ADVANTAGE

K141152 · Stevenson Industries, Inc. · BZD · Oct 17, 2014 · Anesthesiology

Device Facts

• Record ID: K141152
• Device Name: ADVANTAGE
• Applicant: Stevenson Industries, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The CPAP/Pro Interface with Advantage is an oral appliance system used in conjunction with commercially available CPAP devices. It consists of upper and lower dental mouthpieces (boil-and-bite) that are affixed anteriorly to limit mouth opening and minimize mouth breathing during CPAP therapy. The upper mouthpiece features a slotted post design allowing forward/backward and lateral movement for patient comfort. The device is intended for use by adults in home, hospital, or sleep lab settings. By reducing mouth breathing, the device helps maintain the efficacy of CPAP therapy for snoring and OSA. It is a single-patient, reusable device.

Clinical Evidence

Bench testing only. Testing confirmed the device meets design requirements and specifications. Validation demonstrated product equivalency with the predicate. Post-market studies of the original CPAP/Pro support the safety and effectiveness of the product line.

Technological Characteristics

Materials include Teflon, polyethylene, silicone, elastomer, styrene, nylon, and EVA thermoplastic. Design features a boil-and-bite dental appliance with a slotted post for jaw positioning and CPAP cannula support. Reusable, single-patient device. Cleaning via warm water and detergent followed by surface disinfection. Performance standards include ASTM (e.g., D1238).

Indications for Use

Indicated for adults >66 lb (30 kg) with obstructive sleep apnea (OSA) or snoring, for use with CPAP in home or clinical settings.

Regulatory Classification

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.

Predicate Devices

• CPAP/PRO (K992384)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

______________________________________________________________________________________________________________________________________________________________________________

Or

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: [phone] Fax: [phone]

. Primary Contact: Serrah Namini, Regulatory [e-mail] [phone]

■ 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

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

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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 device<br>CPAP/PRO with<br>Advantage™ |
|--------------|------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use | To reduce or alleviate night time<br>snoring and obstructive sleep<br>apnea (OSA) for adult patients | Similar |

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| | for use at home or clinical<br>setting; for adult patients<br>(>66lb/30kg) | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Materials | Teflon, polyethylene, silicone,<br>elastomer, styrene, nylon, EVA<br>thermoplastic | Similar |
| Design CPAP nasal | Nasal cannula CPAP | Similar |
| Design Oral<br>Appliance | Dental appliance holds nasal<br>CPAP cannula. Appliance<br>positions jaw and holds nasal<br>CPAP cannula (including upper<br>mouthpiece) | Same with additional<br>mouth-piece<br>(AdvantageTM) for<br>minimizing mouth-<br>breathing |
| Performance<br>standard | ASTM (ex: D1238) | Similar |
| Reusable | Yes (single patient) | Similar |
| Method of<br>cleaning/disinfection | Wash with warm water and<br>detergent followed by surface<br>disinfection (See Instruction for<br>Use) | 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.