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

K190533 · Sleepnet Corporation · CBK · Jul 26, 2019 · Anesthesiology

Device Facts

• Record ID: K190533
• 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
• Applicant: Sleepnet Corporation
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Full face masks (Mojo 2, Veraseal 3) serve as patient interfaces for noninvasive ventilation; used in home or hospital/institutional settings. Devices connect to ventilators to deliver positive pressure ventilation. Features include elbow and optional anti-asphyxia valve (AAV). Veraseal 3 offered as disposable (single-use) or single-patient multi-use (up to 7 days); Mojo 2 offered as single-patient multi-use. Masks available in multiple sizes. Healthcare providers select appropriate mask size and type based on patient needs. AAV allows ambient air intake if ventilator fails. Benefits include effective delivery of noninvasive ventilation therapy to adult patients.

Clinical Evidence

Bench testing only. Performance testing included internal volume/dead space, pressure drop, AAV opening/closing pressure, biocompatibility (ISO 10993), cleaning validation, mechanical drop test, and ISO 17510 compliance. No clinical data provided.

Technological Characteristics

Full face masks with elbow and optional AAV. Materials are identical to predicate (permanent duration, surface contact/externally communicating). Available in multiple sizes. Non-vented design. Bench testing performed per ISO 17510. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for adult patients (>30 kg) requiring noninvasive positive pressure ventilation. Used as an accessory to ventilators equipped with adequate alarms and safety systems for ventilator failure.

Regulatory Classification

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.

Predicate Devices

• Sleepnet Mojo Full Face mask (K063806)

Reference Devices

• Respironics AF531 SE Full Face Mask (K101129)
• MiniMe 2 nasal (K121692)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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510(k) Summary

| Date: | July 25, 2019 |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sleepnet Corporation<br>5 Merrill Industrial Drive<br>Hampton, NH 03842 | Tel - 603-758-6625<br>Fax - 603-758-6699 |
| Official Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Proprietary or Trade Name: | Veraseal 3 Full Face Non-Vented Mask<br>Veraseal 3 Full Face AAV Non-Vented Mask<br>Mojo 2 Full Face Non-Vented Mask<br>Mojo 2 Full-Face AAV Non-Vented Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | CBK - Noncontinuous ventilator)<br>CFR 868.5895 |
| Device: | Veraseal 3 Full Face Non-Vented Mask<br>Veraseal 3 Full Face AAV Non-Vented Mask<br>Mojo 2 Full Face Non-Vented Mask<br>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<br>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

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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-Vented<br>and AAV Non-Vented Full Face Masks are<br>intended to provide a patient interface for<br>application of noninvasive ventilation. The mask<br>is to be used as an accessory to ventilators that<br>have adequate alarms and safety systems for<br>ventilator failure, and which are intended to<br>administer positive pressure ventilation. The mask<br>will be offered in a disposable version and a<br>multiuse version. It is intended for use on adult<br>patients (>30 kg), who are appropriate candidates<br>for noninvasive ventilation.<br>Veraseal 3 -<br>Disposable single use (hospital/institutional)<br>Single patient, multi-use up to 7 days<br>(hospital/institutional)<br>Mojo 2 -<br>Single patient, multi-use (home or<br>hospital/institutional) | The Sleepnet Mojo-NV Full Face Mask is<br>intended to provide a patient interface for<br>application of noninvasive ventilation. The<br>mask is to be used as an accessory to<br>ventilators that have adequate alarms and<br>safety systems for ventilator failure, and which<br>are intended to administer positive pressure<br>ventilation. The mask will be offered in a<br>disposable version and a multiuse version. It is<br>intended for use on adult patients (>30 kg),<br>who are appropriate candidates for<br>noninvasive ventilation.<br>(Applies to the standard version):<br>For homecare applications, the Sleepnet Mojo-<br>NV Full Face Mask, Non-vented may be<br>reused multiple times by a single patient. For<br>institutional applications (i.e. hospital or other<br>clinical settings), this interface may be reused<br>multiple times by multiple patients.<br>(Applies to the disposable version):<br>The Sleepnet Mojo-NV Full Face Mask, Non-<br>vented Disposable is a single patient, single<br>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<br>hospital/institutional environment. | The masks are intended for use in the home or<br>hospital/institutional environment. | Identical for each model. |

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# K190533

510(k) Summary

| Attributes | Subject - Non-Vented and AAV Non-<br>Vented Full Face Mask<br>Mojo 2, Veraseal 3 | Predicate – K063806<br>Full Face Mask<br>Mojo | Explanation of<br>Differences |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Duration of Use | Veraseal 3<br>Disposable, single patient use<br>Single patient, multi-use up to 7 days<br><br>Mojo 2<br>Single patient, multi-use | Mojo<br>Single patient, multi-use<br>Multi-patient, multi-use | Added Veraseal 3 model<br>which has similar durations<br>of use to the predicate |
| Useful life | Veraseal 3 –<br>Single use disposable<br>Up to 7 days<br>Mojo 2 –<br>Expected useful life - 6 months | Mojo –<br>Expected useful life - 6 months | Performance testing done to<br>support this length of use.<br>The products are all still<br>single patient, multi-use |
| Cleaning methods | Soap and water<br>Isopropyl alcohol | Soap and water | Similar |
| Features | | | |
| Available sizes | 4 | 3 | Adding new size |
| Shape | Similar | Similar | Similar |
| Incorporates an elbow and<br>Anti-asphyxia valve (AAV) | Elbow – Yes<br>AAV - Yes | Elbow – Yes<br>AAV - No<br>Reference K101129 | Predicate has elbow but we<br>have added the AAV which<br>is similar to the reference<br>Respironics - K101129 |
| Shell | Veraseal 3 - Rigid<br>Mojo 2 - Soft | Mojo - Soft | Added the rigid shell for the<br>Veraseal model |
| Materials / Patient Contact per<br>ISO 10993-1 | Surface contact, intact skin<br>Externally Communicating, Tissue<br>Permanent Duration of Use | Surface contact, intact skin<br>Externally Communicating, Tissue<br>Permanent Duration of Use | Identical safety profile |

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# K190533

510(k) Summary

| Attributes | Subject - Non-Vented and AAV Non-<br>Vented Full Face Mask<br>Mojo 2, Veraseal 3 | Predicate - K063806<br>Full Face Mask<br>Mojo | Explanation of<br>Differences | |
|--------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------|
| Dead space (nominal ml) | Veraseal 3 w/o AAV<br>180 ml<br>193 ml<br>203 ml<br>215 ml | w/AAV<br>180 ml<br>194 ml<br>203 ml<br>213 ml | Reference K101129<br>308 ml<br>423 ml<br>469 ml<br>N/A | Less than reference and<br>similar to the predicate<br>Mojo |
| | Mojo 2 w/o AAV<br>177 ml<br>194 ml<br>209 ml<br>216 ml | w/ AAV<br>176 ml<br>193 ml<br>206 ml<br>220 ml | Mojo w/o AAV<br>180 ml<br>220 ml<br>255 ml<br>N/A | w/ AAV<br>N/A<br>N/A<br>N/A<br>N/A |
| Pressure AAV<br>Opening / closing | Mojo 2<br>Opening - 1.15 cm H2O<br>Closing - 1.55 cm H2O | Reference – K101129 – Respironics<br><3 cmH2O | | Similar<br>Pass / Fail criteria is < 3 cm<br>H2O |
| | Veraseal 3<br>Opening - 1.2 cm H2O<br>Closing - 1.5 cm H2O | | | Reference - K101129 –<br>Respironics mask includes<br>an AAV |
| Resistance to Flow (cmH2O) | Mojo 2 w/o AAV<br>50 lpm – 0.1<br>100 lpm – 0.24 | w/AAV<br>0.22<br>0.45 | Reference K101129<br>50 lpm - 0.6<br>100 lpm - 1.2 | |
| | Veraseal 3 w/o AAV<br>50 lpm – 0.1<br>100 lpm – 0.32 | W/AAV<br>0.3<br>0.5 | | |
| Resistance of AAV opening<br>(cmH2O) | Insp – 1.2<br>Exp – 1.3 | | Reference K101129<br>Insp – 0.9<br>Exp – 0.7 | ISO 17510 criteria < 10<br>cmH2O |