The Sleepnet Moio 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 - Single patient, multi-use (home or hospital/institutional)

Device Description

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

. Slight redesign of the shape of the masks but no appreciable differences as the elbow is identical to the predicate
Add an anti-asphyxia valve (AAV) option .
Add an additional size, ex-large, mask to the product line ●

Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

AI/ML Overview

The provided FDA 510(k) summary (K190533) describes the acceptance criteria and supporting studies for the Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented Masks.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (K063806 - Sleepnet Mojo Full Face mask) and reference devices (K101129 – Respironics - AF531 SE Full Face Mask, K121692 - MiniMe 2 nasal) through non-clinical bench testing. The acceptance criteria are implicitly based on being "similar" to the predicate or reference device, or meeting specific ISO standards.

Acceptance Criteria / Attribute	Reported Device Performance (Subject Device)	Predicate/Reference Device Performance	Explanation of Differences / Compliance
Indications for Use	The Sleepnet Mojo 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3: Disposable single use (hospital/institutional); Single patient, multi-use up to 7 days (hospital/institutional). Mojo 2: Single patient, multi-use (home or hospital/institutional).	The Sleepnet Mojo-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. (Standard version): For homecare applications, the Sleepnet Mojo-NV Full Face Mask, Non-vented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Disposable version): The Sleepnet Mojo-NV Full Face Mask, Non-vented Disposable is a single patient, single use interface.	Similar. The subject devices maintain the same core intended use and patient population as the predicate, with expanded specific use cases for the new models (Veraseal 3 disposable/multi-use, Mojo 2 multi-use).
Patient Population	Adult (>30 kg)	Adult (>30 kg)	Identical.
Environment of Use	The masks are intended for use in the home or hospital/institutional environment.	The masks are intended for use in the home or hospital/institutional environment.	Identical for each model.
Duration of Use	Veraseal 3: Disposable, single patient use; Single patient, multi-use up to 7 days. Mojo 2: Single patient, multi-use.	Mojo: Single patient, multi-use; Multi-patient, multi-use.	Added Veraseal 3 model, which has similar durations of use to the predicate. The overall duration intent is similar or further defined.
Useful Life	Veraseal 3: Single use disposable; Up to 7 days. Mojo 2: Expected useful life - 6 months.	Mojo: Expected useful life - 6 months.	Performance testing was done to support this length of use. The products are all still single patient, multi-use. This indicates that the new devices' useful life meets the predicate's established useful life where applicable, or has been validated.
Biocompatibility	Materials in patient contact are identical to predicate device, evaluated as permanent duration. Meets ISO 10993 for biocompatibility via Material Certification.	Materials in patient contact (for predicate) also meet ISO 10993-1 categories for surface contact, intact skin, externally communicating, tissue, and permanent duration of use.	Identical safety profile. This implies the new materials are either identical to the predicate or have been tested to the same standard (ISO 10993) and deemed safe for the specified contact and duration.
Internal Volume / Dead space	Veraseal 3 w/o AAV: 180 ml, 193 ml, 203 ml, 215 ml. Veraseal 3 w/AAV: 180 ml, 194 ml, 203 ml, 213 ml. Mojo 2 w/o AAV: 177 ml, 194 ml, 209 ml, 216 ml. Mojo 2 w/AAV: 176 ml, 193 ml, 206 ml, 220 ml.	Mojo w/o AAV: 180 ml, 220 ml, 255 ml. (Reference K101129): 308 ml, 423 ml, 469 ml.	Less than reference and similar to the predicate Mojo. The acceptance criterion is likely to maintain dead space within clinically acceptable ranges, often implying values no greater than the predicate or established safe limits. The subject devices demonstrate lower or comparable dead space to the predicate and significantly lower than the reference.
Anti-asphyxia valve (AAV) Pressure Opening / Closing	Mojo 2: Opening - 1.15 cm H2O; Closing - 1.55 cm H2O. Veraseal 3: Opening - 1.2 cm H2O; Closing - 1.5 cm H2O.	(Reference K101129 – Respironics): < 3 cmH2O.	Similar. Pass / Fail criteria is < 3 cm H2O. The subject device values are well within the acceptable range.
Resistance to Flow (cmH2O)	Mojo 2 w/o AAV: 50 lpm – 0.1; 100 lpm – 0.24. Mojo 2 w/AAV: 50 lpm – 0.22; 100 lpm – 0.45. Veraseal 3 w/o AAV: 50 lpm – 0.1; 100 lpm – 0.32. Veraseal 3 w/AAV: 50 lpm – 0.3; 100 lpm – 0.5.	(Reference K101129): 50 lpm - 0.6; 100 lpm - 1.2. The predicate device's resistance to flow values are not explicitly stated, but the "Explanation of Differences" column is empty, implying similarity or better performance compared to the predicate, and definitely better than the reference.	This indicates the resistance to flow is acceptable, presumably meeting or being better than the predicate and certainly better than the reference device. The accepted industry standard or a predicate's performance is the implicit criterion.
Resistance of AAV Opening (cmH2O)	Insp: 1.2; Exp: 1.3.	(Reference K101129): Insp – 0.9; Exp – 0.7. ISO 17510 criteria < 10 cmH2O.	The reported values are well below the ISO 17510 criteria of < 10 cmH2O, indicating compliance.
Cleaning Validation	Performed.	(Implicitly also performed for multi-use models). The new devices also use "Soap and water" and "Isopropyl alcohol" as cleaning methods, which are similar to the predicate's "Soap and water".	Ensures the device can be effectively cleaned for multi-use applications.
Mechanical Drop Test	Performed.	(Implicitly performed for predicate).	Ensures durability and structural integrity.
ISO 17510 Testing	Meets ISO 17510 testing.	(Implicitly expected for predicate/reference).	Confirms compliance with the standard for respiratory and anaesthetic equipment – Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment. This provides a comprehensive safety and performance benchmark.
Additional Size	4 available sizes.	3 available sizes.	Adding a new size (ex-large); this is a difference but not framed as a new safety concern, implying it has been validated to perform similarly to the existing sizes.
Anti-asphyxia valve (AAV) inclusion	Elbow – Yes; AAV - Yes.	Elbow – Yes; AAV - No. Reference K101129 (Respironics) includes an AAV.	Predicate has an elbow but the AAV has been added, which is similar to the reference Respironics - K101129. This means the functionality of the AAV is considered substantially equivalent to the reference device.
Shell Material	Veraseal 3: Rigid. Mojo 2: Soft.	Mojo: Soft.	Added the rigid shell for the Veraseal model; again, a difference but not raising new safety concerns.

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

The document primarily describes bench testing for the comparative performance.

Sample Size: The sample sizes used for each specific bench test (e.g., dead space, pressure drop, AAV pressure, resistance to flow, mechanical drop) are not explicitly stated in this summary. It's implied that sufficient samples were tested to demonstrate compliance and provide the reported performance data.
Data Provenance: The data is generated from non-clinical bench testing. The country of origin of the data is not specified, but it would typically be generated by the manufacturer or a contracted testing facility. This is retrospective in the sense that the testing was performed on the completed device designs to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the summary focuses on non-clinical bench testing. The "ground truth" for these tests are objective, measurable physical properties (e.g., volume, pressure, resistance) determined by established engineering and testing standards (e.g., ISO, internal methods). Clinical expert review is not typically part of establishing the ground truth for these types of purely technical performance metrics.

4. Adjudication Method for the Test Set

This section is not applicable as the summary describes objective bench testing, which does not involve subjective interpretations requiring adjudication by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This is a submission for a patient interface (mask) for non-invasive ventilation, not an AI-powered diagnostic or assistive technology that would require an MRMC study.

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

This section is not applicable. This submission is for a physical medical device (mask), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims in this submission is based on:

Objective physical measurements determined through standardized bench testing protocols.
Compliance with international standards such as ISO 10993 (biocompatibility) and ISO 17510 (sleep apnoea breathing therapy equipment).
Comparison to the performance characteristics of a legally marketed predicate device (K063806) and reference devices (K101129, K121692).

8. The Sample Size for the Training Set

This section is not applicable. This is not a study involving machine learning or AI, so there is no "training set."

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

This section is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 26, 2019

Sleepnet Corporation % Paul Dryden, President, ProMedic, LLC Sleepnet Corporation 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K190533/S001

Trade/Device Name: Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: July 1, 2019 Received: July 2, 2019

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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)

K190533

Device Name

Veraseal 3 Full Face Non-Vented Mask Veraseal 3 Full Face AAV Non-Vented Mojo 2 Full Face Non-Vented Mask Mojo 2 AAV Non-Vented Full-Face Mask

Indications for Use (Describe)

Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 - Single patient, multi-use (home or hospital/institutional)

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date:	July 25, 2019
Sleepnet Corporation5 Merrill Industrial DriveHampton, NH 03842	Tel - 603-758-6625Fax - 603-758-6699
Official Contact:	Jennifer Kennedy - Director of Regulatory and Quality
Proprietary or Trade Name:	Veraseal 3 Full Face Non-Vented MaskVeraseal 3 Full Face AAV Non-Vented MaskMojo 2 Full Face Non-Vented MaskMojo 2 Full-Face AAV Non-Vented Mask
Common/Usual Name:	Patient interface
Classification Code/Name:	CBK - Noncontinuous ventilator)CFR 868.5895
Device:	Veraseal 3 Full Face Non-Vented MaskVeraseal 3 Full Face AAV Non-Vented MaskMojo 2 Full Face Non-Vented MaskMojo 2 Full-Face AAV Non-Vented Mask
Predicate Device:	K063806 - Sleepnet Mojo Full Face mask
Reference Devices:	K101129 – Respironics - AF531 SE Full Face MaskK121692 - MiniMe 2 nasal

Device Description:

The subject of this submission is:

. Slight redesign of the shape of the masks but no appreciable differences as the elbow is identical to the predicate
Add an anti-asphyxia valve (AAV) option .
Add an additional size, ex-large, mask to the product line ●

Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

Indications for Use:

The Sleepnet Mojo 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be

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510(k) Summary

offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

Veraseal 3 Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 - Single patient, multi-use (home or hospital/institutional)

Patient Population: For adults (>30 kg)

Environment of Use: Home or hospital / institutional environments

Substantial Equivalence Discussion:

We discuss the major attributes for demonstrating substantial equivalence below.

The Sleepnet Veraseal 3 and Mojo 2 Non-Vented Full face mask are viewed as substantially equivalent to the predicate device because:

Indications -

The Veraseal 3 and Mojo 2 masks are intended to be used as a patient interface for ● application of noninvasive ventilation. The masks are to be used on adult patients (>30 kg) on noninvasive ventilation.
Identical to Sleepnet masks K063806 ●

Patient Population -

The masks are to be used on adult patients (>30 kg) for whom positive airway pressure ● therapy has been prescribed.
. Identical to Sleepnet - K063806

Environment of Use -

The masks are intended for use in the home or hospital/institutional environment. ●
Identical to predicate - Sleepnet - K063806

Technology -

Identical technology to - Sleepnet mask - K063806
The incorporation of an AAV is similar to the reference Respironics K101129 .

Non-clinical testing

Biocompatibility -

The materials in patient contact are identical to predicate device evaluated as permanent ● duration.

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510(k) Summary

Bench testing -

We have performed the following comparative performance test:

Internal Volume / Dead space ●
. Pressure drop
Anti-asphyxia valve pressure testing ●
. ISO 10993 for biocompatibility via Material Certification
Cleaning validation
. Mechanical drop test
. Meets ISO 17510 testing

Differences –

There are no differences between the predicate and the proposed devices which would raise new safety concerns. The subject devices were found to be substantially equivalent to the identified predicate device.

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K190533

510(k) Summary

Table of Comparison to Predicate

Attributes	Subject - Non-Vented and AAV Non-	Predicate - K063806	Explanation of
	Vented Full Face Mask	Non-Vented Full Face Mask	Differences
	Mojo 2, Veraseal 3	Mojo
Indications for Use	The Sleepnet Mojo 2 and Veraseal 3 Non-Ventedand AAV Non-Vented Full Face Masks areintended to provide a patient interface forapplication of noninvasive ventilation. The maskis to be used as an accessory to ventilators thathave adequate alarms and safety systems forventilator failure, and which are intended toadminister positive pressure ventilation. The maskwill be offered in a disposable version and amultiuse version. It is intended for use on adultpatients (>30 kg), who are appropriate candidatesfor noninvasive ventilation.Veraseal 3 -Disposable single use (hospital/institutional)Single patient, multi-use up to 7 days(hospital/institutional)Mojo 2 -Single patient, multi-use (home orhospital/institutional)	The Sleepnet Mojo-NV Full Face Mask isintended to provide a patient interface forapplication of noninvasive ventilation. Themask is to be used as an accessory toventilators that have adequate alarms andsafety systems for ventilator failure, and whichare intended to administer positive pressureventilation. The mask will be offered in adisposable version and a multiuse version. It isintended for use on adult patients (>30 kg),who are appropriate candidates fornoninvasive ventilation.(Applies to the standard version):For homecare applications, the Sleepnet Mojo-NV Full Face Mask, Non-vented may bereused multiple times by a single patient. Forinstitutional applications (i.e. hospital or otherclinical settings), this interface may be reusedmultiple times by multiple patients.(Applies to the disposable version):The Sleepnet Mojo-NV Full Face Mask, Non-vented Disposable is a single patient, singleuse interface.	Similar
Patient Population	Adult (>30 kg)	Adult (>30 kg)	Identical
Prescriptive	Yes	Yes	Identical
Environment of Use	The masks are intended for use in the home orhospital/institutional environment.	The masks are intended for use in the home orhospital/institutional environment.	Identical for each model.

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K190533

510(k) Summary

Attributes	Subject - Non-Vented and AAV Non-Vented Full Face MaskMojo 2, Veraseal 3	Predicate – K063806Full Face MaskMojo	Explanation ofDifferences
Duration of Use	Veraseal 3Disposable, single patient useSingle patient, multi-use up to 7 daysMojo 2Single patient, multi-use	MojoSingle patient, multi-useMulti-patient, multi-use	Added Veraseal 3 modelwhich has similar durationsof use to the predicate
Useful life	Veraseal 3 –Single use disposableUp to 7 daysMojo 2 –Expected useful life - 6 months	Mojo –Expected useful life - 6 months	Performance testing done tosupport this length of use.The products are all stillsingle patient, multi-use
Cleaning methods	Soap and waterIsopropyl alcohol	Soap and water	Similar
Features
Available sizes	4	3	Adding new size
Shape	Similar	Similar	Similar
Incorporates an elbow andAnti-asphyxia valve (AAV)	Elbow – YesAAV - Yes	Elbow – YesAAV - NoReference K101129	Predicate has elbow but wehave added the AAV whichis similar to the referenceRespironics - K101129
Shell	Veraseal 3 - RigidMojo 2 - Soft	Mojo - Soft	Added the rigid shell for theVeraseal model
Materials / Patient Contact perISO 10993-1	Surface contact, intact skinExternally Communicating, TissuePermanent Duration of Use	Surface contact, intact skinExternally Communicating, TissuePermanent Duration of Use	Identical safety profile

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K190533

510(k) Summary

Attributes	Subject - Non-Vented and AAV Non-Vented Full Face MaskMojo 2, Veraseal 3	Predicate - K063806Full Face MaskMojo	Explanation ofDifferences
Dead space (nominal ml)	Veraseal 3 w/o AAV180 ml193 ml203 ml215 ml	w/AAV180 ml194 ml203 ml213 ml	Reference K101129308 ml423 ml469 mlN/A	Less than reference andsimilar to the predicateMojo
	Mojo 2 w/o AAV177 ml194 ml209 ml216 ml	w/ AAV176 ml193 ml206 ml220 ml	Mojo w/o AAV180 ml220 ml255 mlN/A	w/ AAVN/AN/AN/AN/A
Pressure AAVOpening / closing	Mojo 2Opening - 1.15 cm H2OClosing - 1.55 cm H2O	Reference – K101129 – Respironics<3 cmH2O		SimilarPass / Fail criteria is < 3 cmH2O
	Veraseal 3Opening - 1.2 cm H2OClosing - 1.5 cm H2O			Reference - K101129 –Respironics mask includesan AAV
Resistance to Flow (cmH2O)	Mojo 2 w/o AAV50 lpm – 0.1100 lpm – 0.24	w/AAV0.220.45	Reference K10112950 lpm - 0.6100 lpm - 1.2
	Veraseal 3 w/o AAV50 lpm – 0.1100 lpm – 0.32	W/AAV0.30.5
Resistance of AAV opening(cmH2O)	Insp – 1.2Exp – 1.3		Reference K101129Insp – 0.9Exp – 0.7	ISO 17510 criteria < 10cmH2O

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).