Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (a full face mask for noninvasive ventilation) and its intended use, design modifications, and performance testing. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on physical characteristics and safety, not algorithmic performance.

Therapeutic

No

Explanation: The device is a face mask intended for noninvasive ventilation, which is an accessory to therapeutic ventilators, but not a therapeutic device itself.

Diagnostic

No

This device is described as a patient interface for noninvasive ventilation, specifically a full face mask, and its function is to deliver positive pressure ventilation. It does not perform any diagnostic functions or analyze patient signals to provide medical insights.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate this is a physical medical device (full face mask) with hardware components and associated testing (bench testing, mechanical drop test, biocompatibility). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide a patient interface for noninvasive ventilation. This is a therapeutic application, not a diagnostic one.
Device Description: The device is a full face mask used with ventilators. This is a medical device used for delivering air/oxygen, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a respiratory accessory used for delivering therapy.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

Product codes

CBK

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult patients (>30 kg)

Intended User / Care Setting

Home or hospital / institutional environments

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

Bench testing was performed:

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

Key Metrics

Dead space (nominal ml):
- 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
Pressure AAV 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
Resistance to Flow (cmH2O):
- Mojo 2 w/o AAV: 50 lpm – 0.1, 100 lpm – 0.24
- Mojo 2 w/AAV: 0.22, 0.45
- Veraseal 3 w/o AAV: 50 lpm – 0.1, 100 lpm – 0.32
- Veraseal 3 W/AAV: 0.3, 0.5
Resistance of AAV opening (cmH2O): Insp – 1.2, Exp – 1.3

Predicate Device(s)

K063806 - Sleepnet Mojo Full Face mask

Reference Device(s)

K101129 – Respironics - AF531 SE Full Face Mask, K121692 - MiniMe 2 nasal

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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)

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)

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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FORM FDA 3881 (7/17)

Page 1 of 1

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510(k) Summary

Date:	July 25, 2019
Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842	Tel - 603-758-6625
Fax - 603-758-6699
Official Contact:	Jennifer Kennedy - Director of Regulatory and Quality
Proprietary or Trade Name:	Veraseal 3 Full Face Non-Vented Mask
Veraseal 3 Full Face AAV Non-Vented Mask
Mojo 2 Full Face Non-Vented Mask
Mojo 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 Mask
Veraseal 3 Full Face AAV Non-Vented Mask
Mojo 2 Full Face Non-Vented Mask
Mojo 2 Full-Face AAV Non-Vented Mask
Predicate Device:	K063806 - Sleepnet Mojo Full Face mask
Reference Devices:	K101129 – Respironics - AF531 SE Full Face Mask
K121692 - MiniMe 2 nasal

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)

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

4

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.

5

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.

6

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-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)	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.
(Applies to the 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.
(Applies to the disposable version):
The Sleepnet Mojo-NV Full Face Mask, Non-
vented Disposable is a single patient, single
use 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 or
hospital/institutional environment.	The masks are intended for use in the home or
hospital/institutional environment.	Identical for each model.

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K190533

510(k) Summary

| Attributes | Subject - Non-Vented and AAV Non-
Vented Full Face Mask
Mojo 2, Veraseal 3 | Predicate – K063806
Full Face Mask
Mojo | Explanation of
Differences |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Duration of Use | Veraseal 3
Disposable, single patient use
Single patient, multi-use up to 7 days

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K190533

510(k) Summary

| Attributes | Subject - Non-Vented and AAV Non-
Vented Full Face Mask
Mojo 2, Veraseal 3 | Predicate - K063806
Full Face Mask
Mojo | Explanation of
Differences | |
|--------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------|
| Dead space (nominal ml) | Veraseal 3 w/o AAV
180 ml
193 ml
203 ml
215 ml | w/AAV
180 ml
194 ml
203 ml
213 ml | Reference K101129
308 ml
423 ml
469 ml
N/A | Less than reference and
similar to the predicate
Mojo |
| | Mojo 2 w/o AAV
177 ml
194 ml
209 ml
216 ml | w/ AAV
176 ml
193 ml
206 ml
220 ml | Mojo w/o AAV
180 ml
220 ml
255 ml
N/A | w/ AAV
N/A
N/A
N/A
N/A |
| Pressure AAV
Opening / closing | Mojo 2
Opening - 1.15 cm H2O
Closing - 1.55 cm H2O | Reference – K101129 – Respironics