Intended use of the new device is similar to the predicate.	"Similar"
Design Equivalence (CPAP nasal)	CPAP nasal design is similar to the predicate.	"Similar"
Design Equivalence (Oral Appliance - core component)	Core oral appliance design is similar, with the addition of the Advantage™ mouthpiece.	"Same with additional mouth-piece (AdvantageTM) for minimizing mouth-breathing"
Performance Standard Equivalence	Adherence to similar performance standards (e.g., ASTM D1238).	"Similar"
Reusable Equivalence	Reusability (single patient) is similar.	"Similar"
Cleaning/Disinfection Equivalence	Method of cleaning/disinfection is similar.	"Similar"

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a specific "test set" in the context of a clinical study or performance evaluation for the Advantage™ component. The summary mentions "Bench testing was performed" and "Validation was also satisfactory completed," but does not provide details on the number of subjects or cases involved in these validations for the new device. Instead, it relies heavily on the substantial equivalence to the predicate device (CPAP/PRO, K992384).

The data provenance is largely retrospective in the sense that the new device's safety and effectiveness are supported by "Post-market studies of CPAP/Pro [the predicate device]." There is no mention of a prospective clinical trial specifically for the Advantage™ component to establish its independent performance metrics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As the evaluation relies on bench testing, validation, and equivalency to a predicate, the concept of "ground truth established by experts" in a clinical setting for a test set is not directly applicable or reported here.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described clinical test set involving human interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the CPAP/Pro Interface with Advantage™ as described in this document. The submission focuses on demonstrating substantial equivalence through bench testing, validation, and material/design similarities to the predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, if we interpret "standalone performance" as the device functioning independently to meet its design specifications and demonstrating performance (e.g., material properties, fit, mechanical function), then this aligns with the "Bench testing" and "Validation" mentioned. These tests would evaluate the device itself, without human interpretation or real-time clinical assessment beyond general use.

7. The Type of Ground Truth Used

The "ground truth" for the Advantage™ device appears to be primarily based on:

Engineering specifications and design requirements: For bench testing and validation where the device's physical and functional properties are assessed against predetermined criteria.
Predicate device's established safety and effectiveness: The new device's safety and effectiveness are inferred by its substantial equivalence to a legally marketed predicate device, for which post-market studies had already supported its performance.

8. The Sample Size for the Training Set

This information is not applicable as the device is a mechanical medical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2014

Stevenson Industries, Incorporated Ms. Serrah Namini Regulatory 780 Chambers Lane, #200 Simi Valley, CA 93065

Re: K141152

Trade/Device Name: CPAP/Pro® Interface with Advantage Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 15, 2014 Received: September 16, 2014

Dear Ms. Namini:

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 - Ms. Namini

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Stevenson Industries, Inc.CPAP/PRO with Advantage™

INDICATION FOR USE STATEMENT

Page __ 1_ of __ 1__

K141152 510(k) Number (if known):

Device Name:

CPAP/Pro Interface with Advantage TM

Indication for Use: The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.

Prescription Use: __ (Per 21 CFR 801.109)

Over-The-Counter______________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Stevenson Industries, Inc.CPAP/PRO with Advantage™

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510(k) Summary

■ Summary Date: May 1, 2014

Submitter Information: I Mr. Joseph Goldstein, President Stevenson Industries, Inc. 780 Chambers Ln #200 Simi Valley, CA 93065 Tel: 800-538-8803 Fax: 805-426-3551

. Primary Contact: Serrah Namini, Regulatory naminib@yahoo.com (949) 734-3570

■ Trade/ Device Name: CPAP/Pro Interface with Advantage TM

Common Name: . CPAP interface

트 Device Classification Name: Ventilator, Non-Continuous (Respirator)

Regulation: ■ 21 CFR 868.5905

Regulatory Class: Class II
. Primary Product Code(s): BZD

트 Predicate Information

CPAP/PRO by Stevenson Industries, Inc. ; K992384

트 Device Description

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opening, while still permitting a degree of mouth opening through spacers and resiliency.

The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.

I Indications for Use

The Advantage ™ is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.

■ Technological Characteristics

Technological characteristics of the device is the same as predicate. The additional accessory, Advantage TM , uses the same design and materials as the upper mouthpiece provided with the predicate. It is available with upper and lower mouthpiece with a post and without a bracket. The post allows a comfortable forward/backward movement as well as some lateral side -to- side capability. No new questions of safety and effectiveness were introduced.

. Performance Data

All applicable tests were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications. Validation was also satisfactory completed. Post-market studies of CPAP/Pro has supported the safety and effectiveness of the product. The Advantage ™ has also been validated to demonstrate product equivalency with the predicate.

. Substantial Equivalence

Based on the information drawn from the Testing and Validation as well as the risk assessment, it is demonstrated that the device is substantially equivalent and performs as well as the predicate device.

Feature	CPAP/PRO (K992384)	New deviceCPAP/PRO withAdvantage™
Intended Use	To reduce or alleviate night timesnoring and obstructive sleepapnea (OSA) for adult patients	Similar

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	for use at home or clinicalsetting; for adult patients(>66lb/30kg)
Materials	Teflon, polyethylene, silicone,elastomer, styrene, nylon, EVAthermoplastic	Similar
Design CPAP nasal	Nasal cannula CPAP	Similar
Design OralAppliance	Dental appliance holds nasalCPAP cannula. Appliancepositions jaw and holds nasalCPAP cannula (including uppermouthpiece)	Same with additionalmouth-piece(AdvantageTM) forminimizing mouth-breathing
Performancestandard	ASTM (ex: D1238)	Similar
Reusable	Yes (single patient)	Similar
Method ofcleaning/disinfection	Wash with warm water anddetergent followed by surfacedisinfection (See Instruction forUse)	Similar
Manufacturer	Stevenson Industries, Inc.	Same

■ Conclusion

The primary difference is the use of Advantage™, the oral appliance for minimizing mouth-breathing. Previously a dental appliance held the nasal CPAP cannula. Which, positions jaw and holds nasal CPAP cannula (including upper mouthpiece). The results of the testing support the claim that the Advantage™ is substantially equivalent to the predicate.

The device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties remain similar as the predicate. The Advantage™ is substantially equivalent to its predicate and reference devices.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).