(288 days)
No
The device description and performance studies focus on the physical components and performance characteristics of a CPAP mask, with no mention of AI or ML.
Yes
The device is intended to provide an interface for Positive Airway Pressure (PAP) ventilation therapy, which is a therapeutic intervention.
No
This device is a nasal mask intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy, which is a treatment, not a diagnostic procedure. It does not perform any diagnostic functions or analyze patient data to provide a diagnosis.
No
The device description clearly outlines physical components such as a mask, headgear, cloth cushion, and tubing connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SleepWeaver Advance Pediatric Nasal Mask is an interface for delivering positive airway pressure (PAP) therapy. It is a physical device that connects a patient to a therapy machine. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide an interface for noninvasive PAP ventilation therapy, which is a treatment method, not a diagnostic test.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, patient's nose
Indicated Patient Age Range
Between 2 and 7 years of age.
Intended User / Care Setting
Single-patient use in the home and single-patient use in the hospital / institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Therapy Pressure Range: 4 - 20 cm H2O
- Physical Dead Space: 130 mL
- A-weighted Sound levels: Sound Power Level: 26 dBA; Sound Pressure Level at 1m: 18 dBA
- Resistance (pressure drop): 0.4 cm H2O at 50 L/min; 1.0 cm H2O at 100 L/min
- Carbon Dioxide Washout Profile: The amount of CO2 being rebreathed by the patient in all scenarios listed in ISO 17510-2:2009 is less than the maximum allowable percentage increase under normal conditions (20% for 4, 5, and 10 cm H2O).
- Leak Rate: Pressure (cm H2O) Flow (L/min) 4 14, 5 16, 10 25, 15 33, 20 40
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (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
2
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Circadiance, LLC 1300 Rodi Road, Turtle Creek, PA 15145 Phone: (724) 858-2837 Facsimile: (412) 202-4583 Contact Person: David Groll, CEO, David.Groll@Circadiance.com
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.
5
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:
SleepWeaver Advance
Pediatric Nasal CPAP Mask | Predicate Device: ResMed Pixi
Pediatric Mask (K102224) | Equivalence Narrative |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Pixi Pediatric Mask channels
airflow noninvasively to a patient from a
continuous positive airway pressure
(CPAP) or bilevel device.
The Pixi Pediatric Mask is:
To be used by children aged
●
between 2 and 7 for whom
continuous positive airway
pressure (CPAP) or bilevel
therapy has been prescribed.
Intended for single-patient re-use
●
in the home environment and
single-patient re-use in the
hospital/ institutional environment. | Same |
| Contra-
indications | None | None | Same |
| Product
Code | BZD | BZD | Same |
| Environment
of Use | Hospital, Home | Hospital, Home | Same |
| Patient
Population | Pediatric patients between 2 and
7 years of age | Pediatric patients between 2 and 7
years of age | Same |
| Use Case(s) | Single Patient Use | Single Patient Use | Same |
| | | | |
| Components
/
Accessories | Headgear, Mask, Interface,
Swivel Connector, Feather
Weight Tube (Optional) | Headgear, Mask frame, Frame nodes,
Mask socket, Short tube assembly,
Elbow, Plug tether, Plug, Cushion, Vent,
Cushion shoulder, Pressure port, Top
headgear strap and buckle, Middle
headgear strap and buckle, Lower
headgear strap and buckle, Quick
release clip, Lower headgear arms, 22
mm Swivel | The SleepWeaver Pediatric and
predicate ResMed Pixi both have
a nasal mask, adjustable
headgear, an interface swivel
connection, and a tube assembly.
The SleepWeaver Pediatric mask
is manufactured from cloth
whereas the ResMed Pixi mask
has a silicone cushion and a
plastic stability feature. The
SleepWeaver Pediatric Mask is
supported by performance testing;
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, in
regards to this comparison. |
| Design | Image: SleepWeaver Pediatric Mask | Image: ResMed Pixi Pediatric Mask | The SleepWeaver Pediatric Mask
and predicate ResMed Pixi are
both nasal CPAP masks with
adjustable headgear. The
SleepWeaver Pediatric mask is
manufactured from cloth whereas
the ResMed Pixi mask has a
silicone cushion and a plastic
stability feature. The
SleepWeaver Pediatric Mask is
supported by performance testing;
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, in
regards to this comparison. |
| Materials | Headgear: Nylon,
Elastane, Polyurethane
Mask: Blue Polyester
Interface: Polyester, Nylon,
Lycra, Polyurethane
Swivel Connector: Polycarbonate | Information not available | The SleepWeeaver Pediatric Mask
and headgear are made of
materials 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)) and the
predicate ResMed Pixi is made of
plastic and silicone. The
SleepWeaver Pediatric Mask uses
biocompatible materials; 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, in
regards to this comparison. |
| Therapy
Pressure
Range | $4 - 20 cm H_2O$ | $3 to 20 cm H_2O$ | The SleepWeaver Pediatric has a
therapy range from $4 to 20 cm$
$H_2O$ whereas he ResMed Pixi has
a therapy range from $3 to 20 cm$
$H_2O$ . Since the SleepWeaver
Pediatric therapy range is within
the therapy range for the ResMed |
Table 1: Technological Characteristics and Comparison to the Predicate
6
7
| | | | Pixi, it can be concluded that the
SleepWeaver Advance Pediatric
Nasal CPAP Mask, is substantially
equivalent to the predicate device,
the ResMed Pixi Pediatric Mask, in
regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sizing | 1 size | 1 size | SleepWeaver Pediatric and
ResMed Pixi are both sized to
accommodate the intended patient
population. | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical
Dead Space | 130 mL | 101.7 mL | The dead space for the
SleepWeaver Pediatric is larger
than the predicate ResMed Pixi;
however, since the SleepWeaver
Pediatric mask has exhalation
holes and seams that enable
continuous purging of the volume
of air around the periphery of the
mask, it prevents CO2 build-up.
This is supported by the
performance testing since the
mask has passed the rebreathing
tests under ISO 17510-2. 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, in
regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
| A-weighted
Sound
levels | Sound Power Level:
26 dBA;
Sound Pressure Level at 1m:
18 dBA | Not available | Not applicable | | | | | | | | | | | | | | | | | | | | | | | | |
| Resistance
(pressure
drop) | 0.4 cm H2O at 50 L/min;
1.0 cm H2O at 100 L/min | 0.8 cm H2O at 50 L/min;
3.1 cm H2O at 100 L/min | The resistance for the
SleepWeaver Pediatric is lower
than the predicate ResMed Pixi;
however, a lower pressure drop
may be considered preferential as
the patient will receive therapy
closer to the intended pressure.
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, in
regards to this comparison. | | | | | | | | | | | | | | | | | | | | | | | | |
| Carbon
Dioxide
Washout
Profile | The amount of CO2 being
rebreathed by the patient in all
scenarios listed in ISO 17510-
2:2009 is less than the maximum
allowable percentage increase
under normal conditions (20% for
4, 5, and 10 cm H2O). | Not available | The SleepWeaver Pediatric meets
ISO 17510-2. | | | | | | | | | | | | | | | | | | | | | | | | |
| Leak Rate | Pressure
(cm H2O) Flow
(L/min) 4 14 5 16 10 25 15 33 20 40 | | | | | | | | | | | | | Pressure
(cm H2O) Flow
(L/min) 3 18 7 28 12 36 16 43 20 49 | | | | | | | | | | | | | The leak rate is lower than the
predicate ResMed Pixi. Since the
leak rate of the SleepWeaver
Pediatric mask is greater than a
patient would exhale per minute
and the SleepWeaver Pediatric
mask passed the rebreathing tests
under ISO 17510-2, it can be
concluded that the SleepWeaver
Advance Pediatric Nasal CPAP
Mask, is substantially equivalent to |
8
| | | | the predicate device, the ResMed
Pixi Pediatric Mask, in regards to
this comparison. |
|----------------------|-------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------------------------------------------------------|
| Applied
Standards | ISO 14971, ISO 10993-1, 10993-
5, ISO 10993-10, ISO 5356-1,
IEC 62366, ISO 5367, ISO
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)).
9
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.