SLEEPWEAVER NASAL CPAP MASK

K092362 · Circadiance, LLC · BZD · Nov 2, 2009 · Anesthesiology

Device Facts

• Record ID: K092362
• Device Name: SLEEPWEAVER NASAL CPAP MASK
• Applicant: Circadiance, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SleepWeaver Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 1bs/ 30 kg.

Device Story

SleepWeaver Nasal CPAP Mask provides interface between patient and CPAP/bi-level air pressure source; maintains open airway for obstructive sleep apnea treatment. Device consists of 100% polyester cloth cushion; head strap; 22mm tubing connector. Operates via inflation mechanism: air pressure from CPAP device inflates cloth mask, conforming to facial contours to create leak-free seal. Used in home or hospital settings; operated by patient or clinician. Diffuse exhalation vents integrated into cloth. Benefits include improved comfort, flexibility, and seal maintenance during sleep position changes compared to rigid plastic masks. Healthcare providers use device to deliver prescribed pressure therapy; patient compliance improved via reduced discomfort.

Clinical Evidence

Bench testing only. Evaluated leak rate performance (fixed and inadvertent) compared to predicate devices (ResMed Mirage Swift, Respironics ComfortLite). Durability testing performed via 180 simulated wash cycles; results confirmed leak rates remain equivalent to new masks. Biocompatibility testing (cytotoxicity and skin irritation) confirmed no reactivity of 100% polyester material.

Technological Characteristics

Interface: 100% polyester cloth cushion. Connectivity: 22mm industry-standard tubing. Pressure range: 4-20 cm H2O. Form factor: Flexible, non-rigid, balloon-inflation design. Sterilization: High-level disinfectant (e.g., Control III) for multi-patient use; hand or machine wash for home use. No electronic components or software.

Indications for Use

Indicated for adult patients (≥30 kg) diagnosed with obstructive sleep apnea requiring CPAP or bi-level positive airway pressure therapy. Suitable for home and hospital use. Contraindicated for mouth breathers unless used with a chin strap.

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

• Respironics ComfortLite™ Nasal Mask (K082558)
• Resmed Mirage Swift Nasal Mask (K042403)

Submission Summary (Full Text)

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K092362

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# 510(k) Summary

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| 510(k) Owner: | Circadiance LLC.<br>3554 North Hills Rd.<br>Murrysville, PA 15668<br>Phone: [phone]<br>Fax: [phone] | NOV - 2 2009 |
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| Establishment<br>Registration Number: | 3006182632 | |
| Contact Person: | David G. Groll, CEO | |
| Date Prepared: | | |
| Trade Name: | SleepWeaver™ Nasal CPAP Mask | |
| Common Name: | Nasal Mask | |
| Classification Name: | Non-continuous Ventilator IPPB | |
| Regulation Number: | 21 CFR 868.5905 | |
| Product Code: | BZD | |
| Regulatory Classification: | Class II | |
| Legally Marketed | | |

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Predicate Devices: Respironics ComfortLite™ Nasal Mask K082558- BZD Resmed Mirage Swift Nasal Mask K042403- BZD

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## Device Description:

Image /page/1/Figure/1 description: The image is a black and white drawing of a gas mask. The mask has a strap that goes over the head and a filter on the side. The filter is connected to the mask with a hose. There are arrows pointing to the filter, indicating that it is the source of the air supply. The mask is designed to protect the wearer from harmful gases and particles.

The SleepWeaver™ Nasal CPAP Mask serve as a mechanism for reliably connecting an adult patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal masks are fastened over a patient's nose by use of an 'elastic strap around the head. A cloth cushion contacts the patient's face. The mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing.

Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP or Bi-Level type device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask exhaust vents.

# Statement of Intended Use:

The SleepWeaver Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 1bs/ 30 kg.

## Technological Characteristics Comparison:

The SleepWeaver Nasal CPAP Mask is strapped to the patient's face covering the nose, and connected via 22mm tubing to a source of continuous or Bilevel positive air pressure, creating an airway splint in the throat. Positive pressure ventilation is thus applied to the lungs in a noninvasive way. The mask is made entirely of cloth which provides a comfortable, secure and leakfree interface with the patient. The positive pressure within the system keeps the cloth mask open during use, while providing a leak-free interface to the patient's face. The Sleep Weaver Nasal CPAP Mask is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all function in providing a reliable mechanism of connection to a continuous or Bilevel positive air pressure source for the treatment of Obstructive Sleep Apnea.

The only new technology that has been introduced in the SleepWeaver Nasal CPAP Mask device is the use of cloth for the interface. This cloth cushion improves patient comfort over the use of a plastic cushion. Not only does the cloth make the mask more comfortable, the SleepWeaver™ Nasal CPAP Mask is the softest, smallest, most lightweight and flexible mask available. The single biggest determinant in achieving patient compliance with CPAP therapy is patient comfort. The single biggest reason for non-compliance is discomfort from or dissatisfaction with the CPAP Mask. So the SleepWeaver Nasal CPAP Mask offers a new choice to CPAP patient's to provide a more comfortable alternative to the hard plastic masks currently available on the market (see Appendix A, section 2)

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The fundamental property of the mask that increases user comfort is that it operates like a balloon. The mask has no structure, and without air pressure it is floppy. like the throat of a person having an apnea. But once the CPAP pressure is applied, the mask inflates like a balloon. The air pressure inside the mask pushes the cloth surface against the patient's face. The mask takes on the contour of the patient's facial structure. Since the mask acts like a balloon, and all points in a balloon have the same pressure, the mask makes a leak-free seal with no pressure points.

The SleepWeaver Soft Cloth CPAP Mask is made entirely of cloth. The cloth is 100% polvester that is used to produce clothing, so there are no concerns about allergic or contact reactions, which is an issue for plastic masks. Cytotoxicity and skin irritation data (Appendix B) demonstrate no reactivity of the cloth material. Certain versions of cloth containing polyurethane have also been tested with no reactivity, but these alternative materials are not currently used in the product.

The mask can be used on Adult (30 Kg and up) Obstructive Sleep Apnea patients using CPAP or Bi-level systems. It has been tested at pressures from 4 - 20 cm H2O.

The mask features a series of pin holes that serve as an exhalation vent. The air coming out of these holes is very diffuse and quiet. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. If the user holds their hand six inches away from the exhalation vent they can barely feel the air flow from the mask. Yet the exhalation vent provides comparable leak performance to the ResMed Mirage Swift Nasal Pillow System and the Respironics ComfortLite Nasal mask (Appendix A, section 1).

The SleepWeaver mask does not touch the bridge of the nose and can be worn while wearing glasses, which benefits people like to read in bed or watch TV before they go to sleep.

The SleepWeaver is a Nasal mask, which fits over the nose, so there is nothing that goes inside of the nostrils to irritate the inside of the nose. The SleepWeaver will work for patients who have previously used hard plastic nasal masks, hard plastic nasal prongs or a hard plastic full masks mask, but who are not mouth breathers. Mouth breathers can use the SleepWeaver Nasal CPAP Mask in conjunction with a chin strap.

The Sleep Weaver Nasal CPAP Mask allows the patient to sleep on either side or their back. They can switch sides during the night. The patient can even lay on their face and the mask will stay sealed, unlike conventional hard plastic CPAP masks, which are easily dislodged by the pillow. One of the problems with all hard plastic CPAP masks and nasal pillows is that when the patient rolls over and the mask contacts the pillow, the force on the side of the mask causes it to lose its seal. The SleepWeaver Nasal CPAP Mask overcomes this problem. If a person contacts the mask to the pillow, the mask just conforms to the pillow without losing its seal.

The mask can be cleaned by hand washing in a mild detergent or in a washing machine on a gentle cycle. The mask will last over six months with normal care. In the Sleep Lab, the mask can be disinfected between patients with a high level disinfectant like Control III.

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Cloth may be considered to be less durable that molded plastic. The feature most likely to be affected by the cloth wearing out is the leak rate through the exhalation ports and other inadvertent leaks in the mask is wearing out, the leak rate will increase. So the testing conducted to qualify the SleepWeaver™ Nasal CPAP Mask emphasizes verifying the leak rate (both fixed and inadvertent) of the mask is acceptably low when the mask is initially removed from the package, after it has been stored for a long time, and after it has been cleaned multiple times. The cleaning is considered to be the process which is most likely to cause deterioration of the material in the mask. The testing included (Appendix A, sections 5 & 6) with this submission demonstrates that the material used to produce the SleepWeaver™ Nasal CPAP Mask is very durable. Not only is the leak rate matched to the predicate devices, even after 6 months of use (as simulated by 180 washings), the leak rate through the mask is effectively the same as a new mask.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, positioned to the right. To the left of the bird, there is a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

NOV - 2 2009

Mr. David G. Groll Chief Executive Officer Circadiance, L.L.C. 3554 North Hills Road Murrysville, Pennsylvania 15668

Re: K092362

Trade/Device Name: SleepWeaver™ Nasal CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator IPPB Regulatory Class: II Product Code: BZD Dated: July 27, 2009 Received: August 4, 2009

#### Dear Mr. Groll:

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.

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. Groll

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/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

h for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: SleepWeaver™ Nasal CPAP Mask.

Indications for Use:

The SleepWeaver™ Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs/ 30 kg.

Prescription Use _ X

OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k092362

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