Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

K190254 · Sleepnet Corporation · BZD · Jul 5, 2019 · Anesthesiology

Device Facts

• Record ID: K190254
• Device Name: Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.

Device Story

Full face vented masks (Mojo 2, Veraseal 3, V3) interface between positive airway pressure (PAP) device and patient. Input: pressurized air from CPAP/bi-level device. Operation: mask delivers air to patient airway; includes exhalation elbow and anti-asphyxia valve (AAV) for safety. Used in home or hospital/institutional settings. Operated by patient or clinician. Output: delivery of prescribed pressure therapy. Benefits: facilitates non-invasive ventilation/PAP therapy for respiratory support. Subject devices feature slight shape redesign, additional extra-large size, and extended useful life (up to 6 months for V3/Mojo 2).

Clinical Evidence

Bench testing only. Performance evaluated for internal volume/dead space, pressure drop, anti-asphyxia valve pressure, CO2 washout, simulated life testing post-cleaning, and mechanical drop testing. All testing met ISO 17510 requirements.

Technological Characteristics

Full face vented mask with exhalation elbow and anti-asphyxia valve. Materials identical to predicate K120463. Complies with ISO 17510. Dimensions include new extra-large size. Non-powered, passive interface.

Indications for Use

Indicated for adult patients (>30 kg) prescribed positive airway pressure therapy (CPAP or bi-level) at or above 3 cm H2O.

Regulatory Classification

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.

Predicate Devices

• Sleepnet Veraseal and Mojo Full Face mask (K120463)

Reference Devices

• MiniMe 2 nasal (K121692)

Submission Summary (Full Text)

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July 5, 2019

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

Re: K190254

Trade/Device Name: Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 5, 2019 Received: June 6, 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

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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 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 (QS) 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 medical devices and radiation-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,

for

James Lee, PhD 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K190254

Device Name

Mojo 2 Full Face Vented Mask Veraseal 3 Full Face Vented Mask V3 Full Face Vented Mask

#### Indications for Use (Describe)

The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H₂O.

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

| Veraseal 3 | Disposable single use (hospital/institutional)<br>Single patient, multi-use up to 7 days (hospital/institutional) |
|------------|-------------------------------------------------------------------------------------------------------------------|
| V3 | Single patient, multi-use (home) |
| Mojo 2 | Single patient, multi-use (home or hospital/institutional) |

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

_ Over-The-Counter Use (21 CFR 801 Subpart C) XX Prescription Use (Part 21 CFR 801 Subpart D)

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Form Approved: OMB No. 0910-0120

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# 510(k) Summary 5-July 19

| 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: | Mojo 2 Full Face Vented Mask<br>Veraseal 3 Full Face Vented Mask<br>V3 Full Face Vented Mask |
| Common/Usual Name: | Patient interface for CPAP |
| Classification Code/Name: | BZD - non-continuous ventilator (IPPB)<br>CFR 868.5905 |
| Device: | Mojo 2 Full Face Vented Mask<br>Veraseal 3 Full Face Vented Mask<br>V3 Full Face Vented Mask |
| Predicate Devices:<br>Reference Devices: | K120463 - Sleepnet Veraseal and Mojo Full Face mask<br>K121692 - MiniMe 2 nasal |

#### Device Description:

The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation 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 identical . exhalation elbow and anti-asphyxia valve (AAV)
- · Add an additional size, ex-large, mask to the product line
- . Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask

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

V3 is intended as a Single patient, multi-use (home)

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

# Indications for Use:

The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O.

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

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#### 510(k) Summary

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

V3 -Single patient, multi-use (home)

Moio 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. These refer to the table below this discussion.

The Sleepnet Veraseal 3, V3, and Mojo 2 Full face mask are viewed as substantially equivalent to the predicate device because:

#### Indications -

- The Veraseal 3, V3, and Mojo 2 masks are intended to be used with positive airway pressure devices, such as CPAP or bi-level operating at or above 3 cm H2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed.
- Identical to Sleepnet masks K120463 ●

# Patient Population -

- The masks are to be used on adult patients (>30kg) for whom positive airway pressure ● therapy has been prescribed.
- Identical to Sleepnet - K120463

# Environment of Use -

- The masks are intended for use in the home or hospital/institutional environment. ●
- . Identical to predicates - Sleepnet - K120463

# Technology -

- . Identical technology to - Sleepnet mask - K120463
# Non-clinical testing

# Biocompatibility -

- The materials in patient contact are identical to predicate devices. ●

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# 510(k) Summary

### Bench testing

We compared performance for:

- Internal Volume / Dead space
- Pressure drop
- Anti-asphyxia valve pressure testing ●
- CO2 washout
- Simulated life testing post-cleaning
- Mechanical drop test ●
- . Meets ISO 17510 testing

# Differences –

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