MOJO, VERASEAL
Device Facts
| Record ID | K120463 |
|---|---|
| Device Name | MOJO, VERASEAL |
| Applicant | Sleepnet Corporation |
| Product Code | BZD · Anesthesiology |
| Decision Date | Jul 27, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The SleepNet Mojo and Veraseal 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 (>30kg) for whom positive airway pressure therapy has been prescribed. Veraseal - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo - Single patient, multi-use (home or hospital/institutional)
Device Story
Mojo and Veraseal are full-face masks for delivery of positive airway pressure (CPAP/bi-level) to adult patients. Devices interface between pressure generator and patient airway; function via mask shell, cushion, and exhaust elbow. Modifications from predicate include updated exhaust elbow design and varied durations of use: Veraseal (disposable single-use or single-patient multi-use up to 7 days in hospital); Mojo (single-patient multi-use for home/hospital). Operated by clinicians or patients; masks channel airflow to patient. Benefit includes non-invasive respiratory support. Performance validated via bench testing of dead space, exhaust flow, pressure drop, anti-asphyxia valve function, and CO2 washout.
Clinical Evidence
Bench testing only. No clinical data. Testing included dead space, exhaust flow, pressure drop, anti-asphyxia valve pressure, CO2 washout (ISO 17510-2), biocompatibility (ISO 10993), cleaning validation, and storage/aging. CO2 washout results at 3, 5, 10 cm H2O and occluded states were compared to predicates, showing similar performance.
Technological Characteristics
Full face mask with headgear, shell, cushion, and swivel exhaust elbow. Materials tested per ISO 10993. Connectivity: interfaces with standard CPAP/bi-level tubing. Sterilization: not specified (disposable/multi-use cleaning protocols provided). Technology is identical to predicate Mojo mask.
Indications for Use
Indicated for adult patients (>30kg) requiring positive airway pressure therapy (CPAP or bi-level) at or above 3 cm H2O. Used in home or hospital/institutional settings.
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
Submission Summary (Full Text)
{0}------------------------------------------------
JUL 2 7 2012
#### 4120463 510(k) Summary Page I of 6 6-Jul-12
| 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 Quality |
|----------------------------|------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Mojo Full Face Mask<br>Veraseal Full Face mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD - non-continuous ventilator (IPPB)<br>CFR 868.5905<br>Class II |
| Device: | Mojo Full Face Mask<br>Veraseal Full Face mask |
| Predicate Devices: | K060273 - SleepNet Mojo Full Face mask<br>K063122 - ResMed Mirage Quattro Full Face mask |
| Device Description: | |
The SleepNet Mojo and Veraseal Full Face mask are modifications of the SleepNet Mojo Full Face mask cleared under K060273.
The modifications to the cleared Mojo Full Face mask are:
- different durations of use
- o single use, disposable (Hospital/Institutional) Veraseal
- o single patient, multi-use up to 7 days (Hospital/Institutional) Veraseal
- o single patient, multi-use (Home or Hospital/Institutional) MoJo
- a change in materials .
- updated design of the exhaust elbow used with the mask
As a result of these modifications we have established two (2) product tradenames to help distinguish them.
Veraseal model has 2 durations of use - single use, disposable or single patient, multi-use up to 7 days in the hospital.
Mojo model is single patient, multi-use (typically more than 7 days) for use in the home or hospital.
### Indications for Use:
●
The SleepNet Mojo and Veraseal 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 (>30kg) for whom positive airway pressure therapy has been prescribed.
{1}------------------------------------------------
# 510(k) Summary Page 2 of 6 6-Jul-12
Veraseal -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo -
Single patient, multi-use (home or hospital/institutional)
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
The SleepNet Veraseal and Mojo Full face mask are viewed as substantially equivalent to the predicates device because:
### Indications -
- The Veraseal and Mojo 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 (>30kg) for whom positive airway pressure therapy has been prescribed.
- Identical to ResMed Mirage Quattro (K063122) with pressure minimum identical to . SleepNet Mojo (K060273)
### Patient Population -
- The masks are to be used on adult patients (>30kg) for whom positive airway pressure . therapy has been prescribed.
- Identical to SleepNet MoJo (K060273) and ResMed Mirage Quattro (K063122) .
### Technology -
- Identical technology to SleepNet Mojo Full Face mask (K060273) .
#### Materials -
- The materials in patient contact are identical to predicate devices or have been tested in . accordance with ISO 10993.
#### Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment .
- Identical to predicates SleepNet MoJo (K060273) and ResMed Mirage Quattro . (K063122)
### Duration of Use and Cleaning Method
- The duration of use and cleaning methods for single patient Less 7 days, single patient, . multi-use, disposable are identical to the predicate - SleepNet MoJo (K060273)
### Differences -
- There are no differences between the predicates and the proposed modified devices which . would raise any new safety or risks and thus can be found to be substantially equivalent.
{2}------------------------------------------------
510(k) Summary Page 3 of 6 6-Jul-12
# Comparative Performance
We have performed comparative performance testing pre- and post- cleaning or conditioning that included:
- Dead space .
- Exhaust Flow ●
- Pressure drop ●
- Anti-asphyxia valve (AAV) pressure testing .
- Exhaust Elbow Change Performance .
- CO2 washout per ISO 17510-2 .
- ISO 10993 for biocompatibility .
- Cleaning validation ●
- Storage and aging .
The results demonstrated that the devices are substantially equivalent.
{3}------------------------------------------------
510(k) Summary
Table of Comnarison to Predicates
| ante of Compal Boll | | | | Attributes | Modified<br>Mojo and Veraseal<br>Full Face Mask | Mojo Full Face Mask<br>K060273 | ResMed Mirage Quattro<br>K063122 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------|
| ttributes | | | ResMed Mirage Quat K063122 | Features | | | |
| | Modified Modernets Marka Morith Mojio masks are The United Manika Movich positi as The United Maska Movith positi as announds and research are are ar Sboray pressure de | Mojo Full Face M. K060273 | | Available sizes | 3 | 3 | 4 |
| | | | | Shape | Similar | Similar | Similar |
| ications for | | | e Mirage Quattro channels airflow ninvasively to a patient from a possive way pressure device such as comments of the many pressure airway pressure airway pressure airway pre | Shell | Veraseal<br>Rigid for single patient models | Soft only | |
| | | | | Materials ISO 10993<br>CO₂ washout profile<br>Tested per ISO 17510-2 | Mojo<br>Soft<br>Yes | Yes | N/A |
| | | | | | Pressure | Pressure | Not tested as this predicate for duration of<br>use, environment of use, and cleaning<br>method only |
| | | | | | ETCO₂% at mask<br>(% increase) | ETCO₂% at mask<br>(% increase) | |
| | | | evel system | | 3 cm H₂O<br>6.1 (17%) | 3 cm H₂O<br>5.9 (15%) | |
| | | | | | 5 cm H₂O<br>5.9 (14%) | 5 cm H₂O<br>5.8 (14%) | |
| | | | | | 10 cm H₂O<br>5.8 (12%) | 10 cm H₂O<br>5.6 (9%) | |
| | The masks are to be used on adult patients (230kg) for whom positive airway pressure therapy has been prescribed | The Sin Bir More More Maria Massal Massal Massa Short All Properti Andress Marin Marian Managing Marian Managiri Marian Manakar Manakar Manakar Manakari Marin Marian Manakari | The Mirage Quattro is to be used by adult patients (> 66 lbs. /> 30 Kg) for whom positive airway pressure has been | | Occluded<br>6.3 (21%) | Occluded<br>6.0 (17%) | |
| | | | | Deadspace | Mojo | | Varies according to cushion size |
| | | | prescribed | Small | 160 ml | 200 ml | |
| tient Populati | Adult (≥30 kg) The masks are intended for use in the home or hospital/institutional environment. | dult (>30 kg | dult (>30 kg | Medium | 185 ml | 245 ml | |
| vironment of | | | | Large | 205 ml | 295 ml | 242 ml |
| | | The masks are intended for use in the nome or hospital/institutional | he masks are intended for use ome or hospital/institutional | Exhaust - pressure / flow | Mojo | | |
| | | environment | environment | | Pressure (cmH₂O) Flow (lpm) | Pressure (cmH₂O) Flow (lpm) | Pressure (cmH₂O) Flow (lpm) |
| | Yes | Yes | Y es | | 3<br>21.20 | 3<br>32.00 | 4<br>22 |
| escriptive uration of U | | | | | 10<br>37.20 | 10<br>43.00 | 8<br>32 |
| | | | | | 20<br>53.10 | 20<br>55.00 | 12<br>41 |
| | | | | | Veraseal | | 20<br>54 |
| | Veraseal Disposable, single patient use (hospital) Single patient, multi-use up to 7 days (hospital) | Single patient, multi-use (home | Single patient, multi-use but does not the length of re-use (home / hospital) | | Pressure (cmH₂O) Flow (lpm) | | |
| | | hospital | | | 3<br>21.10 | | |
| | | | | | 10<br>36.40 | | |
| | patient, multi-use (hon<br>្រទេសចរនា ជា ជាចំនួនដែន ស្ថិតនៅក្នុងស្រុក និង ស្រីបន្ត ស្រុកស្រីប ស | ingle patient, multi-use (hom | | | 20<br>53.00 | | |
| | | hospital) | | | | | |
| eaning metho | Soap and water | oap and wate | | | | | |
| | Isopropyl alcoho Yes | sopropyl alcoh | OPA | | | | |
| corporates an Exhaust elbo | | Yes | Yes | | | | |
:
Page 16
:
{4}------------------------------------------------
510(k) Summary
:
Page 17
T
{5}------------------------------------------------
510(k) Summary
| Attributes | Modified Mojo and Veraseal Full Face Mask | Mojo Full Face Mask<br>K060273 | ResMed Mirage Quattro<br>K063122 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Pressure AAV<br>Opening / closing | Mojo<br>Opening - 1.10 cm H₂O<br>Closing - 1.60 cm H₂O<br><br>Veraseal<br>Opening - 1.29 cm H₂O<br>Closing - 1.45 cm H₂O | Opening - 0.65 cm H₂O<br>Closing - 1.38 cm H₂O | Not disclosed |
| Resistance to Flow | Pass / Fail criteria is <3 cm H₂O<br><br>Mojo<br>50 lpm - 0.40 cm H₂O<br>100 lpm - 0.65 cm H₂O<br><br>Veraseal<br>50 lpm - 0.49 cm H₂O<br>100 lpm - 0.89 cm H₂O | Pass/Fail criteria is < 3 cm H₂O<br><br>50 lpm - 0.38 cm H₂O<br>100 lpm - 0.80 cm H₂O | 50 lpm - 0.5 cm H₂O<br>100 lpm - 1.6 cm H₂O |
| Components | Headgear<br>Shell / Cushion<br>Swivel elbow | Headgear<br>Shell / Cushion<br>Swivel elbow | Headgear<br>Shell / Cushion<br>Swivel elbow |
Page 18
ﺷﺮ ﺍﻟ
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2012
Sleepnet Corporation C/O Mr. Paul Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K120463
Trade/Device Name: Veraseal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 6, 2012 Received: July 9, 2012
Dear Mr. 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. 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.
{7}------------------------------------------------
# Page 2 - Mr. Dryden
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm_for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
# Enclosure
{8}------------------------------------------------
# Indications for Use Statement
Page 1 of 1
510(k) Number:
K120463
Device Name:
Mojo Mask Veraseal Mask
## Indications for Use:
The SleepNet Mojo and Veraseal 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 (>30kg) for whom positive airway pressure therapy has been prescribed.
Veraseal -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo -
Single patient, multi-use (home or hospital/institutional)
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulten
(Division Sign-Off) Division of Anestheslology, General Hospital Intection Control, Dental Devices
510(k) Number: K120463
