SleepWeaver Advance Pediatric Nasal CPAP Mask

K151683 · Circadiance, LLC · BZD · Apr 5, 2016 · Anesthesiology

Device Facts

• Record ID: K151683
• Device Name: SleepWeaver Advance Pediatric Nasal CPAP Mask
• Applicant: Circadiance, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

Device Story

SleepWeaver Advance Pediatric Nasal CPAP Mask provides interface for noninvasive PAP ventilation therapy. Device consists of cloth cushion, adjustable elastic headgear, and 360-degree rotating 22-mm tubing swivel connector. Used in home or hospital/institutional environments by pediatric patients (ages 2-7). Air supplied by external therapy device; patient inhales air from mask; exhales into mask; continuous airflow from therapy device purges exhaled CO2 through mask exhalation holes. Cloth cushion contacts patient face; headgear secures mask. Optional Feather Weight tube extension available. Healthcare provider prescribes therapy; mask facilitates delivery of prescribed pressure (4-20 cm H2O) to maintain open airway. Benefits include noninvasive airway support for pediatric patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing per ISO 17510-2, including CO2 rebreathing, flow resistance, leak rate, and physical dead space measurements. Biocompatibility testing performed per ISO 10993-1, 10993-5, and 10993-10.

Technological Characteristics

Materials: Blue polyester fabric, nylon, elastane, polyurethane, polycarbonate swivel. Sensing/Actuation: Passive interface for PAP therapy. Dimensions: 1 size. Connectivity: Standard 22mm tubing interface. Standards: ISO 14971, ISO 10993-1/5/10, ISO 5356-1, ISO 5367, ISO 17510-2, IEC 62366.

Indications for Use

Indicated for pediatric patients aged 2 to 7 years requiring noninvasive Positive Airway Pressure (PAP) ventilation therapy. No contraindications reported.

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

• ResMed Ltd., Pixi Pediatric Mask (K102224)

Reference Devices

• SleepWeaver Advance Nasal CPAP Mask (K092362)
• SleepWeaver Elan Nasal CPAP Mask (K120757)
• SleepWeaver Anew Full Face Mask CPAP (K130481)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 5, 2016

Circadiance, LLC % Pooja Roychoudhury Operation Manager Regulatory & Quality Solutions, LLC 2790 Mosside Blvd, Suite 800 Monroeville, Pennsylvania 15146

Re: K151683

Trade/Device Name: SleepWeaver Advance Pediatric Nasal CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 1, 2016 Received: March 3, 2016

Dear Ms. Roychoudhury:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K151683

#### Device Name

SleepWeaver Advance Pediatric Nasal CPAP Mask

#### Indications for Use (Describe)

The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Circadiance, LLC 1300 Rodi Road, Turtle Creek, PA 15145 Phone: [phone] Facsimile: [phone] Contact Person: David Groll, CEO, [e-mail]

Date Originally Prepared: June 19, 2015 Date Revised: April 5, 2016

#### Name of Device and Name/Address of Sponsor

SleepWeaver Advance Pediatric Nasal CPAP Mask

## Common or Usual Name

Vented Nasal Mask

## Classification Name

Accessory to Non-Continuous Ventilator, Class II, 21 CFR 868.5905, Product Code: BZD

#### Predicate Devices

ResMed Ltd., Pixi Pediatric Mask (K102224)

#### Indications for Use

The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

#### Description of Device

The SleepWeaver Advance Pediatric Nasal CPAP Mask serves as a mechanism for connecting a pediatric patient between 2 and 7 years of age for whom PAP therapy has been prescribed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has a tubing swivel connector which is compatible with the industry standard 22 mm air tubing.

Air is supplied to the mask by a therapy device. The patient inhales air from the mask and exhales into the mask where continuous airflow from the therapy device purges the exhaled carbon dioxide from the mask through the mask exhalation holes.

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The SleepWeaver Advance Pediatric Nasal CPAP Mask can be used in the home environment (single-patient use) or the hospital/institutional environment (single-patient use).

The mask features a cloth cushion made of a blue polyester fabric with a polyester / nylon / lycra / polyurethane interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is a 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be removed by unwrapping the white medical tape for cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for cleaning and replacement.

The SleepWeaver Advance Pediatric Nasal CPAP Mask product also offers an optional accessory: the Feather Weight tube. The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757. The Feather Weight tube is an 18" plastic extension tube compliant to ISO 5356-1 and ISO 5367 that connects between the SleepWeaver Advance Pediatric Nasal CPAP Mask and standard CPAP tubing.

# Technological Characteristics

The SleepWeaver Advance Pediatric Nasal CPAP Mask consists of a cloth cushion, headgear, and a swivel connector. Table 1 is provided below which lists additional technological characteristics for the SleepWeaver Advance Pediatric Nasal CPAP Mask as well as a comparison of the described feature to the predicate device.

| Feature | Proposed Device:<br>SleepWeaver Advance<br>Pediatric Nasal CPAP Mask | Predicate Device: ResMed Pixi<br>Pediatric Mask (K102224) | Equivalence Narrative |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The SleepWeaver Advance<br>Pediatric Nasal Mask is intended<br>to provide an interface for<br>noninvasive Positive Airway<br>Pressure (PAP) ventilation<br>therapy. This mask is intended<br>for single-patient use in the home<br>and single-patient use in the<br>hospital / institutional<br>environment. This mask is to be<br>used on patients between 2 and<br>7 years of age. | The Pixi Pediatric Mask channels<br>airflow noninvasively to a patient from a<br>continuous positive airway pressure<br>(CPAP) or bilevel device.<br>The Pixi Pediatric Mask is:<br>To be used by children aged<br>●<br>between 2 and 7 for whom<br>continuous positive airway<br>pressure (CPAP) or bilevel<br>therapy has been prescribed.<br>Intended for single-patient re-use<br>●<br>in the home environment and<br>single-patient re-use in the<br>hospital/ institutional environment. | Same |
| Contra-<br>indications | None | None | Same |
| Product<br>Code | BZD | BZD | Same |
| Environment<br>of Use | Hospital, Home | Hospital, Home | Same |
| Patient<br>Population | Pediatric patients between 2 and<br>7 years of age | Pediatric patients between 2 and 7<br>years of age | Same |
| Use Case(s) | Single Patient Use | Single Patient Use | Same |
| | | | |
| Components<br>/<br>Accessories | Headgear, Mask, Interface,<br>Swivel Connector, Feather<br>Weight Tube (Optional) | Headgear, Mask frame, Frame nodes,<br>Mask socket, Short tube assembly,<br>Elbow, Plug tether, Plug, Cushion, Vent,<br>Cushion shoulder, Pressure port, Top<br>headgear strap and buckle, Middle<br>headgear strap and buckle, Lower<br>headgear strap and buckle, Quick<br>release clip, Lower headgear arms, 22<br>mm Swivel | The SleepWeaver Pediatric and<br>predicate ResMed Pixi both have<br>a nasal mask, adjustable<br>headgear, an interface swivel<br>connection, and a tube assembly.<br>The SleepWeaver Pediatric mask<br>is manufactured from cloth<br>whereas the ResMed Pixi mask<br>has a silicone cushion and a<br>plastic stability feature. The<br>SleepWeaver Pediatric Mask is<br>supported by performance testing;<br>thus it can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. |
| Design | Image: SleepWeaver Pediatric Mask | Image: ResMed Pixi Pediatric Mask | The SleepWeaver Pediatric Mask<br>and predicate ResMed Pixi are<br>both nasal CPAP masks with<br>adjustable headgear. The<br>SleepWeaver Pediatric mask is<br>manufactured from cloth whereas<br>the ResMed Pixi mask has a<br>silicone cushion and a plastic<br>stability feature. The<br>SleepWeaver Pediatric Mask is<br>supported by performance testing;<br>thus it can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. |
| Materials | Headgear: Nylon,<br>Elastane, Polyurethane<br>Mask: Blue Polyester<br>Interface: Polyester, Nylon,<br>Lycra, Polyurethane<br>Swivel Connector: Polycarbonate | Information not available | The SleepWeeaver Pediatric Mask<br>and headgear are made of<br>materials used in legally marketed<br>devices (SleepWeaver Advance<br>Nasal CPAP Mask (K092362),<br>SleepWeaver Elan Nasal CPAP<br>Mask (K120757), and<br>SleepWeaver Anew Full Face<br>Mask CPAP (K130481)) and the<br>predicate ResMed Pixi is made of<br>plastic and silicone. The<br>SleepWeaver Pediatric Mask uses<br>biocompatible materials; thus it<br>can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. |
| Therapy<br>Pressure<br>Range | $4 - 20 cm H_2O$ | $3 to 20 cm H_2O$ | The SleepWeaver Pediatric has a<br>therapy range from $4 to 20 cm$<br>$H_2O$ whereas he ResMed Pixi has<br>a therapy range from $3 to 20 cm$<br>$H_2O$ . Since the SleepWeaver<br>Pediatric therapy range is within<br>the therapy range for the ResMed |

# Table 1: Technological Characteristics and Comparison to the Predicate

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| | | | Pixi, it can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sizing | 1 size | 1 size | SleepWeaver Pediatric and<br>ResMed Pixi are both sized to<br>accommodate the intended patient<br>population. | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical<br>Dead Space | 130 mL | 101.7 mL | The dead space for the<br>SleepWeaver Pediatric is larger<br>than the predicate ResMed Pixi;<br>however, since the SleepWeaver<br>Pediatric mask has exhalation<br>holes and seams that enable<br>continuous purging of the volume<br>of air around the periphery of the<br>mask, it prevents CO2 build-up.<br>This is supported by the<br>performance testing since the<br>mask has passed the rebreathing<br>tests under ISO 17510-2. Thus it<br>can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
| A-weighted<br>Sound<br>levels | Sound Power Level:<br>26 dBA;<br>Sound Pressure Level at 1m:<br>18 dBA | Not available | Not applicable | | | | | | | | | | | | | | | | | | | | | | | | |
| Resistance<br>(pressure<br>drop) | 0.4 cm H2O at 50 L/min;<br>1.0 cm H2O at 100 L/min | 0.8 cm H2O at 50 L/min;<br>3.1 cm H2O at 100 L/min | The resistance for the<br>SleepWeaver Pediatric is lower<br>than the predicate ResMed Pixi;<br>however, a lower pressure drop<br>may be considered preferential as<br>the patient will receive therapy<br>closer to the intended pressure.<br>Thus it can be concluded that the<br>SleepWeaver Advance Pediatric<br>Nasal CPAP Mask, is substantially<br>equivalent to the predicate device,<br>the ResMed Pixi Pediatric Mask, in<br>regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
| Carbon<br>Dioxide<br>Washout<br>Profile | The amount of CO2 being<br>rebreathed by the patient in all<br>scenarios listed in ISO 17510-<br>2:2009 is less than the maximum<br>allowable percentage increase<br>under normal conditions (20% for<br>4, 5, and 10 cm H2O). | Not available | The SleepWeaver Pediatric meets<br>ISO 17510-2. | | | | | | | | | | | | | | | | | | | | | | | | |
| Leak Rate | Pressure<br>(cm H2O) Flow<br>(L/min) 4 14 5 16 10 25 15 33 20 40 | | | | | | | | | | | | | Pressure<br>(cm H2O) Flow<br>(L/min) 3 18 7 28 12 36 16 43 20 49 | | | | | | | | | | | | | The leak rate is lower than the<br>predicate ResMed Pixi. Since the<br>leak rate of the SleepWeaver<br>Pediatric mask is greater than a<br>patient would exhale per minute<br>and the SleepWeaver Pediatric<br>mask passed the rebreathing tests<br>under ISO 17510-2, it can be<br>concluded that the SleepWeaver<br>Advance Pediatric Nasal CPAP<br>Mask, is substantially equivalent to |

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| | | | the predicate device, the ResMed<br>Pixi Pediatric Mask, in regards to<br>this comparison. |
|----------------------|-------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------------------------------------------------------|
| Applied<br>Standards | ISO 14971, ISO 10993-1, 10993-<br>5, ISO 10993-10, ISO 5356-1,<br>IEC 62366, ISO 5367, ISO<br>17510-2 | ISO 10993-1 | Not applicable |

# Non-Clinical Testing Summary:

Bench top testing for the SleepWeaver Advance Pediatric Nasal CPAP Mask included the following tests or evaluations:

- . Product performance;
- Fixed leak rate per ISO 17510-2; O
- Resistance to flow per ISO 17510-2; O
- o CO2 rebreathing testing per ISO 17510-2:
- Physical dead space; and O
- O Headgear attachment;
- Reliability/Cleaning:
- Fit evaluation and anthropometric analysis; and ●
- Simulated use case;
- . Biocompatibility:
- Patient contact Duration: Permanent o
- Gas Pathway (External Communicating) Components: Swivel connector, O mask body material, nasal interface, and internal surface of the oral interface. The materials in these components have been used in legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362), SleepWeaver Elan Nasal CPAP Mask (K120757), and SleepWeaver Anew Full Face Mask CPAP (K130481)).
- Surface Contact (Skin) Components: Headgear/mask wings and external o surface of the oral interface. The materials in these components have been used in legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362), SleepWeaver Elan Nasal CPAP Mask (K120757), and SleepWeaver Anew Full Face Mask CPAP (K130481)).

The packaging of the SleepWeaver Advance Pediatric Nasal CPAP mask uses the same packaging and is stored in the same way as other legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362)).

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# Clinical Data

Use of the SleepWeaver Advance Pediatric Nasal CPAP Mask is supported by bench testing and is sufficient to demonstrate substantial equivalence to the ResMed Pixi Pediatric Mask.

## Substantial Equivalence (Conclusion)

The new device, the SleepWeaver Advance Pediatric Nasal CPAP Mask, is substantially equivalent to the predicate device, the ResMed Pixi Pediatric Mask (K102224):

- . it has the same intended use;
- it has the same patient population;
- . it has similar technological characteristics;
- it has similar performance characteristics; and
- it does not raise new questions of safety and effectiveness ●

Thus it can be concluded that the SleepWeaver Advance Pediatric Nasal CPAP Mask, is substantially equivalent to the predicate device, the ResMed Pixi Pediatric Mask.