The SleepWeaver 3D Nasal 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 single-patient reuse in the hospital / institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).

Device Description

The SleepWeaver 3D Nasal Mask consists of a fabric cushion, headgear, and a swivel connector. The device is to be used as an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. The mask consists of an elastic polyester fabric that provides a seal around the user's nose once positive airway pressure therapy is applied. The mask is held in place with a 4-point adjustable elastic fabric headgear that contains an integrated plastic component to direct the headgear away from the patient's ears. The headgear is attached through slots in the fabric mask to support the mask fit. The mask and headgear are designed to be hand washed in the home (single patient reuse) and the hospital / institutional environment (single patient reuse). Attached to the cushion is an L-shaped swivel connector that can rotate 360 degrees and is compatible with the industry standard 22mm air tubing.

AI/ML Overview

This document describes the premarket notification for the SleepWeaver 3D Nasal Mask (K162905). It focuses on demonstrating substantial equivalence to a predicate device, the SleepWeaver élan Nasal CPAP Mask (K120757), rather than primary efficacy or performance against new clinical endpoints. Therefore, the information regarding acceptance criteria and study design will reflect this context of substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format alongside "reported device performance" for each feature. Instead, it lists performance tests and their outcomes, indicating that the device "met all predefined acceptance criteria" or "results were satisfactory to demonstrate substantial equivalence."

For non-clinical tests, here's a summary:

Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance (SleepWeaver 3D Nasal Mask)
Fixed Leak Rate (Acceptable per ISO 17510:2015)	Met
CO2 Rebreathing (Acceptable per ISO 17510:2015)	Met
Pressure Drop (Resistance to Flow) at 50 LPM	0.3 cmH2O
Pressure Drop (Resistance to Flow) at 100 LPM	0.5 cmH2O
Sound Power Level (dBA)	26 dBA
Sound Pressure Level at 1m (dBA)	18 dBA
Reliability (Wash cycles without damage/loss of function)	90 wash cycles without damage or loss of function
Biocompatibility (for new skin-contacting materials based on ISO 10993 series)	All tests successfully completed with acceptable results

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

The document specifies no clinical tests were performed or required to demonstrate substantial equivalence. All performance assessments were based on non-clinical (laboratory/bench) tests. Therefore, there is no "test set" in the context of human subjects or patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As no clinical studies were conducted and the assessment was based on engineering and manufacturing standards, there was no ground truth requiring expert consensus from medical professionals. The "ground truth" here would be the standards themselves (e.g., ISO 17510:2015).

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not mentioned and would not typically be performed for a device seeking substantial equivalence based on non-clinical testing of a nasal mask.

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

Not applicable. The SleepWeaver 3D Nasal Mask is a physical medical device (nasal mask), not an algorithm or a software-based diagnostic tool. Performance relates to its physical properties and interaction with a CPAP system, not independent algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on established international standards (e.g., ISO 17510:2015, ISO 14971:2007, ISO 10993 series). Device performance was compared against the requirements and acceptable limits specified within these standards.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device and not an AI/ML model that requires training data.

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

Not applicable, as there was no training set.

Summary

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

March 15, 2017

Circadiance, LLC James Gianoutsos Manager of Quality Assurance & Regulatory Affairs 1300 Rodi Rd Turtle Creek, Pennsylvania 15145

Re: K162905

Trade/Device Name: Sleepweaver 3D Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: February 8, 2017 Received: February 9, 2017

Dear James Gianoutsos:

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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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 of medical devicerelated 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 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,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". Below the name, there is a "-s" present. The signature is complex and illegible. The background of the image has a light blue watermark.

Tina Kiang, Ph.D. Acting 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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SleepWeaver 3D Nasal Mask Models

Part Number	Description	Color	Size
101496	SleepWeaver 3D Nasal Mask Only, Blue	Blue	N/A*
101516	SleepWeaver 3D Regular Headgear Only	Black	Regular
101517	SleepWeaver 3D Large Headgear Only	Black	Large
101486	SleepWeaver 3D Nasal Mask & Regular Headgear, Blue	Mask: BlueHeadgear: Black	Mask: N/A*Headgear: Regular
101491	SleepWeaver 3D Nasal Mask & Large Headgear, Blue	Mask: BlueHeadgear: Black	Mask: N/A*Headgear: Large

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Indications for Use

510(k) Number (if known) K162905

Device Name SleepWeaver 3D Nasal Mask

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

(as per 21 CFR 807.92)

SUBMITTER .

Circadiance, LLC 1300 Rodi Road Turtle Creek, PA 15145

Phone: (724) 858-2837 Facsimile: (412) 202-4583

Contact Person: James Gianoutsos Title: Manager of Quality Assurance & Regulatory Affairs Date Prepared: October 14, 2016

II. SUBJECT DEVICE

Name of Device: SleepWeaver 3D Nasal Mask Common or Usual Name: Nasal Mask Classification Name: Noncontinuous Ventilator (IPPB) (21 CFR 868.5905) Review Panel: Anesthesiology Regulatory Class: II Product Code: BZD Prior Submissions: None

III. PREDICATE DEVICE

SleepWeaver élan Nasal CPAP Mask, K120757 510(k) Holder: Circadiance, LLC This predicate has not been subject to a design-related recall

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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Associated accessories include: (Previously cleared under K120757 and have not been modified)

Feather Weight Tube .
. Tether Strap

V. INDICATIONS FOR USE

The Indications for Use statement for the SleepWeaver 3D Nasal Mask device is not identical to the predicate device; however, the differences do not alter the intended use of the device as both the subject and predicate devices have the same intended use for providing an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy for the home and hospital / institutional environment.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The SleepWeaver 3D Nasal Mask has the following similarities to the previously cleared predicate device, the SleepWeaver élan Nasal CPAP (K120757):

. Substantially equivalent intended use
. Same operating principle
. Similar mask and headgear design
Similar materials that have passed biocompatibility testing
. Same patient population for patients greater than 66 lbs (30 kg)

The SleepWeaver 3D Nasal Mask has the following differences to the previously cleared predicate device, the SleepWeaver élan Nasal CPAP (K120757):

. The nasal interface material and geometry was changed compared to the predicate device.
. Headgear geometry was changed and includes an integrated plastic component that positions the lower straps below the patient's ears.
. Headgear is provided in two (2) sizes compared to the predicate which only had one (1) size.

Table 1 details a side-by-side comparison of similarities and differences of the SleepWeaver 3D Nasal Mask to the previously cleared predicate device, the SleepWeaver élan Nasal CPAP (K120757)

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Feature	Predicate Device:SleepWeaver élan (K120757)	Subject Device:SleepWeaver 3D Nasal Mask	Comments
Intended Use	The SleepWeaver élan NasalCPAP Mask is intended to providean interface for ContinuousPositive Airway Pressure (CPAP)or Bi-Level therapy. TheSleepWeaver élan Nasal CPAPMask is intended for single-patientreuse in the home and multi-patient, multi-use in thehospital/institutional environment.This mask is to be used onpatients greater than 66 lbs (30kg).	The SleepWeaver 3D NasalMask is intended to provide aninterface for Continuous PositiveAirway Pressure (CPAP) or Bi-Level therapy. This mask isintended for single-patient reusein the home and single-patientreuse in the hospital / institutionalenvironment. This mask is to beused on patients greater than 66lbs (30 kg).	Substantially Equivalent.The inclusion of "single-patientreuse" is a narrower indication tothe "multi-patient, multi-use" in thehospital / institutional environmentand does not alter the intendeduse of the device. The device isnot approved for reprocessing(cleaning and disinfectingmethods) in the clinical setting.
Environment of Use	Home / Hospital	Home / Hospital	Identical
Patient Population	Sleep Apnea Patients > 66 Ibs /30 kg	Sleep Apnea Patients > 66 Ibs /30 kg	Identical
Availability	Prescription Use	Prescription Use	Identical
Contraindications	None	None	Identical
Product Code	BZD	BZD	Identical
Anatomical Sites	Mask topically interfaces withnose and skin on the face.	Mask topically interfaces withnose and skin on the face.	Identical
Sterile/Non-Sterile	Non-Sterile	Non-Sterile	Identical
Therapy PressureRange	4 - 20 cmH2O	4 - 20 cmH2O	Identical
Connecting Element	22mm L-Shaped SwivelConnector (Removable)Polycarbonate	22mm L-Shaped SwivelConnector (PermanentlySecured)Polycarbonate	Substantially Equivalent.An identical 22mm L-ShapedSwivel Connector is utilized in thepredicate and subject device. Theconnector in the subject device ispermanently secured.
Device Design(Nasal Interface)	Soft Fabric Seal	Soft Fabric Seal	Substantially Equivalent.The structure of the nasalinterface are similar in design andmaterials. Verification andvalidation testing was performedand the subject device met allpredefined acceptance criteria.Any new materials have beenassessed and tested forbiocompatibility.
Device Design(Mask Body)	Soft Fabric	Soft Fabric	Substantially Equivalent.Mask Body geometry waschanged. Verification andvalidation testing was performedand the subject device met allpredefined acceptance criteria.Materials utilized in the design areidentical.
Feature	Predicate Device:SleepWeaver élan (K120757)	Subject Device:SleepWeaver 3D Nasal Mask	Comments
Device Design(Headgear)	4-Point Adjustable Elastic Fabric	4-Point Adjustable Elastic Fabric(Addition of Integrated PlasticComponent)	Substantially Equivalent.The "Integrated PlasticComponent" positions the lowerstraps below the patient's ears.Materials utilized in the design areidentical.
Accessories	Feather Weight Tube & TetherStrap	Feather Weight Tube & TetherStrap	Identical(Previously cleared underK120757 and has not beenmodified)
Size (Mask)	Three (3) Sizes(Small, Medium, Large)	One (1) Size	Substantially Equivalent.The subject device has one sizeof mask due to the nasal interfacedesign and material. Verificationand validation testing wasperformed and the subject devicemet all predefined acceptancecriteria.
Size (Headgear)	One (1) Size	Two (2) Sizes(Regular, Large)	Substantially Equivalent.The subject device has two sizesof headgear to accommodate abroader range of use among thepatient population. Verificationand validation testing wasperformed and the subject devicemet all predefined acceptancecriteria.

Table 1: Comparison Table of SleepWeaver 3D Nasal Mask and Predicate

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VII. PERFORMANCE DATA

Non-Clinical Tests

Extensive performance testing was conducted in accordance with ISO 17510:2015 and results were satisfactory to demonstrate substantial equivalence. Performance testing included:

. Fixed Leak Rate (Acceptable per ISO 17510:2015)

Pressure (cmH2O)	4	5	10	15	20
Flow (LPM)	18	21	32	41	50

Pressure Drop (Resistance to Flow) (@50LPM: 0.3cmH2O; @100LMP: 0.5cmH2O) .
CO2 Rebreathing (Acceptable per ISO 17510:2015)
Sound Pressure (Power Level: 26dBA; Pressure Level @ 1m: 18dBA) ●
Reliability (90 wash cycles without damage or loss of function)

The SleepWeaver 3D Nasal Mask has been designed and tested to meet the requirements of the following standards:

1. ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices
1. ISO 17510:2015 Medical Devices -- Sleep Apnoea Breathing Therapy -- Masks and Application Accessories
1. ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation And Testing within a Risk Management Process
1. ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
1. ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

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The skin contacting portion of the nasal interface material is new and was identified as direct patient contacting, permanent duration (> 30 days) and biocompatibility testing was conducted by applying the principles of biological evaluation of medical devices, in accordance with ISO 10993-1. All tests were successfully completed with acceptable results. Biocompatibility for all other materials utilized in the device is based on the previously cleared predicate device, the SleepWeaver élan Nasal CPAP (K120757).

Clinical Tests

Clinical tests were not required to demonstrate the substantial equivalence of the SleepWeaver 3D Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.

VIII. CONCLUSIONS

Design verification and validation testing was performed on the SleepWeaver 3D Nasal Mask and the subject device met all predefined acceptance criteria. Circadiance has determined that the modifications do not raise different types of safety and effectiveness questions. In summary, the performance and technological characteristics of the SleepWeaver 3D Nasal Mask has been adequately assessed by nonclinical tests and is substantially equivalent to the predicate device, the SleepWeaver élan Nasal CPAP Mask (K120757).

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).