(116 days)
No
The summary describes a mask for positive airway pressure therapy and its modifications, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is a mask that works with therapeutic devices (CPAP/bilevel devices) but is not itself a therapeutic device. It is an accessory to deliver the positive airway pressure.
No
These devices are full face masks intended for use with positive airway pressure devices to deliver therapy, not to perform diagnostic assessments.
No
The device description clearly indicates it is a physical mask used with positive airway pressure devices, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a mask used with positive airway pressure devices (CPAP, bilevel) to deliver air to the patient's respiratory system. It is a physical interface for therapy, not a tool for analyzing biological samples.
- Intended Use: The intended use is to provide positive airway pressure therapy for patients with conditions like sleep apnea. This is a therapeutic intervention, not a diagnostic test.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, 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.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets
- Change to the headgear material
- Addition of an XL size
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask
- Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version
- Addition of the Ascend Full Face Vented Mask version
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face (seals around nose and mouth)
Indicated Patient Age Range
Adult (>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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing - Testing demonstrating conformance to ISO 17510 - Medical Devices - Sleep Apnoea Breathing Therapy - Masks And Application Accessories:
- Exhaust flow
- Resistance to Flow
- Anti-asphyxia valve (AAV) pressure test
- AAV Inspiratory/Expiratory Resistance in Single Fault Condition
- Internal Volume / Dead space
- CO2 rebreathing
The performance test results from the predicate device were leveraged for the Mojo and Veraseal 2 models. New testing was conducted for the Innova and Ascend models.
Biocompatibility - The materials in gas pathway and skin contact for all subject devices are identical to Sleepnet's own devices cleared under K120463 and K190254, which have similar intended use, environment of use, and duration of use as the subject devices using material certifications. The biocompatibility test results from the predicate device were leveraged for all subject devices.
Transportation and Shelf-life - There have been no changes in the transportation or shelf-life - the subject devices leverage the predicate device testing for transportation and shelf-life. The performance post transportation and shelf-life test results from the predicate device were leveraged for the subject device.
Reprocessing - There has been no change in the reprocessing – the subject and predicate device utilize the same reprocessing instructions. The reprocessing test results from the predicate device were leveraged for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Exhaust flow characteristics are disclosed in Flow (lpm) at 3, 10, and 20 cmH2O.
AAV Opening/Closing Pressure:
Mojo: Opening - 1.10 cm H2O, Closing - 1.60 cm H2O
Veraseal: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O
Innova: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O
Ascend: Opening - 1.92 cm H2O, Closing - 1.85 cm H2O
Resistance to Flow (Pressure drop):
Mojo: 50 lpm - 0.40 cm H2O, 100 lpm - 0.65 cm H2O
Veraseal 2: 50 lpm - 0.07 cm H2O, 100 lpm - 0.39 cm H2O
Innova: 50 lpm - 0.07 cm H2O, 100 lpm - 0.39 cm H2O
Ascend: 50 lpm - 0.11 cm H2O, 100 lpm - 0.59 cm H2O
Magnets: 4 Magnets are used in the mask (2) and headgear clips (2) with a field strength of 380mT.
CO2 washout profile ISO 17510:2015:
Mojo: 3 cmH2O 5.1 (0 %), 5 cmH2O 3.5 (-31 %), 10 cmH2O 2.1 (-58 %), SingleFault1 7.4 (48 %), SingleFault2 7.5 (51 %)
Veraseal 2 / Innova: 3 cmH2O 5.9 (16 %), 5 cmH2O 5.9 (16 %), 10 cmH2O 5.7 (12 %), SingleFault1 6.4 (25 %), SingleFault2 7.4 (45 %)
Ascend: 3 cmH2O 5.0 (0 %), 5 cmH2O 5.0 (0 %), 10 cmH2O 4.8 (-4 %), SingleFault1 6.5 (30 %), SingleFault2 7.3 (46 %)
Sound Pressure and Sound Power Level:
Mojo: Sound Pressure – 30.07 dBA, Sound Power – 33.09 dBA
Veraseal 2 / Innova / Ascend: Sound Pressure – 29.98 dBA, Sound Power – 32.99 dBA
AAV Inspiratory/Expiratory Resistance in Single Fault Condition:
Mojo: Inspiratory - 0.8 cm H2O, Expiratory – 0.8 cm H2O
Veraseal 2 / Innova / Ascend: Inspiratory - 0.6 cm H2O, Expiratory - 0.5 cm H2O
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 18, 2024
Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K241830
Trade/Device Name: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 19, 2024 Received: September 19, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is from Binoy J. Mathews. The signature was created on October 18, 2024 at 15:47:34 with a time zone offset of -04'00'.
For
Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241830
Device Name
Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask, Ascend Full Face Vented Mask
Indications for Use (Describe)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, 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.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
| Sponsor: Sleepnet Corporation 5 Merrill Industrial Drive Hampton, NH 03842 | Tel - 603-758-6625 |
|---|---|
| Sponsor Contact: | Jennifer Kennedy – Director of Regulatory and Quality |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | Mojo Full Face Vented Mask |
| Veraseal 2 Full Face Vented Mask | |
| Innova Full Face Vented Mask | |
| Ascend Full Face Vented Mask | |
| Common/Usual Name: | Patient interface for CPAP |
| Regulation Number: | |
| Regulation Code: | |
| Product Code: | 21CFR 868.5905 |
| Non-continuous ventilator (IPPB) | |
| BZD | |
| Predicate Device: | |
| Regulation Number: | |
| Regulation Code: | |
| Product Code: | K120463 - Mojo Full Face Mask and Veraseal Full Face Mask |
| 21CFR 868.5905 | |
| Non-continuous ventilator (IPPB) | |
| BZD |
Device Description:
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets ●
- Change to the headgear material ●
- Addition of an XL size ●
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask ●
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version ●
- Addition of the Ascend Full Face Vented Mask version ●
Indications for Use:
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O.
5
510(k) Summary Page 2 of 12 18-Oct-24
The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment. Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital/institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
6
510(k) Summary Page 3 of 12
18-Oct-24
Table of Comparison to Predicate
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend Full
Face Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,
K120463 | Explanation of Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification
CFR | BZD
CFR 868.5905 | BZD
CFR 868.5905 | Identical |
| List of Devices | Mojo Full Face Vented Mask
Veraseal 2 Full Face Vented Mask
Innova Full Face Vented Mask
Ascend Full Face Vented Mask | Mojo Full Face mask
Veraseal Full Face mask | Identical |
| Indications for Use | The Sleepnet Mojo Full Face Vented Mask, Veraseal
2 Full Face Vented Mask, Innova Full Face Vented
Mask and Ascend Full Face Vented Mask are
intended to be used with positive airway pressure
devices, such as CPAP or bilevel, 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.
Mojo -
Single patient, multi-use in the home or
hospital/institutional environment.
Veraseal 2 -
Short Term Single Patient use (maximum of 7 days)
in the hospital/institutional environment.
Innova -
Single patient, multi-use in the home or
hospital/institutional environment.
Ascend -
Single patient, multi-use in the home or
hospital/institutional environment. | The Sleepnet Mojo and Veraseal masks are intended
to be used with positive airway pressure devices, such
as CPAP or bilevel, 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.
Mojo -
Single patient, multi-use and Multi-patient, multi-use
Veraseal -
Disposable single use; Single patient, multi-use up to
7 days
The masks are intended for use in the home or
hospital/institutional environment. | Similar.
The multi-patient use is being
removed. |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend Full
Face Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,
K120463 | Explanation of Differences |
| Patient type | Patients who are appropriate candidates for positive
pressure therapy | Patients who are appropriate candidates for positive
pressure therapy | 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 |
| Duration of Use | Mojo -
Single patient, multi-use
Veraseal 2 -
Short Term Single Patient use (maximum of 7 days)
Innova -
Single patient, multi-use
Ascend -
Single patient, multi-use | Mojo -
Single patient, multi-use and Multi-patient, multi-use
Veraseal -
Disposable single use; Single patient, multi-use up to
7 days | Similar.
Multi-patient use for the Mojo
mask is being removed.
Single use for the Veraseal
mask is being removed. |
| Principle of Operation | Provides a seal over the face (nose and mouth) to
allow for delivery of pressurized air from a positive
pressure device. Mask includes an exhalation port
and AAV for flushing out exhaled CO2. | Provides a seal over the face (nose and mouth) to
allow for delivery of pressurized air from a positive
pressure device. Mask includes an exhalation port and
AAV for flushing out exhaled CO2. | Identical |
| Therapy Pressure | Greater than 3 cm H2O
Typically determined by the equipment to which it is
attached. | Greater than 3 cm H2O
Typically determined by the equipment to which it is
attached. | Identical |
| Anatomical site | Face (seals around nose and mouth) | Face (seals around nose and mouth) | Identical |
| User Interface to
administer therapy | Masks have a standard 22mm connector (compliant
with ISO 5356-1) that connects to 22mm CPAP
circuits. | Mask has a standard 22mm connector (compliant with
ISO 5356-1) that connects to 22mm CPAP circuits. | Identical |
| Contraindications | Mojo has an contraindication that is identical to the
predicate K120463. Veraseal 2, Innova and Ascend
do not have contraindications. | Mojo mask has a contraindication. | Similar. The first
contraindication in the Mojo
mask is identical to the predicate.
New contraindication related to
presence of magnets added as
per recall event #94169. |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend Full
Face Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,
K120463 | Explanation of Differences |
| | New Contraindication (Mojo only)
Do not use this mask if you or anyone (example:
household members, bed partners, caregivers, etc.) in
close physical contact with your mask has an active
medical implant or metallic implant that will interact
with magnets. Implant examples include, but are not
limited to, pacemakers, implantable cardioverter
defibrillators (ICD), neurostimulators, aneurysm clips,
metallic stents, ocular implants, insulin/infusion
pumps, cerebral spinal fluid (CSF) shunts, embolic
coils, metallic splinter, implants to restore hearing or
balance with implanted magnets (such as cochlear
implants), flow disruption devices, contact lenses with
metal, dental implants, metallic cranial plates, screws,
burr hole covers, bone substitute device, magnetic
metallic implants/electrodes/valves placed in upper
limbs, torso, or higher, etc. If you have any questions
regarding the implant, consult your physician or the
manufacturer of your implant. | | |
| Warnings | Updated Warning
Magnets are used in the mask and headgear clips with
a field strength of 380mT. With the exception of the
devices identified in the contraindication, ensure that
the mask is kept at least 6 inches (approx.16 cm)
away from any other medical implants or medical
devices that can be impacted by the magnetic fields to
avoid possible effects from localized magnetic fields.
For instance, the functioning of implants may change,
or implants may move within the body due to
magnetic attraction/repulsion. This applies to you or
anyone in close physical contact with your mask | Unchanged from K120463 | Updated warning for magnets to
labeling |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend Full
Face Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,
K120463 | Explanation of Differences |
| Useful life | Mojo -
Single patient use - 6 months
Veraseal 2 -
Short Term Single Patient use (maximum of 7 days)
Innova -
Single patient use - 6 months
Ascend -
Single patient use - 6 months | Mojo -
Single patient, multi-use and Multi-patient, multi-use
– 6 months
Veraseal -
Disposable single use; Single patient, multi-use up to
7 days | Similar.
Multi-patient use for Mojo
mask has been removed.
Single use for Veraseal mask
has been removed. |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mojo -
Mild Soap and water
Veraseal 2 -
Mild Soap and water
Isopropyl alcohol
Innova -
Mild Soap and water
Ascend -
Mild Soap and water | Mojo -
Mild Soap and water
Veraseal -
Mild Soap and water
Isopropyl alcohol | Identical |
| Features | | | |
| Available sizes | Mojo - 4
Veraseal 2 - 4
Innova - 3
Ascend - 3 | Mojo - 3
Veraseal - 3 | Similar.
XL size has been added to the
Mojo and Veraseal 2 masks.
These sizes utilize all the same
components as the
corresponding large size,
except for the gel cushion
which is slightly larger in
length and width. |
| Shape | Similar | Similar | Similar |
| Incorporates an Exhaust
port | Yes | Yes | Identical |
| Attributes | Subject – Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask | Predicate – Mojo, Veraseal Full Face Mask, K120463 | Explanation of Differences |
| Components of the mask | • Mask shell
• Gel bladder (cushion)
• Vented elbow assembly
• Forehead arm/forehead pad
• Headgear | • Mask shell
• Gel bladder (cushion)
• Vented elbow assembly
• Forehead arm/forehead pad
• Headgear | Similar |
| Shell design | Mojo – soft shell
Veraseal 2 – hard shell
Innova – hard shell
Ascend – hard shell | Mojo – soft shell
Veraseal 2 – hard shell | Identical |
| Patient Contact per
ISO 10993-1 | Skin contact
Externally Communicating with tissue (air pathway)
Permanent contact | Skin contact
Externally Communicating with tissue (air pathway)
Permanent contact | Identical |
| Performance Characteristics | | | |
| Deadspace | Mojo
Small 160 ml
Medium 185 ml
Large 205 ml
XL 210 ml
Veraseal 2
Small 155.3 ml
Medium 181.7 ml
Large 196.6 ml
XL 200.6 ml
Innova
Small 155.3 ml
Medium 181.7 ml
Large 196.6 ml
Ascend
Small 165 ml
Medium 212 ml
Large 221 ml | Mojo
Small 160 ml
Medium 185 ml
Large 205 ml
Veraseal
Small 138 ml
Medium 165 ml
Large 181 ml | Similar.
XL size has been added to the
Mojo and Veraseal 2 masks.
The deadspace for all subject
devices is within 5% of the
predicate Mojo mask. The CO2
washout profile of all the
subject devices has been
verified to be adequate. |
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510(k) Summary Page 6 of 12
18-Oct-24
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510(k) Summary Page 7 of 12
18-Oct-24
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510(k) Summary Page 8 of 12
18-Oct-24
| Attributes | Subject – Mojo, Veraseal 2, Innova, Ascend Full
Face Vented Mask | | Predicate – Mojo, Veraseal Full Face Mask,
K120463 | Explanation of Differences | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Exhaust flow
characteristics | Mojo
Pressure (cmH2O)
3
10
20
Veraseal 2
Pressure (cmH2O)
3
10
20
Innova
Pressure (cmH2O)
3
10
20
Ascend
Pressure (cmH2O)
3
10
20 | Flow (lpm)
17.88
32.57
48.90
Flow (lpm)
22.08
38.50
54.30
Flow (lpm)
22.08
38.50
54.30
Flow (lpm)
26.80
41.50
58.00 | Mojo
Pressure (cmH2O)
3
10
20
Veraseal
Pressure (cmH2O)
3
10
20 | Flow (lpm)
21.20
37.20
53.10
Flow (lpm)
21.10
36.40
53.00 | Similar.
The exhaust flow
characteristics of the subject
devices are similar to the
predicate. |
| AAV Opening/Closing
Pressure | Mojo
Opening - 1.10 cm H2O
Closing - 1.60 cm H2O
Veraseal
Opening - 2.1 cm H2O
Closing - 2.28 cm H2O
Innova
Opening - 2.1 cm H2O
Closing - 2.28 cm H2O
Ascend
Opening - 1.92 cm H2O
Closing - 1.85 cm H2O | | Mojo
Opening - 1.10 cm H2O
Closing - 1.60 cm H2O
Veraseal
Opening - 1.29 cm H2O
Closing - 1.45 cm H2O | | Similar.
Pass/Fail criteria as per ISO
17510 is 30 kg) for whom positive airway pressure ● therapy has been prescribed.
- . Identical to the predicate - K120463.
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment. ●
- Identical to the predicate K120463. ●
Technological Characteristics -
- Identical technology to the predicate K120463. ●
Non-Clinical Testing Summary -
Bench testing - Testing demonstrating conformance to ISO 17510 - Medical Devices - Sleep Apnoea Breathing Therapy - Masks And Application Accessories:
- Exhaust flow ●
- Resistance to Flow
- Anti-asphyxia valve (AAV) pressure test
- AAV Inspiratory/Expiratory Resistance in Single Fault Condition ●
- . Internal Volume / Dead space
- CO2 rebreathing .
Discussion - The performance test results from the predicate device were leveraged for the Mojo and Veraseal 2 models. New testing was conducted for the Innova and Ascend models.
Biocompatibility -
The materials in gas pathway and skin contact for all subject devices are identical to Sleepnet's own devices cleared under K120463 and K190254, which have similar intended use, environment of use, and duration of use as the subject devices using material certifications.
Discussion - The biocompatibility test results from the predicate device were leveraged for all subject devices.
Transportation and Shelf-life -
There have been no changes in the transportation or shelf-life - the subject devices leverage the predicate device testing for transportation and shelf-life.
Discussion - The performance post transportation and shelf-life test results from the predicate device were leveraged for the subject device.
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510(k) Summary Page 12 of 12 18-Oct-24
Reprocessing -
There has been no change in the reprocessing – the subject and predicate device utilize the same reprocessing instructions.
Discussion - The reprocessing test results from the predicate device were leveraged for the subject device.
Substantial Equivalence Conclusion
We have demonstrated that the subject devices are equivalent to the predicate, K120463.